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东曜药业祝贺合作伙伴乐普生物EGFR ADC新药获NMPA批准上市
Xin Lang Cai Jing· 2025-10-31 10:26
Core Insights - Dongyao Pharmaceutical celebrates the conditional approval of its partner Lepu Biopharma's innovative drug, Vebekotamab, marking a significant milestone in the commercialization of ADCs in China [1][3] - The successful collaboration between Dongyao and Lepu demonstrates the company's capabilities in complex molecule production and quality control, essential for ADC manufacturing [1][2] Company Overview - Dongyao Pharmaceutical (stock code: 1875.HK) is a leading global CDMO specializing in biopharmaceuticals, providing comprehensive services from early development to commercial production [8] - The company has extensive experience in large-scale biopharmaceutical production compliant with GMP standards, with certifications from multiple countries including China, Brazil, and Japan [2][8] Product Details - Vebekotamab is an EGFR-targeted ADC designed for treating recurrent or metastatic nasopharyngeal carcinoma (R/M NPC), representing the first approved EGFR-targeted ADC in China [5] - The drug combines a monoclonal antibody targeting EGFR with a potent payload, leading to tumor cell death through a specific mechanism [5] Industry Context - The approval of Vebekotamab highlights the growing importance of ADCs in targeted cancer therapies, providing new treatment options for patients with limited alternatives [3][4] - The collaboration between Dongyao and Lepu sets a precedent for effective partnerships in the biopharmaceutical industry, emphasizing the need for high-quality production and regulatory compliance [2][4]