5-Fluorodeoxyuridine

In February 2025, the global pharmaceutical industry witnessed a series of milestone post-marketing collaboration deals, highlighting a deep integration of pharmaceutical innovation and market expansion that transcends geographical boundaries. From treatments for rare diseases to cancer management, and from improving sleep quality to alleviating chronic pain, drug development and distribution partnerships are advancing at an unprecedented pace. In February, Eisai joined forces with SciClone Pharmaceuticals to advance the application of tasurgratinib in the Greater China region, offering new hope to patients with cholangiocarcinoma. Meanwhile, Nxera Pharma’s partnership with Holling Bio-Pharma Corp. aims to introduce daridorexant to the Taiwanese market, providing a novel treatment option for insomnia sufferers. In another example of global collaboration, Bavarian Nordic and Biological E Limited announced a partnership to expand global supply of the chikungunya vaccine, underscoring the cooperative spirit of multinational companies in addressing public health challenges. 1. Eisai and SciClone Partner to Advance the Development and Distribution of Tasurgratinib in Greater China On February 28, 2025, Eisai announced a significant licensing agreement with a subsidiary of SciClone Pharmaceuticals. The agreement grants SciClone exclusive rights to develop and commercialize tasurgratinib in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. Tasurgratinib is a novel tyrosine kinase inhibitor that selectively inhibits FGFR1, FGFR2, and FGFR3. It has already been approved in Japan for the treatment of unresectable cholangiocarcinoma with FGFR2 gene fusions or rearrangements that have progressed after chemotherapy, and it was successfully launched in November 2024. Through this collaboration, Eisai aims to leverage SciClone’s strong market presence and commercialization capabilities in the region to accelerate the local deployment of tasurgratinib, bringing hope to more patients. Under the terms of the agreement, Eisai will receive an upfront payment in recognition of the licensing rights. In addition, milestone payments will be made as the drug progresses through development stages and secures regulatory approvals. Following product launch, Eisai will also receive royalties based on net sales, providing a return on its R&D investment and reflecting confidence in the drug’s market performance. This financial structure is designed to promote close collaboration between both parties and maximize the value of tasurgratinib. Tasurgratinib, as an orally bioavailable tyrosine kinase inhibitor, exerts its effects through selective inhibition of FGFR1, FGFR2, and FGFR3. This selectivity allows tasurgratinib to target specific types of cancer cells effectively without interfering with other essential physiological processes. In particular, tumors associated with FGFR abnormalities—such as cholangiocarcinoma and certain breast cancers—present promising therapeutic targets. In addition to its approved use in cholangiocarcinoma in Japan, tasurgratinib is currently undergoing a Phase I clinical trial in Japan for patients with estrogen receptor-positive, HER2-negative breast cancer, further exploring its potential in broader oncology indications. 2. Nxera Pharma and Holling Collaborate to Commercialize Daridorexant in Taiwan On February 28, 2025, Tokyo- and Cambridge-based Nxera Pharma announced it had signed a licensing, supply, and commercialization agreement with Holling Bio-Pharma Corp., Taiwan’s largest pharmaceutical distributor, to bring daridorexant to the Taiwanese market. The collaboration seeks to address the growing demand for effective insomnia treatments in the region. Daridorexant is a new oral dual orexin receptor antagonist (DORA) that helps regulate overactive wakefulness signals by selectively binding to and inhibiting orexin receptors OX1R and OX2R, thereby promoting better sleep onset and maintenance. Under the agreement, Nxera will supply the drug product, while Holling will handle regulatory approval, commercialization, and distribution activities, retaining all regulatory rights. Holling is expected to submit a New Chemical Entity (NCE) application to the Taiwan Food and Drug Administration by mid-2025. If approved, daridorexant could be launched in Taiwan by mid-2026. Nxera will receive an upfront payment upon signing, along with additional milestone payments based on regulatory progress and sales performance. Nxera is also entitled to royalties on net sales from product supply, reflecting the mutual confidence in daridorexant’s market potential and supporting further development efforts. Daridorexant works by blocking the binding and activity of orexins—neuropeptides that promote wakefulness—through dual inhibition of their receptors. The drug has already been launched in Japan under the brand name QUVIVIQ™ following approval in September 2024 and a subsequent market launch in December 2024 by Nxera Pharma Japan in collaboration with Shionogi. Nxera is also conducting a Phase III clinical trial in South Korea to evaluate daridorexant’s efficacy and safety in adults with insomnia. Notably, QUVIVIQ™ has also received regulatory approval in the United States, Europe, and several other countries, where Idorsia Pharmaceuticals Ltd. is responsible for marketing activities. This broad international recognition further supports daridorexant’s status as a best-in-class treatment option. The development of daridorexant continues to progress positively. In addition to its successful launch in Japan, the Phase III trial in South Korea is ongoing, aiming to confirm the drug’s safety and efficacy in improving insomnia symptoms in adults. Given the significant number of insomnia patients in Taiwan, the introduction of daridorexant is expected to have a meaningful impact on clinical practice in the region. Furthermore, this collaboration is part of Nxera’s broader strategy to enhance access to innovative medicines across Japan and the wider Asia-Pacific region by partnering with leading regional commercial players, thus reaching a larger patient population while leveraging the company’s internal expertise in specialty and rare disease medicines. 3. Bavarian Nordic Partners with Biological E Limited to Expand Global Access to Chikungunya Vaccine On February 28, 2025, Bavarian Nordic announced a strategic partnership with Indian biopharmaceutical company Biological E Limited to enhance the global supply of its Chikungunya vaccine. This collaboration underscores both companies’ commitment to improving access to this important vaccine in developing countries. Through this partnership, Bavarian Nordic and Biological E Limited plan to co-invest in the further development of the vaccine and ensure its availability across more countries and regions. The product at the center of this agreement is a vaccine specifically designed to prevent Chikungunya virus infection. This innovative vaccine mimics the structural features of the virus—particularly its surface proteins—to induce a specific antibody response from the human immune system. These antibodies can recognize and neutralize the actual Chikungunya virus during infection, thereby preventing disease onset. Utilizing virus-like particle (VLP) technology, the vaccine delivers robust immune protection without containing live virus, significantly enhancing its safety profile. This Chikungunya VLP vaccine has already received its first regulatory approval in the United States for the prevention of Chikungunya fever. It has also been granted multiple special regulatory designations in both the U.S. and the European Union, including Accelerated Approval, Breakthrough Therapy Designation, Fast Track, and Priority Review—highlighting the recognized public health value of the vaccine. Beyond U.S. approval, additional clinical trials and regulatory submissions are underway in various other countries and regions to expand its global reach. Originally developed by PaxVax Holding Co., Ltd., the vaccine has achieved several critical development milestones. After Bavarian Nordic acquired the program, it advanced the clinical research and secured the initial U.S. approval. Through its new collaboration with Biological E Limited, the vaccine is expected to gain more rapid market access in Asia and other developing regions. Biological E Limited's deep market knowledge and extensive distribution network in these areas make it a key partner in achieving this objective. Moreover, early-stage development efforts were supported by Emergent BioSolutions, Inc. and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), laying a solid foundation for the vaccine’s success. This partnership marks a significant step toward broader protection against Chikungunya fever worldwide. 