Afimkibart

The Crohn's disease pipeline includes several drugs in mid- and late-stage development, poised for approval in the near future in both adults and pediatrics. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including RHB-104, Tulisokibart, LITFULO (ritlecitinib), AGMB-129, Duvakitug, and others. The expected launch of these therapies shall further create a positive impact on the Crohn's disease market. LAS VEGAS, Aug. 25, 2025 /PRNewswire/ -- DelveInsight's Crohn's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Crohn's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Crohn's Disease Market Report According to DelveInsight's analysis, the market size for Crohn's disease was found to be USD 10.8 billion in the 7MM, with roughly 8-10% of it being the pediatric market in 2024. The United States accounted for the highest market size of Crohn's disease, approximately 78% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Adalimumab (HUMIRA and its generics) accounted for the highest market share of ~ USD 4 billion in 2024 for the treatment of Crohn's disease in the 7MM. Based on DelveInsight's assessment in 2024, the 7MM had 2.1 million diagnosed prevalent cases of Crohn's disease, out of which almost 200,000 cases are pediatric. In 2024, it was estimated that almost 60% of the cases were within the moderate-to-severe category as compared to mild severity in the US. Leading Crohn's disease companies developing emerging therapies, such as RedHill Biopharma, Merck, Teva Pharmaceutical, Pfizer, Agomab Therapeutics, Sanofi, Medibiofarma, Eli Lilly, NImmune, Avobis Bio, Abivax, Roche, Telavant, Mesoblast, Takeda, AstraZeneca, and others, are developing novel Crohn's disease drugs that can be available in the Crohn's disease market in the coming years. The promising Crohn's disease therapies in the pipeline include RHB-104, Tulisokibart (MK-7240, PRA023), Duvakitug (TEV-574), LITFULO (Ritlecitinib/PF-06651600), AGMB-129, Balinatunfib (SAR441566), MBF-118, MORF-057, Omilancor (BT-11), AVB-114, Obefazimod (ABX464), Afimkibart (RVT-3101 or RG6631), RYONCIL (Remestemcel-L), Zasocitinib (TAK-279), AZD7798, and others. Discover what is the best medicine for Crohn's disease @ Crohn's Disease Medication List Crohn's Disease Market Dynamics Crohn's disease can be managed through nutritional support, medication, and surgery in more severe cases. Treatment typically begins with glucocorticosteroids such as budesonide, although 5-Aminosalicylates (5-ASA) are considered when steroids are not suitable. For moderate disease, immunomodulators like azathioprine, methotrexate, and 6-mercaptopurine are commonly used. However, long-term steroid use is generally avoided due to potential side effects. Over time, biologic and small-molecule therapies for Crohn's disease have seen considerable advancements, varying in approval timelines, mechanisms of action, dosing schedules, and clinical effectiveness. REMICADE, the first TNF inhibitor approved in 1998, later gained approval for pediatric use in 2006. HUMIRA, introduced in 2007, provided an alternative for patients not responding to traditional treatments or REMICADE. In 2008, CIMZIA became the first PEGylated TNF inhibitor, offering extended half-life and reduced immune response. These therapies differ in administration routes; REMICADE is given via IV infusion every eight weeks, whereas HUMIRA and CIMZIA are administered subcutaneously, allowing for at-home treatment. In addition to TNF inhibitors, newer biologics and small molecules have broadened therapeutic