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- BioDlink received a formal letter of appreciation from Chengdu Kanghong Pharmaceutical Group for its contribution to advancing KH815, the world’s first dual-payload antibody–drug conjugate (ADC) to enter clinical development.
- BioDlink enabled IND approval 1.5 months ahead of schedule through efficient process development, manufacturing, and analytical execution.
SUZHOU, China, Feb. 9, 2026 /PRNewswire/ — BioDlink announced that it has received a formal letter of appreciation from its client, Chengdu Kanghong Pharmaceutical Group (“Kanghong Pharmaceutical”), recognizing BioDlink’s critical contribution to the successful clinical approval of KH815, the world’s first dual-payload antibody–drug conjugate (ADC) to enter clinical development.
KH815 is a first-in-class dual-payload ADC independently developed by Kanghong Pharmaceutical. The program achieved a major regulatory milestone with approval from Australia’s Human Research Ethics Committee (HREC) on March 21, 2025 followed by clinical trial authorization in China on April 15, 2025.
As Kanghong Pharmaceutical’s CDMO partner, BioDlink supported the program across the full development lifecycle, including process development, analytical method development and validation, and formulation research.
Efficient Execution of a Complex First-in-Class Program
KH815 required advanced process design and analytical control, including precise management of drug-to-antibody ratio (DAR) and comprehensive product characterization. Leveraging its expertise in complex ADC development, BioDlink delivered a robust, scalable, and reproducible manufacturing solution despite limited material availability and aggressive timelines.
Despite the complexity of conjugation process development and analytical characterization, BioDlink applied strong technical expertise to define and lock robust process and analytical strategies, enabling successful scale-up and batch release. Through continuous process optimization, development, manufacturing, and regulatory submission activities were completed 1.5 months ahead of plan, exceeding client expectations and demonstrating strong execution capability, which earned high recognition from Kanghong Pharmaceutical for BioDlink’s technical expertise and service excellence.
Advancing Innovation in ADC Development
The successful progression of KH815 underscores the growing potential of dual-payload ADC technologies and highlights the value of close collaboration across industry and research. BioDlink remains committed to providing end-to-end CDMO services to global partners, accelerating the development of complex biologics from early development through commercialization.
About Kanghong Pharmaceutical
Kanghong is a publicly traded pharmaceutical company based in the province of Sichuan, China. It was founded in 1996 and researches, develops, manufactures, and distributes medicines for ophthalmic, neuropsychiatric and others.
Kanghong is devoted to the lives of patients through high quality, innovation and responsibility. Since its establishment, the company keeps researching, producing, and commercializing safer and more efficient drugs for pressing unmet medical needs.
The company’s purpose is to fundamentally improve patients’ physical ability and social medical efficacy by using innovative science and breakthrough treatments to achieve progress in human health.
About BioDlink
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, Colombia and Bolivian.
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://biodlink.com/
