China's National Medical Products Administration (NMPA) has granted conditional marketing approval to MEIYOUHENG (Becotatug Vedotin injection), marking a significant milestone as the world's first approved EGFR-targeted antibody-drug conjugate (ADC). Developed by Lepu Biopharma and manufactured by BioDlink, this Class 1 innovative therapy is indicated for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).
The approval, secured on October 30, 2025, represents a first-in-class innovation and the world's first approved non-photoimmunological EGFR-targeted ADC. This breakthrough offers new therapeutic options for patients with R/M NPC who have failed anti-PD-(L)1 and platinum-based therapies, addressing a significant unmet medical need in oncology.
Mechanism of Action and Clinical Rationale
Becotatug Vedotin is comprised of an EGFR-targeted monoclonal antibody conjugated with monomethyl auristatin E, a potent microtubulin inhibiting payload, via a valine-citrulline linker. The ADC binds specifically with high affinity to EGFR on tumor cell surfaces, releases its cytotoxic payload upon internalization and lysosomal protease cleavage of the linker, ultimately resulting in tumor cell death.
The therapeutic rationale is supported by EGFR's widespread expression across multiple cancer types. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer, and other malignant solid tumors. Critically, EGFR is expressed in 89% of advanced nasopharyngeal carcinoma cases, making it an important target for cancer treatment in this indication.
Manufacturing Excellence and Regulatory Success
The program achieved remarkable regulatory success, designated as a Breakthrough Therapy Project that required rapid technology transfer and full production line delivery from monoclonal antibody drug substance through ADC drug product. BioDlink's performance demonstrated exceptional capabilities, achieving 100% first-pass success across technology transfer, Process Performance Qualification (PPQ), and Pre-Approval Inspection (PAI).
BioDlink participated in the entire development and production cycle, from technology transfer and process development to analytical method establishment, clinical sample production, and GMP-compliant commercial batch manufacturing. This comprehensive involvement reflects the company's end-to-end capabilities in supporting complex biologics from R&D to market launch.
The collaboration established an integrated quality management system through close coordination with Lepu Biopharma and multiple regulatory authorities. This system ensures seamless coordination across the entire production chain and aligns with global GMP standards, including those of China, the U.S., and the EU.
Industry Impact and Global Implications
This approval represents BioDlink's first commercial ADC manufacturing initiative globally, validating the company's robust capabilities in the commercialization of complex biologics. 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, with EU-QP certification achieved five times in recent years.
Dr. Ziye Sui, Executive Director and CEO of Lepu BioPharma, emphasized the collaborative achievement: "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 of BioDlink, noted the broader implications: "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."
Pipeline and Future Development
Lepu Biopharma maintains a robust oncology pipeline covering three major areas: immunotherapies, ADC targeted therapies, and oncolytic virus drugs. The company's current portfolio includes two commercialization-stage drug candidates, eight clinical-stage drug candidates (six of which are ADC drug candidates), and three clinical-stage combination therapies. This positions Lepu Biopharma as housing the leading ADC drug candidate pipeline in China.
The successful approval sets a practical model for efficient multi-party industry collaboration and resource integration in the biopharmaceutical sector, potentially accelerating future ADC development programs and expanding treatment options for cancer patients globally.
