#China #Suzhou #BioDlink #Lepu Biopharma #EGFR-Targeted

BioDlink Celebrates Major Milestone with Lepu Biopharma

On November 5, 2025, BioDlink (1875.HK) proudly congratulated its partner Lepu Biopharma (2157.HK) on achieving a groundbreaking milestone with the conditional marketing approval of MEIYOUHENG (Becotatug Vedotin injection) in China. This achievement is particularly notable as it marks the first time that a non-photoimmunological EGFR-targeted antibody-drug conjugate (ADC) has received such approval globally, setting a remarkable standard within the biopharmaceutical industry.

A Game-Changer for Cancer Treatment

This innovative therapy is specifically designed to target the epidermal growth factor receptor (EGFR), which plays a pivotal role in the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). The approval reflects the culmination of intensive research and development efforts aimed at providing new hope for patients suffering from this challenging condition.

Dr. Ziye Sui, Executive Director and CEO of Lepu Biopharma, expressed deep gratitude to BioDlink for their unwavering support and expert Contract Development and Manufacturing Organization (CDMO) services throughout the process. He emphasized that this achievement not only enhances collaboration within the industry but also signals a significant advancement for patients who have previously exhausted other treatment options, such as anti-PD-(L)1 and platinum-based therapies.

BioDlink's Commitment to Quality and Innovation

The successful approval builds upon the proven track record of BioDlink in managing complex biologics. The manufacturing initiative for the Becotatug Vedotin injection represents BioDlink's inaugural endeavor in ADC production—a testament to its capabilities in the commercialization of biologics.

BioDlink has consistently demonstrated strong performance across several stages of this project, highlighting a 100% first-pass success rate in areas such as technology transfer and pre-approval inspections. This feat is attributed to BioDlink’s comprehensive approach to production, which includes development, stringent quality controls, and regulatory compliance measures that meet both local and international standards.

The Einstein project, classified as a Breakthrough Therapy Project, required prompt technology transfer and expedited full production line delivery, showcasing BioDlink’s agility and competence in meeting aggressive timelines. Notably, the Biologics License Application (BLA) was successfully approved on October 30, 2025, directly validating BioDlink's commitment to ensuring readiness for entry into global markets.

The Complexity of ADC Manufacturing

Creating ADCs like Becotatug Vedotin injection is a highly intricate process that demands exceptional technological prowess and reliable quality systems. BioDlink’s involvement spanned the entirety of the developmental cycle, from the initial phases of technology transfer and process development to the production of Good Manufacturing Practice (GMP)-compliant commercial batches. This extensive engagement underscores its end-to-end capabilities in supporting the lifecycle of advanced biologics from conception to market delivery.

In conjunction with Lepu Biopharma and various regulatory authorities, BioDlink has established a robust integrated quality management system ensuring synchronized coordination across every aspect of the production chain. This protocol has enabled accelerated timelines for pivotal clinical batches, significantly enhancing efficiency in meeting regulatory submission deadlines.

Building the Future of Cancer Therapy

BioDlink's manufacturing facilities have already achieved multiple GMP certifications, expanding their capacity to meet demanding international standards across several countries, including the U.S. and various emerging markets. Such certifications not only reflect rigorous operational excellence but also position BioDlink as a leader in the biopharma sector.

Dr. Jian Zhang, COO of BioDlink, remarked on the pivotal nature of this pilot batch approval, noting that it emphasizes the increasing need for coordination between both Marketing Authorization Holders (MAHs) and CDMOs in advancing innovative therapies to market. Looking to the future, BioDlink is committed to continuing its collaboration with industry partners to fast-track the introduction of groundbreaking medications that will ultimately improve patient outcomes worldwide.

Conclusion

In summary, the approval of MEIYOUHENG (Becotatug Vedotin injection) signifies a monumental step forward in the battle against recurrent and metastatic nasopharyngeal carcinoma. Not only does it represent a significant advancement in targeted cancer therapies, but also serves as a collaborative model that exemplifies the potential for innovation through partnership. With a strong pipeline and commitment to quality, both BioDlink and Lepu Biopharma are poised to lead the charge in advancing cancer treatment and improving the lives of patients globally.