With the third week of July coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 5 sections: approval, R&D, policies, transactions, and miscellany that happened during July 13-17, including 30 pieces.
Approval
NMPA
1. Yangtze River’s 4 generic drugs applied for according to new Class 4 were approved by the NMPA for marketing on July 13 and deemed as passing the consistency evaluation, making it separately the third and second enterprise in passing the consistency evaluation of “Rivaroxaban Tablets” and “Doxofylline Injection” and the fourth enterprise in passing the consistency evaluation of “Lenalidomide Capsules” and “Tofacitinib Citrate Tablets” in China.
2. HEC’s Class 4 generic drug: “Linagliptin Tablets” was approved by the NMPA for marketing on July 13, which is the first generic of its variety in China. As a DPP-4 inhibitor, linagliptin is used to improve the blood sugar control of patients with type 2 diabetes. Developed by Boehringer Ingelheim, the original drug was approved by the FDA in May 2011 and entered China in Mar. 2013, with the median bid-winning price in China being RMB8.96/tablet.
3. Nanjing Hencer Pharmaceutical’s Class 4 generic drug: “Sevelamer Carbonate Tablets” was approved by the NMPA for marketing on July 13, which is the first generic of its variety in China. Sevelamer Carbonate Tablets are used to control hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are receiving dialysis treatment. Developed by Sanofi, the original drug was approved to enter China in June 2013 and has been included in the NRDL (National Reimbursement Drug List of China), with a median bid-winning price of RMB8.10/tablet.
4. Fosun Pharma’s Class 1 new drug: FCN-338 tablets received a clinical trial implied permission on July 13, which is planned to treat hematopoietic malignancies. FCN-338 is a selective small-molecule inhibitor of BCL-2 that plays an important role in cell apoptosis and is overexpressed in some cancer types and associated with the formation of drug resistance, being a new target in blood cancer treatment.
5. CSPC Ouyi’s marketing application for “Celecoxib Capsules”, a Class 4 generic drug, was approved by the NMPA on July 13, which was deemed as passing the consistency evaluation. Celecoxib is a COX-2 inhibitor co-developed by Pfizer and Astellas to treat osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain in adults, etc. The drug was first approved by the FDA in 1999 and entered China in 2012, with a trade name: Celebrex.
6. Nanjing Chiatai Tianqing’s marketing application for Class 4 generic drug: “Iopamidol Injection” was approved by the NMPA on July 13, which was deemed as passing the consistency evaluation. Developed by Italian Bracco, iopamidol is an X-ray non-ionic iodinated contrast agent, with similar varieties including iohexol, iodixanol, iopromide, and iomeprol, etc.
7. Nanjing Sanhome Pharmaceutical’s Class 4 generic drug: “Vildagliptin Tablets” was approved for marketing on July 13, making it the fourth Chinese bio pharmaceuticals company that will produce the drug. And the variety has also appeared in the local quantity quotation list in the third-batch centralized procurement of pharmaceutical products in China.
8. Humanwell Healthcare’s Class 1 new drug: “Remimazolam Besylate for Injection” entered the “Under approval” stage on July 14. The drug will be used for sedation during treatment or diagnosis operation and is expected to be approved soon. The product is a same-class product in competition with Hengrui’s remimazolam tosylate that was approved in Dec. 2019.
9. Hengrui Medicine’s marketing application for “Diquafosol Sodium Eye Drops”, a new Class 4 generic drug, was accepted by the CDE on July 14. Clinically, the drug is mainly indicated for patients diagnosed with dry eye, associated with keratoconjunctival epithelium disorders that accompany lacrimal fluid abnormality. Developed by Santen Pharmaceutical, the original drug is a dinucleotide derivative.
10. Suzhou Homesun Pharmaceutical’s Class 4 Read More
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