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On December 22, the clinical application of Hengrui Medicine's 2 Class 1 new drugs was accepted by CDE.
In addition, it was the first company to submit 10% fat emulsion (OO)/5.
5% amino acid (15)/glucose (20%) injection under the new registration classification.
Liquid listing application
.
According to data from Meinenet, in the past week, Hengrui Medicine has 7 new drugs (6 of which are Class 1 new drugs) for clinical application
Source: CDE official website
On December 22, Hengrui Medicine's clinical application for 2 new category 1 drugs and the marketing application for 1 category 4 generic drugs were accepted by the CDE
.
At present, only Baxter’s 10% fat emulsion (OO)/5.
Innovative drugs and first generic drugs are the focus of Hengrui Pharmaceuticals.
On December 17-23, Hengrui Medicine applied for listing/clinical varieties
On December 17-23, Hengrui Medicine applied for listing/clinical varieties
Source: Meinenet MED2.
Among the 6 Class 1 new drugs, SHR-1816 injection and HRS-2261 tablets were submitted for clinical application in China for the first time
Among the new drugs not declared for the first time, SHR0302 tablets are a selective inhibitor of JAK1 kinase, and the indications for active rheumatoid arthritis and atopic dermatitis are in phase III clinical trials; SHR-1316 injection is PD-L1 monoclonal antibody Indications such as extensive-stage small cell lung cancer have entered phase III clinical trials; SHR-1501 for injection is an interleukin-15 (IL-15) fusion protein, and advanced malignant tumor indications are in phase I clinical trials; for injection SHR-A1811 is an ADC drug targeting Her2, and its indications for advanced non-small cell lung cancer are in phase I/II clinical trials