西米普利单抗新适应症获FDA批准用于术后辅助治疗CSCC

2025年10月8日，FDA批准由再生元与赛诺菲联合开发的PD-1单抗Libtayo®（西米普利单抗，cemiplimab-rwlc）用于手术和放疗后高复发风险皮肤鳞状细胞癌（CSCC）的辅助治疗。该批准基于C-POST研究结果，显示疾病复发或死亡风险降低68%，进一步拓展PD-1抑制剂在皮肤癌领域的应用。Libtayo®此前已获批用于CSCC、BCC及NSCLC等适应症。

Libtayo® Gains FDA Approval as First Adjuvant PD-1 Therapy for High-Risk Cutaneous Squamous Cell Carcinoma

The FDA has approved cemiplimab-rwlc (Libtayo®) for adjuvant treatment of adults with high-risk cutaneous squamous cell carcinoma after surgery and radiation. Libtayo is already approved for advanced CSCC, basal cell carcinoma, and NSCLC.

Zenas与诺诚健华达成逾20亿美元许可合作，获奥布替尼全球权益

Zenas BioPharma与诺诚健华签署总额超20亿美元许可协议，获得BTK抑制剂奥布替尼及两款自身免疫候选药物全球或区域权益，强化神经免疫及自身免疫管线布局。

Zenas and InnoCare Sign $2B+ Global License Deal for Orelabrutinib

Zenas BioPharma and InnoCare Pharma announce a $2 billion-plus global license agreement covering orelabrutinib (BTK inhibitor) for multiple sclerosis and two additional autoimmune programs, expanding Zenas’s neuroimmunology pipeline.

FDA批准JASCAYD：近10年首款IPF新药，中国同步布局

美国FDA批准JASCAYD®（nerandomilast）用于成人特发性肺纤维化（IPF）治疗，这是十年来FDA批准的首个新IPF疗法。中国的IPF及PPF上市申请也已获NMPA受理。

FDA Approves JASCAYD® (Nerandomilast) for Idiopathic Pulmonary Fibrosis — First New Therapy in Over a Decade

Boehringer Ingelheim’s JASCAYD® (nerandomilast) gains FDA approval for IPF, offering an oral PDE4B inhibitor with favorable tolerability and the first new treatment option in 10+ years.

首个！芦比替定联合阿替利珠单抗获 FDA 批准用于广泛期小细胞肺癌一线维持治疗

FDA 批准芦比替定（Zepzelca®）联合阿替利珠单抗（Tecentriq®）用于广泛期小细胞肺癌成人患者一线维持治疗，基于 III 期 IMforte 研究结果。

FDA Approval of Zepzelca® (Lurbinectedin) Plus Tecentriq® (Atezolizumab) for Extensive-Stage Small Cell Lung Cancer

FDA grants approval for Zepzelca + Tecentriq combination in first-line ES-SCLC, offering a new immunotherapy-chemotherapy treatment option.

百济神州专利纠纷落幕、首度盈利、迁址瑞士迈向全球肿瘤巨头之路

百济神州有限公司（纳斯达克代码：ONC；香港联交所代码：06160.HK；上交所代码：688235.SH），现已更名为 BeOne Medicines Ltd.，宣布艾伯维（AbbVie）已撤销针对百悦泽®（泽布替尼，zanubrutinib）的美国专利诉讼。这一专利纠纷的解决恰逢 BeOne 报告历史上首个季度盈利，并完成总部迁址瑞士的品牌重塑，标志着公司从中国本土创新走向全球肿瘤巨头的重要一步。 专利纠纷解决 2025年4月29日，美国专利商标局（USPTO）作出最终书面决定，宣布艾伯维旗下 Pharmacyclics 公司在 803 专利授权后复审（PGR）程序中受到质疑的 803 专利的全部权利无效。同年9月30日，双方又向美国地方法院提交联合申请，以“有偏见”方式撤销相关诉讼，彻底解决了该专利纠纷。 该专利原本涉及 BTK 抑制剂在 CLL/SLL 治疗中的用药方法（

BeOne Resolves AbbVie Patent Dispute as Brukinsa Powers First Profit and Swiss Rebrand

BeOne,, formerly BeiGene, resolves AbbVie’s patent dispute over Brukinsa®, achieves first-ever quarterly profit, and finalizes Swiss rebrand, signaling its evolution from China-based biotech to global oncology player.

诺和诺德两款新药在美递交上市申请：依柯胰岛素与Mim8

诺和诺德今日宣布向FDA递交依柯胰岛素（icodec）和Mim8的上市申请。依柯胰岛素是超长效基础胰岛素，可每周一次注射，已在欧盟和中国获批用于2型糖尿病。Mim8为血友病A患者提供非凝血因子类预防治疗，在多项FRONTIER III期研究中显著降低出血事件。此次递交标志着诺和诺德在糖尿病和血友病创新治疗领域的持续推进。

Novo Nordisk Resubmits Awiqli® and Submits Mim8 BLA to FDA for Diabetes and Hemophilia A

On September 29, 2025, Novo Nordisk submitted Biologics License Applications (BLA) for Awiqli® (icodec) and Mim8 to the U.S. FDA. Awiqli® offers once-weekly basal insulin for adults with type 2 diabetes, while Mim8 provides a highly effective non-factor prophylactic treatment for hemophilia A.