This week, in China, Nanjing Biosnwill Pharma's Class 2.2 new drug Edaravone Sublingual Tablets and Yichang Humanwell's Class 3 generic drug Clobazam Tablets have been approved by the NMPA for marketing. Meanwhile, new indications have been approved for both Junshi Biosciences' Toripalimab and AstraZeneca's Olaparib Tablets; New progress with the EMA and FDA approvals has been achieved for some popular drugs. For example, Roche's bispecific antibody ophthalmic drug Faricimab has been approved for marketing in the EU. Although there has been nothing new in R&D during the week, on the business side, Chiatai Tianqing entered into a collaboration agreement with Inventiva for the development of lanifibranor, a pan-PPAR agonist. Besides, InnoCare Pharma was successfully listed on the STAR. This week’s news review covers 25 pieces of information in 4 sections, i.e., drug review, R&D, and business and listing.
Drug Review
NMPA – Marketing
[Approval]
1. On September 19, the NMPA official website released the approval that, a new indication for Junshi Biosciences' PD-1 monoclonal antibody, Toripalimab, in combination with standard first-line chemotherapy has been approved for marketing for the treatment of untreated, driver gene (EGFR/ALK)-negative and advanced NSCLC. This is the sixth indication for which Toripalimab has been approved in China.
2. On September 19, the NMPA official website released the approval that, the new indication for AstraZeneca/ MSD's PARP inhibitor Olaparib Tablets has been approved for marketing. It is used for the maintenance treatment of adult patients with homologous recombination deficiency (HRD)-positive and advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after complete response or partial response with first-line platinum-containing chemotherapy in combination with bevacizumab. This is the fourth indication for which Olaparib Tablets have been approved in China.
3. On September 19, the NMPA official website released the approval that Nanjing Biosnwill Pharma's new class 2.2 drug Edaravone Sublingual Tablets has been approved for marketing, with an indication of inhibiting the progression of dysfunction caused by amyotrophic lateral sclerosis (ALS). Thus, Nanjing Biosnwill Pharma emerged as the first pharmaceutical company to obtain marketing approval for Edaravone Sublingual Tablets.
(All Rights Reserved)