注射用HRS8179

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太平洋医药日报:拜耳小分子肺癌新药SEVABERTINIB在华申报上市
Xin Lang Cai Jing· 2025-07-25 10:36
Market Performance - The pharmaceutical sector increased by 1.92% on July 24, 2025, outperforming the CSI 300 index by 1.21 percentage points, ranking 7th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, vaccines (+8.53%), hospitals (+3.95%), and medical research outsourcing (+3.37%) showed the best performance, while pharmaceutical distribution (+1.24%), medical consumables (+1.34%), and other biological products (+1.37%) lagged behind [1] - Top three gainers in individual stocks were Zhendong Pharmaceutical (+19.96%), Opcon Vision (+14.13%), and Maipu Medical (+10.58%); the largest decliners were Chengda Pharmaceutical (-13.12%), Renmin Tongtai (-8.95%), and Kangentai (-7.77%) [1] Industry News - The China National Medical Products Administration (NMPA) has accepted Bayer's application for the new drug BAY 2927088, an oral, reversible tyrosine kinase inhibitor (TKI) Sevabertinib, which has received breakthrough therapy designation from both the FDA and NMPA for treating adults with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 activating mutations who have received prior systemic therapy [2] Company News - Heng Rui Medicine (600276) announced that its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received approval from the NMPA for the clinical trial of HRS-1893 tablets, aimed at treating heart failure with preserved ejection fraction [3] - Heng Rui Medicine (600276) also reported that its subsidiary Beijing Shengdi Pharmaceutical Co., Ltd. received approval for the clinical trial of HRS-8179 injection, intended for the prevention of severe cerebral edema after large-area cerebral infarction [3] - Sino Medical (688108) projected a revenue of 240 million yuan for the first half of 2025, a year-on-year increase of 12.53%, with a net profit attributable to shareholders of 13.84 million yuan, up 296.54%, and a non-recurring net profit of 7.98 million yuan, up 163.35% [3] - Three Life National Health (688336) announced a collaboration with Pfizer, granting exclusive development and commercialization rights for 707 projects in mainland China, with total option and exercise fees not exceeding 150 million USD [3]
集采报价持续优化;天津医保局原党组成员、副局长被查
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-25 01:13
Policy Developments - The National Healthcare Security Administration (NHSA) has initiated the 11th batch of centralized procurement, optimizing the selection rules by no longer solely relying on the lowest bid as a reference. Companies with the lowest bids must now justify the reasonableness of their pricing and ensure it does not fall below cost [2] Drug and Medical Device Approvals - Senxuan Pharmaceutical's subsidiary has received approval for the market launch of Ritonavir raw materials, an antiviral drug primarily used for treating AIDS and also utilized during the COVID-19 pandemic [4] - Hengrui Medicine's subsidiary has received a clinical trial approval notice for the injectable HRS8179 drug, aimed at preventing severe brain edema after large-scale cerebral infarction. The project has seen a cumulative R&D investment of approximately 47.4 million yuan [5] Financial Reports - Sino Medical anticipates a 296.54% year-on-year increase in net profit for the first half of 2025, with expected revenue of 240 million yuan, reflecting a 12.53% growth [7] - WuXi Biologics forecasts a revenue growth of about 16% for the first half of the year, with profits expected to increase by approximately 54% and 56% for the company and its equity shareholders, respectively [8] Capital Markets - Lianhuan Pharmaceutical plans to issue up to 500 million yuan in technology innovation bonds to enhance R&D capabilities and optimize its debt structure. The bonds will be publicly issued with a term of no more than three years [10] Industry Developments - The NHSA has reported that over 100 drug varieties have applied to be included in the commercial health insurance innovative drug directory, which aims to incorporate high-value innovative drugs that cannot yet be included in the basic medical insurance directory [12] - As of the end of 2024, the cumulative recovery of medical insurance funds has reached 104.5 billion yuan, with a total balance of 3.86 trillion yuan in the insurance fund [14]