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The Establishment of the Facility Demonstrates the Company's Commitment to Delivering Differentiated Solutions to Gynecology and Pediatrics Challenges SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th. With an increasing focus on women`s and children`s health, the Chinese government has been intensifying efforts to improve healthcare services for these demographics, embedding their care within the wider framework of the country's economic and social development policies. The establishment of the R&D center sets the stage for GenSci to further advance the convergence of industry, academia, research and the medical community. By leveraging cutting-edge R&D capabilities and the application of artificial intelligence technologies, GenSci is well-positioned to provide premium health solutions for women and children. The initiative aligns with GenSci's commitment to harnessing science and technology to protect and enhance the health of these vulnerable groups. Continue Reading Changchun GeneScience Pharmaceutical Co., Ltd. The construction of this facility is progressing as planned, and it is expected to be fully operational by 2027, providing a capacity to accommodate up to 2,000 R&D professionals. Supporting the Healthy China Initiative: Focusing on the Health Needs of Women and Children Recognizing the pivotal role of women and children's health in the nation's overall well-being, the government has designated this field as a critical priority. This is evident in the implementation of significant strategic initiatives such as the Healthy China Initiative (2019-2030), the Outline for Children's Development in China (2021-2030), and the Outline for Women's Development in China (2021-2030). These key documents underscore our unwavering commitment to enhancing nationwide awareness regarding the specific needs of women and children, with an overarching objective of safeguarding their health. The health of women and children confronted with new challenges. While the incidence of common childhood diseases has decreased, there is a rise in lifestyle-related health issues in children, including early puberty, myopia, growth deficiencies, body image concerns, immune system abnormalities, and mental health disorders. In addition, women are generally grappling with reproductive health issues and the effects of menopause that can significantly impact their quality of life. Moreover, the periods of pregnancy and early childhood present vital opportunities to avert diseases that can develop later in life. Enhanced health management for women and children during these key stages can help prevent long-term health issues, carrying significant implications for the broader society. Providing Premier Global Maternal and Child Health Solutions through Distinctive Innovation Aligned with national healthcare directives, GenSci has ramped up its R&D investments to address the unmet health needs of women and children. The company has already developed the capability to innovate across various product categories, including biopharmaceuticals, chemical drugs, live bacterial preparations (LBPs) and medical devices. The GenSci general manager, Dr. Jin, pointed out that their product innovations are designed to deliver substantial unique benefits. The establishment of the Zhangjiang R&D center is a testament to GenSci's commitment to independent innovation. Since its founding in 1997, GenSci has introduced several groundbreaking therapies, including the GenSci Recombinant Human Growth Hormone, GenSci Heng Recombinant Human Follicle-Stimulating Hormone and Jinfuning Recombinant Human Granulocyte-Stimulating Factor Gel. The company's proprietary innovations and outstanding contribution in the field of child growth and development were recognized when its "Development and Industrialization of Recombinant Human Growth Hormone Series Products" project won the Second Prize of the 2015 National Science and Technology Progress Award. The accolade underscores GenSci's expertise in independent innovation within China's pharmaceutical sector. With an ongoing focus on growth disorders in children, GenSci has expanded its attention to the broader spectrum of children's health. This includes addressing concerns such as abnormal sexual development, obesity, respiratory and digestive health, allergies and autoimmune disorders, neurological and speech development, as well as concerns related to body image. As an illustration, GenSci has been develop an industry-leading ultra-long-acting growth hormone that is administered monthly since 2020, as well as innovative oral treatments for short stature. The company has also been creating comprehensive range of solutions designed to diagnose and treat precocious puberty, including rapid sex hormone tests and long-acting gonadotropin-releasing hormone analogs for treating central precocious puberty. Furthermore, GenSci has been adopting a comprehensive approach that addresses women's health needs throughout their life cycle. This initiative includes support for assisted reproduction, menopausal health, and the treatment of prevalent gynecological conditions. Significantly, the company has been developing the world's first lytic enzyme and live bacterial preparation (LBP) for treating vaginitis caused by drug-resistant bacteria, offering an alternative to antibiotics and addressing the issue of drug resistance. "GenSci has built a globally innovative