21st -25th Feb. is the statistical time for the weekly review that covers four sections, Review, R&D, Trading, Investment & Financing, and IPO, and contains 18 pieces of information.
Review
NMPA
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1. On February 24, Yifan Pharmaceutical Co., Ltd. announced that the marketing application for the holding subsidiary Evive Biotech is developing the product Albertine α Injection (hereinafter referred to its proposed trade name as Yi Li Shu, 'F-627'), used to prevent and treat neutropenia caused by chemotherapy in tumor patients has been officially accepted by the CDE.
2. On February 24th, it was shown on the NMPA official website that a new indication of Ciprofol Injection of Haisco Pharmaceutical Group was approved for marketing. The drug is for induction and maintenance of general anesthesia. HSK3486 is a class 1.1 innovative drug developed by Haisco with fully independent intellectual property rights, and it is also the first intravenous anesthetic drug with independent compound innovation in China.
3. On February 24, it was shown on the NMPA website that AbbVie's JAK1 inhibitor Upadacitinib sustained release tablets were approved for marketing in China. AbbVie's Upadacitinib is a selective and reversible JAK1 inhibitor administered orally once daily. The drug was first approved by the US FDA in August 2019.
Breakthrough Therapy
4. On February 18, it was announced on the CDE official website that AB-106, a new-generation ROS1/NTRK inhibitor under development by AnHeart Therapeutics/Innovent Biologics, is to be included as a breakthrough therapy, with the proposed indications of non-small cell lung cancer (NSCLC) carrying ROS1 fusion gene and failed by ROS1-TKI treatment.
Clinic
5. On February 22, Huahai Pharmaceuticals announced that its subsidiaries Huaota Biopharmaceutical Co., Ltd. and Huabo Biopharm had received CDE approval for the clinical trial application of HB0028 injection to be used in advanced solid tumors. According to the announcement, HB0028 is a bispecific antibody targeting PD-L1/TGF-β.
6. On February 22, it was announced on the CDE official website that the combination therapy targeting PD-L1/CTLA-4 by bispecific antibody (KN046) from Alphamab Oncology and small molecule tyrosine kinase inhibitor MAX-40279-01 capsules from Maxinovel Pharmaceuticals was approved for clinical use in the treatment of advanced/metastatic solid tumors. Last November, Maxinovel Pharmaceuticals entered into a clinical collaboration with Alphamab Oncology on the combination of the two drugs for treating solid tumors.
FDA
7. On February 21, Applied Pharmaceutical Science, Inc. announced that its independent R&D second-generation RET inhibitor APS03118, has been granted Fast Track by the U.S. FDA for patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) that is drug-resistant to selective RET inhibitors. Data from preclinical studies of the drug were the main reason for approval, and the results of the relevant studies will be presented in an e-poster at the American Association for Cancer Research (AACR) annual meeting in April 2022.
R&D
8. On February 21, Innovent Biologics announced that its development of the world's first generic "modular" Claudin18.2 chimeric antigen receptor T-cell (CAR-T) injection (R&D code: IBI345) completed the first patient dosing in clinical trials for the treatment of advanced Claudin18.2-positive solid tumors. The new drug comes from the cooperation between Innovent and Roche on June 9, 2020.
9. On February 21, AstraZeneca and Daiichi Sankyo jointly announced that the Phase III registration clinical DESTINY-Breast04 research of the HER2-ADC drug Enhertu in patients with unresectable/metastatic breast cancer with low HER2 expression met its primary endpoint. It significantly improved progression-free survival (PFS) and overall survival (OS) in this group, regardless of HR expression status. It is the first phase II...
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