The news review of this week is from March 7 to 12, covering a total of 20 pieces of information in 4 sections, i.e. review, R&D, business, and listing.
Approval & Review
NMPA
Marketing
1. On March 9, Innovent announced that its biosimilar Bevacizumab Injection (brand name: BYVASDA) was officially approved by NMPA for two new indications. It can be applied with carboplatin and paclitaxel for the first-line treatment of patients with Stage III or IV epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma after initial surgical resection, and can also be applied with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of patients with persistent, recurrent or metastatic cervical carcinoma.
2. On March 11, the NMPA official website revealed that Hansoh Pharmaceutical Group's CD19 monoclonal antibody Inebilizumab was approved for marketing in neuromyelitis optica spectrum disorder (NMOSD). This is the first biological drug approved for marketing by Hansoh. In May 2019, Hansoh acquired the development and commercialization rights of the drug in China from VielaBio for more than USD 220 million in down payment and milestone payments.
3. On March 11, the NMPA official website revealed that a new indication marketing application of PD-1 inhibitor, Tislelizumab, of BeiGene, has been approved. It can be applied for previously treated locally advanced unresectable or Microsatellite Instability-High (MSI-H) or deficient DNA mismatch repair (dMMR) solid tumors.
4. On March 11, NMPA’s official website revealed that CSTONE Pharmaceuticals received marketing approval for a new indication of pralsetinib capsules. It can be applied for the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy, as well as those with advanced or metastatic RET fusion-positive thyroid carcinoma requiring systemic therapy and refractory to radioactive iodine (if radioactive iodine is indicated).
5. On March 11, the NMPA official website revealed that the marketing approval for the Class 5.1 new drug, nitric oxide for inhalation, of Zhaoke Pharmaceutical. Nitric oxide for inhalation (brand name: INOmax) is a vasodilator that selectively allows pulmonary vascular relaxation and improves oxygenation in the vulnerable neonatal population by combining it with an air interchanger and other appropriate medications.
6. On March 12, NMPA issued an announcement to approve the application changes of COVID-19 antigen self-testing products application of Beijing Savant Biotechnology Co., Ltd., Nanjing Vazyme Biotech Co., Ltd, Beijing Jinwofu Bioengineering Tech, Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd, and Guangzhou Wondfo Biotech Co., Ltd. Just in one night, there are five such products officially marketed in China, and the market valued RMB 100 billion for COVID-19 self-testing in China is officially open.
Clinical
7. On March 7, the CDE official website revealed that JS001SC, a PD-1 monoclonal antibody subcutaneous injection from Junshi Biosciences, was approved for the first time in China (acceptance No.: CXSL2101506) for advanced nasopharyngeal carcinoma. JS001SC injection is a subcutaneous injection formulation developed by Junshi Biosciences on the basis of the marketed product, Toripalimab injection.
8. On March 7, Hengrui Medicine announced that the Phase 3 clinical trials for a new indication of the investigational JAK1 inhibitor, SHR0302 tablets, were approved by NMPA, targeting active non-radiographic axial spondyloarthritis. According to publicly available information, SHE0302 has already been in Phase 3 clinical development for various indications.
9. On March 8, CDE newly announced that enpatoran, which was filed by Merck, Germany, was approved clinically in China for the indication of systemic lupus erythematosus (SLE). According to public information, enpatoran is a potential "first-in-class" oral TLR 7/8 inhibitor developed by Merck, Germany. It is proposed to be developed for the treatment of cutaneous lupus erythematosus, systemic lupus erythematosus, and other indic...
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