BioDlink and Lepu Biopharma Celebrate Successful Launch of the World's First EGFR-Targeting ADC Drug, Marking a Major Milestone in Mutual Collaboration in Biologics CMC

• Celebrating a Shared Milestone: BioDlink and Lepu Biopharma celebrated the launch of MEIYOUHENG^®, the world's first EGFR-Targeting ADC, and their partnership spanning over two years.
• Demonstrating Robust Capabilities: Throughout the collaboration, all technology transfers and GMP manufacturing batches were achieved successfully in a single attempt, underscoring robust commercial capability and a top-tier quality system of BioDlink.
• 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.

SUZHOU, China, Nov. 21, 2025 /PRNewswire/ -- On November 20, 2025, BioDlink (Stock Code: 1875.HK), a leading biologics CDMO, together with Lepu Biopharma (2157.HK), announced 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.

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.

About Lepu Biopharma

Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is an innovation-driven company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. The company is dedicated to developing innovative ADCs through its advanced ADC technology platform. Lepu Biopharma highly values the continuing build-out of its own commercialization capabilities and is determined to pursue the goal towards strong transformation from core technology to drugs and industrialization. At present, the product pipeline of Lepu Biopharma covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including two commercial-stage products, eight clinical-stage drug candidates (six of which are ADCs), and three clinical-stage combination therapies of the key candidates in its pipeline. The company houses the leading ADC drug candidate pipeline in China.

About BioDlink Biopharm Co., Ltd.

BioDlink (1875.HK) is a leading global CDMO specializing in biologics and bioconjugates (ADCs/XDCs). Headquartered in Suzhou with centers in Shanghai and Beijing, the company provides fully integrated, end-to-end services spanning early R&D through commercial manufacturing.

With its one-base integrated platform and proprietary technologies—such as BDKcell® for rapid cell line development and GL-DisacLink® for site-specific conjugation—BioDlink helps partners accelerate development, improve efficiency, and reduce costs.

The company operates four commercial manufacturing lines with large-scale sterile fill-finish capabilities, backed by a global GMP-aligned quality system that has earned PMDA accreditation in Japan and supported product approvals across China, Indonesia, Nigeria, Pakistan, and Colombia.

Guided by the philosophy of "Quality First, Innovation Driven, Success Together," BioDlink is committed to advancing global access to next-generation biologics and building trusted partnerships worldwide. For more information, please visit: https://www.biodlink.com/

SOURCE BioDlink Biopharm Co., Ltd.