options with unique mechanisms. ENTYVIO, approved in 2014, is a gut-specific α4β7 integrin blocker, initially given intravenously with maintenance every eight weeks; a subcutaneous version was introduced in 2024. STELARA, launched in 2016, targets IL-12 and IL-23 by blocking the p40 subunit, with an IV induction followed by SC dosing every eight weeks. SKYRIZI, approved in 2022, inhibits IL-23 and follows an IV induction schedule at Weeks 0, 4, and 8, then shifts to subcutaneous maintenance. It demonstrated 61% clinical remission at Week 52 in trials. RINVOQ, a JAK1 inhibitor approved in 2023, represents a small-molecule alternative targeting the JAK/STAT pathway and is taken orally, 45 mg daily for induction, followed by 15 mg or 30 mg maintenance. OMVOH, a selective IL-23 p19 subunit blocker, received approval in 2025, with IV induction and subcutaneous maintenance every four weeks. While currently small molecules and biologics are ruling the Crohn's disease treatment space, in 2018, a cell therapy was also introduced in the market. ALOFISEL (darvadstrocel), an allogeneic stem cell therapy, was approved in the EU (2018) and Japan (2021) for complex perianal fistulas in Crohn's disease patients. However, despite initial promise, Takeda discontinued its marketing authorization in the EU (December 2024), withdrawing the product as the clinical benefit of ALOFISEL was no longer sufficient to justify its continued use in the EU. Additionally, the company has removed the planned pediatric trial for refractory complex perianal fistulas from its pipeline, limiting future expansion into younger patient populations. The discontinuation of ALOFISEL highlights the ongoing challenges in developing and commercializing advanced regenerative therapies for Crohn's disease, particularly in niche indications. Regarding the challenges for biologics, the rise of biosimilars has lowered treatment costs and increased accessibility to biologic therapies. The first REMICADE biosimilar was introduced in 2016; as of now several biosimilars of REMICADE are approved, including INFLECTRA, RENFLEXIS, AVSOLA, and others. In 2023, biosimilars for HUMIRA, including AMJEVITA and CYLTEZO, entered the market, further enhancing affordability. TYRUKO, the first biosimilar for TYSABRI, was approved in Germany in 2024, indicating continued growth in the biosimilars landscape. With STELARA experiencing a 4% sales decline, now amplified by the entry of biosimilars in the US, Johnson & Johnson has now TREMFYA. TREMFYA's FDA approval in March 2025—offering both IV and SC induction and a dual-acting mechanism is expected to solidify Johnson & Johnson's IBD leadership. Despite these advances, challenges such as physician resistance, patient hesitation, and payer-related issues persist. In the pediatric segment, treatment-related challenges are even more pronounced due to limited approved options. HUMIRA and REMICADE remain the primary TNF inhibitors, but early disease onset, aggressive progression, and long-term immunosuppression risks create significant unmet needs. Recently, in April 2025, the European Commission approved STELARA for the treatment of moderately to severely active Crohn's disease in paediatric patients. While biologics have improved management, immunogenicity and secondary loss of response remain key concerns. To address these gaps, pharmaceutical companies are advancing novel mechanisms of action, including integrin blockers, IL-12/IL-23 inhibitors, and JAK inhibitors, aiming for improved efficacy, safety, and durability in pediatric