4. RedHill and Hyloris Sign Global (Excluding North America) Commercialization Agreement for RHB-102 to Improve Quality of Life for Cancer and Gastrointestinal Patients On February 25, 2025, RedHill Biopharma Ltd. announced the signing of an exclusive development and commercialization licensing agreement with Hyloris Pharmaceuticals SA for RHB-102 (Bekinda®). Under this agreement, Hyloris gains the rights to develop and commercialize RHB-102 in all global markets except the United States, Canada, and Mexico. This collaboration reflects the shared commitment of both companies to provide effective treatment options to more patients worldwide, particularly those suffering from chemotherapy/radiation-induced nausea and vomiting (CINV/RINV), acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D). As part of the agreement, Hyloris will pay RedHill an upfront fee and milestone payments of up to $60 million based on the achievement of specific commercial targets. Additionally, Hyloris will pay mid-to-high double-digit percentage royalties on net sales, subject to certain cost deductions and inclusive of minimum annual payments. This financial structure not only provides RedHill with necessary funding support but also incentivizes Hyloris to actively promote RHB-102 and ensure its success in global markets. RHB-102 is a once-daily, dual-release, proprietary oral tablet formulation of ondansetron, a 5-HT3 receptor antagonist used to treat nausea and vomiting. It is available in two dosage strengths: 12 mg and 24 mg, aimed respectively at IBS-D and other indications such as acute gastroenteritis and gastritis. The extended-release profile allows for 24-hour symptom control, representing a significant therapeutic advancement for cancer patients undergoing chemotherapy or radiotherapy, as well as for those with gastrointestinal disorders. RHB-102 has completed multiple key clinical trials, including a Phase III study in the United States for acute gastroenteritis and gastritis (24 mg dose) and a Phase II study for IBS-D (12 mg dose), both of which met their primary endpoints. Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a positive opinion, paving the way for a Marketing Authorization Application (MAA) in the UK. If approved, RHB-102 would become the first 24-hour extended-release oral ondansetron formulation indicated for CINV/RINV. RedHill also plans to continue pursuing FDA approval for RHB-102 in the United States. 5. Pharmanovia and Er-Kim Reach Exclusive Distribution Agreement for Sunosi® in Eastern Europe In February 2025, Pharmanovia announced that it had entered into an exclusive distribution agreement with Er-Kim, a leading Turkish pharmaceutical company, for Sunosi® (solriamfetol) in Eastern Europe. This collaboration brings Sunosi® to the Eastern European market to meet the treatment needs of patients suffering from narcolepsy and obstructive sleep apnea (OSA). Although specific financial details have not been fully disclosed, it can be inferred that the agreement involves an upfront payment, milestone payments, and a royalty structure based on sales performance. This arrangement not only supports further development and marketing efforts for the product but also reflects both parties' confidence in the commercial potential of Sunosi®. Sunosi® is a medication indicated for the treatment of excessive daytime sleepiness associated with narcolepsy and OSA. Its active ingredient, solriamfetol, is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). By increasing the concentrations of these neurotransmitters in the brain, Sunosi® effectively enhances wakefulness and alertness, helping patients regain a normal daily rhythm. This mechanism of action makes it an important treatment option, particularly for patients who do not respond well to or cannot tolerate traditional therapies. Sunosi® has been approved and is commercially available in several countries and regions. Originally developed by Jazz Pharmaceuticals, it received FDA approval in the United States in 2019 for the treatment of excessive daytime sleepiness in adults with narcolepsy or OSA. Since then, Sunosi® has gradually expanded its market presence globally. The partnership between Pharmanovia and Er-Kim marks a significant step toward deeper penetration into the Eastern European market, allowing more patients to benefit from the treatment. Ongoing monitoring of Sunosi®'s long-term safety and efficacy continues to ensure the provision of optimal treatment options for patients. Beyond its current indications, Sunosi® may also demonstrate potential efficacy in treating other types of excessive daytime sleepiness disorders, providing new directions for future research. Pharmanovia will continue to monitor the accumulation of clinical data for Sunosi® and explore broader application possibilities. Through its collaboration with Er-Kim, Pharmanovia aims to establish a strong market position in Eastern Europe while raising awareness of the disease and available treatment options. Furthermore, as the understanding of the pathophysiology of excessive daytime sleepiness deepens, Sunosi® is expected to introduce new research findings in the coming years, offering a stronger scientific foundation for its use. This partnership between Pharmanovia and Er-Kim not only enhances the accessibility of Sunosi® in Eastern Europe but also highlights both companies' shared commitment to improving public health. Leveraging Er-Kim's strong local presence and extensive distribution network will be key to achieving this goal. Such cross-border collaborations accelerate the entry of innovative therapies into emerging markets, offering patients more treatment choices. With increasing recognition and support for Sunosi® across more countries and regions, the medication is expected to significantly improve the quality of life for patients with excessive daytime sleepiness worldwide in the coming years. 