and competitive R&D product pipeline," Dr. Jin declared. "By 2025, the firm will boast an extensive portfolio, with the expectation of launching more than four top-tier innovative drugs and five novel medical devices annually in the years to come." Enhancing Collaboration Across Industry, Academia, Research, and Healthcare Providers to Tackle Key Issues in Women's and Children's Health GenSci, through a combination of proprietary R&D and collaborative efforts with partners, has developed a suite of sophisticated R&D technology platforms that drive forward-thinking product development. The platforms focus on the protein drug sustained-release technology, mucosal delivery systems for nucleic acid medications, antibody-drug conjugate (ADC) technology, and innovations in ultrasound and hydrogel technologies. Integrating AI technology, GenSci covers the entire drug innovation process, from initial design and screening to process development and formulation. Moreover, the company promotes the introduction and adoption of cutting-edge concepts and technologies by facilitating synergistic integration of industry, academia, research and the medical community, ensuring effective cooperation among these stakeholders. GenSci has formed enduring and robust partnerships with nearly 20 prominent universities, including Shanghai Jiao Tong University and Zhejiang University. The company has also engaged in various scientific research collaborations with institutions such as Shanghai Jiao Tong University, Shandong University, and the Center for Excellence in Brain Science and Intelligence Technology at the Chinese Academy of Sciences. Additionally, GenSci has joined forces with numerous maternity and pediatric departments within both general and specialized hospitals through multicenter clinical trials and joint applications for national projects. As part of these alliances, the company contributes its substantial technical expertise and digital platform capabilities — skills acquired during product development — to these hospitals at no cost. Frontline doctors are engaged to review and provide feedback on these tools, aiding the ongoing enhancement of GenSci's research and digital capabilities in gynecology and pediatrics. Additionally, GenSci has established collaborations with numerous hospitals in the development of digital medical assistance systems，it actively engages in medical research to achieve technological breakthroughs and plays a pivotal role as a high-tech innovation platform in specialized treatment fields. Through deep cooperation and extensive coverage, it truly realizes co-creation and win-win outcomes in medical research. The groundbreaking of GenSci's global innovation hub and R&D center enpowers the company to fully utilize its expertise in gynecology and pediatrics. GenSci intends to introduce innovative therapies for oncology, immunology, hearing loss, and drug-resistant bacterial infections, aiming to address unmet clinical needs. With its advanced strategic positioning, substantial investment in R&D, and unwavering commitment to product innovation, GenSci continues to strive towards tackling significant medical challenges while providing exceptional exceptional treatment options for healthcare professionals and patients. SOURCE Changchun GeneScience Pharmaceutical Co., Ltd.

If approved, eftansomatropin alfa will enter a market that already features a once-weekly option. Genexine’s once-weekly growth hormone has matched daily injections in a pivotal trial in China, teeing it and its partners I-Mab and Jumpcan up to file for approval next year and prepare to launch the medicine.  The phase 3 clinical trial compared eftansomatropin alfa, Genexine’s long-acting growth hormone, to Novo Nordisk’s daily injectable Norditropin in children with growth hormone deficiency. After 52 weeks, the mean annualized height velocity in the eftansomatropin alfa arm was 10.76 cm a year, compared to 10.28 cm a year in the control cohort. The result caused the trial to meet its primary endpoint. “We are pleased with the results from this registration trial as this demonstrates clear safety and efficacy in this potential best-in-class drug to treat children with growth hormone deficiency,” Genexine CEO Neil Warma said in a statement. “This is a significant milestone for Genexine as we demonstrate our ability to bring our novel products to market and the value of our proprietary long-acting hyFc platform.” Genexine granted Tasgen Biotech, a company subsequently bought by I-Mab, the rights to develop, manufacture and commercialize eftansomatropin alfa in China in 2015 as part of a multi-asset deal worth $13 million upfront plus up to $40 million in milestones tied specifically to the growth hormone. I-Mab partnered with Jumpcan to commercialize the drug in China in 2021. The collaborators plan to file for approval in China next year. If approved, eftansomatropin alfa will enter a market that already features a once-weekly option. GenSci won approval for its once-weekly Jintrolong in China after showing the treatment is noninferior to daily injections.  Jintrolong and eftansomatropin alfa are part of a wave of once-weekly growth hormone drugs including Ascendis Pharma’s Skytrofa and Pfizer’s Ngenla. The developers have achieved once-weekly dosing using a variety of approaches. Jintrolong is a pegylated growth hormone, whereas eftansomatropin alfa uses hyFc, a component made of a portion of human immunoglobulin D and G4.