Regent Pacific Group Ltd. Announces Progress in NDA Review for Senstend™ in China, Approval Expected by End of 2025
Reuters
Jul 22
<a href="https://laohu8.com/S/RPGLF">Regent Pacific</a> Group Ltd. Announces Progress in NDA Review for Senstend™ in China, Approval Expected by End of 2025
Regent Pacific Group Ltd. has announced a significant update regarding the ongoing regulatory review of its product, Fortacin™/Senstend™, in China. The company's commercial strategic partner, Jiangsu Wanbang Biopharmaceutical Group Co., Ltd., is actively progressing the new drug application (NDA) with China's National Medical Products Administration (NMPA). The review process has moved forward with Wanbang Biopharmaceutical submitting a comprehensive response to the first round of questions from the NMPA. Additionally, 900 commercial samples have been submitted to the Centre of Drug Evaluation. The company remains optimistic about obtaining NDA approval by the end of 2025, with commercial launch anticipated in the first quarter of 2026. Upon approval, Regent Pacific Group Ltd. is set to receive a payment of US$5 million from Wanbang Biopharmaceutical.
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