This week, the hot topic in terms of drug review was that the first highly selective PI3Kδ inhibitor in China, linperlisib of YL-Pharma, was approved for marketing. In terms of R&D, positive progress has been made in several clinical trials, but the Phase III clinical trial of GSK's BCMA ADC combined with pomalidomide in the treatment of myeloma failed. In terms of business, Jumpcan Pharmaceutical entered into a cooperation agreement with Newsoara and obtained the development rights of two drugs.
The news review of this week is from November 7 to 11, covering a total of 26 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA – Marketing
[Approval]
1. On November 7, the NMPA official website revealed that the Insulin Aspart 30 injection of HEC had been approved for marketing. The Insulin Aspart 30 injection is premixed insulin with 30% soluble Insulin Aspart and 70% protamine Insulin Aspart. Up to now, the Insulin Aspart 30 of three Chinese pharmaceutical companies has been approved for marketing, including HEC, United Laboratories, and Gan & Lee Pharmaceuticals.
2. On November 7, the NMPA official website revealed that the Linagliptin and Metformin Hydrochloride Tablets of Qilu Pharmaceutical had been approved for marketing, following the first generic drug from HEC and being the second one in China. The first research of Linagliptin and Metformin Hydrochloride Tablets was jointly developed by Boehringer Ingelheim/Eli Lilly for improving the blood glucose control of type 2 diabetic patients. The import was approved in China in March 2017, with the brand name Trajenta Duo.
3. On November 9, the NMPA official website revealed that the first-in-class, linperlisib tablets of Shanghai YL-Pharma (brand name: Itari) had been conditionally approved for marketing. Linperlisib is for adult patients with recurrent or refractory follicular lymphoma who have received at least two kinds of systematic treatment in the past. Linperlisib (YY-20394) is a phosphatidylinositol-3-kinases δ subtype (PI3K Read More
(All Rights Reserved)