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 

Go public 

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 III trial result of Enhertu in patients with HER2 low-expression breast cancer. The drug is expected to change the current treatment status of this disease. 

10. On February 22, a press issued by Bayer China stated that positive results were achieved in the pivotal Phase 3 clinical trials (ARASENS) with Darolutamide combined with androgen deprivation therapy (ADT) plus Docetaxel: Darolutamide plus ADT and Docetaxel, reduced the risk of mortality in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by 32.5% compared to ADT plus docetaxel. 

11. On February 23, Simcere Pharmaceutical Group Limited announced that the China-registered Phase 3 clinical trials of Trilaciclib, a comprehensive myelo protective agent developed in collaboration with G1Therapeutics, against extensive-stage small cell lung cancer (ES-SCLC) met its primary endpoint. Research shows that Trilaciclib significantly reduces the duration of severe neutropenia in the first cycle in Chinese patients with SCLC. Simcere Pharmaceutical Group Limited plans to announce specific data at a subsequent academic conference. 

12. On February 24, in accordance with the China Drug Trials, CSPC Pharmaceutical Group Co., Ltd registered and started the BE clinical trials for Roxadustat, which is the fifth Roxadustat generic drug to enter clinical development in China. Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor developed by FibroGen, is the first HIF-PH inhibitor for CKD anemia. 

Trading, Investment & Financing 

13. On February 21, Beijing StarMab BioMed Technology Ltd announced that it has completed a Series A financing of nearly RMB100 million. The series was led by CCIG Qide Fund, a subsidiary of China Capital Investment Groups (CCIG), followed by Golden China Fund and Chang'an Capital with Probe Capital acting as the exclusive financial advisor. Beijing StarMab BioMed Technology Ltd has developed a series of innovative antibody drugs, of which the most advanced, SM3321, will soon be launched for clinical filing in China and the US, to be developed for the neoplastic hematologic disorder. 

14. On February 22, Luye Pharma announced that it had signed an agreement with Beijing Biostar to cooperate and promote the natural microbial small molecule antitumor drug and national Class 1 new drug Utidelone Injection (trade name: Utidelone) in 26 provinces in the Chinese Mainland. Utidelone injection is a genetically engineered derivative of epothilone, which is independently developed by Biostar. It is also a new class of non-paclitaxel anti-microtubule protein polymerization antitumor drug. 

15. On February 22nd, Imbioray announced the completion of a Series A financing of RMB 230 million to advance its spot-type allogeneic CAR-NK and NK cell therapeutic drugs to the clinical phase. The round of financing was co-led by Lucky Source Fund and South China Venture Capital and followed by Longmen Capital, Zhongguancun Kaiyuan Capital, Orient Huisheng, Bayfish Parade Fund, and many other investment institutions. 

16. On February 23, Henlius announced that it has entered into a license and supply agreement with GetzPharma for, among other things, the commercialization of Adalimumab (trade name: Handa Yuan) in 11 countries, including Pakistan, the Philippines, Vietnam, Myanmar, Cambodia, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan, Uzbekistan, and any other mutually agreed-upon territories. 

17. On February 23, Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmeihuadong Pharmaceutical Co., has signed an exclusive product license agreement with Kiniksa. ZhongmeiHuadong received exclusive licenses, including development, registration, and commercialization rights, for two autoimmune global innovations from Kiniksa that is Rilonacept, and Mavrilimumab in 24 Asia-Pacific countries and regions (excluding Japan), including China, Korea, Australia, New Zealand, and India. 

Listing 

18. On February 23, Lepu Biopharma was officially listed on the main board of the Hong Kong Stock Exchange. The company, founded in 2018, is a biopharmaceutical company focusing on the field of oncology therapeutics. In line with the prospectus, Lepu Biopharma is listed on the Hong Kong Stock Exchange subject to Chapter 18A of the Listing Rules. Through a diversified approach, Lepu Biopharma has built a pipeline of multiple oncology therapeutic products, including eight clinical-stage drug candidates, three preclinical drug candidates, and three combination therapies of clinical-stage drug candidates. 

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.