Workflow
Rezdiffra(resmetirom)
icon
Search documents
太平洋医药日报:MADRIGAL创新疗法RESMETIROM在欧盟获批 用于治疗 MASH
Xin Lang Cai Jing· 2025-08-21 12:30
Market Performance - The pharmaceutical sector experienced a slight decline of -0.07% on August 20, 2025, underperforming the CSI 300 index by 1.21 percentage points, ranking 31st among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, hospitals (+0.63%), blood products (+0.30%), and medical research outsourcing (+0.29%) showed positive performance, while other biopharmaceuticals (-1.02%), in vitro diagnostics (-0.46%), and medical consumables (-0.38%) lagged behind [1] - Top three gainers in individual stocks were Huabang Health (+10.11%), Jimin Health (+10.02%), and Tianmu Pharmaceutical (+10.01%), while the biggest losers were Xintian Pharmaceutical (-10.01%), Fuyuan Pharmaceutical (-10.00%), and Chengyi Pharmaceutical (-9.99%) [1] Industry News - Madrigal announced that the European Commission has conditionally approved its drug Rezdiffra (resmetirom) for treating adult patients with moderate to severe liver fibrosis due to non-alcoholic steatohepatitis (MASH) [2] - Resmetirom is a "first-in-class" oral thyroid hormone receptor (THR)-β selective agonist targeting the underlying causes of MASH [2] - This approval marks the first MASH therapy to receive EU approval, based on results from the pivotal MAESTRO-NASH Phase 3 clinical trial, which showed that 25.9% and 29.9% of patients in the 80mg and 100mg Resmetirom groups, respectively, achieved symptom resolution without worsening liver fibrosis at week 52, compared to 9.7% in the placebo group (P<0.001) [2] Company News - Heng Rui Medicine (600276) reported a revenue of 15.761 billion yuan for the first half of 2025, a year-on-year increase of 15.88%, with a net profit attributable to shareholders of 4.450 billion yuan, up 29.67% [3] - Lizhu Group (000513) posted a revenue of 6.272 billion yuan for the first half of 2025, a slight decline of 0.17%, while net profit attributable to shareholders increased by 9.40% to 1.281 billion yuan [3] - Te Bao Biological (688278) achieved a revenue of 1.511 billion yuan, reflecting a growth of 26.96%, with a net profit of 428 million yuan, up 40.60% [3] - Zhong Yao Holdings (000950) reported a revenue of 41.188 billion yuan, a growth of 3.54%, and a net profit of 282 million yuan, increasing by 18.56% [3]
石药集团(01093):公司的口服GLP-1RA授权出海,总金额超20亿美元
Investment Rating - The report does not explicitly state an investment rating for CSPC Pharmaceutical Group Core Insights - CSPC Pharmaceutical Group has entered into an exclusive licensing agreement with Madrigal Pharmaceuticals for the global development, production, and commercialization of its oral GLP-1 receptor agonist, SYH2086, with a total deal value exceeding USD2 billion [6][8] - The agreement includes an upfront payment of USD120 million, potential milestone payments of up to USD1.955 billion, and royalties based on annual net sales of SYH2086 [6][8] - The partnership with Madrigal, a leading biotech in the metabolic disease space, is seen as a strong validation of CSPC's oral GLP-1RA and is expected to accelerate clinical development in the U.S. [8][9] - This deal is considered an additional upside beyond previously guided licensing deals, highlighting the value of CSPC's small-molecule platform [9] - CSPC's AI-powered small-molecule platform has also licensed multiple assets to AstraZeneca, with a total deal value reaching USD5.3 billion [10] Summary by Sections Licensing Agreement - CSPC has granted Madrigal exclusive rights to develop, manufacture, and commercialize SYH2086 globally while retaining rights for other oral GLP-1 products in China [6][8] - The total potential revenue from this agreement could reach USD2.075 billion, including upfront and milestone payments [6][8] Clinical Development - SYH2086 is currently in the preclinical stage, and the competitive landscape in the metabolic disease field is noted to be highly challenging [7][8] - CSPC's EGFR ADC has shown superior efficacy in Phase I clinical trials compared to conventional ADC drugs, with lower rates of hematologic toxicity [11] - CSPC's siRNA platform has advanced three candidates into clinical stages, indicating potential for future collaborations [12] Market Potential - The partnership with Madrigal opens up potential markets in obesity, diabetes, and MASH, enhancing the growth prospects for CSPC [8][9] - The report expresses optimism regarding future out-licensing opportunities for other products in CSPC's pipeline, which could act as catalysts for stock price growth [9]