patients. The anticipated approvals of ENTYVIO in the near future, followed by RINVOQ and OMVOH for pediatric Crohn's disease patients, will diversify the therapeutic landscape, offering more personalized treatment options based on disease severity and individual patient response. The Crohn's disease market dynamics are expected to change in the coming years. Biologics continue to dominate Crohn's disease treatment, with TNF inhibitors (HUMIRA, REMICADE), IL-12/23 inhibitors (STELARA), and IL-23 inhibitors (SKYRIZI) offering strong efficacy and long-term disease control. In contrast, the development of new treatments such as JAK inhibitors, immunomodulators, and first-in-class therapies like Tulisokibart (TL1A inhibitor) and AGMB-129 (ALK5/TGFβR1 inhibitor) reflects a promising shift toward more targeted options with improved clinical profiles, subcutaneous formulations, and greater convenience, driving higher penetration in the moderate-to-severe patient population and paving the way for Crohn's disease market innovation. Overall, the Crohn's disease market is undergoing a transformative shift. With continued investment in next-generation biologics, oral small molecules, and novel combinations, the Crohn's disease treatment landscape is set to evolve significantly, reshaping the standard of care for both adult and pediatric patients. To know more about FDA-approved drugs for Crohn's disease, visit @ Crohn's Disease Treatment Crohn's Disease Pipeline Therapies and Key Companies The promising late- and mid-stage emerging pipeline assets for Crohn's disease include RHB-104 (RedHill Biopharma), Tulisokibart (Merck), LITFULO (Pfizer), AGMB-129 (Agomab Therapeutics), Duvakitug (Teva Pharmaceuticals and Sanofi), and others. RHB-104, developed by RedHill Biopharma, is an investigational oral capsule with strong intracellular, antimycobacterial, and anti-inflammatory properties. It has the potential to be a groundbreaking therapy. RedHill has completed two Phase III clinical trials (NCT03009396 and NCT01951326). The MAP US study, a randomized, double-blind, placebo-controlled Phase III trial in Crohn's disease, achieved both its primary and key secondary endpoints. Further clinical trials are needed to support a New Drug Application (NDA), with a new study expected to launch in mid-2025. No recent updates are available, and the drug is not visible in the company's pipeline. RedHill Biopharma is also developing RHB-204, a next-generation formulation of RHB-104 with an optimized formulation for the treatment of Crohn's disease. RHB-204 is patent-protected until at least 2041, and has an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104). Tulisokibart is a humanized monoclonal antibody targeting the novel protein TL1A, which is linked to intestinal inflammation and fibrosis. The antibody is believed to bind both soluble and membrane-bound forms of TL1A, potentially blocking inflammatory pathways and reducing fibrosis in inflammatory bowel disease (IBD). This could be significant in modifying disease progression. Following Merck's acquisition of Prometheus Biosciences in June 2023, Tulisokibart is now part of Merck's portfolio. The drug is protected by US patents extending into the 2040s and is currently in two Phase III trials for Crohn's disease. AGMB-129 is an orally administered, gastrointestinal-restricted small molecule that inhibits ALK5 (TGFβR1), a key mediator in fibrotic processes. It is specifically developed for treating Fibrostenosing Crohn's Disease (FSCD). TGFβ is a central regulator of fibrosis, and