Keytruda Subcutaneous Injection
Merck’s Keytruda subcutaneous injection (MK-3475A, Keytruda Qlex) approved by FDA, offering 1–2 minute dosing for adult patients with most solid tumors.
NewCo模式
中国创新药企正加速采用NewCo模式出海，将资产海外孵化，融合授权、股权和风险投资支持。Mabwell→Kalexo、恒瑞→Hercules等交易显示，该模式提升全球开发效率，助力中国创新药国际化。
NewCo Model
Chinese biotechs are increasingly spinning assets into offshore NewCos, blending licensing, equity, and VC/PE backing. Deals like Mabwell→Kalexo and Hengrui→Braveheart accelerate global development, unlock capital, and position China as a key exporter of early- and mid-stage biotech assets.
Vepdegestrant
Vepdegestrant是全球首个提交FDA的新药上市申请（NDA）的PROTAC药物，代表蛋白降解治疗在肿瘤学领域的重要里程碑。VERITAC-2 III期临床显示，ESR1突变患者中疗效显著，中位PFS达到5.0个月，而总人群未达主要终点。受此影响，辉瑞与Arvinas决定寻求第三方合作伙伴负责商业化。
Vepdegestrant
Arvinas and Pfizer’s Vepdegestrant is the first PROTAC to reach FDA review, a milestone for the modality. But Pfizer’s retreat after mixed Phase 3 data—showing benefit only in ESR1-mutant patients—raises doubts over its commercial impact and leaves PROTAC oncology’s future hanging on this outcome.
Raludotatug Deruxtecan
默沙东与第一三共联合开发的CDH6靶向ADC Raludotatug Deruxtecan（R-DXd）获FDA突破性疗法认定。早期临床显示ORR 46%，DCR 98%，彰显潜力。
Raludotatug Deruxtecan
The FDA has granted Breakthrough Therapy Designation to Raludotatug Deruxtecan (R-DXd), a CDH6-targeting ADC, for patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Early-phase trials show ORR 46% and DCR 98%.
Kalexo Bio
Kalexo Bio 由迈威生物与 Aditum 成立，推进 2MW7141 双靶点 siRNA 药物，用于血脂调控及心血管高危患者。交易包括 1200 万美元现金、优先股及最高 10 亿美元里程碑付款，体现 NewCo 出海趋势。
Kalexo Bio
Mabwell Bioscience and Aditum Bio launch Kalexo Bio, a NewCo spinout to develop 2MW7141, a dual-target siRNA therapy for dyslipidemia and high-risk cardiovascular disease. Deal includes $12M upfront, preferred shares, and up to $1B in milestones.
PTK7 ADC
Genmab宣布终止PTK7靶向ADC PRO1107开发，辉瑞及艾伯维的Cofetuzumab Pelidotin早期项目也已中止。科伦博泰SKB518成为全球首个进入II期的PTK7 ADC，同时DAY301、LY4175408等新一代ADC正在推进临床，PTK7 ADC领域迎来新局面。
PTK7 ADC
Explore the evolving PTK7 ADC field as Genmab halts PRO1107 and Pfizer/AbbVie discontinue cofetuzumab pelidotin, while Kelun’s SKB518 advances into Phase II and Lilly joins with LY4175408 alongside Day One’s DAY301.
Lasker Award 2025
Discover how scientists Michael Welsh, Paul Negulescu, and Jesús “Tito” González revolutionized CF treatment with the triple-drug therapy that transformed patient outcomes and won the 2025 Lasker Award.