The most talked-about news of this week is the successful overseas marketing of Nanjing LEGN.US's CAR-T, which not only demonstrates the strength of China's innovative biologics but also eases the anxiety of Chinese innovative drug companies.

The news review of this week is from February 28th  to March 4th, covering a total of 19 pieces of information in 3 sections, i.e. review, R&D, transaction & investment, and financing.

Review

NMPA

Marketing

1. On February 28, the CDE official website revealed that Sihuan Pharm submitted a marketing application (acceptance No.: CXHS2200012) for the Class 1 new drug, janagliflozin, for the treatment of type 2 diabetes and was accepted. Currently, five SGLT-2 inhibitors have been marketed in China, and janagliflozin is the second among the new drugs declared for marketing in China.

2. On February 28, NMPA released the latest approval, the infliximab biosimilar of Yuxi Genor Biopharma Co., Ltd. was approved for marketing, becoming the third Chinese infliximab biosimilar. Infliximab is a mouse/human chimeric monoclonal antibody specifically blocking tumor necrosis factor-alpha (TNF-α) developed by Johnson & Johnson/MSD.

3. On February 28, NMPA released the latest approval for a new indication of rituximab biosimilar from Henlius for treating rheumatoid arthritis. The original rituximab has not yet been approved for this indication in China.

4. On March 2, the NMPA official website revealed that the marketing application of Inebilizumab injection, introduced by Hansoh Pharmaceutical Group Company Limited with over RMB 220 million, entered the administrative approval stage. It is expected to be approved for marketing in the near future for neuromyelitis optica spectrum disorder (NMOSD). Inebilizumab is a humanized monoclonal antibody with a high affinity for CD19, and no CD19 monoclonal antibody has been approved in China yet.

5. On March 2, Zhaoke Pharmaceutical’s marketing application for the Class 5.1 new drug, nitric oxide for inhalation, entered the administrative approval stage. It is expected to be approved for marketing in the near future. Nitric oxide for inhalation is a vasodilator that selectively allows pulmonary vascular relaxation and improves oxygenation in the vulnerable neonatal population by combining with an air interchanger and other appropriate medications.

6. On March 2, NMPA announced that it has granted conditional approval for the marketing registration application of recombinant novel coronavirus protein vaccine (CHO cell) from Zhifei Longcom Biopharmaceutical Co., Ltd. According to the announcement, the vaccine is the first Chinese-made recombinant novel coronavirus protein vaccine approved for the prevention of diseases caused by novel coronavirus infection (COVID-19).

7. On March 3, the latest announcement on NMPA official website showed that the marketing application for adalimumab biosimilar (UBP1211) submitted by Junshi Biosciences has been approved. As announced by Junshi Biosciences, the approved indications for the drug are rheumatoid arthritis, ankylosing spondylitis, and psoriasis.

8. On March 3, the latest announcement on NMPA official website showed that Lee's Pharm's lidocaine hydrochloride powder needle-free transdermal drug delivery system for children (trade name: Zingo) has been officially approved. The approved indication for it is the preoperative local skin anesthesia for venipuncture or peripheral intravenous cannulation in minors aged 3 to 18.

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Breakthrough therapy designation

9. On March 1, Innovent and AnHeart Therapeutics announced that Taletrectinib has been added to the CDE's list of breakthrough therapeutic drugs for patients with ROS1 fusion-positive NSCLC who have or have not been previously treated with the ROS1-TKI. Taletrectinib is a novel, best-in-class, next-generation ROS1 inhibitor.

Priority review

10. On March 1, CDE official website revealed that Boehringer Ingelheim's Spesolimab marketing application is proposed for priority review approval. This is a pioneer IL36 monoclonal antibody for the treatment of generalized pustular psoriasis (GPP), and the drug was first submitted for marketing in China in November 2021.

11. On March 2, the CDE official website revealed that the new indication of Jardiance tablets from Boehringer Ingelheim/Eli Lilly's for reducing the risk of cardiovascular death or hospitalization due to heart failure in adult patients with heart failure is proposed for priority review and approval. The marketing pace is expected to be accelerated.

Clinic

12. On February 28, Simcere Pharmaceutical Group Limited announced that varoglutamstat (SIM0408), regionally licensed by VivoryonTherapeuticsN.V., has received a notice of approval for the drug clinical trials issued by NMPA. It is for the proposed treatment of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).

13. On March 2, CDE official website announced that Omeros' declared OMS721 was approved for clinical use in China, with the proposed indication of immunoglobulin A (IgA) nephropathy. Public information shows that OMS721 is a monoclonal antibody in research targeting MASP-2 and is currently in Phase 3 clinical trials overseas for the treatment of IgA nephropathy.

14. On March 2, InnoCare Pharma announced that its Phase 2 clinical trials of BTK inhibitor, Orelabrutinib, for the treatment of neuromyelitis optica spectrum disorders have been approved by NMPA. This follows the approval of Orelabrutinib in China for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed/refractory mantle cell lymphoma (MCL). It was included in China's national reimbursement drug list at the end of 2021.

FDA

15. On February 28, cilta-cel, a BCMA CAR-T developed by Janssen, a subsidiary of Johnson & Johnson, and LEGN.US, has been approved for marketing by the U.S. FDA. It is for the treatment of adult patients with relapsed/refractory multiple myeloma (MM). This is also the second FDA-approved CAR-T therapy targeting BCMA and the second Chinese drug successfully going global.

R&D

16. On March 2, Nicox announced that its partner, OcuMension, has obtained favorable results from the Phase 3 clinical trials of Zerviate, a drug for allergic conjunctivitis, in China. Zerviate is a histamine H1 receptor antagonist introduced by OcuMension, which has been approved by the U.S. FDA for the treatment of eye itch associated with allergic conjunctivitis.

17. On March 3, CARsgen announced that its self-developed CAR-T cell candidate CT041 was approved by CDE to enter a confirmatory Phase 2 clinical trial. It is for the treatment of patients with Claudin18.2 (CLDN18.2) positive advanced gastric cancer/adenocarcinomas of the esophagogastric junction (GC/GEJ) that have failed at least previous second-line therapy. CT041 is the first CAR-T cell candidate for solid tumors to enter the confirmatory Phase 2 clinical trials.

Transaction & investment and financing 

18. On March 1, Kejin Bio announced that it has recently completed the angel funding of nearly RMB 100 million. The funding is led by Med-Fine Capital and followed by GP Healthcare and Wuxi Jinchengyingyue Angel Investment. This round of financing was primarily used to advance two IND filings for its first rare disease pipeline, pyruvate kinase deficiency (PKD), in China and Europe.

19. On March 4, InxMed announced that it has completed the Series B financing of US$ 50 million. This round of financing was led by SDIC, with the participation of AIHC Capital, Shaanxi Growth Management, and Hosencare Investment. The funds raised in the round will be used to accelerate the clinical trials of IN10018, a highly efficient and selective FAK inhibitor, for multiple cancer types with different combination regimens in China and the U.S., respectively.