MEIYOUHENG Wins NMPA Approval as World’s First EGFR-Targeting ADC from TOT BIOPHARM, BioDlink, and Lepu Biopharma

Reuters
2025.11.21 13:00
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TOT BIOPHARM, in collaboration with BioDlink and Lepu Biopharma, has received NMPA approval for MEIYOUHENG®, the first EGFR-targeting ADC drug. This marks a significant milestone as the first ADC fully manufactured by a CDMO to reach the Chinese market, showcasing advancements in the biopharmaceutical sector.

TOT BIOPHARM International Co. Ltd., in partnership with BioDlink and Lepu Biopharma, has announced the successful regulatory approval and launch of MEIYOUHENG®, the world’s first EGFR-targeting ADC drug. The product received marketing approval from China’s National Medical Products Administration (NMPA) on October 30, 2025. This milestone marks the first time an antibody-drug conjugate (ADC) fully manufactured by a contract development and manufacturing organization (CDMO) has reached the market in China, highlighting significant progress in the region’s biopharmaceutical sector. The achievement underscores the robust collaboration and operational excellence among the involved organizations throughout the development, technology transfer, and manufacturing process. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. TOT BIOPHARM International Co. Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN30878) on November 21, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)