6. Apotex Partners with Grünenthal to Bring Qutenza® to the Canadian Market On February 24, 2025, Apotex Inc., Canada’s largest pharmaceutical company, and Grünenthal, a global leader in pain management and related diseases, announced a strategic licensing agreement. Under the agreement, Apotex will obtain exclusive rights to Qutenza® in Canada. This partnership aims to introduce Qutenza® as an innovative treatment option for patients suffering from neuropathic pain in Canada. Although specific financial terms have not been fully disclosed, it can be inferred that Grünenthal will receive an upfront payment, additional milestone payments upon achieving specific regulatory milestones, and royalties based on sales. This financial arrangement not only supports further development and commercialization of the product but also reflects both parties’ confidence in the commercial potential of Qutenza®. Qutenza® is a topical, non-systemic, non-opioid pain treatment patch indicated for the management of neuropathic pain. Its active ingredient is high-concentration capsaicin (8%), a naturally occurring compound that is applied directly to the skin to alleviate pain. Capsaicin works by activating and subsequently desensitizing the TRPV1 receptors in sensory nerves, which play a key role in the transmission of pain signals. Through this mechanism, Qutenza® provides effective relief from chronic pain caused by nerve damage without causing systemic side effects or the risk of addiction. This treatment is particularly beneficial for patients who do not respond well to or cannot tolerate traditional therapies. Since acquiring global rights to Qutenza® in 2018, Grünenthal has continued to invest resources in the product’s development and expansion. Qutenza® has been commercialized in the European Union and the United States, with its indication broadened through relaunch and label expansion efforts. In the U.S. market, Qutenza® has experienced a significant brand resurgence, laying a strong foundation for its further promotion worldwide. Apotex’s subsidiary, Searchlight Pharma, will be responsible for seeking marketing authorization for Qutenza® in Canada and for its subsequent commercialization and distribution upon regulatory approval. This partnership is expected to further enhance the global availability and impact of Qutenza®. Since 2017, Grünenthal has invested over €2 billion in successful mergers and acquisitions, continually creating synergies across manufacturing, logistics, and commercial activities by integrating acquired brands into its infrastructure. For Apotex, this partnership not only strengthens its ability to meet patient needs but also expands its global portfolio, which includes more than 550 branded, generic, and biosimilar products. With the launch of Qutenza® in the Canadian market, an effective new treatment option will soon be available for many patients suffering from neuropathic pain. 7. Daré Bioscience Partners with Theramex to Develop the First Biodegradable Long-Acting Contraceptive Implant, Casea S On February 20, 2025, Daré Bioscience, a company focused on innovation in women’s health, announced a co-development and licensing agreement with Theramex, a global specialty pharmaceutical company dedicated to women’s health. This collaboration aims to advance the development of a first-in-class, biodegradable, long-acting contraceptive implant based on etonogestrel. The agreement marks a significant partnership in promoting women’s health management. Etonogestrel is a small-molecule drug used for contraception. It was first approved on July 17, 2006, in the United States for contraceptive use. As the current Phase 1 study is foundation-funded, there are no direct development costs for either Daré or Theramex at this stage. Under the agreement, Daré receives a royalty-free, exclusive, fully paid-up, and sublicensable license to the U.S. patent for Casea S, recently acquired by Theramex. If Phase 1 results are positive, Daré will take responsibility for conducting Phase 2 studies in the U.S., and funding for future Phase 3 trials in the U.S. will be negotiated between Daré and Theramex based on market opportunity. Etonogestrel is a synthetic progestin that primarily works by inhibiting ovulation to prevent pregnancy. It also thickens cervical mucus, making it harder for sperm to reach the egg, and alters the endometrium to reduce the likelihood of implantation. As a long-acting reversible contraceptive (LARC), etonogestrel is typically delivered via a subdermal implant that can continuously release the hormone for up to three years, offering extended contraceptive protection. Due to its high efficacy and convenience, etonogestrel has become one of the preferred contraceptive options for many women. Since its initial approval, etonogestrel has been authorized for contraceptive use in multiple countries and regions worldwide. It has also been studied for other indications such as dysmenorrhea, bleeding disorders, lower urinary tract symptoms, and benign prostatic hyperplasia. Although some indications are no longer under investigation, the use of etonogestrel in contraception continues to evolve. Companies such as Organon NV are actively working to expand its applications and improve efficacy through ongoing research. 8. SK Chemicals Partners with Jeil Health Science to Boost Pharmacy Sales of Ginexin and Trast On March 17, 2025, SK Chemicals announced a co-marketing agreement with Jeil Health Science, a leading South Korean manufacturer of over-the-counter (OTC) pharmaceuticals. The partnership is aimed at increasing pharmacy sales of two SK Chemicals products—Ginexin-F Soft Cap 120mg and Trast Patch 30—by leveraging Jeil Health Science’s extensive distribution network. Previously, these products were distributed through general pharmaceutical wholesalers. Ginexin-F Soft Cap 120mg: This product is a circulation enhancer formulated with ginkgo biloba extract and comes in a soft capsule format, sold exclusively through pharmacies. Ginkgo biloba extract is renowned for its antioxidant properties and is widely used to improve blood circulation and alleviate symptoms related to poor circulation. Trast Patch 30: This is a pain relief patch available in packs of 7, 10, and 30 units, with the 30-pack being particularly suited for patients requiring repeated use. The patch is applied directly to the skin and delivers active ingredients to relieve localized pain, making it suitable for conditions such as muscle aches and arthritis. Both products are already on the market and have established brand recognition and customer bases. Ginexin enjoys a strong reputation as a natural-origin blood circulation booster, while Trast is favored by consumers for its convenient application and effective pain relief. The goal of the partnership is to further expand the market share of these two products in the pharmacy channel and to enhance consumer awareness and trust through more targeted marketing strategies. Through this collaboration, SK Chemicals aims to take advantage of Jeil Health Science’s powerful sales network—serving over 12,000 pharmacies directly—and its proven track record in promoting OTC products, especially in pain management with successful brands like Kefentech and Jeil Cool Pap. Han Sang-chul, CEO of Jeil Health Science, expressed his enthusiasm for the partnership, stating that they are honored to work with SK Chemicals to promote products that have earned long-term trust in the fields of blood circulation and pain relief. Together, the two companies hope to strengthen Ginexin and Trast’s positions as leading brands in their respective markets and to provide more therapeutic options for patients. This partnership not only aims to enhance the market standing of both companies but also to deliver higher-quality products and services to a broader consumer base. 9. X4 Pharmaceuticals and Taiba Rare Enter Exclusive Agreement to Advance Distribution and Commercialization of XOLREMDI® (Mavorixafor) in Select Middle Eastern Countries On February 19, 2025, X4 Pharmaceuticals, a company committed to improving the lives of patients with rare immunodeficiency diseases, announced an exclusive agreement with Taiba Rare, a division of Taiba Healthcare. The agreement grants Taiba Rare exclusive rights to distribute and commercialize XOLREMDI® (mavorixafor) in Saudi Arabia, the United Arab Emirates, Qatar, Oman, Kuwait, Bahrain, and Egypt, contingent upon obtaining local regulatory approvals. Although specific financial terms have not been disclosed, agreements of this nature typically include upfront payments, sales-based milestone payments, and royalties. These arrangements align the interests of both parties and incentivize Taiba Rare to