This week, a steady flow of good news kept pouring into the Chinese pharmaceutical market. The local "first-in-class" Benvimod was successfully approved by FDA while Hengrui's SHR3680 tablets in treating prostate cancer had a successful Phase III clinical trial. As the icing on the cake, TopAlliance's COVID-19 oral drug Renmindevir hit the prespecified endpoint.
The news reviewed this week is from May 23 to 27, covering a total of 22 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA
Marketing Application
1. On May 23, CDE’s official website announced that the marketing application for TQ-B3139 capsule had been submitted by Nanjing Shunxin Pharmaceuticals of Chiatai Tianqing and was accepted. The Phase III clinical trial of TQ-B3139, a new generation of ALK inhibitor, was started in 2019 to evaluate its safety and efficacy in newly treated patients with ALK-positive advanced non-small cell lung cancer (NSCLC).
2. On May 24, the CDE official website revealed that the new indication marketing application for Novartis's Eltrombopag Olamine Tablets (Brand name: REVDLADE) was accepted. Eltrombopag Olamine Tablet, developed by Novartis, is a non-peptide thrombopoietin receptor (TPO-R) agonist. The drug was approved for marketing by FDA in November 2008.
3. On May 26, CDE announced that the marketing application of Hengrui Pharmaceuticals’ investigational new drug, Ertugliflozin and Metformin sustained-release tablet, had been submitted and accepted. It is a compound sustained release formulation for treating type 2 diabetes mellitus (T2DM), composed of the SGLT2 inhibitor Ertugliflozin and Metformin.
Clinical Approval
4. On May 24, the CDE official website announced that Class I biological new drug LY3209590 Injection delivered by Eli Lilly got an implied license for the clinical trial. It is proposed to be used for adult patients with type 2 diabetes mellitus who need insulin therapy. LY3209590 is a novel and once-weekly long-acting basal insulin, which has entered Phase III clinical trials globally.
5. On May 24, Genor Biopharma Co., Ltd. announced that its CD20/CD3 bispecific antibody GB261 got the implied license of Phase I/II clinical trial. It is proposed to be used for the treatment of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
6. On May 25, CDE announced that the clinical trial application of first-in-class RP903 filed by TopAlliance and Risen had got the implied license. It is proposed to be used for the PIK3CA-mutated, advanced, and malignant solid tumors. RP903 tablet is an investigational oral small-molecule alpha-specific PI3K inhibitor developed by Risen. TopAlliance has obtained 50% of the global rights and interests of the program through cooperation.
7. On May 26, InnoCare Pharma announced that it had received approval to conduct a single-arm, open-label, multicenter Phase II clinical trial evaluating the safety and efficacy of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). Tafasitamab is a humanized monoclonal antibody targeting CD19 and introduced by InnoCare Pharma in 2021.
Application
8. On May 24, Qilu Pharmaceutical submitted a clinical trial application for Semaglutide Injection for the first time in Class 2.2 of chemical drugs and the company becomes the fifth enterprise to compete for Semaglutide in China. CDE has accepted the application the next day. Semaglutide, a GLP-1 receptor agonist developed by Novo Nordisk, was approved for treating type 2 diabetes mellitus in the Un...
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