On November 21, 2025 BioDlink (Stock Code: 1875.HK), a leading biologics CDMO, together with Lepu Biopharma (2157.HK), reported the successful market launch of MEIYOUHENG(Becotatug Vedotin injection) , the world’s first EGFR-targeting antibody-drug conjugate (ADC). The launch also represents the first ADC fully manufactured by a CDMO to reach the market in China, underscoring a new level of maturity for the region’s biopharmaceutical ecosystem.
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Senior leadership and project teams from both companies gathered at BioDlink’s Suzhou headquarters to commemorate this achievement—a milestone that reflects deep scientific collaboration, disciplined execution, and shared commitment to advancing complex biologics.
A Fully Integrated CDMO Success Story
The approval and launch of MEIYOUHENG validate BioDlink’s end-to-end CDMO capability, spanning: technology transfer, pivotal clinical production , PPQ batches, pre-Approval Inspection (PAI) preparation, comprehensive BLA support through granted marketing approval by China’s National Medical Products Administration (NMPA) on October 30, 2025. The tech transfer was achieved in less than 3 months, and the PPQ was completed in less than 11 months, with minimal deviations.
Operational Excellence That Sets a New Benchmark
All technology transfers and GMP production batches were successfully completed at the first go, highlighting BioDlink’s strength in quality systems, regulatory alignment, and manufacturing reliability. The collaboration demonstrates how high-performing CDMOs can serve as strategic partners—not just service providers—across the entire lifecycle of cutting-edge therapies.
Dr. Jian Zhang, Chief Operating Officer, BioDlink, 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. This achievement is not only a breakthrough for the industry but also a testament to our shared vision and execution excellence. This partnership strongly validates BioDlink’s commercial-ready capabilities and quality systems."
Dr. Ziye Sui, Executive Director and CEO of Lepu Biopharma, commented, "BioDlink has been far more than a traditional CDMO partner. In this collaboration, CDMO has meant Commitment, Dedication, and Mutual Objective. The team’s technical expertise and seamless collaboration were instrumental in the efficient launch of MEIYOUHENG. We look forward to deepening our partnership to deliver more innovative therapies to patients in China and around the world."
Looking ahead, BioDlink will continue to leverage its integrated CDMO platform to support global partners in accelerating the development and commercialization of biologics, including monoclonal antibodies, biosimilars, and complex molecules such as ADCs.
(Press release, BioDlink, NOV 21, 2025, View Source [SID1234660869])