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....
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