This week, in terms of drug review and approval, the two most noteworthy events were the approval of the two-drug HIV therapy developed by GSK for marketing in China and the submission of the marketing application for Zevorcabtagene Autoleucel injection of CARsgen, which is the second BCMA CAR-T product to be declared for marketing in China. In terms of R&D, several important clinical research has made key progress, and the results of the Phase I study of Innovent’s GLP-1R/GCGR dual agonist were published, with a weight loss of over 11.5% at 12 weeks of dosing. In terms of t listing, Hrain Biotechnology has submitted the application for IPO on the STAR market and was accepted.
The news review of this week is from October 17 to 21, covering a total of 21 pieces of information in 3 sections, i.e., drug review, R&D, and listing.
Drug Review
NMPA – Marketing
[Approval]
1. On October 21, the NMPA official website revealed that a new indication for Tofacitinib Citrate Sustained Release Tablets of Pfizer was approved for marketing. Tofacitinib is a JAK inhibitor developed by Pfizer, with approved indications worldwide for rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. In August 2021, the sustained-release tablet formulation was approved for marketing in China, making it the first once-daily sustained-release tablet approved in China for tofacitinib. On the same day, according to the NMPA, the Class 3 generic drug Tofacitinib Citrate Sustained Release Tablets of CSPC Pharmaceutical were also approved for marketing, which is the second generic tofacitib sustained release tablet marketed in China.
2. On October 21, the NMPA official website revealed that Dolutegravir Edurant Tablets of GSK were approved for marketing, which is used for adult human immunodeficiency virus type 1 (HIV-1) infected patients who have achieved virological suppression (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least six months, have no history of virological failure, and have no known or suspected resistance to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors.
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