BioDlink and Lepu Biopharma Join Forces to Release the First EGFR-Targeting ADC Drug
A Milestone in Biopharmaceutical Collaboration
On November 20, 2025, a historic event unfolded in Suzhou, China, as BioDlink Biopharm Co., Ltd. (Stock Code 1875.HK) and Lepu Biopharma (Stock Code 2157.HK) celebrated the successful launch of MEIYOUHENG® (Becotatug Vedotin injection), the world's first EGFR-targeting antibody-drug conjugate (ADC). This launch not only marks a significant achievement for both companies but also establishes a new standard for the biopharmaceutical landscape in China, being the first ADC fully manufactured by a Contract Development and Manufacturing Organization (CDMO) to reach the market in the region.
At the event, senior leaders and project teams from both companies gathered at BioDlink’s headquarters to acknowledge their shared success—an accomplishment built upon a robust scientific partnership and diligent execution. The collaboration has proved instrumental in advancing complex biologics, showcasing the potential of cooperation in the realm of biotechnology.
Unmatched CDMO Capabilities
The successful introduction of MEIYOUHENG® serves as a testament to BioDlink's extensive capabilities as a CDMO. With a streamlined process, the company managed to conduct technology transfers, pivotal clinical production, and pre-Approval Inspection (PAI) preparation efficiently. It took less than three months for the tech transfer to be accomplished, and less than eleven months to complete the Process Performance Qualification (PPQ), with minimal deviations.
Every aspect of the GMP manufacturing batches and technology transfers was successfully executed on the first attempt, showcasing a high level of operational excellence that sets a new benchmark in the biopharmaceutical industry. This achievement highlights BioDlink’s robust quality systems, regulatory alignment, and reliability in manufacturing processes, positioning the company as a strategic partner capable of delivering cutting-edge therapies across their entire lifecycle.
Insight from Leaders
Dr. Jian Zhang, the Chief Operating Officer at BioDlink, expressed his pride in supporting Lepu Biopharma throughout the journey of developing the world's first approved EGFR-targeting ADC drug. He highlighted that not only does this achievement represent a breakthrough in the industry, but it also affirms BioDlink’s readiness to meet commercial demands and quality control expectations.
On the other hand, Dr. Ziye Sui, the Executive Director and CEO of Lepu Biopharma, underscored the importance of their collaborative efforts, referring to their partnership as a commitment-driven relationship where CDMO encapsulates Commitment, Dedication, and Mutual Objective. He recognized the technical prowess and efficient teamwork that facilitated the successful launch of MEIYOUHENG®, emphasizing their aspirations to further enhance collaboration to bring even more innovative therapies to patients both in China and globally.
Future Prospects
Looking forward, BioDlink is poised to further develop its integrated CDMO platform, aiding global partners in the expedited development and commercialization of biologics like monoclonal antibodies, biosimilars, and complex molecules such as ADCs. This commitment to innovation continues to shape BioDlink's role within the evolving biopharmaceutical ecosystem, as it strives to rise above industry standards and expectations.
About Lepu Biopharma
Founded with a focus on oncology therapeutics, Lepu Biopharma designs innovative ADCs from its advanced technology platform. With a strong foundation established in China, it has a worldwide vision, aiming to develop various therapeutic options including immunotherapies and oncolytic virus drugs. Boasting a comprehensive product pipeline with commercial-stage and clinical candidates, Lepu Biopharma actively champions the advancement of oncology treatments.
About BioDlink Biopharm Co., Ltd.
BioDlink specializes in biologics and bioconjugates, offering a fully integrated range of services from early R&D to commercial manufacturing phases. With a commitment to quality and innovation, it has built a reputable standing in the biopharmaceutical world, receiving PMDA accreditation and supporting numerous successful product approvals across various regions worldwide. Through proprietary technologies like BDKcell® and GL-DisacLink®, BioDlink strives to facilitate the rapid development of life-saving therapies, promoting broader access to next-generation biologics on a global scale.