actively promote XOLREMDI®. Given that XOLREMDI® is the first and only treatment approved for WHIM syndrome (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis), the therapy holds significant market potential, making the partnership attractive to both companies. XOLREMDI® (mavorixafor) is an oral, once-daily treatment approved by the U.S. Food and Drug Administration (FDA) in April 2024 for patients aged 12 and older with WHIM syndrome. It works by increasing the number of circulating mature neutrophils and lymphocytes, thereby enhancing the body's ability to fight infections. Mavorixafor functions by inhibiting the CXCR4 receptor, promoting the release of white blood cells from the bone marrow into the bloodstream. While XOLREMDI® has already received FDA approval in the U.S., its Marketing Authorization Application (MAA) is currently under review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The collaboration with Taiba Rare will accelerate the product's introduction into Middle Eastern markets, offering new treatment options for patients with WHIM syndrome. Under the agreement, Taiba Rare will be responsible for XOLREMDI®’s distribution, promotion, marketing, and sales in the designated region and will jointly develop key strategic decisions with X4 Pharmaceuticals. 10. Beihai Biotechnology Partners with Zydus Lifesciences to Commercialize BEIZRAY® (BH009) in the U.S. On February 18, 2025, Beihai Biotechnology announced a strategic partnership with Zydus Lifesciences. Under the agreement, Beihai grants Zydus exclusive commercialization rights for its novel oncology drug BEIZRAY® in the United States. Following the agreement, Beihai will receive an upfront payment of USD 15 million, with an additional USD 10 million upon the first product delivery—amounting to nearly RMB 200 million in total. Beihai will also benefit from future sales-based milestone payments and a high double-digit percentage share of profits. This payment structure not only provides Beihai with early financial support but also motivates both parties to ensure the commercial success of the product. BEIZRAY® (BH009) is a proprietary, improved formulation of docetaxel developed by Beihai Biotechnology for the treatment of various solid tumors, including breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer, and head and neck squamous cell carcinoma. It acts by stabilizing microtubules and preventing their depolymerization, arresting the cell cycle in the mitotic phase and thereby inhibiting tumor cell proliferation. BEIZRAY® is distinguished by its use of targeted molecular delivery technology that eliminates the use of polysorbate 80—a common component in traditional docetaxel formulations—significantly reducing adverse reactions and improving patient safety. BEIZRAY® received FDA approval in October 2024, making it the first clinically validated and demonstrably superior docetaxel reformulation approved in nearly 30 years. Clinical trials have shown that BEIZRAY® reduces the risk of hematologic toxicity and severe allergic reactions, thereby enhancing the benefit-risk profile for patients. This partnership will leverage Zydus Lifesciences’ robust sales infrastructure in the U.S. to expedite market access and deliver this innovative treatment to a broader patient population. 11. Baheal Pharmaceutical Partners with Roche to Advance Commercialization of Rituximab in China On February 13, 2025, Baheal Pharmaceutical announced that it had entered into a collaboration agreement with Roche. Under this agreement, Baheal has obtained the exclusive rights to promote Roche’s well-known oncology-targeted therapy Rituximab in mainland China. According to the agreement, Roche will pay Baheal a quarterly service fee for its promotional efforts. This arrangement ensures that while Baheal bears the promotional costs, it also receives a corresponding economic return based on sales performance. Additionally, the agreement stipulates that Roche may not appoint any third party to promote the product in the region without prior notice to Baheal, ensuring Baheal’s exclusivity in the market. Rituximab is the world’s first monoclonal antibody specifically targeting the CD20 antigen and marked the beginning of a new era in targeted cancer therapy. It is primarily used for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and other related diseases. Rituximab binds to the CD20 antigen on the surface of B lymphocytes, inducing immune responses against the cancer cells and promoting their apoptosis, thereby inhibiting tumor growth. Since its initial approval in the U.S. in 1997, Rituximab has accumulated over two decades of clinical use and has benefited more than 6.8 million patients worldwide. In China, Rituximab was approved in April 2000, and with approvals for multiple indications—including maintenance therapy for treatment-naïve follicular lymphoma and combination chemotherapy for chronic lymphocytic leukemia—its market potential continues to grow. 12. Chong Kun Dang Secures Exclusive Distribution and Sales Rights for Bayer’s Nexavar and Stivarga in South Korea Chong Kun Dang Pharmaceutical has announced that it has reached an agreement with German pharmaceutical giant Bayer to exclusively distribute and sell two of Bayer’s key oncology drugs—Nexavar and Stivarga—in the South Korean market. This partnership aims to leverage Chong Kun Dang’s robust market network and sales capabilities to expand the local market share of both therapies. Although the specific financial terms have not been disclosed, such agreements typically involve an upfront payment, milestone payments based on sales performance, and profit-sharing arrangements. These structures align the interests of both parties and incentivize Chong Kun Dang to actively promote the products and expand their market presence. Nexavar: A multi-kinase inhibitor indicated for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, and radioactive iodine-refractory differentiated thyroid cancer. It works by inhibiting several intracellular protein kinases involved in tumor growth and angiogenesis. Stivarga: Also a multi-kinase inhibitor, Stivarga is indicated for metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma. It shares a similar mechanism of action with Nexavar but is approved for different indications and is sometimes used as a follow-up treatment after Nexavar. Both Nexavar and Stivarga are globally approved and have been widely used in clinical practice across many countries and regions. They have demonstrated significant efficacy in treating specific types of cancer and have accumulated extensive real-world usage data. With Chong Kun Dang now taking over the distribution and sales of these two drugs in South Korea, the accessibility of these innovative therapies for local patients is expected to increase substantially. For Chong Kun Dang, this partnership strengthens its presence in the oncology sector by adding two well-recognized therapeutic options to its portfolio, potentially creating new growth drivers for the company. For Bayer, choosing Chong Kun Dang as its local partner reflects confidence in the latter’s commercial capabilities and market expertise in South Korea. This strategic alliance is expected to accelerate market penetration of Nexavar and Stivarga in South Korea, ultimately benefiting more patients with access to advanced cancer treatments. Furthermore, it highlights the growing trend of multinational pharmaceutical companies partnering with strong local firms to optimize resource allocation and achieve mutually beneficial outcomes in global market expansion. 