early clinical data support its potential as a therapeutic target. In October 2024, the company raised USD 89 million in a Series D round, with participation from new investors including Sanofi and Invus, along with support from existing backers. In May 2025, Agomab Therapeutics presented interim data from the Phase IIa STENOVA trial at Digestive Disease Week 2025. The primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses. The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients. The other therapies in the pipeline for Crohn's disease treatment include Omilancor (BT-11): NImmune AVB-114: Avobis Bio/Alimentiv Obefazimod (ABX464): Abivax RVT-3101 (RG6631): Roche RYONCIL (Remestemcel-L): Mesoblast Zasocitinib (TAK-279): Takeda AZD7798: AstraZeneca Balinatunfib (SAR441566): Sanofi MBF-118: Medibiofarma MORF-057: Eli Lilly/Morphic Therapeutic And others As potential therapies are being investigated for the treatment of Crohn's disease, it is safe to predict that the treatment space will significantly impact the Crohn's disease market during the forecast period. Moreover, the anticipated launch of emerging therapies are poised to transform the Crohn's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Crohn's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. However, several factors may impede the growth of the Crohn's disease market. Despite the emergence of novel treatments, a significant portion of Crohn's disease patients remains refractory to multiple therapies, underscoring the need for breakthrough innovations beyond current biologic and small-molecule options; however, biological therapies remain expensive and face accessibility challenges, JAK inhibitors like RINVOQ are limited by serious safety concerns, and brand erosion following the patent expiry of market leaders such as REMICADE, HUMIRA, ENTYVIO, and STELARA is expected to lead to sales decline. Moreover, Crohn's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Crohn's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Crohn's disease market growth. Discover more about Crohn's disease drugs in development @ Crohn's Disease Clinical Trials Recent Developments in the Crohn's Disease Market In July 2025, the Phase III trial evaluating VELSIPITY (Etrasimod) a product of Arena (a wholly owned subsidiary of Pfizer), for the treatment of adult participants with moderately to severely active Crohn's disease, was terminated due to lack of efficacy in sub-study 1. In June 2025, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand approval of STELARA for the treatment of children two years and older with moderately to severely active Crohn's disease. In March 2025, the FDA approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease. In March 2025, Celltrion announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following FDA approval in December 2024. STEQEYMA is approved for the same indications as STELARA, offering consistent treatment for patients and healthcare providers. In February 2025, Eli Lilly and Company announced the results from the VIVID-2 open-label extension study, which showed the majority of patients with moderate-to-severely active Crohn's disease receiving 2 years of continuous treatment with OMVOH achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure at the Crohn's and Colitis Congress (CCC). In January 2025, the FDA approved OMVOH (mirikizumab) for Crohn's disease, further solidifying the IL-23 inhibitor class. With strong long-term efficacy, OMVOH is also being investigated for pediatric