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塞纳帕利胶囊(派舒宁)
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华东医药创新药又获进展 肿瘤管线临床申请获FDA批准
Core Insights - Company East China Pharmaceutical has received FDA approval for its clinical trial application of HDM2012, a novel antibody-drug conjugate targeting MUC-17 for advanced solid tumors [1][2] - HDM2012 is a first-in-class biologic with global intellectual property rights, demonstrating good drug-like properties, safety, and efficacy in preclinical studies [1][2] - The ADC market is projected to grow significantly, with global sales expected to reach $64.7 billion by 2030, reflecting a compound annual growth rate of 30% [2] Company Developments - The clinical trial application for HDM2012 was submitted to the FDA in May 2025 and received approval shortly thereafter, with a similar application accepted in China in June 2025 [2] - East China Pharmaceutical has previously launched other ADC products, including the first-in-class drug Somatuzumab Injection, which received conditional approval in November 2024 [3] - The approval of HDM2012's clinical trial is a significant advancement in the company's R&D process, enhancing its competitiveness in the oncology treatment sector [3]
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]