13. Lotus Pharmaceutical Partners with Formycon to Advance Commercialization of FYB203/AHZANTIVE® in the Asia-Pacific Region On February 5, 2025, Klinge Biopharma GmbH, the exclusive global commercialization rights holder of FYB203/AHZANTIVE® (Aflibercept), announced an exclusive licensing agreement with multinational pharmaceutical company Lotus Pharmaceutical. Under the terms of the agreement, Lotus will be responsible for the commercialization of FYB203/AHZANTIVE® in the Asia-Pacific region, including Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, Vietnam, and the Hong Kong Special Administrative Region. Concurrently, Formycon also signed a finished product supply agreement with Lotus. According to the agreement, Klinge will receive an upfront payment from Lotus and is eligible for additional milestone payments tied to product launch and sales achievements. Furthermore, Klinge will receive royalties based on Lotus’ net sales, with Formycon sharing in Klinge’s revenues at a rate ranging from mid-single to low-double-digit percentages. This payment structure not only provides Klinge with initial financial support but also incentivizes all parties to collaborate closely toward the successful commercialization of the product. FYB203/AHZANTIVE® is a biosimilar to Eylea® (Aflibercept), used for the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The drug works by inhibiting vascular endothelial growth factor (VEGF), thereby reducing the formation of abnormal blood vessels in the retina. VEGF is a protein that promotes the formation of new blood vessels, but its overexpression in certain eye diseases can lead to vision loss or even blindness. By blocking the action of VEGF, FYB203/AHZANTIVE® helps stabilize or improve patients’ vision. FYB203/AHZANTIVE® has achieved significant progress in development, receiving approval from the U.S. Food and Drug Administration (FDA) in June 2024, followed by European Commission approval in January 2025. Currently, Formycon and Lotus are working closely together to prepare submissions to regulatory authorities in the Asia-Pacific region, in accordance with local regulations, to facilitate the timely launch of FYB203/AHZANTIVE® in these markets. This process includes the consolidation of clinical data and adaptations to meet local market requirements. 14. Daewon Pharmaceutical Partners with AstraZeneca Korea to Promote Asthma Treatment Products In early February 2025, Daewon Pharmaceutical announced a collaboration agreement with AstraZeneca Korea to take on the distribution responsibilities for AstraZeneca’s asthma treatment products in the South Korean market. This partnership aims to leverage Daewon’s robust sales network and market expertise to broaden the reach of these essential medications, ensuring that more patients have access to effective treatment options. The agreement includes an upfront payment, sales-based milestone payments, and royalties calculated based on net sales. This structure ensures mutual benefit: AstraZeneca Korea can rapidly expand market share for its products through Daewon’s extensive distribution channels, while Daewon Pharmaceutical gains financial returns from successful product promotion and strengthens its presence in the respiratory disease market. Budesonide/Formoterol (Symbicort) is one such combination product included in this partnership. It consists of a long-acting β2-agonist (LABA) and an inhaled corticosteroid (ICS), designed for long-term control of asthma symptoms. Budesonide helps reduce airway inflammation, while Formoterol relaxes the airway smooth muscles, making breathing easier. This combination therapy effectively alleviates asthma symptoms and reduces the risk of acute exacerbations. These asthma treatment products have been approved globally and have been marketed in numerous countries for years, backed by extensive clinical experience and safety data. For certain products within this collaboration, additional registration steps or labeling adjustments may be required to comply with Korean regulatory standards. However, given their proven efficacy and safety profiles in other markets, it is expected that they will quickly gain recognition and be widely adopted in South Korea. 15. MITEM Pharma Acquires FLISINT® from Sanofi, Committed to Safeguarding the Interests of Patients with Rare and Life-Threatening Diseases In February 2025, MITEM Pharma announced the successful acquisition of the specialty drug FLISINT® from Sanofi. This acquisition underscores MITEM Pharma’s ongoing mission to improve the quality of life for patients suffering from rare and life-threatening diseases. Through this collaboration with Sanofi, MITEM Pharma not only expands its product portfolio but also strengthens its expertise in targeted therapeutic areas. FLISINT® is a specialty medication designed for the treatment of specific rare diseases. Although its exact indication was not disclosed, the name suggests that it may be intended for the treatment of a genetic disorder or metabolic condition requiring specialized attention. The mechanism of action of FLISINT® likely involves addressing enzyme deficiencies or abnormal protein expression caused by genetic mutations, thereby alleviating symptoms and slowing disease progression. For example, it may function through enzyme replacement therapy or by modulating intracellular signaling pathways to restore normal physiological functions. FLISINT® has successfully completed multiple phases of clinical trials and has been approved by regulatory authorities in several countries and regions. This confirms the drug's safety and efficacy, offering an effective treatment option for patients with specific rare conditions. However, with ongoing scientific advancements and the accumulation of new data, further studies may be necessary to explore broader applications or to optimize the formulation for enhanced efficacy and reduced side effects. Conclusion The series of partnership agreements and acquisitions in February 2025 reveals an overarching trend: globalization, specialization, and technological advancement are reshaping the pharmaceutical industry. Whether it's deepening market penetration through local collaboration (such as the partnership between Daewon Pharmaceutical and AstraZeneca Korea) or entering emerging markets (such as X4 Pharmaceuticals' agreement with Taiba Rare for the Middle East), these partnerships demonstrate how pharmaceutical companies are leveraging each other's strengths for mutual benefit. More importantly, they share a common goal—to enhance healthcare access and outcomes for patients worldwide. It is noteworthy that these collaborations go beyond traditional sales and distribution agreements and extend into R&D partnerships. For instance, MITEM Pharma’s acquisition of FLISINT® from Sanofi, as well as Daré Bioscience’s co-development of the biodegradable long-acting contraceptive implant Casea S with Theramex, highlight the growing importance of long-term strategic alliances in driving innovation and accelerating product development in today's rapidly evolving healthcare environment. In summary, the pharmaceutical collaborations of February 2025 mark the dawn of a new era—one characterized by cooperation, resource sharing, and a focus on addressing complex health challenges. As technology continues to evolve and societal awareness of health deepens, we can expect to see more such partnerships emerge, further advancing the frontier of medicine and delivering new therapeutic possibilities to patients around the globe. How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date.  Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). Targeting transactions involving renowned pharmaceutical companies that are of interest to the industry, such as Merck, Roche, etc., Synapse has identified a group of "leading companies" through drugs that have achieved global sales exceeding 1 billion US dollars in 2022. Transactions involving drugs from these leading companies can be filtered by clicking on the "Leading Company" tag on the left-hand side. In addition to the drug transaction module, you can also view related transaction history on the drug detail page and the institution detail page. Click on the image below to explore new pharmaceutical funding transactions! 

