Four Domestic New Drugs Receive NDA Acceptance in China This Week

　　【Pharmaceutical Network Industry DynamicsIn recent years, driven by long-term commitment to innovative research and development as well as multiple contributing factors, China's innovative drug industry has been continuously achieving breakthroughs, with outcomes now emerging in rapid succession. According to data, 48 Class I innovative drugs were approved in China in 2024, and as of October this year, 63 have already been approved. Currently, domestically produced innovative drugs continue to emerge, with four new drug marketing applications accepted this week alone, soon to benefit a wide range of patients!
 

　　TransThera: Tenoctinib Tablets
 

On December 19, TransThera announced on the Hong Kong Stock Exchange that the new drug application for Tinentogrel film-coated tablets had been accepted by the Center for Drug Evaluation of the National Medical Products Administration of China. It is intended for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment. Previously, this indication for Tinentogrel film-coated tablets had been approved for inclusion in the priority review category and the breakthrough therapy category.
 

Tinengotinib is an innovative multi-target small molecule kinase inhibitor independently developed and currently in the registrational clinical stage, primarily targeting three key pathways—FGFR/VEGFR, JAK, and Aurora kinase. TransThera stated that the drug has the potential to address multiple drug-resistant, recurrent, or refractory solid tumors, including cholangiocarcinoma, prostate cancer, liver cancer, breast cancer, biliary tract cancer, and pan-FGFR solid tumors. As of June 30, a total of nine company-sponsored clinical trials for tinengotinib have been conducted or are ongoing worldwide.
 

　　Bio-Thera: Verasitamab Injection
 

On December 18, the application for Bio-Thera Solutions, Ltd.'s Verasitamab Injection (BAT5906) has been accepted, with the acceptance number CXSS2500142. According to the announcement, BAT5906 is an innovative recombinant humanized monoclonal antibody drug independently developed and produced by Bio-Thera. It is a full-length IgG1-type antibody with a molecular weight of 149 kDa, capable of specifically binding to human VEGF-A165 and inhibiting new blood vessel formation.
 

Currently, the Phase III clinical trial of BAT5906 for diabetic macular edema (DME) is underway, while other indications such as macular edema secondary to central retinal vein occlusion (CRVO-ME) and choroidal neovascularization due to pathological myopia (pmCNV) are in the recruitment phase of Phase II/III clinical trials.
 

　　Qilu Pharmaceutical: Aripitant Palonosetron Emulsion Injection
 

On December 15, Qilu Pharmaceutical (Hainan) Co., Ltd.'s new drug application for Aprepitant Palonosetron Emulsion Injection (Category 2.3) was accepted, with the acceptance number CXHS2500156. Aprepitant, originally developed by Merck, is a highly selective neurokinin-1 (NK-1) receptor antagonist that works by blocking the binding of substance P to the NK-1 receptor. Currently, Qilu Pharmaceutical is the only company in China to have submitted a new product application.
 

　　NeuronDawn: Y-3 (Lobemilu) for Injection
 

December 12 News: The New Drug Application (NDA) for Y-3, a novel class 1 drug co-developed by NeuronDawn and Guangdong Sunho Pharmaceutical, has been accepted. Y-3 is an nNOS/PSD95 uncoupler and GABRA2 agonist developed by NeuronDawn that can simultaneously intervene in neuronal excitotoxicity and synaptic plasticity changes following ischemic stroke. With its rapid antidepressant and anxiolytic effects, Y-3 is expected to become the first novel neuroprotective agent capable of treating both stroke and post-stroke depression.
 

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