Workflow
注射用HY05350
icon
Search documents
恒生港股通创新药指数即将修订;恒瑞医药斑秃药物获批上市丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-06-30 23:31
Group 1: Index and Market Trends - The Hang Seng Hong Kong Stock Connect Innovative Drug Index will be revised to exclude CXO companies, focusing solely on innovative drug firms, achieving a 100% purity in its index composition [1] - This adjustment is expected to increase the weight of Hong Kong innovative drug companies in the index, better reflecting the core trends and valuation logic of the innovative drug industry [1] Group 2: Company Developments - Heng Rui Medicine received approval from the National Medical Products Administration for its innovative drug SHR0302 for treating severe alopecia areata, marking a significant advancement in domestic JAK1 inhibitors [2] - The approval addresses a substantial patient population in China, with approximately 3.49 million alopecia areata patients reported in 2021, highlighting the unmet medical need in this area [2] - Huiyu Pharmaceutical's TCE tri-antibody drug HY05350 has received clinical trial approval for treating advanced solid tumors, showcasing the company's capabilities in innovative drug development [3] - Han Yu Pharmaceutical expects a net profit of 142 to 162 million yuan for the first half of 2025, driven by strong global market demand and successful product approvals, indicating a recovery from previous losses [4] - The company's performance is significantly influenced by a few products in overseas markets, raising questions about future sustainability [4]
汇宇制药:注射用HY05350获药物临床试验批准
news flash· 2025-06-30 09:45
汇宇制药公告,全资子公司汇宇海玥收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》,注射用HY05350用于治疗晚期实体瘤的临床试验获得批准。注射用HY05350为自主研发的三特异 抗体TCE产品,以CD3、MSLN、PD-L1为靶点,注册分类为1类创新型治疗用生物制品。截至公告披露 日,国内外尚无同靶点产品获批上市。 ...