Tsingke Biotech Gathers Industry Leaders to Advance RNA Therapeutics

Shijin Ma, CEO of Tsingke Biotech, opened the forum by emphasizing that progress in nucleic acid medicine relies on a synchronized value chain. According to Ma, the industry must integrate everything from raw material synthesis and complex delivery systems to CMC development and regulatory strategy to maintain momentum.

Technical sessions highlighted the shift toward targeted delivery. Dr. Jun Bai of Haichang Biotech reviewed the evolution of siRNA therapeutics, focusing on the transition from simple sequence design to sophisticated antibody-oligonucleotide conjugates and kidney-directed delivery. Building on this, Professor Qixian Chen of the Yangtze River Delta Intelligent Green Innovation Center explored methods to bypass intracellular barriers, specifically aiming to extend therapeutic applications into the central nervous system and oncology.

Regulatory and manufacturing concerns dominated the later discussions. Dr. Yaning Wang, a former FDA division director, provided a framework for navigating regulatory approval, citing specific case studies on surrogate endpoint selection. Simultaneously, Dr. Chengjiang Zhao of Youjia Biomedical emphasized that strategic planning during the CMC process is vital for successful IND submissions, noting that quality studies and toxicology batch manufacturing remain the bedrock of commercial viability.

The event concluded with a consensus that long-term competitiveness in the global market requires an ecosystem-wide approach. Tsingke Biotech, which provides integrated services ranging from research-grade synthesis to GMP-compliant manufacturing, is currently leveraging artificial intelligence to refine sequence design and process optimization. By aligning its proprietary synthesis equipment with these emerging digital tools, the company aims to compress timelines for drug developers worldwide.