BioDlink and Lepu Biopharma have made significant strides in the biopharmaceutical sector with the launch of MEIYOUHENG®, the world’s first EGFR-targeting antibody-drug conjugate (ADC). This product also marks the first ADC fully manufactured by a Contract Development and Manufacturing Organization (CDMO) to reach the market in China. The official announcement was made at BioDlink’s headquarters in Suzhou, where senior executives from both companies celebrated this landmark achievement.
The approval for MEIYOUHENG® by the China National Medical Products Administration was granted on October 30, 2025. This approval underscores BioDlink’s comprehensive CDMO capabilities, which include technology transfer, pivotal clinical production, and support for pre-marketing approval inspections. The technology transfer process was notably completed in less than three months, while the production of pivotal process qualification (PPQ) batches took under eleven months.
BioDlink highlighted that all technology transfer and Good Manufacturing Practice (GMP) batches were successfully completed on the first attempt. This achievement exemplifies how CDMOs can function as strategic partners throughout the development and commercialization lifecycle of complex biologics.
Jian Zhang, Chief Operating Officer at BioDlink, expressed pride in the collaboration, stating, “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.”
The collaboration between the two companies has been characterized by a strong partnership and effective execution, leading to the successful launch of MEIYOUHENG®. Dr. Ziye Sui, Executive Director and CEO of Lepu Biopharma, emphasized that BioDlink had gone “far beyond a traditional CDMO partner,” recognizing the technical expertise and collaborative spirit that facilitated the launch of this innovative drug.
As the pharmaceutical landscape continues to evolve, the successful launch of MEIYOUHENG® positions both BioDlink and Lepu Biopharma at the forefront of biopharmaceutical innovation in China. The introduction of this EGFR-targeting ADC represents not only a technological advancement but also a significant step forward in the treatment of diseases associated with the epidermal growth factor receptor, potentially impacting numerous patients in need of effective therapies.
In summary, the launch of MEIYOUHENG® is a noteworthy milestone, demonstrating the growing capabilities of CDMOs in bringing advanced therapeutics to market and highlighting the importance of collaboration in the biopharmaceutical industry.
