贝达药业公告，公司申报的盐酸恩沙替尼胶囊拟用于ALK阳性的IB期至IIIB期非小细胞肺癌患者的术后 辅助治疗，患者须既往接受过手术切除治疗，并由医生决定接受或不接受辅助化疗的上市许可申请已获 得NMPA受理。恩沙替尼是一种新型强效、高选择性的新一代ALK抑制剂，其"适用于此前接受过克唑 替尼治疗后进展的或者对克唑替尼不耐受的ALK阳性的局部晚期或转移性NSCLC患者的治疗"(二线适 应症)于2020年11月获得NMPA批准上市。2025年10月，恩沙替尼术后辅助治疗数据在2025年欧洲肿瘤 内科学会(ESMO)年会上首次披露，中期结果显示，恩沙替尼术后辅助治疗2年无病生存期(DFS)率达 86.4%，2年无病生存期风险比(HR)为0.20，复发风险降低80%，显著减少了疾病复发的可能。 ...

贝达药业(300558)11月26日午间公告，公司收到国家药品监督管理局（简称"NMPA"）签发的《受理通 知书》，公司申报的盐酸恩沙替尼胶囊（商品名：贝美纳®）拟用于"间变性淋巴瘤激酶（ALK）阳性 的IB期至IIIB期非小细胞肺癌（NSCLC）患者的术后辅助治疗，患者须既往接受过手术切除治疗，并由 医生决定接受或不接受辅助化疗"的上市许可申请已获得NMPA受理。 ...

Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, and has received the acceptance notice [1] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [1] - Chengdu Rongsheng is actively conducting work to support the review process since the acceptance of the application [1] - The NMPA has requested additional clinical trial data for the pediatric population (under 12 years old), leading Chengdu Rongsheng to withdraw the drug registration application [1] Group 2 - Chengdu Rongsheng plans to supplement and improve the relevant clinical data before resubmitting the marketing authorization application [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration of China, indicating progress in the commercialization of this product for chronic constipation treatment [1][1]. Group 1: Company Developments - The drug is intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1]. - As of October 2025, the total R&D investment for the series of Compound Polyethylene Glycol Electrolyte Powder products, including this drug, is approximately RMB 6.21 million (unaudited) [1]. - The acceptance of the drug registration application is not expected to have a significant impact on the company's current performance [1]. Group 2: Market Potential - According to the latest data from IQVIA CHPA, the sales revenue of Compound Polyethylene Glycol Electrolyte Powder in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 873 million in 2024 [1].