The news review of this week is from April 24 to 29, covering a total of 20 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Approval
NMPA
Marketing
Application
1. On April 24, CDE's official website revealed that Jingxin Pharmaceutical submitted the application for a first-in-class drug, EVT201 capsule, for insomnia. As for the partial positive allosteric modulator for the receptor of EVT201 GABAA (Gamma-aminobutyric acid A), Jingxin Pharmaceutical collaborated with Evotec of Germany in 2010 and acquired the exclusive patent license and development right of it in China.
2. On April 24, CDE accepted the marketing application of Qilu Pharmaceutical's dolutegravir sodium. It is the first time for a generic drug of this type to be declared for marketing in China. Dolutegravir was an anti-AIDS drug developed by GSK/ViiV, which is categorized as an integrase inhibitor. In 2015, dolutegravir tablets were approved for marketing in China.
3. On April 24, CDE's official website revealed that Bayer's marketing application for new indications of darolutamide tablets for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) was accepted. As an oral androgen receptor inhibitor (ARi), Darolutamide tablets are approved for marketing in China in February 2021 for the treatment of adult patients with nmCRPC.
4. On April 25, CDE revealed that a marketing application for new indications of nimotuzumab injection, submitted by Biotech Pharma, was accepted. Nimotuzumab was an anti-EGFR humanized monoclonal antibody, which had been approved for the treatment of nasopharyngeal carcinoma in China earlier.
5. On April 27, Suzhou Zelgen Biopharmaceuticals Co., Ltd. announced the submission of the marketing application for its recombinant protein new drug, recombinant human thrombin for external use. Independently developed by Zelgen, recombinant human thrombin for external use is a highly specific human serine protease. The Phase III trial of this drug has reached the presupposed primary endpoint.
6. On April 28, the CDE official website revealed that Qilu Pharmaceutical's Aflibercept Intravitreous Injection was accepted for a marketing application. It was the first biosimilar drug applied in this variety in China. Aflibercept, an anti-VEGF drug jointly developed by Regeneron and Bayer, was approved for marketing in China in February 2018.
Clinical
Application
7. On April 26, CDE revealed that a first-in-class drug of Henlius, HLX53 was declared for clinical use, which is the initial declaration of this drug for clinical use in China. HLX53 is an anti-TIGIT monoclonal antibody independently developed by Henlius. Currently, there were 17 TIGIT antibody projects in the clinical stage in China, including 11 monoclonal antibodies and 6 bispecific antibodies.
Approval
8. On April 26, the CDE official website revealed that allogeneic endothelial progenitor cells (EPCs) injection (ALF201) declared by Allife Medicine had acquired an implied license for clinical trials. It is intended to be developed for the treatment of large-artery atherosclerosis acute ischemic stroke. ALF201 was an endothelial progenitor cell injection prepared by Allife Medicine based on iPSC directional differentiation endothelial progenitor cell stock solution.
9. On April 28, a new indication of Eli Lilly's GLP-1R/GIPR double agonist, Tirzpatide, was approved for a clinical trial in China. It is used for single intervention drug treatment of adult patients with moderate to severe obstructive sleep apnea (OSA) and body mass index (BMI) ≥ 30kg/m2.
Priority review
10. On April 24, CDE intended to include the marketing application of a HER2-directed ADC drug Enhertu of Daiichi Sankyo/AstraZeneca in the updated publicity list of priority review. Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more anti-HER2 based regimens.[RH1]
Breakthrough therapy
11. On...
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