5月5日，君实生物与瑞迪博士实验室（Dr. Reddy’s Laboratories）签署了《独占许可与商业化协议》，同意向后者授予许可，于巴西、墨西哥、哥伦比亚、阿根廷、秘鲁、智利、巴拿马、乌拉圭、印度及南非开发及独占地商业化特瑞普利单抗注射液（TAB001/JS001）。瑞迪博士实验室可选择将许可范围扩大至涵盖澳大利亚及新西兰以及其他9个国家。 根据协议，君实生物可获得700万美元的首付款以及用于潜在扩大许可区域的300万美元的款项，并于约定的里程碑事件达成后，君实生物最多可获得7.183亿美元的里程碑款，外加含特瑞普利单抗注射液的产品销售净额两位数百分比的特许权使用费。 特瑞普利单抗注射液是以PD-1为靶点的单抗药物，至今已在全球（包括中国、美国、东南亚及欧洲等地）开展了覆盖超过15个适应症的30多项由公司发起的临床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评估特瑞普利单抗的安全性及疗效，包括肺癌、鼻咽癌、食管癌、胃癌、膀胱癌、乳腺癌、肝癌、肾癌及皮肤癌等。截至目前，特瑞普利单抗的6项适应症已于中国获批，其中3项适应症已被纳入中国国家医保目录（2022年版）。 在国

Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies today announced achievement of a milestone in its ongoing collaboration with Exelixis for development of novel masked antibody-drug conjugate (ADC) candidates leveraging Adagene’s proprietary SAFEbody precision masking technology. Under the terms of a collaboration and licensing agreement established in 2021, the milestone

5月2日，西比曼生物科技宣布与强生（Johnson & Johnson）旗下杨森（Janssen）公司达成一项全球独家合作，共同开发和商业化下一代新型CAR-T细胞治疗产品C-CAR039（靶向CD19/CD20）和C-CAR066（靶向CD20），用于治疗非霍奇金淋巴瘤（NHL）。根据协议，西比曼生物科技将获得2.45亿美元的首付款、潜在的里程碑付款和未来商业化后的销售分成。 西比曼生物科技是一家专注开发新型细胞疗法的全球创新生物制药公司。目前，该公司临床阶段的血液肿瘤产品包括靶向CD19/CD20的新型双靶点自体CAR-T细胞产品C-CAR039，靶向CD20的新型自体CAR-T细胞产品C-CAR066，以及特异性靶向B细胞成熟抗原（BCMA）的新型自体CAR-T细胞产品C-CAR088。该公司的实体瘤细胞治疗产品包括自体铠装抗肝癌特异性抗原GPC3 CAR-T细胞产品C-CAR031、肿瘤浸润T淋巴细胞（TIL）治疗产品C-TIL051。此外，西比曼生物科技还拥有多款新型针对血液肿瘤、实体瘤和自身免疫性疾病的临床前细胞产品。 根据协议条款，通过本次合作，杨森将获得C-CAR039

Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced it has entered into a preclinical research collaboration with AstraZeneca (LSE/STO/Nasdaq:AZN) to evaluate the use of Sernova’s Cell Pouch System™ in combination with AstraZeneca’s novel therapeutic cells. “Sernova has developed a novel cell therapy approach for the potential treatment of insulin-dependent diabetes, hypothyroidism and hemophilia A,” said Dr. Philip To

Tuesday, Johnson & Johnson subsidiary Janssen Biotech entered into a worldwide collaboration and license agreement with Chinese biotech Cellular Biomedicine Group to develop next-generation CAR-T therapies for diffuse large B-cell lymphoma. Under the terms of the deal, Janssen will pay $245 million upfront. CBMG will also be entitled to potential development, regulatory and sales milestones as well as tiered royalty payments on future sales. The companies are not disclosing the exact amounts f

5月1日，安斯泰来（Astellas）宣布将通过其全资子公司Berry Merger Sub约59亿美元收购Iveric Bio公司，以打造世界一流的眼科药企。新闻稿指出，Iveric Bio公司拟用于治疗地理萎缩的先导候选药物avacincaptad pegol在美国的PDUFA日期为今年8月19日。本次收购推进了安斯泰来对“失明与复明”的关注。IVERIC Bio是一家生物制药公司，致力于研发视网膜疾病的新型治疗方案。该公司于2023年2月宣布，美国FDA受理了avacincaptad pegol的新药申请（NDA），用于治疗继发于年龄相关性黄斑变性（AMD）的地理萎缩（GA），且授予这一NDA优先审评资格。此前，该候选药物还获FDA授予突破性疗法资格，用于这一适应症。Avacincaptad Pegol是一种补体C5抑制剂，其在两项关键临床试验（GATHER临床试验）中达到了其主要疗效终点（降低GA进展速度），具有统计学意义。AMD是老年人中度和重度中央视力丧失的主要原因，影响大多数患者的双眼。黄斑是视网膜中央部分的一个小区域，负责中央视力。随着AMD的进展，黄斑中视网膜细胞和下

Sanofi announced today the completion of its acquisition of Provention Bio, Inc. (“Provention Bio”). The acquisition adds TZIELD (teplizumab-mzwv), an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. Olivier Charmeil Executive Vice President, General Medicines, Sanofi “We are excited to finalize our acquisition of Provention Bio, Inc. This

Polydex Pharmaceuticals Limited (OTC Pink: POLXF) (the “Company” or “Polydex”) announced today that it has entered into a Plan of Arrangement agreement (the “Arrangement Agreement”) whereby BioSpectra, Inc. and BioSpectra Canada, Ltd (together, “BioSpectra”) will acquire all of the outstanding common and preferred shares of the Company for total consideration of $6,940,000, of which US$6,924,980.02 will be paid for 3,432,478 common shares outstanding and US$15,019.98 will be paid for 899,400 Cla

Triggers milestone payment of approximately $0.3 million OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported today that its German subsidiary Curetis GmbH has met the remaining key milestones under the initial research and development (“R&D”) collaboration agreement with FIND. Following the delivery of a comprehensive milestone report at the end of first qua

Sanofi announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), applicable to Sanofi’s proposed acquisition of Provention Bio, Inc. (“Provention Bio”, NASDAQ: PRVB) has expired. On March 24, 2023, Sanofi commenced a cash tender offer (the “Offer”) to purchase all outstanding shares of common stock of Provention Bio (the “Shares”), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any wit