patients, potentially addressing a significant unmet need in this population. Crohn's Disease Overview Crohn's disease is a long-term inflammatory disorder of the gastrointestinal (GI) tract and is classified under inflammatory bowel disease (IBD). Although it can impact any part of the digestive tract, from the mouth to the anus, it most frequently affects the small intestine and colon. Its exact cause is still unknown, but it's thought to arise from a mix of genetic predisposition, environmental triggers, and immune system irregularities. Crohn's disease symptoms can differ in intensity and may include abdominal discomfort, persistent diarrhea, weight loss, fatigue, and nutrient deficiencies. While a cure has yet to be found, treatment aims to control inflammation, relieve symptoms, and prevent complications through the use of medications, biologic therapies, lifestyle adjustments, and sometimes surgical intervention. Continuous research and innovation in targeted treatments are expanding the options available, offering renewed hope for better management and improved quality of life for those affected. Diagnosing Crohn's disease can be complex due to symptom overlap with other GI disorders, such as ulcerative colitis and irritable bowel syndrome (IBS). Physicians use a comprehensive diagnostic approach that includes a clinical assessment, lab work, imaging, and endoscopic evaluations. Blood tests can reveal signs of inflammation, anemia, or nutritional imbalances, while stool tests help exclude infections. Imaging methods like CT scans, MRIs, and intestinal ultrasounds provide detailed insights into areas of inflammation, narrowing, or abnormal connections. Endoscopic procedures, such as colonoscopy and upper endoscopy, offer a direct look at the intestinal lining and allow for tissue biopsies to confirm the diagnosis. Because no single test can definitively confirm Crohn's, a combination of diagnostic tools is used to establish an accurate diagnosis and guide effective treatment planning. Crohn's Disease Epidemiology Segmentation The Crohn's disease epidemiology section provides insights into the historical and current Crohn's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Crohn's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Crohn's Disease Prevalence Age-specific Diagnosed Crohn's Disease Prevalence Severity-specific Diagnosed Crohn's Disease Prevalence Scope of the Crohn's Disease Market Report Therapeutic Assessment: Crohn's Disease current marketed and emerging therapies Crohn's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Crohn's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Crohn's Disease Market Access and Reimbursement Download the report to understand which factors are driving Crohn's disease market trends @ Crohn's Disease Market Forecast Table of Contents Related Reports Inflammatory Bowel Disease Market Inflammatory Bowel Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IBD companies including Takeda Pharmaceutical, Janssen Pharmaceuticals, Hoffmann-La Roche, Genentech, AbbVie, Boehringer Ingelheim, Gilead Sciences, Arena Pharmaceuticals, Eli Lilly, AstraZeneca, among others. 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Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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精彩内容随着系列政策的大力推动，叠加国内创新同质化严重的背景下，越来越多中国创新药企业纷纷踏上“创新转型、扬帆出海”的新赛道。据不完全统计，2024年至今达成的License-out交易150余项，交易总金额合计超1350亿美元；恒瑞医药、石药集团、三生制药等头部药企全速推进，合作交易金额屡创新高，国产1类新药频频登场......密集的出海交易，体现出中国创新药企业积极摆脱内卷、完成商业闭环并走向更高格局的决心。$1350亿总额惊呆了！