To learn more about BioDlink's services or its commitment to advancing biologics, visit BioDlink.
On November 20, 2025, a historic event unfolded in Suzhou, China, as BioDlink Biopharm Co., Ltd. (Stock Code 1875.HK) and Lepu Biopharma (Stock Code 2157.HK) celebrated the successful launch of MEIYOUHENG® (Becotatug Vedotin injection), the world's first EGFR-targeting antibody-drug conjugate (ADC). This launch not only marks a significant achievement for both companies but also establishes a new standard for the biopharmaceutical landscape in China, being the first ADC fully manufactured by a Contract Development and Manufacturing Organization (CDMO) to reach the market in the region.
At the event, senior leaders and project teams from both companies gathered at BioDlink’s headquarters to acknowledge their shared success—an accomplishment built upon a robust scientific partnership and diligent execution. The collaboration has proved instrumental in advancing complex biologics, showcasing the potential of cooperation in the realm of biotechnology.
Unmatched CDMO Capabilities
The successful introduction of MEIYOUHENG® serves as a testament to BioDlink's extensive capabilities as a CDMO. With a streamlined process, the company managed to conduct technology transfers, pivotal clinical production, and pre-Approval Inspection (PAI) preparation efficiently. It took less than three months for the tech transfer to be accomplished, and less than eleven months to complete the Process Performance Qualification (PPQ), with minimal deviations.
Every aspect of the GMP manufacturing batches and technology transfers was successfully executed on the first attempt, showcasing a high level of operational excellence that sets a new benchmark in the biopharmaceutical industry. This achievement highlights BioDlink’s robust quality systems, regulatory alignment, and reliability in manufacturing processes, positioning the company as a strategic partner capable of delivering cutting-edge therapies across their entire lifecycle.
Insight from Leaders
Dr. Jian Zhang, the Chief Operating Officer at BioDlink, expressed his pride in supporting Lepu Biopharma throughout the journey of developing the world's first approved EGFR-targeting ADC drug. He highlighted that not only does this achievement represent a breakthrough in the industry, but it also affirms BioDlink’s readiness to meet commercial demands and quality control expectations.
On the other hand, Dr. Ziye Sui, the Executive Director and CEO of Lepu Biopharma, underscored the importance of their collaborative efforts, referring to their partnership as a commitment-driven relationship where CDMO encapsulates Commitment, Dedication, and Mutual Objective. He recognized the technical prowess and efficient teamwork that facilitated the successful launch of MEIYOUHENG®, emphasizing their aspirations to further enhance collaboration to bring even more innovative therapies to patients both in China and globally.
Future Prospects
Looking forward, BioDlink is poised to further develop its integrated CDMO platform, aiding global partners in the expedited development and commercialization of biologics like monoclonal antibodies, biosimilars, and complex molecules such as ADCs. This commitment to innovation continues to shape BioDlink's role within the evolving biopharmaceutical ecosystem, as it strives to rise above industry standards and expectations.
About Lepu Biopharma
Founded with a focus on oncology therapeutics, Lepu Biopharma designs innovative ADCs from its advanced technology platform. With a strong foundation established in China, it has a worldwide vision, aiming to develop various therapeutic options including immunotherapies and oncolytic virus drugs. Boasting a comprehensive product pipeline with commercial-stage and clinical candidates, Lepu Biopharma actively champions the advancement of oncology treatments.
About BioDlink Biopharm Co., Ltd.
BioDlink specializes in biologics and bioconjugates, offering a fully integrated range of services from early R&D to commercial manufacturing phases. With a commitment to quality and innovation, it has built a reputable standing in the biopharmaceutical world, receiving PMDA accreditation and supporting numerous successful product approvals across various regions worldwide. Through proprietary technologies like BDKcell® and GL-DisacLink®, BioDlink strives to facilitate the rapid development of life-saving therapies, promoting broader access to next-generation biologics on a global scale.
To learn more about BioDlink's services or its commitment to advancing biologics, visit BioDlink.
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