Core Viewpoint - Four Seasons Pharmaceutical (00460) announced that its non-wholly owned subsidiary, Xuan Zhu Bio-Tech Co., Ltd., has received Fast Track designation from the FDA for the product NG-350A, aimed at treating locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) [1] Group 1 - Xuan Zhu Bio-Tech holds exclusive rights for the development, production, and commercialization of NG-350A in Greater China [1] - The Fast Track designation is a method to expedite the development and approval of potential drugs that address serious conditions and unmet medical needs [1] - NG-350A is currently being tested in the Phase Ib FORTRESS clinical trial (NCT06459869) in combination with chemoradiotherapy for adult patients with pMMR locally advanced rectal cancer [1]
四环医药(00460)：NG-350A获授美国FDA快速通道资格认定