BioDlink and Lepu Biopharma have successfully launched MEIYOUHENG® (Becotatug Vedotin injection), marking a significant milestone as the world’s first EGFR-targeting antibody-drug conjugate (ADC). This product is also notable for being the first ADC fully manufactured by a Contract Development and Manufacturing Organization (CDMO) to enter the market in China. The launch was celebrated by senior executives from both companies at BioDlink’s headquarters in Suzhou.
The approval from the National Medical Products Administration was granted on October 30, 2025, underscoring the significance of this achievement. The collaboration highlights BioDlink’s comprehensive CDMO capabilities, encompassing technology transfer, pivotal clinical production, and preparation for pre-Approval Inspection.
According to the press release, the technology transfer for MEIYOUHENG® was completed in under three months, while the Process Performance Qualification (PPQ) activities took less than eleven months. BioDlink confirmed that all technology transfer and Good Manufacturing Practice (GMP) batches were successfully completed on the first attempt.
Significance of the Collaboration
This partnership between BioDlink and Lepu Biopharma exemplifies how CDMOs can serve as strategic allies throughout the development and commercialization process of complex biologics. Jian Zhang, Chief Operating Officer at BioDlink, expressed pride in supporting Lepu Biopharma in the production of this groundbreaking EGFR-targeting ADC. He remarked, “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.”
Dr. Ziye Sui, Executive Director and CEO of Lepu Biopharma, acknowledged the strength of the partnership, emphasizing that BioDlink had provided far more than traditional CDMO support. He highlighted the collaboration and technical expertise that were crucial in bringing MEIYOUHENG® to market.
As the pharmaceutical landscape continues to evolve, the successful launch of MEIYOUHENG® not only enhances treatment options for patients but also sets a precedent for future innovations in ADCs. This achievement reflects the growing capabilities of CDMOs in driving the biopharmaceutical industry forward, particularly in emerging markets like China.
