NMPA Conditionally Approves Tinengotinib Tablets and Xiao'er Tongbian Granules

The National Medical Products Administration (NMPA) recently, through a priority review and approval process, conditionally approved the marketing of the Class 1 innovative drug Tinengotinib Tablets (trade name: Jieentai) submitted by Yaojie Ankang (Nanjing) Technology Co. , Ltd. The drug is indicated for adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received systemic therapy and FGFR inhibitor treatment and have fibroblast growth factor receptor (FGFR) 2 fusions or rearrangements. The approval provides a new treatment option for these patients.

The NMPA recently approved the marketing of the Class 1.1 traditional Chinese medicine innovative drug Xiao'er Tongbian Granules submitted by Jumpcan Pharmaceutical Group Co. This drug is the first Chinese medicine innovative drug whose primary indication is a syndrome since the issuance of the 'Special Provisions for Registration Management of Traditional Chinese Medicines'. It has the effects of strengthening the spleen, promoting qi movement, removing stagnation, and relieving constipation. It is used for pediatric constipation diagnosed as food retention syndrome in traditional Chinese medicine, characterized by dry hard stools, difficult defecation, red tongue, thick greasy coating, and slippery pulse. The approval provides a new option for the treatment of pediatric constipation.