Dongyao Pharma Congratulates Partner Lepu Bio on NMPA Approval of First-in-Class EGFR ADC Drug Meiyouheng®

ADC drug manufacturing involves complex processes and high technical barriers, imposing stringent requirements on companies’ commercial production capabilities and quality systems.As the contract manufacturing organization, Tot Biopharm was deeply involved in the entire process of this product, ranging from technology transfer, process development, and analytical method establishment to clinical sample production and commercial manufacturing. This demonstrates its comprehensive capability in providing full-cycle services for complex molecules from R&D to market launch, particularly showcasing production and quality control capabilities in high-barrier fields such as antibody-drug conjugates (ADCs) that are on par with international standards.

Under the guidance of relevant policies introduced by the National Medical Products Administration (NMPA), Tot Biopharm and LEPU BIOPHARMA worked closely together to establish an efficient quality management system. This enabled end-to-end coordination across all stages—from raw material control, process validation, and data analysis to product release—thereby ensuring the quality and safety of pharmaceutical products. Through close collaboration with various regulatory authorities, the project successfully obtained approval.

Tot Biopharm possesses extensive experience in the large-scale commercial manufacturing of biologics in compliance with Good Manufacturing Practice (GMP) standards. Leveraging its mature technology platforms and international quality systems, the company has achieved seamless integration and data integrity control across the entire process, from antibody production and conjugation reactions to formulation and fill-finish operations. Tot Biopharm’s manufacturing facilities have currently obtained GMP certifications in multiple countries, including China, Brazil, Argentina, Indonesia, Egypt, Colombia, and Pakistan, as well as certification as a Foreign Manufacturer by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), demonstrating global recognition of its international quality system.This successful breakthrough in the commercial manufacturing of ADC drugs has provided a proven practical pathway for multi-party industry collaboration, pioneering a new model for efficient resource synergy.

The company’s quality management system covers the entire lifecycle of pharmaceutical products, from research and development to commercial manufacturing, and complies with the regulatory standards of China, the United States, and the European Union. To address quality risks that are a key focus of regulators in segmented manufacturing, we have established a comprehensive control strategy to ensure consistent product quality, providing the industry with a safe, efficient, and compliant model for segmented manufacturing practices.

We are delighted that the pilot product for the segmented manufacturing of our EGFR ADC drug has successfully received conditional approval, providing a more effective treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). We extend our gratitude to the Tot Biopharm team for their outstanding CDMO services and collaborative capabilities, which provided a solid foundation for the efficient advancement of this project. This approval establishes a proven practical pathway for multi-party industrial collaboration and holds promise for delivering more effective therapeutic options for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based chemotherapy.

We extend our heartfelt congratulations to LEPU BIOPHARMA on the successful market launch of its EGFR ADC drug. The approval of this segmented manufacturing pilot product imposes higher demands on the quality and technical synergy capabilities of MAHs and CDMOs, while also validating Tot Biopharm’s comprehensive strength during the commercialization phase of complex molecules. Moving forward, we will continue to uphold the principle of “Empowering Innovation and Fostering Growth through Quality.””the philosophy of accelerating the market launch of innovative drugs in partnership with collaborators, to benefit patients worldwide.

Vebicortuzumab for Injection is an antibody-drug conjugate (ADC) composed of an EGFR-targeting monoclonal antibody linked to the potent microtubule inhibitor payload monomethyl auristatin E (MMAE) via a valine-citrulline linker. It is indicated for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). By binding with high affinity and specificity to EGFR on the surface of tumor cells, it is internalized and subsequently releases the potent payload following lysosomal protease cleavage, thereby inducing tumor cell death. This is the first EGFR-targeting ADC approved for marketing in China, representing a first-in-class therapy.

LEPU BIOPHARMA is an innovative biopharmaceutical company based in China with a global outlook, focusing on targeted therapy and tumor immunotherapy. The company continuously strengthens its commercialization capabilities, driving robust translation and industrialization from core technologies to marketed drugs. Currently, LEPU BIOPHARMA’s product pipeline covers three major areas: immunotherapy, ADC-targeted therapy, and oncolytic virus therapeutics. It includes two commercially launched drugs, eight clinical-stage candidate drugs (comprising six ADC products, one oncolytic virus product, and one multi-specific antibody product), as well as combination therapies involving three clinical-stage candidate drugs. The company’s ADC candidate drug pipeline is leading in China.

Tot Biopharm (Stock Code: 1875.HK), a globally leading contract development and manufacturing organization (CDMO) for biologics, is committed to becoming the industry-leading and most trusted partner in the biopharmaceutical sector. Leveraging our advanced one-stop industrialization platform, we provide end-to-end CDMO services—from early-stage R&D to commercial manufacturing—for protein-based therapeutics represented by antibodies, biosimilars, and conjugated drugs represented by antibody-drug conjugates (ADCs), thereby accelerating our clients’ project timelines.

Tot Biopharm boasts a large-scale commercial manufacturing facility for biologics compliant with Good Manufacturing Practice (GMP) standards, along with an international quality management system that meets Chinese, U.S., and European regulatory requirements. Leveraging its advanced technology platforms and a professional team of technical and service experts, the company empowers client projects across diverse regions and countries worldwide, with business operations spanning Europe, the United States, Asia, and numerous emerging markets.

Tot Biopharm upholds the service philosophy of “Quality, Innovation, and Shared Growth.” Leveraging an experienced team and a core of innovation, while steadfastly adhering to compliance and quality as its foundation, the company builds an ecosystem for collaborative development, empowers its partners, and creates win-win outcomes.