创新药出海热度高涨自2015年开启药政改革以来，国内创新药研发能力快速提升，药物创新性和研发效率的优势逐渐得到国外制药巨头认可，海外授权（License-out）也逐渐成为国内创新药企业迈向国际化的敲门砖。据不完全统计，2024年至今我国创新药License-out交易至少发生150余项，合计交易总金额超1350亿美元。其中，2024年License-out交易共计94项，披露的交易总金额约542.9亿美元；2025年至今，国内已发生56项License-out交易，累计交易总金额超过817亿美元，可统计交易总额已突破去年全年水平，创新药出海热浪持续高涨。近年来License-out交易情况来源：公司公告、公开信息等，米内网整理近年来，随着系列政策的大力推动，叠加国内创新同质化严重的背景下，不论是国内传统大药企，还是Biotech新贵都纷纷踏上“创新转型、扬帆出海”的新赛道，License-out数量与授权合作金额均在逐年攀升。如此背景下，密集的创新药出海交易，NewCo交易新模式的登场，ADC、核药、CAR-T等高技术壁垒疗法的崛起......正体现出中国创新药企积极摆脱内卷、探索新品销售空间、完成商业闭环并走向更高格局的决心。$817亿创新高！三生、信达、石药......当仁不让据不完全统计，2025年至今已有至少56个项目达成出海交易，可统计累计首付款约37亿美元，总交易额超817亿美元，单笔交易达10亿美元及以上的项目有21个，包括三生制药的SSGJ-707、信达生物的IBI3009、石药集团的SYS6005、SYH2086、伊立替康脂质体注射液和免疫疾病小分子口服疗法、恒瑞医药的HRS-9821等。2025年至今创新药出海情况来源：公司公告等，米内网整理注：标红为总金额超10亿美元的交易，未披露交易金额用-表示今年5月，#三生制药 发布公告称，与辉瑞就旗下在研候选新药SSGJ-707达成合作协议。根据协议，三生制药将获得首付款，开发、监管批准和销售里程碑付款合计总额超60亿美元，一举刷新国产创新药单药出海交易总金额的纪录。SSGJ-707是一款靶向PD-1/VEGF双特异性抗体，为三生制药自主研发的1类创新药。据Ⅱ期临床阶段性数据显示，该药在治疗非小细胞肺癌上获得优异的客观缓解率和疾病控制率，具有best-in-class的潜力。今年4月，SSGJ-707获CDE批准纳入突破性治疗品种名单，目前其单药一线治疗非小细胞肺癌适应症已进入Ⅲ期临床，联合化疗一线治疗晚期非小细胞肺癌、一线治疗转移性结直肠癌、晚期妇科肿瘤等适应症均已进入Ⅱ期临床。SSGJ-707临床试验进度情况来源：米内网中国临床试验数据库2025年至今，#石药集团 已达成四项License-out交易，涉及SYS6005、SYH2086、伊立替康脂质体注射液和免疫疾病小分子口服疗法等产品，合计总交易金额超过97亿美元，成为今年以来BD出海交易最大的赢家之一。SYS6005属于靶向ROR1 ADC，为石药集团开发的1类创新药，拟用于治疗血液肿瘤、非小细胞肺癌等晚期肿瘤；SYH2086是石药旗下的一款在研口服小分子GLP-1受体激动剂，临床前数据显示，该药具有优异的体外激动活性和体内降糖、减重效果等；伊立替康脂质体注射液用于治疗转移性胰腺癌等，石药集团为该药首仿+首家过评企业，2024年中国三大终端六大市场（统计范围详见本文末）伊立替康销售额超8亿元；今年6月，石药集团再度牵手阿斯利康，聚焦AI技术驱动免疫疾病等小分子口服疗法的开发，根据协议，石药集团有望获得总潜在价值超53亿美元的合作款项。中国三大终端六大市场伊立替康销售趋势（单位：万元）来源：米内网格局数据库今年7月，恒瑞医药宣布将HRS-9821及至多11个项目的全球独家权益有偿许可给GSK；而GSK将向恒瑞支付5亿美元的首付款，以及未来相关里程碑付款约120亿美元，合计总交易金额超125亿美元。HRS-9821为恒瑞医药自主研发的1类创新药，用于治疗慢阻肺（COPD），作为辅助维持治疗，无需考虑既往治疗方案。据其早期临床和临床前研究显示，该新药展现出强效的PDE3/4抑制作用，可显著增强支气管舒张效应并产生抗炎作用。IBI3009为#信达生物 自主研发的靶向DLL3 ADC，拟用于小细胞肺癌及其他神经内分泌癌。作为潜在同类最佳和开发进度领先的靶向DLL3 ADC，该药在多个肿瘤负荷小鼠模型（尤其在化疗耐药肿瘤类型）中展现出强效的抗肿瘤活性，并具有良好的安全性特征。据此，今年1月，信达生物宣布称，将授予罗氏开发、生产及商业化IBI3009的全球独家权益，同时也有望获得超过10.8亿美元的合作交易款项。$540亿大爆发！恒瑞、石药、明济......成绩斐然回看2024年，国内至少有94个项目达成出海交易，可统计累计首付款超43亿美元，总交易额超540亿美元，单笔交易达10亿美元及以上的项目有22个，包括恒瑞医药的HRS-7535、HRS9531、HRS-4729和SHR-4849、石药集团的YS2302018、翰森制药的HS-10535、明济生物的FG-M701等国产创新药。2024年创新药出海情况来源：公司公告等，米内网整理注：标红为总金额超10亿美元的交易，未披露交易金额用-表示#恒瑞医药 以两项交易、合计总金额超70亿美元的成绩，成为2024年License-out总交易金额最高的国内药企之一。其一项交易涉及1款ADC创新药SHR-4849，授权总额约10.45亿美元。该药为恒瑞自主研发的靶向DLL3 ADC，其有效载荷是拓扑异构酶抑制剂（TOPOi），可通过杀伤DLL3高表达细胞释放毒素来杀伤DLL3低表达细胞。米内网数据显示，全球至今已有20多款ADC新药（不含生物类似药）获批上市，2024年全球合计销售额突破100亿美元。另一项GLP-1创新药“打包”出海的交易，合计授权总额超过60亿美元，包括3款1类新药——HRS-7535属于小分子GLP-1受体激动剂，目前全球暂无国产口服小分子GLP-1激动剂获批上市；HRS9531为靶向GLP-1/GIPR双受体激动剂，其同靶点药物礼来的替尔泊肽2024年全球销售额超164亿美元；HRS-4729属于GLP1R/GIPR/GCGR三靶点激动剂，能通过激活多靶点，有望实现更好的控糖、减重等效果。替尔泊肽全球销售销售趋势（单位：亿美元）来源：米内网跨国上市公司数据库YS2302018是一款口服脂蛋白(a)抑制剂，用于开发新型降脂疗法，以及多种心血管疾病的单一疗法或联合疗法。2024年10月，石药集团与阿斯利康就该新品订立独家授权协议。根据协议，石药集团将获得1亿美元的首付款，未来还将有资格获得最高19.2亿美元的开发和商业化里程碑付款，合计授权总额超过20亿美元。据悉，YS2302018能有效阻止脂蛋白(a)的形成，在体外实验及动物模型中均展现出优异的药效和药物代谢动力学表现，并保持较低的安全风险，有望为心血管疾病患者带来新的希望。米内网数据显示，2021-2024年中国三大终端六大市场心脑血管系统药物（化+生）销售额均在1300亿元以上。中国三大终端六大市场心脑血管系统药物（化+生）销售趋势（单位：万元）来源：米内网格局数据库FG-M701是明济生物自主研发的一款TL1A（TNFSF15）抗体药物，可用于治疗炎症性肠病，目前正处于临床前开发阶段。2024年6月，明济生物与艾伯维针对该药达成的合作授权总金额高达17.1亿美元。研究结果指出，根据TL1A靶点开发的药物还有望用于溃疡性结肠炎、克罗恩病等多种自身免疫性疾病，目前全球已有多款TL1A抗体新药处于临床研发阶段，其中默沙东/武田的PRA-023、罗氏/辉瑞的RG-6631已进入Ⅲ期临床，赛诺菲/梯瓦制药的TEV-48574、Xencor的XmAb-942已进入Ⅱ期临床。部分靶向TL1A（TNFSF15）的在研新药情况来源：米内网全球新药研发数据库结语国产创新药License-out已从“试水阶段”进入“深水区”，部分头部药企正通过技术输出和资本运作在全球价值链中占据一席之地。尽管终止合作、退货、里程碑无法兑现等情况偶有出现，但中国凭借系列新政支持、企业研发效率上的优势，不断推动创新药行业从“管线出口”向“全球策源”转型。未来，随着更多国产创新药步入商业化阶段，License-out将成为验证中国创新药全球价值的关键窗口。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月31日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