Group 1 - Roche Pharmaceuticals announced an investment of 2.04 billion RMB to establish a biopharmaceutical production base in Shanghai, aimed at enhancing its supply chain and local production in China, with completion expected in 2029 and production starting in 2031 [1] - Hengrui Medicine's application for the market approval of its CDK4/6 inhibitor, Hydroxyethyl Sulfonate Darsilil Tablets, has been accepted by the National Medical Products Administration, targeting hormone receptor-positive, HER2-negative early or locally advanced breast cancer [2] - Sanyou Medical plans to establish a joint venture with South Korea's CGBio to research innovative cell biological materials in regenerative medicine, marking a significant step in this field [3] Group 2 - ST Kelly has elected a new chairman, Wang Chong, following the recent resignation of both the chairman and the general manager, with the board voting in favor of the appointment [4] - Yunding New Medicine's core product, Naimu Kang, has received full approval from the National Medical Products Administration for treating primary immunoglobulin A nephropathy in adults, becoming the first and only drug in China approved for this indication [5]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-016 江苏恒瑞医药股份有限公司 关于药品临床试验进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）自主研发的羟乙磺 酸达尔西利片联合内分泌治疗在激素受体（HR）阳性、人表皮生长因子受体 2 （HER2）阴性女性乳腺癌辅助治疗中的一项多中心、随机、双盲的Ⅲ期临床试验 （研究方案编号：SHR6390-Ⅲ-303），首次期中分析主要终点达到统计学显著性。 研究结果显示，达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降 低患者复发风险，提高患者无侵袭性疾病生存期（IDFS）[1]。公司已于近期向国 家药品监督管理局药品审评中心递交上市前沟通交流申请。 一、 药品的基本情况 药品名称：羟乙磺酸达尔西利片 剂型：片剂 二、 药品的临床试验情况 达尔西利已于国内获批两项适应症，即本品适用于激素受体（HR）阳性、人 表皮生长因子受体 2（HER2）阴性局部晚期或转移性乳腺癌患者：1.与芳香化酶 抑制剂联合使 ...