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医药生物行业周报:医药生物行业双周报2025年第10期总第133期司美格鲁肽一季度登顶全球药王
Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Viewpoints - The GLP-1 weight loss drugs are experiencing explosive growth globally and in China, with significant sales figures expected for the year [7] - The pharmaceutical and biotechnology industry index increased by 1.50%, ranking 16th among 31 primary industries, underperforming the CSI 300 index [5][15] - The industry PE (TTM) as of May 9, 2025, is 26.77x, showing an upward trend but still below the average [20] Industry Review - The pharmaceutical and biotechnology industry index increased by 1.50%, ranking 16th among 31 primary industries, underperforming the CSI 300 index which increased by 1.56% [5][15] - The medical equipment and pharmaceutical distribution sectors showed the highest gains, with increases of 3.92% and 2.38% respectively, while medical research outsourcing saw a decline of 0.65% [5][15] - As of May 9, 2025, the PE (TTM) for the pharmaceutical and biotechnology industry is 26.77x, up from 26.34x in the previous period, indicating a valuation increase [20] Investment Suggestions - The current trend in GLP-1 weight loss drugs indicates a golden development period for the industry, with significant sales growth expected both globally and in China [7] - The report suggests focusing on companies with solid clinical data, sufficient production capacity, and integrated supply chain capabilities [7] Important Industry News - The NMPA has released new regulations for the quality management of online sales of medical devices, effective from October 1, 2025 [25] - The approval of the first long-acting analgesic new drug in China, "Meloxicam Injection," marks a significant milestone in the industry [31] - Johnson & Johnson's "Guselkumab Injection" has been approved as the first IL-23 inhibitor for treating ulcerative colitis in China [33] - The investment of 2.04 billion RMB by Roche in a new biopharmaceutical production base in Shanghai highlights the ongoing commitment to local production and supply chain enhancement [43]
国产创新药获批新适应症,非小细胞肺癌治疗实现全病程覆盖
Yang Zi Wan Bao Wang· 2025-05-09 12:10
2025年5月9日,翰森制药宣布其自主研发的I类新药甲磺酸阿美替尼片获得国家药品监督管理局批准,用于具有表皮生长因子受体(EGFR)外显子19缺 失或外显子21(L858R)置换突变阳性的非小细胞肺癌(NSCLC)成人患者肿瘤切除术后的辅助治疗。 | 序号 | 受理号 | 药品名称 | 申请人 | 批准文号 | 批准日期 | | --- | --- | --- | --- | --- | --- | | । | CXHS2300077 | 美洛昔康注射液 | 南京清普生物科技 | 国药准字 | 2025年04月30日 | | | | (II) | 有限公司 | H20250012 | | | S | CXHS2300080 | 注射用阿立哌唑微 | 珠海市丽珠微球科 | 国药准字 | 2025年04月30日 | | | | 球 | 技有限公司 | H20250011 | | | 3 | CXHS2400060 | 甲磺酸阿美替尼片 | 江苏豪森药业集团 | 国药准字 | 2025年04月30日 | | | | | 有限公司 | H20200004 | | | 4 | CXSS2300033 | 注射用重组人促 ...