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。
Latest
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.
三迭纪
三迭纪提交中国首款3D打印药物T20j(阿哌沙班片)上市申请
三迭纪提交T20j（阿哌沙班片）上市申请，这是中国首款3D打印药物。申报紧随全国首张3D打印药品生产许可，并凸显与礼来、勃林格殷格翰、默克、BioNTech的全球合作。
Triastek
Triastek Files China’s First 3D-Printed Drug NDA: T20j (Apixaban)
Triastek has submitted an NDA for T20j, China’s first 3D-printed drug, marking a regulatory milestone. The filing follows approval of the nation’s first 3D-printing drug manufacturing license and comes alongside Triastek’s broad 3D-printed pipeline and global pharma collaborations.
FDA批准
全球首个治疗荨麻疹！诺华BTK抑制剂瑞米布替尼获批在美上市
诺华Rhapsido®（瑞米布替尼）获FDA批准，成为全球首个用于CSU的口服BTK抑制剂；中国已获批5款BTK抑制剂，主要用于血液肿瘤，尚未涉及慢性荨麻疹。今年3月6日，1类新药瑞米布替尼片的上市申请已在中国纳入优先审评。
Rhapsido
Novartis’ Rhapsido® (remibrutinib) FDA-Approved as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria
Novartis’ Rhapsido® (remibrutinib) receives FDA approval as the first oral BTK inhibitor for chronic spontaneous urticaria (CSU). Filed in EU, Japan, and China (priority review).
Crystalys Therapeutics
诺和诺德领投 Crystalys 2.05 亿美元融资 助推卫材痛风药多替诺雷欧美临床
诺和诺德支持的 Crystalys Therapeutics 完成 2.05 亿美元融资，推进多替诺雷欧美 III 期临床。该款每日一次的 URAT1 抑制剂已在中国及亚洲获批，即将面向缺乏二线治疗选择的欧美痛风患者。
Crystalys Therapeutics
Crystalys Launches With $205M to Advance Dotinurad Globally, Already Approved in China by Eisai
Novo-backed Crystalys Therapeutics raised $205M to advance dotinurad into global Phase 3 trials. Already approved in China and Asia, the once-daily URAT1 inhibitor will target U.S. and European patients with unmet need for second-line gout therapy.
Met-097i
Metsera公布MET-097i IIb期顶线数据，辉瑞73亿美元收购加速全球III期临床启动
Metsera发布超长效GLP-1候选药MET-097i在VESPER-1和VESPER-3 IIb期临床数据：28周注射最高体重下降14.1%，耐受性良好。VESPER-1总中断率仅2.9%。基于此，全球III期临床将于2025年底启动，同时支撑辉瑞73亿美元收购布局。
Met-097i
Pfizer’s $7.3B Obesity Gamble Pays Early with MET-097i Phase 2b Success
Pfizer’s $7.3 billion acquisition of Metsera is backed by new Phase 2b data for MET-097i, an ultra-long-acting GLP-1 candidate showing 14% weight loss and promising tolerability. Phase 3 initiation is slated for late 2025. Monthly dosing could give Pfizer an edge in the obesity race.
HPV疫苗
首个国产 HPV 四价疫苗“爱薇佳”获批，完成全系列国产化
国家药监局批准首个国产四价 HPV 疫苗爱薇佳（国药集团）上市，继国产二价和九价之后，中国市场第二个获批四价疫苗，适用于 18–45 岁女性，覆盖 HPV 6/11/16/18 型。
Quadrivalent HPV Vaccine
Aiweijia: China’s First Domestic Quadrivalent HPV Vaccine Completes Full Homegrown HPV Lineup
NMPA has approved China’s first domestic quadrivalent HPV vaccine (Aiweijia) from Sinopharm’s CNBG. Following the launch of domestic bivalent and nine-valent vaccines, and after Merck’s Gardasil, it is the second quadrivalent on the Chinese market, targeting HPV 6/11/16/18 for women aged 18–45.
甘李药业
甘李药业携手巴西Fiocruz与Biomm签署10年胰岛素本土化协议
甘李药业与巴西Fiocruz、Biomm签署10年技术转让与供应协议，推动胰岛素在巴西的本土化生产。协议金额≥30亿元人民币，助力PDP计划和糖尿病公共健康保障。
Gan & Lee
China’s Gan & Lee to Localize Insulin Production in Brazil via 10-Year Partnership
Gan & Lee Pharmaceuticals signs a landmark 10-year Technology Transfer and Supply Agreement with Fiocruz and Biomm to localize insulin glargine production in Brazil’s PDP program, securing ≥ RMB 3 billion in supply and boosting public health access.