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 29-July 3, including 29 pieces.
Approval
NMPA
1. Luye Pharma announced on June 29 that the clinical trial application for lurbinectedin, an innovative anti-tumor drug, introduced by it from the Spanish company: PharmaMar was accepted by the CDE for the treatment of small cell lung cancer (SCLC). As an inhibitor of RNA polymerase II, lurbinectedin has received the FDA’s accelerated approval for marketing in the U.S. this June for the treatment of adult patients with relapsed SCLC whose disease has progressed on or after platinum-based chemotherapy.
2. HEC’s marketing application for Class 3 generic drug: Oseltamivir Phosphate for Oral Suspension was accepted by the CDE on June 29, making it the third manufacturer applying for the marketing of the dosage form in China following BrightGene Pharmaceutical and Brilliant Pharmaceuticals.
3. Aosaikang’s marketing application for Class 4 generic drug: Eltrombopag Olamine Tablets was accepted by the CDE on June 29, making it the first manufacturer applying for the marketing of the generic drug in China. As a TPO-R agonist developed by Novartis, the original drug is indicated for the treatment of patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids or immunoglobulins, etc.; it was approved by the FDA for marketing in Nov. 2008 and entered the Chinese market in Dec. 2017.
4. Kelun Pharmaceutical’s Class 4 generic drug: Tofacitinib Citrate Tablets was approved by the NMPA for marketing on June 30 and deemed as passing the consistency evaluation, making it the 3rd enterprise in passing the consistency evaluation of the variety in China following Chiatai Tianqing and Qilu Pharmaceutical. Developed by Pfizer, tofacitinib was approved by the FDA in Nov. 2012 and approved in China in Mar. 2017. The drug is one of the important varieties in the centralized procurement of the 3rd batch of drugs organized by China, and Kelun Pharmaceutical has become a strong competitor in providing the drug.
5. Salubris’ clinical trial applications for 2 new drugs (enarodustat tablets, and recombinant human neuregulin-1-anti-HER3 antibody fusion protein for injection) were accepted by the CDE on June 30.
6. JW Therapeutics’ marketing application for JWCAR029 was accepted by the CDE on June 30, which is the 2nd CAR-T therapy applied for marketing in China following the Fosun Kite’s axicabtagene ciloleucel.
7. The clinical trial application filed by Amgen/BeiGene for AMG910 was accepted by the CDE on July 1. The drug is currently in a global phase 1 clinical trial for gastric and gastroesophageal junction adenocarcinoma. AMG910 is an anti-CD3/CLDN18.2 bispecific antibody, while CLDN18.2 is a protein encoded by the CLDN18 gene, belongs to the claudin family and can control the flow of molecules between cells in a layer.
8. Hengrui announced on July 1 that the clinical trial applications for its 2 Class 1 new drugs: HRS5091 tablets and HRS9950 tablets were approved by the NMPA, both of which will be used to treat chronic hepatitis B.
9. Yuxi Zerun Biotechnology’s marketing application for the Recombinant Human Papillomavirus Bivalent (Type 16/18) Vaccine (Yeast) was accepted by the CDE on July 1, marking the production application for the second Chinese-produced bivalent HPV vaccine. The company is expected to be a new competitor in the Chinese-produced HPV vaccines.
10. BeiGene announced on July 2 that the CDE accepted its marketing application (sNDA) for the new indication of tislelizumab injection, its anti...
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