According to the latest announcement from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, two new drugs are planned to be included in priority review, namely Betta Pharmaceuticals' ALK inhibitor Ensatinib and Cinda Bio's FGFR inhibitor pemigatinib tablets. .
Source: CDE official website
Betta Pharmaceuticals plans to prioritize review of new indications for "Ensatinib" Ensatinib is a new, potent and highly selective next-generation anaplastic lymphoma kinase (ALK) inhibitor, jointly developed by Betta Pharmaceuticals and its holding subsidiary Xcovery. In November 2020, Ensatinib was approved for marketing in China. It is suitable for the treatment of ALK-positive locally advanced or metastatic NSCLC patients who have previously received crizotinib treatment or who are intolerant to crizotinib. (Indications for second-line treatment). This time, it is proposed to be included in the priority review application for a new indication for the first-line treatment of ALK-positive patients with locally advanced or metastatic NSCLC. Cinda Bio's FGFR inhibitor "pemigatinib tablets" will be included in the priority review Pemigatinib is a selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, jointly developed by Incyte and Innovent. Innovent is responsible for the commercialization of China, Hong Kong, Macau and Taiwan. The drug has been approved in the United States, Europe and Japan for the treatment of FGFR2 gene fusion/rearranged cholangiocarcinoma and other suitable patients. In June 2021, pemigatinib was approved in Taiwan, China, for the treatment of FGFR2 fusion or rearrangement, non-resectable locally advanced or metastatic cholangiocarcinoma, and became the first small molecule innovative drug product approved by Cinda Biotech . The indications to be included in the priority review are: for the treatment of adult patients with advanced, metastatic or unresectable cholangiocarcinoma who have received at least one systemic treatment in the past and confirmed the presence of FGFR2 fusion or rearrangement. .
July 30, 2021
