On December 9, 2025, Dr. Wang Yaning delivered a keynote presentation titled "Development and Approval of the First Non-Opioid NaV1.8 Pain Product" at Vastpro Pharmaceuticals. In his presentation, he systematically examined the research and development pathways, critical technical challenges, clinical translation strategies, and key considerations for global registration and approval of novel NaV1.8-targeted analgesics. The talk provided comprehensive technical details, a holistic perspective, and regulatory insights spanning from target validation to market authorization.
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Over the course of more than an hour, Dr. Wang thoroughly analyzed VX-548 (Suzertrin)—the first nonopioid NaV1.8 inhibitor analgesic—tracing its journey from preclinical research to regulatory approval. His analysis encompassed: approved indications, dosing regimens, R&D timelines, patient enrollment volumes achieved under an accelerated development schedule, Phase I study details, two Phase II and two Phase III trials focused on acute pain, as well as related preclinical investigations, addiction studies, and human metabolism data. Dr. Wang also discussed the discontinuation of VX993 development, the enrollment progress of Halneuron’s Phase II CINP trial, and upcoming interim analysis reports. Following the presentation, Dr. Wang and the company's Chief Scientific Officer, Dr. Tielin Wang, engaged in lively Q&A sessions with the R&D team and participating company project collaboration experts.
Dr. Wang Yaning is the founder and CEO of Shanghai Ruiningkang Biomedical Technology Development Co., Ltd., and serves as a visiting professor at Peking University, the University of Florida, Shanghai University of Traditional Chinese Medicine, and the Xiangya School of Pharmacy at Central South University. He joined the FDA in 2003 and served for nearly two decades, including as Director of the Clinical Quantitative Pharmacology Review Division. During his tenure, he oversaw quantitative pharmacology reviews across all therapeutic areas and witnessed key milestones in the application of quantitative pharmacology in drug evaluation. His contributions have been recognized with multiple awards, including the FDA’s highest honor, the Award of Merit, and the Outstanding Service Award.




