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一周3款小分子创新药获批!“不是癌症的癌症”治疗药物实现中美同步;人用破伤风抗毒素龙头江西生物二次冲击港交所 | 掘金创新药
Mei Ri Jing Ji Xin Wen· 2025-10-28 14:33
Core Insights - The pharmaceutical and biotechnology sector is experiencing a mixed performance, with the medical biotechnology index underperforming the Shanghai Composite Index for five consecutive weeks [4] - Jiangxi Biological Products Research Institute has submitted a new application for listing on the Hong Kong Stock Exchange, heavily reliant on a single product, human tetanus antitoxin (TAT), which constitutes over 93% of its revenue [5][7] - Recent approvals of innovative drugs include a treatment for idiopathic pulmonary fibrosis (IPF) and a new oral hypoglycemic agent, indicating ongoing advancements in the pharmaceutical industry [12][13] Industry Performance - The medical biotechnology index rose by 0.35% from October 20 to October 24, lagging behind the Shanghai Composite Index by 0.36 percentage points [4] - The Hong Kong healthcare index fell by 0.77%, continuing a downward trend despite some positive developments in the sector [4] Company Developments - Jiangxi Biological, the largest provider of human TAT in China, reported revenues of 221 million yuan for 2024 and 99.7 million yuan for the first half of 2025, with a significant reliance on a low-priced product [5][7] - The company has a market share of 36.6% globally and 65.8% domestically for human TAT, but faces risks due to its dependence on a single product [7] Clinical Trials and Approvals - A total of 95 clinical trial registrations were disclosed by the National Medical Products Administration, with 30 trials in Phase II or higher, primarily in oncology and cardiovascular fields [8] - Three small molecule innovative drugs were approved recently, including a PDE4B inhibitor for IPF and a new combination oral hypoglycemic agent for type 2 diabetes [12][13] Market Trends - The recent decline in shares of Huahao Zhongtian Pharmaceutical-B, which has dropped over 33% in two weeks, reflects broader market challenges for innovative drug companies [15][16] - The company has not yet achieved profitability, with a reported revenue of 14.78 million yuan in the first half of the year, down 55.36% year-on-year [15]
海思科:获得创新药HSK44459片新适应症IND申请《受理通知书》
Zheng Quan Shi Bao Wang· 2025-10-28 09:45
人民财讯10月28日电,海思科(002653)10月28日公告,获得创新药HSK44459片新适应症IND申请 《受理通知书》,适应症为炎症性肠病。海思科同日发布2025年第三季度报告,第三季度实现归母净利 润1.66亿元,同比下降23.32%。 ...
海思科:HSK44459片新增适应症IND申请获受理
Xin Lang Cai Jing· 2025-10-28 09:41
Core Viewpoint - The company has received a notice from the National Medical Products Administration regarding the acceptance of the clinical trial application for HSK44459 tablets, aimed at treating inflammatory bowel disease [1] Group 1: Product Development - HSK44459 tablets are independently developed by the company for the treatment of inflammatory bowel disease [1] - Preclinical research results indicate that HSK44459 has independent intellectual property rights, confirmed efficacy, and good safety [1] Group 2: Clinical Trials - HSK44459 tablets have already received clinical trial approval notices for other indications, including interstitial lung disease, Behçet's disease, psoriasis, and atopic dermatitis, all of which are currently undergoing Phase II clinical studies [1]
医药生物行业周报(3月第2周):国家卫健委将持续推进体重管理
Century Securities· 2025-03-17 00:48
Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.77%, outperforming the Wind All A index (1.49%) and the CSI 300 index (1.59%) [3][8] - Offline pharmacies and pharmaceutical distribution significantly outperformed the index with increases of 10.38% and 4.91% respectively, while in vitro diagnostics (0.77%), raw materials (0.83%), and other biological products (0.89%) lagged behind [3][9] - The report highlights the ongoing "Weight Management Year" initiative launched by the National Health Commission, emphasizing the need for continuous efforts in managing obesity and related chronic diseases [3][12] - The introduction of a pricing guide for brain-computer interface services by the National Medical Insurance Administration aims to accelerate the clinical application of new technologies [3][12] Market Weekly Review - The pharmaceutical and biotechnology sector increased by 1.77%, outperforming the Wind All A index (1.49%) and the CSI 300 index (1.59%) [3][8] - Key performers included offline pharmacies (10.38%) and pharmaceutical distribution (4.91%), while in vitro diagnostics (0.77%) and raw materials (0.83%) underperformed [3][9] - Top gainers included Kingmed Diagnostics (42.43%), Sanyou Medical (34.47%), and Dongfang Ocean (25%), while the largest declines were seen in Shuangcheng Pharmaceutical (-16.56%), Haichuang Pharmaceutical-U (-12.21%), and Ailis (-11.09%) [3][10] Industry News and Key Company Announcements - The National Health Commission's initiative on weight management aims to address obesity and its associated health risks, with a focus on chronic disease prevention [3][12] - The National Medical Insurance Administration has established pricing for brain-computer interface services, facilitating the transition of innovative technologies to clinical use [3][12] - Roche announced a collaboration with Zealand Pharma to develop a long-acting insulin analog, with a total transaction value of $5.3 billion [3][12] - Clinical trials for various drugs, including those for obesity and hypertension, have shown promising results, indicating potential market opportunities [3][14][16][18]