BioDlink Congratulates Lepu Biopharma on Securing Approval for the World's First Approved EGFR-Targeted ADC

• BioDlink helps Lepu Biopharma win China's marketing approval for EGFR-targeted ADC treating recurrent or metastatic nasopharyngeal carcinoma
• This Becotatug Vedotin injection approval is BioDlink's first commercial ADC manufacturing initiative worldwide, validating its complex biologics commercialization capabilities

SUZHOU, China, Nov. 5, 2025 /PRNewswire/ -- BioDlink (1875.HK) congratulates its partner Lepu Biopharma (2157.HK) on receiving conditional marketing approval from China's National Medical Products Administration (NMPA) for MEIYOUHENG (Becotatug Vedotin injection). This Class 1 innovative antibody-drug conjugate (ADC) targets the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Significantly, this is the world's first approved non-photoimmunological EGFR-targeted ADC and a first-in-class innovation. This project is BioDlink's first commercial ADC manufacturing initiative globally, validating its robust capabilities in the commercialization of complex biologics.

This approval builds on BioDlink's earlier success with Lepu Biopharma's ADC program that achieved 100% first-pass success across technology transfer, Process Performance Qualification (PPQ), and Pre-Approval Inspection (PAI).

The program, designated as a Breakthrough Therapy Project, required rapid tech transfer and full production line delivery from monoclonal-antibody Drug Substance through ADC Drug Product.

BioDlink's performance in this project secured BLA approval on October 30, 2025, demonstrating its capacity to meet aggressive regulatory timelines and ensure commercial readiness for global markets.

ADC manufacturing is technologically demanding, requiring exceptional process capabilities and robust quality systems. BioDlink participated in the entire development and production cycle, from technology transfer, process development, and analytical method establishment to clinical sample and GMP-compliant commercial batch manufacturing. This reflects the company's end-to-end capabilities in supporting complex biologics from R&D to market launch.

Through close coordination with Lepu Biopharma and multiple regulatory authorities, BioDlink established an integrated quality management system. This system ensures seamless coordination across the entire production chain—accelerate the timeline for pivotal clinical batch production and subsequent PPQto meet aggressive regulatory submission goals and aligns with global GMP standards, including those of China, the U.S., and the EU. BioDlink's manufacturing facilities have obtained GMP certifications from several countries and Foreign Manufacturer Approval from Japan's PMDA. This collaboration sets a practical model for efficient multi-party industry collaboration and resource integration in the biopharma sector.

BioDlink's manufacturing facilities have obtained GMP certifications from China, Brazil, Argentina, Indonesia, Egypt, Colombia, Pakistan and Thailand, as well as Foreign Manufacturer Approval from Japan's PMDA. And also passed EU-QP 5 times in these years. This achievement marks a major step forward for ADC commercialization and demonstrates a practical model for multi-party industry collaboration and efficient resource integration.

Dr. Ziye Sui, Executive Director and CEO of Lepu BioPharma, commented: "We sincerely thank the BioDlink team for their outstanding CDMO services and strong collaboration. This approval also establishes a practical pathway for multi-party collaboration, offering new hope for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based therapies."

Dr. Jian Zhang, Chief Operating Officer, BioDlink, noted: "The approval of this pilot batch highlights the increasing technical and quality coordination demands placed on both the Marketing Authorization Holder (MAH) and the CDMO. Moving forward, we will continue working closely with our partners to accelerate the launch of innovative medicines to benefit patients worldwide."

About Becotatug Vedotin

MEIYOUHENG (Becotatug Vedotin injection) is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It is the world's first approved EGFR-targeted ADC and a first-in-class innovation, for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.

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 commercialization- stage drug candidates, eigth clinical-stage drug candidates (six of which are ADC drug candidates) 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.