GOOD NEWS | Congratulations to GenFleet Therapeutics on the marketing approval of their innovative drug, Fulzerasib

On August 21, 2024, Dupert^® (Fulzerasib tablets) developed by GenFleet Therapeutics was approved by the National Medical Products Administration (NMPA) for marketing as a treatment of advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) in patients who have received at least one prior line of systemic therapy, marking it as the first approved KRAS G12C inhibitor in China.

During the new drug application (NDA) process for this product, Yeedozencom collaborated closely with GenFleet Therapeutics regarding summary of questions proposed during the pre-NDA communication meeting, reviewing of meeting materials, technical assessments of application dossiers, providing technical support, and risk management. In 2023, Fulzerasib was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) and received NDA acceptance and priority review qualifications.
In September 2021, Innovent Biologics and GenFleet Therapeutics reached a licensing agreement, obtaining the rights for the development and commercialization of Fulzerasib in China (including mainland China; Hong Kong, China; Macau, China; and Taiwan,China).
With high requirements and standards, Yeedozencom provided comprehensive technical support and consulting services for this project and obtained approval from the regulatory authority in a swift and smooth manner, gaining widespread recognition in the industry.