With the third week of June 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 listing that happened during June 15-19, including 30 pieces.
Approval
NMPA
1. The marketing application filed by Shanghai Zerun Biotechnology, a controlled subsidiary of Walvax Biotechnology, for the Recombinant Human Papillomavirus Bivalent (Type 16/18) Vaccine (Yeast) (Bivalent HPV Vaccine) was accepted by the NMPA on June 15, which will be used to prevent cervical cancer due to the infection by HPV 16 and 18
2. The marketing application (acceptance No.: JXSS1900044) of MSD’s anti-PD-1 monoclonal antibody: Keytruda changed to “Under approval” on June 15, which is likely to be approved this month. The indication applied for this time is the second-line treatment of patients with esophageal squamous cell carcinoma (ESCC), and if approved, it will be the 5th indication of Keytruda approved in China.
3. The Recombinant Human Insulin Injection of HEC Pharm, a subsidiary of HEC, was approved by the NMPA for marketing on June 15, which is the first biological product of HEC Pharm approved for marketing.
4. Sanofi’s marketing application (acceptance No.: JXSS1900067) for Dupilumab Injection in China changed to “Under approval” on June 16 and is expected to be officially approved in China soon. It will be used to treat moderate-to-severe atopic dermatitis. The drug is a monoclonal antibody directed against IL-4R co-developed by Sanofi and Regeneron.
5. Chiatai Tianqing’s marketing application for adalimumab injection was accepted by the CDE on June 16, making it the 6th pharmaceutical enterprise applying for the marketing of Humira biosimilar in China; wherein, the applications of Biothera and Hisun Pharmaceutical were separately approved in Nov. 2019 and Dec. 2019.
6. Zhejiang Hacon’s marketing application for Parecoxib Sodium for Injection according to the new Class 4 was approved by the NMPA on June 17, which was deemed as passing the consistency evaluation, making the company the second in passing the consistency evaluation of the product in China following Baiyu Pharmaceutical.
7. Sinqi Pharmaceutical’s Class 3 generic drug: Cyclosporine Eye Drops (II) was approved by the NMPA for marketing on June 17 to treat dry eye. The original drug was developed by Allergan and approved by the FDA for marketing in Dec. 2002, with the trade name: Restasis (0.05%, emulsion), however, it has not been approved in China.
8. Hengrui Medicine filed the marketing application for the Class 1 new drug: Hetrombopag Ethanolamine Tablets on June 18, which was accepted by the CDE on the same day. The drug will be mainly used to treat chronic primary immune thrombocytopenia (ITP) refractory to corticosteroids, immunoglobulins, or splenectomy. Hetrombopag is a highly selective TPO-R agonist with independent intellectual property rights, which is obtained after a series of modifications conducted by Hengrui to the structure of eltrombopag.
9. Kyowa Hakko Kirin’s Darbepoetin Alfa Injection was approved for marketing in China on June 19 to treat anemia in patients with chronic renal failure receiving hemodialysis. Dominating the international EPO market, darbepoetin alfa was co-developed by Amgen and Kyowa Hakko Kirin and approved by the FDA for marketing in Sep. 2001.
10. CSPC’s Class 4 generic drug: Bortezomib for Injection was approved by the NMPA for marketing on June 19, which was deemed as passing the consistency evaluation. As a new proteasome competitive inhibitor, bortezomib is clinically mainly used for multiple myeloma and mantle cell lymphoma. The drug was approved by the FDA in May 2003 and approved in China in Jan. 2005, with the trade name: VELCADE.
11. Innovent Biologics’ bevacizumab injection was approved for marketing on June 19, making the company the 2nd in receiving the ...
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