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江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-05-30 06:13
Group 1: Drug Approval and Indications - Jiangsu Hengrui Medicine Co., Ltd. announced the conditional approval of its innovative drug SHR-A1811 for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy [1][2] - SHR-A1811 is the first antibody-drug conjugate (ADC) approved in China for HER2-mutant NSCLC patients, highlighting a significant advancement in targeted cancer therapy [1][3] - The drug's approval is based on the HORIZON-Lung study, which reported an objective response rate (ORR) of 74.5% and a median progression-free survival (mPFS) of 11.5 months in treated patients [3][4] Group 2: Market Context and Competitors - The global market for similar products, including Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), is projected to reach approximately $6.557 billion in 2024 [5] - The approval of SHR-A1811 positions the company competitively within the ADC market, which has seen limited options for HER2-mutant NSCLC treatment [5] Group 3: Additional Drug Approvals - The company also received approval for HR20013, a combination drug for preventing acute and delayed nausea and vomiting in adults undergoing highly emetogenic chemotherapy (HEC), marking it as China's first ultra-long-acting compound antiemetic injection [8][9] - HR20013 offers a significant advantage with a half-life of nearly 8 days, allowing for a single administration per chemotherapy cycle, thus improving patient compliance and quality of life [9][10] Group 4: Research and Development Investment - The cumulative R&D investment for SHR-A1811 has reached approximately 117 million yuan, while HR20013 has seen an investment of about 18.216 million yuan [5][10] - The company is actively exploring the therapeutic potential of SHR-A1811 in various cancer types beyond lung cancer, with multiple indications recognized by the National Medical Products Administration [3][10]