Sep. 3
Information on two proposed breakthrough therapies was publicized on the CDE website, separately YY-20394 tablets (linperlisib) of YL-Pharma and plinabulin concentrated solution for injection of BeyondSpring. Before this, as a next-generation highly selective PI3Kδ inhibitor, linperlisib received two Orphan Drug Designations issued by the FDA for follicular lymphoma and chronic lymphocytic leukemia indications. Plinabulin is a major product of BeyondSpring, with the indications in development including the prevention of chemotherapy-induced neutropenia (CIN) and non-small cell lung cancer (NSCLC) treatment.
Qilu Pharmaceutical’s new Class 4 generic drug: Afatinib Dimaleate Tablets was approved by the NMPA for marketing, making it the 2nd enterprise approved to market this product in China following Hansoh.
AstraZeneca’s marketing application for its antithrombotic drug: Ticagrelor Orodispersible Tablet was approved by the NMPA. Ticagrelor is one of the blockbuster varieties of AstraZeneca, for which AstraZeneca has separately developed tablets, dispersible tablets, and orally disintegrating tablets. Sales of AstraZeneca’s ticagrelor reached USD1.581 billion in 2019.
Sep. 2
Chiatai Tianqing’s marketing application for the Class 4 generic drug: Saxagliptin Tablets entered the administrative approval stage, which is expected to be approved soon to make the company the 2nd in receiving the marketing approval for this variety in China following Aosaikang.
A marketing application was filed for a new indication of Hengrui’s camrelizumab and planned to be included in priority review (the acceptance No. has not been released at the moment); this new indication, according to an earlier announcement of Hengrui, is for the first-line treatment of nasopharyngeal cancer with local recurrence or distant metastasis in combination with cisplatin and gemcitabine.
Innovent’s Adalimumab Injection was approved by the NMPA for marketing to treat autoimmune diseases such as ankylosing spondylitis, rheumatoid arthritis, and psoriasis, making it the 3rd Chinese enterprise approved to market adalimumab following Bio-Thera and Hisun Pharmaceutical.
Athenex announced that the U.S. FDA accepted the company’s filing of the NDA for oral paclitaxel and granted it a Priority Review designation, with the indication being metastatic breast cancer. The FDA is expected to reply before Feb. 28 next year. Furthermore, the FDA indicated that it was not currently planning to hold an advisory committee meeting to discuss the NDA.
Aug. 31
Huadong Medicine announced that Zhongmei Huadong’s ANDA for the oral solid formulation: Acarbose Tablets filed to the U.S. FDA was approved. It is the first Chinese acarbose formulation product that receives the U.S. FDA’s approval and also the first Chinese acarbose formulation product that possesses marketing authorization in China, the U.S., and Austria in the EU.
Aug. 27
RemeGen’s marketing application for the self-developed HER-2 ADC: Disitamab Vedotin for Injection was accepted by the NMPA for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) and was included in the priority review and approval procedure. It is the first Chinese-produced ADC applied for marketing.
Bayer filed a marketing application for its new heart failure drug: Vericiguat Tablets in China. Vericiguat is an orally administered soluble guanylate cyclase (sGC) stimulator. It will become the first-in-class sGC stimulator for heart failure treatment if successfully marketed.
Qilu Pharmaceutical’s marketing application Tofacitinib Citrate Extended-Release Tablets according to a Class 3 generic drug was accepted by the CDE. As a JAK inhibitor developed by Pfizer, indications approved for tofacitinib worldwide include rheumatoid arthritis, ulcerative colitis, and psoriatic arth...
(All Rights Reserved)