One of the most exciting news of this week was the marketing approval of duvelisib capsules, a dual PI3K inhibitor introduced by CSPC Pharmaceutical Group Co., Ltd. Meanwhile, the oral nucleoside anti-SARS-CoV2 drug from Junshi Biosciences has initiated phase-three clinical research and the enrollment and dosing of the first patient have been completed. The pharma news review of this week covers a total of 24 pieces of news in 3 sections, i.e. review approval, R&D, and business.
Review Approval
NMPA
Marketing
1. On March 14, the CDE official website revealed that InnoCare Pharma’s Supplemental New Drug Application (sNDA) of the BTK inhibitor Orelabrutinib for new indications was accepted for marketing, intending to treat patients with relapsed/refractory Waldenström’s macroglobulinaemia. In December 2020, Orelabrutinib was approved in China for treating relapsed/refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), and for two indications of relapsed/refractory Mantle Cell Lymphoma (MCL).
2. On March 15, the CDE official website revealed that the marketing application for the new indication of PD-1 monoclonal antibody (mAB) Zimberelimab Injection of Gloria Pharmaceuticals and WuXi Biologics was accepted, and the indication is likely to be recurrent or metastatic cervical cancer. Zimberelimab is a whole-human PD-1 mAB with an independent intellectual property right, which was commissioned by Gloria Pharmaceuticals to be developed by WuXi Biologics. It is also the first PD-1 mAB declared for cervical cancer indication in China.
3. On March 16, Bayer announced that the rivaroxaban tablet (brand name: rivaroxaban) was approved in China for the treatment of the new indication of Venous Thromboembolism (VTE) and prevention of VTE recurrence after at least 5 days of initial non-oral anticoagulant therapy in children and adolescents under 18 years of age and weighing 30kg to 50kg and above. The drug is currently the only anticoagulant available in China for the treatment of VTE in children and the prevention of its recurrence.
4. On March 18, according to the latest announcement on the NMPA official website, CSPC’s duvelisib capsule has been approved for the treatment of relapsed or refractory Follicular Lymphoma (FL) after at least two previous systemic treatments. According to public information, duvelisib is a dual inhibitor of PI3K-δ and PI3K-γ, and CSPC has an exclusive license for the development and commercialization of this product in Greater China.
5. On March 18, according to the latest announcement on the NMPA official website, Betta Pharmaceuticals’ ensartinib has been approved for marketing for a new indication in China. The press release issued earlier by Betta Pharmaceuticals indicated that the new indication for the approval is the first-line treatment of non-small cell lung cancer (NSCLC).
6. On March 18, NMPA announced on its website that ramucirumab injection, a VEGFR-2 monoclonal antibody innovative drug declared by Eli Lilly, has been approved for marketing in China. According to an earlier press release issued by Eli Lilly, the indication declared this time is presumed to be the second-line treatment for advanced gastric cancer.
Clinical Trials
7. On March 14, the CDE official website revealed that AstraZeneca’s PD-1/TIGIT bispecific antibody AZD2936 was firstly declared for clinical trials in China. AZD2936’s TIGIT antibody sequence is from Compugen’s COM902. Currently, AZD2936 is in Phase I/II development globally.
8. On March 14, Konruns Pharmaceutical announced to withdraw the application of the Investigational New Drug for teriparatide injection due to the need to further improve the application materials. Teriparatide is a recombinant human parathyroid hormone (PTH) analog (rhPTH[1-34]), developed by Pfenex and approved by the FDA, which is a generic drug of teriparatide injection from the original R&D manufacturer, Eli Lilly.
9. On March 16, CDE publicly announced on its official website that Novartis’s application fo...
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