Jan. 02, 2025 -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has successfully completed the divestiture of its Advanced Rehabilitation business to Accelmed Partners (“Accelmed”), a private equity firm focused on acquiring and growing commercial-stage HealthTech companies. The transaction, announced on October 1, 2024, enables Bioventus to continue improving its focus and execution within the Company’s co

1. 全球首款CLDN18.2单抗在国内获批上市 12月31日，NMPA官网显示，安斯泰来申报的进口新药佐妥昔单抗在国内获批上市，联合含氟尿嘧啶类和铂类药物化疗用于CLDN18.2阳性、人表皮生长因子受体2（HER2）阴性的局部晚期不可切除或转移性胃或胃食管交界处（GEJ）腺癌患者的一线治疗。佐妥昔单抗是安斯泰来自主研发的全球首款靶向CLDN18.2的IgG1单抗，今年10月18日获美国FDA批准上市，此前两项III期临床研究SPOTLIGHT（NCT03504397）和GLOW（NCT03653507）均达到了积极结果。 2. 科伦博泰PD-L1单抗在国内获批上市 12月31日，NMPA官网显示，科伦博泰的塔戈利单抗注射液（商品名：科泰莱）获批上市。适应症为：单药用于既往接受过二线及以上化疗失败的复发或转移性鼻咽癌（R/M NPC）患者的治疗。塔戈利单抗是科伦博泰自主研发的一种人源化IgG1κ亚型单抗，II期KL167-2-05-CTP研究表明，塔戈利单抗在既往接受过治疗的R/M NPC患者中显示出有显著的疗效和可控的安全性，ORR为26.5%，DCR为56.8%；中位DOR为12.

1月4日，恒瑞医药发布公告，其子公司天津恒瑞医药申报的HRS-6768注射液获批临床，将于近期开展晚期实体瘤的临床试验。 HRS-6768注射液为恒瑞医药自主研发的化学药品1类放射性治疗类创新药，国内外均未有同品种获批上市。本品适用于成纤维细胞活化蛋白阳性的晚期实体瘤患者。截至目前，HRS-6768注射液相关项目累计已投入研发费用约1889万元。 内容来源于网络，如有侵权，请联系删除。

2025年1月6日，先声药业集团（2096.HK）旗下抗肿瘤创新药公司先声再明宣布，其自主研发的CDH6抗体偶联药物（ADC）SIM0505于2025年1月2日获得中国国家药品监督管理局签发的临床试验批准通知书，拟开展针对晚期实体瘤的临床试验。2024年12月28日，SIM0505的新药临床试验申请(IND)已获得美国药品监督管理局（FDA）批准。 CDH6（钙粘蛋白-6或K-钙粘蛋白）是一种单次跨膜蛋白，参与细胞间粘附、器官发育和上皮间质转化。CDH6在正常组织中表达极低，而在多种肿瘤中高表达，有望成为晚期肿瘤治疗的重要靶点。 SIM0505为先声再明自有技术平台开发的临床阶段的ADC项目，拟在全球开展多中心临床研究。该分子结合了CDH6抗体分子的肿瘤特异靶向性和喜树碱类毒素分子的高杀伤性，对卵巢癌、肾癌等恶性肿瘤具有治疗潜力。 先声再明是先声药业集团旗下专注于抗肿瘤创新药研发、生产和商业化的生物医药公司，2023年起独立运营，致力于以突破性治疗手段, 解决中国乃至全球肿瘤领域巨大的未满足临床需求。再明着力打造高价值创新管线，已上市产品组合包含科赛拉®、恩维达®、恩度®、恩立妥

1. 全球首款CLDN18.2单抗在国内获批上市 12月31日，NMPA官网显示，安斯泰来申报的进口新药佐妥昔单抗在国内获批上市，联合含氟尿嘧啶类和铂类药物化疗用于CLDN18.2阳性、人表皮生长因子受体2（HER2）阴性的局部晚期不可切除或转移性胃或胃食管交界处（GEJ）腺癌患者的一线治疗。佐妥昔单抗是安斯泰来自主研发的全球首款靶向CLDN18.2的IgG1单抗，今年10月18日获美国FDA批准上市，此前两项III期临床研究SPOTLIGHT（NCT03504397）和GLOW（NCT03653507）均达到了积极结果。 2. 科伦博泰PD-L1单抗在国内获批上市 12月31日，NMPA官网显示，科伦博泰的塔戈利单抗注射液（商品名：科泰莱）获批上市。适应症为：单药用于既往接受过二线及以上化疗失败的复发或转移性鼻咽癌（R/M NPC）患者的治疗。塔戈利单抗是科伦博泰自主研发的一种人源化IgG1κ亚型单抗，II期KL167-2-05-CTP研究表明，塔戈利单抗在既往接受过治疗的R/M NPC患者中显示出有显著的疗效和可控的安全性，ORR为26.5%，DCR为56.8%；中位DOR为12.

— HUTCHMED continues to deliver on its strategy outlined in November 2022 to create value, prioritize its portfolio and bring innovative medicines to patients globally — — Divestment proceeds to advance HUTCHMED’s pipeline and core innovative medicines business — — Focused R&D investment includes HUTCHMED’s proprietary antibody-targeted therapy conjugate platform, with first candidates expected to enter clinical trials in the second half of 2025 — Jan. 01, 2025 -- HUTCHMED (China) Limited (“HUT

December 30, 2024 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announced that it plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares, DKK 1 nominal value (the “ADS ratio”), from the current one (1) ADS representing ten (10) ordinary share to a new ADS ratio of one (1) ADS representing fifty (50) ordinary shares (the “ADS ratio change”). The ADS ratio cha

Intend to announce updated clinical data from Phase 1/2 VBP301 trial of VCAR33ALLO in the first half of 2025 and updated clinical data from Phase 1/2a VBP101 trial of trem-cel in combination with Mylotarg in the second half of 2025 Extends cash runway through release of updated data from VBP101 and VBP301 trials in 2025 Dec. 27, 2024 -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced that it has entered into a securities purchase agreement for a priv

Dec. 23, 2024 -- XBiotech (NASDAQ: XBIT) announced today data that it is halting its clinical program in rheumatological disease while it seeks to understand the outcome from its recently completed Phase II, Double-Blind, Placebo-Controlled, Randomized study in Rheumatoid Arthritis. The Phase II study failed to meet its primary endpoint amid substantial irregularities that make unequivocal interpretation of the findings difficult. XBiotech was planning launch of additional studies in arthritis

Dec. 20, 2024 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This expected communication from the FDA aligns with the company’s previously disclosed strategic decision to discontinue launch pr