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翰森制药:创新药阿美乐 新增两项适应症成功纳入新版2025国家医保目录
Zhi Tong Cai Jing· 2025-12-07 23:13
Core Insights - Hansoh Pharmaceutical (03692) announced that its innovative drug Amivantamab has successfully added two new indications to the 2025 National Medical Insurance Directory, which will be implemented on January 1, 2026 [1][2] Group 1: New Indications for Amivantamab - Amivantamab (brand name: 阿美乐) has received approval for two new indications for the treatment of adult non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1] - The new indications include treatment for patients who have previously undergone surgical resection and for those with locally advanced, unresectable NSCLC who have not shown disease progression during or after platinum-based chemotherapy [1] Group 2: Renewal of Other Drugs in the National Medical Insurance Directory - The drug Pemigatinib (brand name: 圣罗莱) has had its two indications renewed for inclusion in the 2025 National Medical Insurance Directory, specifically for treating anemia caused by chronic kidney disease [2] - The drug Adefovir Dipivoxil (brand name: 恒沐) has also been renewed for chronic hepatitis B treatment in adult patients [2] - Other innovative drugs such as Fluoromethylphenyl (brand name: 豪森昕福), Pegylated Liraglutide (brand name: 孚来美), and Inotuzumab Ozogamicin (brand name: 昕越) are currently under the National Medical Insurance Directory agreement until December 31, 2026 [2]
翰森制药(03692):创新药阿美乐®新增两项适应症成功纳入新版2025国家医保目录
智通财经网· 2025-12-07 23:11
Core Insights - Hansoh Pharmaceutical (03692) announced that its innovative drug Amivantamab has successfully added two new indications to the 2025 National Medical Insurance Directory, effective January 1, 2026 [1][2] - The drug Pemigatinib (brand name: Saintrolai) has renewed its inclusion in the 2025 National Medical Insurance Directory for two indications related to anemia caused by chronic kidney disease [1] - The drug Adefovir Dipivoxil (brand name: Hengmu) has also renewed its inclusion for the treatment of chronic hepatitis B in adults [2] Summary by Category New Indications - Amivantamab (brand name: Amivale) has received approval for two new indications for the treatment of adult non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1] - The new indications include treatment for patients who have undergone surgical resection and those with locally advanced, unresectable NSCLC [1] Renewed Inclusion - Pemigatinib (brand name: Saintrolai) has renewed its inclusion for treating anemia in adults with chronic kidney disease, covering both non-dialysis and dialysis patients [1][2] - Adefovir Dipivoxil (brand name: Hengmu) has renewed its inclusion for chronic hepatitis B treatment in adults [2] Other Relevant Drugs - Other innovative drugs such as Fluoromethylphenidate (brand name: Haosenxinfu), Pegylated Liraglutide (brand name: Fulaimai), and Inalizumab (brand name: Xinyue) are currently under the National Medical Insurance Directory agreement until December 31, 2026 [2]
翰森制药2024年营收122.61亿元增长21.3%,阿美乐冲击60亿目标,合规风险仍存隐患
Jin Rong Jie· 2025-08-18 15:01
Core Insights - The company reported a total revenue of 12.261 billion yuan for 2024, representing a year-on-year growth of 21.3% [2] - The net profit attributable to shareholders reached 4.372 billion yuan, with a year-on-year increase of 33.4% [2] - The basic earnings per share were 0.74 yuan, also reflecting a growth of 33.3% year-on-year [2] Revenue Breakdown - Sales revenue from innovative drugs and cooperative products amounted to 9.477 billion yuan, accounting for 77.3% of total revenue [2] - The company achieved robust growth in core therapeutic areas including oncology, central nervous system, metabolism, and other diseases [2] Product Performance - The core product, Amelot, has been particularly successful, with three indications approved in China and two renewed for inclusion in the national medical insurance directory [3] - The product Housen Xinfu, a novel second-generation TKI for chronic myeloid leukemia, has also been renewed for inclusion in the national medical insurance directory [3] - The product Xinyue, the first humanized CD19 monoclonal antibody approved for treating AQP4 antibody-positive NMOSD, has been included in the national medical insurance directory [3] R&D Investment - The R&D team consists of over 1,800 researchers across four centers in China and the U.S. [4] - The company submitted 57 formal patent applications in China and 222 overseas, with respective authorizations of 48 and 42 [4] - Over 60 innovative drug clinical trials are ongoing, with eight new candidates entering clinical research during the reporting period [4] Compliance Issues - The company faced significant compliance challenges, including a fine of 2.1 million yuan and the confiscation of illegal gains totaling approximately 25.54 million yuan due to unfair competition [6] - Violations included improper payments to doctors and various fraudulent activities during academic events [6] - The core product Amelot was notably involved in these compliance issues, with projected sales reaching 5 billion yuan in 2024, up from 3.5 billion yuan in 2023 [6] Workforce Challenges - The company has experienced a reduction in workforce, with employee numbers decreasing from 10,523 at the end of 2022 to 8,989 at the end of 2024, a total reduction of 1,534 employees [7] - There are 75 ongoing legal cases involving the company, with 25 related to labor disputes [7]