泽沃基奥仑赛注射液(赛恺泽)
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华东医药与生诺医药达成商业化合作
Zhong Zheng Wang· 2025-12-08 02:20
中证报中证网讯(记者傅苏颖)12月7日,华东医药(000963)全资子公司华东医药(杭州)有限公司宣布与 贵州生诺生物科技有限公司及其全资子公司上海生诺医药科技有限公司、江苏太瑞生诺生物医药科技有 限公司(三家合作公司合称为"生诺医药"),就生诺医药产品戊二酸利那拉生酯胶囊及其他剂型达成中国 大陆地区的独家商业化合作。 国家医保局12月7日披露,利那拉生酯针对反流性食管炎适应症和PARP抑制剂塞纳帕利(派舒宁)被纳入 2025年版国家医保目录。同时,泽沃基奥仑赛注射液(商品名:赛恺泽)被纳入2025年版商保创新药目 录,华东医药组建了独立专业、全方位的商业化团队全面推广赛恺泽,利用中国多层次保险体系,提高 患者可及性。目前,赛恺泽完成认证及备案的医疗机构已覆盖全国20多个省市。 近年来,华东医药创新研发聚焦肿瘤、内分泌及自身免疫三大核心治疗领域,通过自主研发、外部合作 和产品授权引进等方式,持续丰富覆盖研发全周期的差异化创新产品管线,为中长期发展提供新动能。 公司的自主研发创新能力持续提升,创新药研发中心正在推进90余项管线项目。 利那拉生酯是生诺医药与Cinclus Pharma合作开发的新一代钾离子竞争性 ...
1款全球首个+1款全球前四!华东医药MUC-17与FGFR2b 两款ADC获批临床
Quan Jing Wang· 2025-06-30 13:53
Core Insights - East China Pharmaceutical (华东医药) has made significant progress in the development of two innovative drugs, HDM2020 and HDM2012, which have received IND approvals in China and the US respectively [1][2][3] Drug Development Progress - HDM2012 is the world's first ADC targeting MUC-17, currently the only ADC in clinical research for this target, showing promising preclinical results for treating MUC-17 positive gastric, colorectal, and pancreatic cancers [2][3] - HDM2020 targets FGFR2b, a potential target associated with aggressive tumors like gastric and breast cancer, and has demonstrated strong anti-tumor activity in preclinical models [3] Clinical Trials and Approvals - HDM2012's clinical trial in China for advanced solid tumors was accepted by the National Medical Products Administration (NMPA) in June 2025 [3] - HDM2020 is the fourth ADC targeting FGFR2b to enter clinical trials, highlighting its clinical significance as recognized in the 2025 CSCO gastric cancer guidelines [3] Strategic R&D Initiatives - The company has built a differentiated product pipeline focusing on endocrine, autoimmune, and oncology therapies, with over 30 innovative oncology drug candidates, including ADCs [4] - Collaborations with companies like ImmunoGen and Heidelberg Pharma aim to strengthen the ADC innovation chain and ecosystem [4] Market Outlook - The global ADC market is projected to grow significantly, with sales expected to reach $64.7 billion by 2030, reflecting a compound annual growth rate of 30% [4] Recent Product Approvals - The ADC drug, Somatuzumab Injection (爱拉赫), received conditional approval in November 2024, with a supplementary application for regular approval submitted in March 2025 [5] - The ovarian cancer drug, Senaparib Capsules (派舒宁), was approved by NMPA in January 2025 [6] Company Vision - The dual approval of HDM2012 and HDM2020 signifies a major breakthrough in target innovation for Chinese pharmaceutical companies, showcasing the company's ambition in innovative R&D and its transition towards becoming a comprehensive innovation leader [7]