In this article, we present a comprehensive overview of drugs that received their first global approvals in January 2025, along with an analysis of these therapies. The drugs discussed in this article include small molecules, biologics, and combination drugs that were globally approved for the first time in January 2025. It is important to note that this compilation excludes generic drugs, biosimilars, traditional Chinese medicines, and allergen extracts. For combination drugs, only Type 4 drugs approved by the FDA are included. Additionally, drugs that were first approved as new drugs by the FDA in January 2025 but had previously received approval in other countries are also included in this analysis and are marked with an asterisk (*) for clarity. Which drugs were approved by the FDA?1. Whole Blood and Blood Components Whole Blood and Blood Components, specifically convalescent plasma derived from COVID-19 patients, received approval from the U.S. Food and Drug Administration (FDA) on January 3, 2025. The approval allows the use of high-titer SARS-CoV-2 antibody-containing whole blood-derived convalescent plasma and apheresis-derived convalescent plasma as a treatment for COVID-19 infection. Developed and manufactured by OneBlood, Inc., COVID-19 convalescent plasma is human plasma collected from eligible blood donors by FDA-registered or licensed blood establishments. These donors must have recovered from symptomatic SARS-CoV-2 infection within the past six months and exhibit high levels of anti-SARS-CoV-2 antibodies in their plasma. The plasma’s neutralizing activity is determined based on donor antibody levels assessed through laboratory testing. Specifically, donor samples are evaluated using the GenScript cPass surrogate virus neutralization assay, which measures the inhibition of wild-type receptor-binding domain (RBD) binding to ACE2. The required inhibition rate must be equal to or greater than 80%. This product is indicated for the treatment of COVID-19 in immunocompromised or immunosuppressed patients, particularly those at high risk of severe disease progression in both inpatient and outpatient settings. Convalescent plasma may be contraindicated in patients with a history of severe allergic reactions to plasma transfusion. The generally recommended dose is one unit (approximately 200 mL), with adjustments based on the patient's clinical response and physician’s discretion. During administration, ABO blood type compatibility must be ensured, but Rh(D) compatibility is not required. Additionally, precautions should be taken to prevent container breakage or thawing issues during storage, and standard transfusion safety protocols should be followed to mitigate potential adverse effects and risks. 2. Datopotamab Deruxtecan* Datopotamab deruxtecan is a Trop-2-targeting antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo and AstraZeneca. On December 27, 2024, Japan approved datopotamab deruxtecan for the treatment of adult patients with unresectable or metastatic hormone receptor-positive (HR+)/HER2-negative breast cancer who have received prior chemotherapy. This marked the drug’s first global marketing authorization. Subsequently, on January 17, 2025, the FDA also approved datopotamab deruxtecan for the treatment of unresectable or metastatic, previously treated HR+/HER2-negative breast cancer in adults. This approval was supported by data from the Phase III TROPION-Breast01 trial, which demonstrated a significant improvement in progression-free survival (PFS) and a reduction in the risk of disease progression or death compared to standard therapy. Datopotamab deruxtecan is designed to precisely target cancer cells expressing the Trop-2 antigen. Trop-2 is a protein widely expressed in various solid tumors, particularly breast and lung cancers. The drug consists of a humanized IgG1 monoclonal antibody conjugated to the potent topoisomerase I inhibitor deruxtecan (DXd). The antibody specifically binds to the Trop-2 antigen, while DXd functions as a cytotoxic chemotherapy agent that is released inside tumor cells, disrupting DNA replication and inducing cancer cell death. These components are linked by a cleavable tetrapeptide linker, ensuring stability in circulation and facilitating targeted drug release within tumor cells, thereby maximizing therapeutic efficacy. Clinical trial results demonstrated that datopotamab deruxtecan provides significant efficacy in treating HR+/HER2-negative advanced breast cancer. In the pivotal Phase III TROPION-Breast01 study, the drug outperformed the standard therapy, docetaxel, in prolonging progression-free survival. With a median follow-up of 10.8 months, the median PFS in the datopotamab deruxtecan group was 6.9 months, compared to 4.9 months in the docetaxel group (HR = 0.63, 95% CI: 0.52–0.76, P < 0.0001), representing a 37% reduction in the risk of disease progression or death. Additionally, datopotamab deruxtecan demonstrated a high objective response rate (ORR), further reinforcing its potential as a novel cancer therapy. The drug also exhibited a favorable safety profile, with a lower incidence of grade ≥3 treatment-related adverse events compared to conventional chemotherapy, contributing to improved patient quality of life. 3. Meloxicam/Rizatriptan The combination drug of meloxicam and rizatriptan, marketed under the brand name Symbravo, received approval from the FDA on January 30, 2025, for the treatment of migraines. This innovative small-molecule drug integrates two distinct mechanisms of action to address migraine symptoms effectively. Developed by Axsome Therapeutics, Inc., meloxicam is a selective cyclooxygenase-2 (COX-2) inhibitor primarily used for pain and inflammation relief. Its high selectivity for COX-2 over COX-1 helps minimize the common gastrointestinal side effects associated with traditional nonsteroidal anti-inflammatory drugs (NSAIDs). By inhibiting the COX-2 enzyme, meloxicam reduces prostaglandin production, thereby alleviating pain. Rizatriptan, on the other hand, is a serotonin 5-HT1D and 5-HT1B receptor agonist, commonly used for the acute treatment of migraine attacks. It works by constricting dilated cerebral blood vessels and preventing the release of calcitonin gene-related peptide (CGRP) from nerve terminals—two key mechanisms believed to be crucial for migraine relief. Additionally, research suggests that rizatriptan may exert effects on the central nervous system, modulating specific receptors involved in pain signal transmission, further enhancing its analgesic efficacy. The uniqueness of AXS-07 lies in its combination of these two active ingredients, aiming to leverage both the anti-inflammatory and analgesic properties of meloxicam and the migraine-specific physiological effects of rizatriptan. This dual-action approach provides a comprehensive treatment strategy, targeting both the pain and inflammation associated with migraines while addressing additional migraine-related symptoms. As a result, Symbravo offers patients more effective relief compared to traditional monotherapies. 