- BioDlink and Lepu Biopharma have launched MEIYOUHENG®, the world’s first EGFR-targeting ADC and the first ADC fully manufactured by a CDMO to reach the market in China.
- The approval and launch validate BioDlink’s end-to-end CDMO capability, covering technology transfer, PPQ, and BLA support.
BioDlink and Lepu Biopharma have announced the market launch of MEIYOUHENG® (Becotatug Vedotin injection), described as the world’s first EGFR-targeting antibody-drug conjugate. The product is also the first ADC fully manufactured by a CDMO to enter the market in China. Senior leaders from both companies marked the achievement at BioDlink’s headquarters in Suzhou.
The companies stated that the approval and launch demonstrate BioDlink’s integrated CDMO capabilities. These include technology transfer, pivotal clinical production, PPQ manufacturing, and preparation for pre-Approval Inspection. MEIYOUHENG® received marketing approval from China’s National Medical Products Administration on 30 October 2025. According to the press release, the technology transfer was completed in less than three months, and PPQ activities in less than eleven months.
BioDlink reported that all technology transfer and GMP batches were completed on the first attempt. The collaboration was positioned as an example of how CDMOs can work as strategic partners across the development and commercialisation lifecycle of complex biologics.
“We are proud to have supported Lepu Biopharma in the development and production of the world’s first approved EGFR-Targeting ADC drug—which is also the first fully CDMO-manufactured ADC successfully launched in China.”
Jian Zhang, Chief Operating Officer at BioDlink
Lepu Biopharma noted the strength of the partnership and the execution of the project. Dr Ziye Sui, Executive Director and CEO of Lepu Biopharma, said that BioDlink had been “far more than a traditional CDMO partner,” highlighting the collaboration and technical expertise involved in launching MEIYOUHENG®.
