BioDlink and Lepu Biopharma have announced the launch of 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 reach the market in China. The launch was celebrated at BioDlink’s headquarters in Suzhou, where senior leaders from both companies gathered to highlight this achievement.
The approval from China’s National Medical Products Administration, granted on October 30, 2025, underscores BioDlink’s comprehensive CDMO capabilities, which encompass technology transfer, pivotal clinical production, and preparation for pre-approval inspections. The companies reported that the technology transfer was completed in under three months, while the process for the production of pivotal batches took less than eleven months.
BioDlink emphasized that all technology transfers and good manufacturing practice (GMP) batches were successfully completed on the first attempt, showcasing the efficiency of their integrated approach. This collaboration illustrates how CDMOs can serve as strategic partners throughout the development and commercialization process of complex biologics.
Jian Zhang, Chief Operating Officer at BioDlink, expressed pride in supporting Lepu Biopharma in the development of this groundbreaking drug. He noted, “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, highlighted the strength of the partnership, praising BioDlink’s role in the project. He stated that BioDlink had proven to be “far more than a traditional CDMO partner,” emphasizing the collaborative nature and technical expertise that facilitated the successful launch of MEIYOUHENG®.
This launch represents a significant advancement in cancer treatment options, particularly for patients with conditions related to the epidermal growth factor receptor (EGFR). The introduction of MEIYOUHENG® into the market not only reflects innovation in biopharmaceutical development but also demonstrates the growing capabilities of CDMOs in China’s evolving healthcare landscape.
The partnership between BioDlink and Lepu Biopharma exemplifies a successful model for future collaborations in the biopharmaceutical industry, highlighting the potential for CDMOs to play a vital role in bringing cutting-edge therapies to market more efficiently.