4. Suzetrigine Suzetrigine received approval from the FDA on January 30, 2025, as a small-molecule drug for the treatment of moderate to severe acute pain in adults. The drug's uniqueness lies in its selective targeting of the voltage-gated sodium ion channel Nav1.8, a channel specifically expressed in peripheral nociceptive neurons responsible for transmitting pain signals. Developed by Vertex Pharmaceuticals, Inc., Suzetrigine is an X-type sodium channel α-subunit blocker that selectively inhibits Nav1.8 to prevent pain signal transmission. This high selectivity allows Suzetrigine to effectively relieve pain without affecting other types of sodium channels, thereby reducing the risk of side effects. Notably, Suzetrigine's mechanism avoids the addictive potential and adverse effects commonly associated with opioid analgesics, such as respiratory depression and constipation. This makes it a crucial new option for patients seeking non-opioid pain management solutions. In the United States, over 80 million people require medication annually for managing moderate to severe acute pain, highlighting the urgent need for effective and non-addictive pain relief options. The successful development and approval of Suzetrigine mark the first market entry of a pain medication with a novel mechanism in nearly two decades. Clinical trials have demonstrated that Suzetrigine significantly reduced pain scores in patients undergoing abdominoplasty and bunionectomy, with no observed risk of addiction. Suzetrigine represents a breakthrough in acute pain management, offering patients an innovative non-opioid, highly targeted analgesic option. Which drugs were approved by the NMPA?1. Amimestrocel Amimestrocel is a human umbilical cord-derived mesenchymal stem cell (MSC) injection developed by Bosheng Excellence Biotechnology. On January 2, 2025, it received conditional approval from China’s National Medical Products Administration (NMPA) through the priority review and approval process, making it the first stem cell therapy to be approved for marketing in China. Amimestrocel is indicated for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) with predominant gastrointestinal involvement in patients aged 14 and older. Graft-versus-host disease (GVHD) is a severe complication that may occur after allogeneic hematopoietic stem cell transplantation when donor immune cells recognize the recipient’s body as "foreign" and launch an immune attack. A multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial demonstrated that, in an intent-to-treat analysis, the MSC group exhibited superior therapeutic efficacy compared to the placebo group on Day 28. Additionally, clinical trial data showed that the therapeutic effects of Amimestrocel injection gradually became evident within an average of two weeks, with significant benefits observed particularly in patients with intestinal involvement. Amimestrocel injection has shown promising efficacy in treating steroid-refractory aGVHD. According to clinical trial data, the treatment demonstrated a gradual therapeutic effect at a median of two weeks. Patients who completed eight infusions, especially those with gastrointestinal involvement, derived significant benefits from MSC therapy. These findings suggest that Amimestrocel may be particularly suitable for patients who have not responded well to conventional second-line treatments. 2. Recaticimab Recaticimab received approval from the NMPA on January 8, 2025, marking its official entry into the Chinese market. Developed by Hengrui Medicine, Recaticimab is a humanized monoclonal antibody specifically targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 primarily influences cholesterol metabolism by promoting the degradation of low-density lipoprotein receptors (LDLRs). Under normal conditions, LDLRs are located on the surface of hepatocytes, where they capture and remove low-density lipoprotein cholesterol (LDL-C) from the bloodstream. However, when PCSK9 binds to LDLRs, it triggers their internalization and subsequent degradation in lysosomes, thereby reducing the liver’s ability to clear LDL-C. Recaticimab specifically binds to PCSK9, preventing its interaction with LDLRs, thereby preserving LDLRs from degradation. This leads to an increased number of LDLRs on the hepatocyte surface, enhancing the body’s ability to clear LDL-C. Recaticimab not only increases the number of LDLRs but also enhances their function. Since LDLRs play a key role in reducing serum LDL-C levels, increasing their quantity and activity is crucial for managing dyslipidemia. Additionally, Recaticimab utilizes "YTE" amino acid mutation technology to optimize its molecular structure, extending its half-life to approximately 27 days, significantly longer than other similar drugs. This allows for longer dosing intervals, such as every 4 or 8 weeks, improving patient adherence by reducing the inconvenience of frequent injections. This extended duration provides a more convenient option for the long-term management of hypercholesterolemia. From a clinical perspective, Phase III clinical trial results demonstrate that Recaticimab significantly reduces LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)], whether used as an adjunct to statins or as monotherapy. Moreover, it exhibits an excellent safety profile. Recaticimab is particularly suitable for patients who have poor responses to statins or are statin-intolerant, including those with primary hypercholesterolemia (both heterozygous familial and non-familial) and mixed dyslipidemia. The approval of Recaticimab brings new hope to the field of cardiovascular disease, offering significant benefits in improving patient quality of life and preventing cardiovascular events. 3. Prusogliptin Prusogliptin received approval from the NMPA in China on January 8, 2025. Developed by CSPC Ouyi Pharmaceutical, Prusogliptin is a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor designed for the treatment of type 2 diabetes in adults. Its primary mechanism of action involves selectively and potently inhibiting DPP-4, thereby preventing the enzymatic degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These two incretin hormones stimulate pancreatic β-cells to release insulin in response to food intake while simultaneously reducing α-cell secretion of glucagon, helping to regulate blood glucose levels. By inhibiting DPP-4, Prusogliptin prolongs the activity of GLP-1 and GIP, promoting postprandial insulin secretion, enhancing β-cell glucose sensitivity, and reducing unnecessary glucagon secretion, ultimately aiding in maintaining blood glucose levels within a healthier range. Prusogliptin plays a crucial role in increasing the levels of endogenous GLP-1 and GIP. Under normal physiological conditions, these incretin hormones function as "intelligent" regulators of blood glucose, promoting insulin secretion only when glucose levels are elevated while avoiding excess insulin release under normal or low glucose conditions, thereby minimizing the risk of hypoglycemia. Moreover, unlike traditional insulin secretagogues that directly stimulate insulin secretion, Prusogliptin indirectly enhances endogenous GLP-1 function, making it less likely to cause hypoglycemia or lead to weight gain—important advantages for the long-term management of type 2 diabetes. A study led by Peking University First Hospital demonstrated that patients in the Prusogliptin group experienced a significant reduction in glycated hemoglobin (HbA1c) levels compared to the placebo group, confirming its strong glucose-lowering efficacy. Additionally, Prusogliptin is suitable for monotherapy or combination therapy with metformin, making it particularly beneficial for patients who respond poorly to or cannot tolerate metformin. It is indicated for improving glycemic control in adult patients with type 2 diabetes, either as monotherapy or in combination with metformin. Furthermore, Prusogliptin exhibits sustained glucose-lowering effects, a low risk of hypoglycemia, and does not contribute to weight gain. It also has a favorable safety profile, with a low incidence of adverse reactions and minimal drug interactions. Notably, for patients with mild to moderate renal impairment, Prusogliptin does not require dose adjustment, further expanding its eligible patient population. 