This week, in terms of drug review and approval, the most exciting thing for the industry is that a first-in-class drug named Dorzagliatin Tablets, which is independently researched and developed by Hua Medicine was approved for marketing, becoming the first approved new drug for GKA diabetes in the world. In terms of R&D, pivotal progress has been made in several important clinical researches, and the PFS superiority has been achieved in the global, Phase III, head-to-head research of Zanubrutinib in BeiGene. In terms of business, it's a bit unremarkable. Immune-Onc Therapeutics and BeiGene have reached a strategic cooperation agreement to jointly research the concomitant medication of myeloid checkpoint inhibitors IO-108, IO-202, and Tislelizumab.
The news review of this week is from October 8 to 14, covering a total of 25 pieces of information in 3 sections, i.e. drug review and approval, R&D, and business.
Drug Review
NMPA – Marketing
[Approval]
1. On October 8, the NMPA official website revealed that a first-in-class drug, Dorzagliatin Tablets, developed by Hua Medicine had been approved for marketing to treat type II diabetes. Dorzagliatin is a first-in-class glucokinase initiator (GKA), which can be used as a monotherapy or in combination with a currently approved diabetes drug.
2. On October 9, the NMPA official website revealed that the new indication for the PD-1 inhibitor Pembrolizumab Injection of MSD was approved. It is the 9th indication approved for Pembrolizumab in China and is intended for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received Sorafenib or Oxaliplatin.
NMPA – Marketing
[Application]
3. On October 8, the CDE official website revealed that the marketing application for the second indication of Dexmedetomidine Hydrochloride Nasal Spray, a class-2.2 new drug of Hengrui Medicine, had been processed fo...
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