5月20日，健友股份（603707.SH）披露，公司子公司Meitheal Pharmaceuticals, Inc.(以下简称"Meitheal") 获得美国食品药品监督管理局(以下简称"FDA")签发 的盐酸伊达比星注射液生产场地转移批准信。 该药品包括5mg/5mL、10mg/10mL和20mg/20mL三种规格，适用于成人急性髓细胞性白血病（AML）的治疗。 此次批准允许在健友股份的另一子公司健进制药有限公司的场地生产该药品。盐酸伊达比星注射液是美国FDA近期重点关注的市场短缺产品，目前美国境内 仅有另一家公司持有其仿制药上市销售。 健友股份总裁黄锡伟在接受经济观察报采访时表示，该产品是2023年公司自以色列药企Teva处购买。在买下该产品后，需将产能转移至自身的肿瘤药基地进 行生产。"在更换生产场地后，FDA需要重新审查数据以符合要求。而在经FDA批准后，新批准产品近期将安排在美国上市销售。" 除该产品外，健友股份即将为双成药业（002693.SZ）刚获FDA批文的产品注射用紫杉醇(白蛋白结合型)(以下简称"白蛋白紫杉醇")展开在美商业化工作。 过去一年，健友股份制剂业务自美国销售收入同比增长近两成 ...

Policy Developments - Abbott Molecular Inc. has initiated a recall of its automated real-time fluorescent nucleic acid amplification analysis system due to design defects [1] - Other companies including Ortho Clinical Diagnostics, Leica Biosystems, Beckman Coulter, and Aesculap have also recalled products due to various issues such as potential bias in reportable range, incorrect labeling, cross-contamination, and rising complaint trends [1] Drug and Device Approvals - Jianyou Co., Ltd. has received FDA approval for the production site transfer of its Idarubicin Hydrochloride Injection in multiple dosages [2] - Xinhua Pharmaceutical has been granted approval for the listing of Eicosapentaenoic Acid Ethyl Ester as a chemical raw material drug [3] Capital Market Activities - Guangzhou Pharmaceutical, a subsidiary of Baiyunshan, will be listed on the New Third Board starting May 20, 2025 [4] - Chuangxin International has completed nearly 100 million RMB in Series B financing led by Yueke Fund and Zhongshan Haochuang Fund [5] Industry Events - Kanghui Pharmaceutical has won a first-instance judgment in a lawsuit against Kelewei Biopharmaceuticals regarding equity repurchase, requiring Kelewei to pay 2 million RMB in deposit and 35.994 million RMB in repurchase funds [6] - Weigao Blood Purification Products Co., Ltd. has officially listed on the Shanghai Stock Exchange, raising approximately 1.09 billion RMB through its IPO [7] Public Sentiment Alerts - Sanleaf Bio has changed its accounting firm due to disagreements over audit fees [8] Management Changes - Dize Pharmaceutical's executives plan to reduce their shareholdings due to personal financial needs, with specific amounts detailed for each individual [9][10] - Jia Ying Pharmaceutical's CFO has resigned for personal reasons and will no longer hold any position within the company [11]