4. Senaparib Senaparib was approved for market authorization in China on January 14, 2025. As a small-molecule chemical drug, Senaparib primarily targets poly (ADP-ribose) polymerase 1 and 2 (PARP1 and PARP2), exerting its anticancer effects by inhibiting the activity of these enzymes. Developed by IMPACT Therapeutics, Senaparib operates based on the principle of synthetic lethality, playing a crucial role in the repair of single-strand DNA breaks. When these enzymes are inhibited, cancer cells with BRCA mutations or other homologous recombination repair deficiencies (HRD) are less able to effectively repair DNA damage, making them more prone to cell death. As a result, Senaparib is particularly suited for tumors that rely on PARP-mediated DNA repair pathways for survival. According to the NMPA approval, Senaparib is indicated in China for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following first-line platinum-based chemotherapy. This means that for patients who have achieved complete or partial remission after receiving first-line platinum-based chemotherapy, Senaparib provides a new maintenance treatment option aimed at prolonging progression-free survival and potentially improving overall survival outcomes. The approval of Senaparib is based on the results of the FLAMES study, a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial. The results demonstrated that, compared to placebo, Senaparib significantly prolonged median progression-free survival (mPFS). Additionally, regardless of BRCA mutation status, patients derived benefits from the treatment. The drug also exhibited good tolerability and a manageable safety profile. 5. Limertinib Limertinib is a novel small-molecule chemical drug that received marketing approval from the NMPA on January 14, 2025. It is a specifically designed inhibitor targeting the epidermal growth factor receptor (EGFR) T790M mutation. As a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI), Limertinib selectively targets and inhibits EGFR proteins carrying the T790M mutation. This mutation commonly occurs in non-small cell lung cancer (NSCLC) patients who develop resistance after treatment with first- or second-generation EGFR-TKIs. By selectively binding to the EGFR T790M mutation site, Limertinib effectively blocks signal transduction pathways, thereby inhibiting tumor cell proliferation and spread. In a pivotal Phase IIB clinical study, Limertinib demonstrated significant antitumor activity. A total of 301 patients with locally advanced or metastatic NSCLC who had progressed after prior EGFR-TKI therapy and tested positive for the EGFR T790M mutation participated in the study. The results, assessed by an independent review committee (IRC), showed an objective response rate (ORR) of 68.8%, a disease control rate (DCR) of 92.4%, a median duration of response (DoR) of 11.1 months, and a median progression-free survival (PFS) of 11.0 months. Furthermore, for patients with evaluable intracranial lesions, Limertinib also demonstrated promising efficacy, with an IRC-assessed best ORR of 65.9% and a median PFS of 10.6 months, indicating its potential effectiveness against central nervous system (CNS) metastases. Limertinib is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI therapy and have been confirmed to harbor the EGFR T790M mutation. This indication addresses a critical unmet need in treating resistance caused by specific genetic mutations, offering new hope to affected patient populations. 6. Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) was approved for marketing in China on January 14, 2025, for the prevention and treatment of chemotherapy-induced neutropenia. Developed by Hangzhou Jiuyuan Gene Engineering, PEG-rhG-CSF is a long-acting biologic drug designed to address chemotherapy-induced neutropenia. This drug is a conjugate of recombinant human granulocyte colony-stimulating factor (rhG-CSF) and polyethylene glycol (PEG), which extends the drug’s half-life in vivo and reduces the frequency of administration. As a CSF-3R (colony-stimulating factor 3 receptor) agonist, PEG-rhG-CSF activates CSF-3R to stimulate the proliferation and differentiation of hematopoietic stem cells and progenitor cells in the bone marrow, leading to an increase in circulating neutrophils and enhancing the body's ability to resist infections. Compared to conventional rhG-CSF, PEG-rhG-CSF offers significant advantages, including prolonged duration of action and reduced injection frequency, which are crucial for improving patient adherence and quality of life. Additionally, the development of this drug addresses the clinical need for efficient, safe, and easy-to-manage treatment options. 7. Efsubaglutide Alfa Efsubaglutide Alfa is an innovative fusion protein drug that was first approved by the NMPA of China on January 24, 2025. Developed by Guangzhou Yinnuo Pharmaceutical, Efsubaglutide Alfa is a glucagon-like peptide-1 receptor agonist (GLP-1RA). It is engineered as a recombinant protein by conjugating the GLP-1 receptor agonist to the Fc fragment of human immunoglobulin G2 (IgG2). This allows it to enhance insulin secretion in a glucose-dependent manner while inhibiting glucagon release, effectively controlling blood glucose levels in adult patients with type 2 diabetes. What sets Efsubaglutide Alfa apart is its ultra-long-acting profile. The drug exhibits higher affinity for the GLP-1 receptor and has a prolonged degradation time in the body, with a half-life of 204 hours. This extended half-life enables a dosing regimen of once weekly or even once every two weeks, significantly improving patient convenience and treatment adherence. Additionally, clinical studies have shown that Efsubaglutide Alfa not only significantly lowers blood glucose levels but also improves lipid profiles, promotes weight loss, and offers potential cardiovascular protective effects. This makes it a comprehensive metabolic management option for patients with type 2 diabetes. Which drugs were approved by the TGA?Garadacimab Garadacimab was first approved in Australia on January 24, 2025, as a novel treatment for hereditary angioedema (HAE). Developed by CSL Behring LLC, Garadacimab is a fully human IgG4 monoclonal antibody specifically designed to target and inhibit activated Factor XII (FXIIa), a key protein in the pathological process of HAE. By targeting and inhibiting FXIIa, the drug prevents excessive activation of the kallikrein-kinin system, thereby reducing the production of bradykinin, which is responsible for HAE symptoms. This mechanism of action provides patients with a long-acting and highly specific prophylactic treatment, significantly reducing the frequency of disease attacks and improving patients' quality of life. Clinical studies, including the VANGUARD trial, have demonstrated that long-term prophylactic treatment with Garadacimab effectively controls acute HAE attacks. Compared to the placebo group, patients receiving Garadacimab reported a higher quality-of-life rating, indicating not only its medical superiority but also its positive impact on patients' overall well-being. Additionally, the drug is administered via subcutaneous injection once every 30 days, greatly enhancing treatment adherence and convenience for patients. The approval of Garadacimab marks a significant advancement in HAE treatment, particularly in the field of prophylactic therapy. Unlike traditional C1 esterase inhibitor replacement therapy or direct blockade of the bradykinin B2 receptor, Garadacimab achieves therapeutic effects by modulating the upstream kallikrein-kinin pathway. This breakthrough not only provides HAE patients with a new treatment option but also showcases the potential of biotechnology in developing targeted therapies for specific molecular pathways. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!