A decade of transformation in China’s biopharma industry: first-in-class drugs, expanded clinical pipelines, R&D talent, and billion-dollar global partnerships reshaping pharma leadership.
China’s semaglutide market is heading toward $61B by 2032, unleashing a biosimilar frenzy. Over 25 drugmakers have filed 90+ applications, eight are nearing approval, and a pending patent ruling could trigger price wars that reshape diabetes and obesity care.
As of September 25, 2025, the FDA has approved 30 novel drugs, emphasizing precision medicine, rare disease advances, and a notable increase in China-origin therapies gaining U.S. approval. This analysis covers key drugs, modalities, and the evolving China biotech footprint.
随着中国生物技术创新的加速发展，越来越多的美国和英国初创公司正在依赖中国许可资产，特别是在肿瘤学、免疫学和代谢疾病领域，推动全球生物技术市场的变革。
FDA批准礼来Imlunestrant（Inluriyo）治疗ESR1突变乳腺癌，中国NDA同步受理，或成为继Elacestrant后又一口服SERD新选择。
The FDA has approved imlunestrant (Inluriyo) for ESR1-mutated ER+, HER2- metastatic breast cancer. With elacestrant already on the market, patients now have two oral SERDs — raising questions of sequencing, safety, and access.
Analysis of US and UK biotech startups operating under the NewCo model, built solely on China-licensed assets. Includes executive summary, company list, trends, and risks.
礼来公司取消了其通过19亿美元收购Versanis获得的bimagrumab的2b期临床试验，原因系“战略商业决策”，该试验尚未招募任何患者。该试验（NCT06901349）旨在评估bimagrumab（一种靶向activin和myostatin信号的抗体）单独及与tirzepatide（Mounjaro/Zepbound）联合使用，在180名肥胖或超重伴2型糖尿病患者中的效果，包含九个试验组以测试不同给药方案。ClinicalTrials.gov显示，该试验最初状态为“尚未招募”，2025年6月变更为“活跃但不招募”，并于2025年9月24日被撤回。此决定是在2025年6月美国糖尿病协会科学会议上公布的2期研究数据之后，该研究显示bimagrumab联合semaglutide（Ozempic/Wegovy）使脂肪特异性体重减轻比例超过90%，而单独使用semaglutide仅为72%。礼来试验采用皮下给药的bimagrumab和tirzepatide，与Versanis的静脉给药bimagrumab和semaglutide组合不同。目前，针对非糖尿病患者的另一项2期试验仍在招募中。礼
Eli Lilly has terminated a phase 2b clinical trial for bimagrumab, a key asset from its $1.9 billion Versanis acquisition, before enrolling any patients, due to “strategic business reasons.” The trial (NCT06901349) was designed to evaluate bimagrumab, an antibody targeting activin and myostatin signaling, alone and in combination with
在2025研发日上，罗氏展示了研发战略与管线亮点，尤其在肥胖和代谢疾病领域动作频频。除了GLP-1、胰淀素及口服候选药物外，公司近期以35亿美元收购89bio及其FGF21候选药Pegozafermin，为MASH治疗补齐关键拼图。
Roche’s Pharma Day 2025 showcased CHF24bn HY sales, 17 blockbusters, and an R&D Excellence program that fast-tracks priority assets — with obesity (CT-388, petrelintide), neurology (trontinemab, prasinezumab) and oncology bispecific combos the top strategic bets.
UniQure 的 AMT-130 基因疗法在一项关键的 I/II 期临床试验中取得了显著成果，成功将亨廷顿病（HD）的疾病进展速度降低了 75%。 该疗法还在功能性能力（TFC）评分上实现了 60% 的进展减缓，认知和运动功能也呈现出积极趋势。 安全性良好，且 AMT-130 已获得 FDA 的突破性疗法（Breakthrough Therapy）和再生医学高级疗法（RMAT）认证。 UniQure 计划于 2026 年第一季度提交生物制品许可申请（BLA），为患者带来新的希望。 在公告发布后，UniQure（纳斯达克股票代码：QURE）的股价飙升 194%，显示出投资者对 AMT-130 潜力的强烈信心。 截至最新交易日，QURE 股价为 $39.56，当日波动区间为 $14.
UniQure’s AMT-130 gene therapy slowed Huntington’s disease progression by 75% in a Phase I/II trial, with favorable cognitive and motor outcomes, manageable safety, and FDA Breakthrough Therapy and RMAT designations. BLA submission planned in early 2026.
恒瑞医药宣布与 Glenmark 达成超 11 亿美元独家许可协议，授权其在部分海外市场开发和商业化瑞康曲妥珠单抗（SHR-A1811）。作为中国首个获批 HER2 ADC，该交易彰显中国 ADC 出海步伐提速。
Hengrui Pharma signed an exclusive license deal worth up to $1.1B with Glenmark Pharmaceuticals for Trastuzumab Rezetecan (SHR-A1811), its HER2-targeted ADC. The deal underscores China’s growing global impact in ADC innovation while giving Glenmark an emerging-market oncology play.