#China #Suzhou #ADC #BioDlink #Kanghong

BioDlink's Recognition in Pioneering Dual-Payload ADC Development

In a groundbreaking achievement, BioDlink has recently received a formal letter of appreciation from its client, Chengdu Kanghong Pharmaceutical Group, for its instrumental role in the advancement of KH815—the world's first dual-payload antibody-drug conjugate (ADC) that is now set to enter clinical development. This recognition underscores BioDlink's expertise in biopharmaceutical manufacturing and the critical support it provides to its partners.

A Milestone in Biopharmaceuticals

BioDlink accelerated the Investigational New Drug (IND) approval process, completing necessary steps 1.5 months ahead of schedule. This swift timeline was achieved through efficient process development, meticulous manufacturing, and comprehensive analytical execution. Thanks to BioDlink's collaborative efforts, KH815 was granted regulatory approval by Australia’s Human Research Ethics Committee (HREC) on March 21, 2025, followed by clinical trial authorization in China on April 15, 2025.

KH815 is a first-of-its-kind dual-payload formulation developed independently by Kanghong, which aims at providing enhanced therapeutic efficacy while minimizing side effects commonly associated with traditional therapies. This innovation represents substantial progress in the field of antitumor drugs and indicates a future trend where precision medicine plays a pivotal role in patient care.

The Contribution of BioDlink

As a Contract Development and Manufacturing Organization (CDMO), BioDlink was integral across the full development lifecycle of KH815. The company provided services that encompass the following critical areas:

• - Process Development: Designing a robust manufacturing pathway tailored for KH815.
• - Analytical Method Development: Establishing and validating precise analytical methodologies that ensure the quality and consistency of the product.
• - Formulation Research: Innovating the formulation of the dual-payload ADC to enhance its stability and effectiveness.

Faced with limited material availability and an aggressive schedule, BioDlink's teams employed strong technical knowledge to navigate the complexities inherent in the conjugation process and analytical characterization. By effectively managing the drug-to-antibody ratio (DAR) and conducting thorough product characterization, BioDlink successfully implemented a scaled-up manufacturing solution.

This level of efficiency not only met but exceeded the expectations of Kanghong Pharmaceutical, further cementing BioDlink's reputation as a leader in ADC development. The successful execution of this program highlights the organization's commitment to quality, innovation, and excellence in service.

Insights into Future Innovations in ADCs

BioDlink's successful collaboration with Kanghong on KH815 reflects the growing potential of dual-payload ADC technologies. This partnership not only advances individual product pipelines but also signifies the importance of close collaboration between industry and research entities.

BioDlink's commitment to supporting the development of complex biologics is unwavering. The company focuses on end-to-end CDMO services to accelerate the journey of these innovations from early stages through to commercialization. BioDlink continues to encourage innovation and collaboration in the biopharmaceutical industry, paving the way for advancements that may one day revolutionize patient care globally.

About the Companies Involved

Kanghong Pharmaceutical is a publicly traded firm based in Sichuan, China, founded in 1996. The company specializes in researching, developing, manufacturing, and distributing pharmaceuticals that address serious medical conditions, particularly in ophthalmic and neuropsychiatric fields.

BioDlink, listed as 1875.HK, is recognized as a leading global CDMO focusing on biologics and bioconjugates like ADCs. The company's headquarters in Suzhou, along with facilities in Shanghai and Beijing, allow them to provide fully integrated services spanning from research and development (R&D) to commercial manufacturing, underscoring their role as a key player in the advancement of biopharmaceutical technologies.

BioDlink operates under the philosophy of “Quality First, Innovation Driven, Success Together,” aspiring to improve global access to next-generation biologics. The recognition received from Kanghong is not just a testament to BioDlink’s capabilities but also highlights the ongoing partnership that aims to transform the therapeutic landscape for patients worldwide.