Chinese Pharma Enters Innovation Harvest Phase: Multiple Class 1 New Drugs Achieve Key Milestones Within a Week

　　【Pharmaceutical Network Product InformationIn recent years, China's innovative drug industry has been continuously thriving. According to the National Medical Products Administration, in 2025, China’s innovative drug development reached a new level, with a total of 76 innovative drugs approved for marketing throughout the year, marking a significant increase from 48 in 2024. Among them, the number of approved Class 1 new drugs was also considerable and of excellent quality, involving various fields of new drug research and development such as bispecific antibodies, fusion proteins, and deuterated compounds, covering multiple therapeutic areas including oncology, autoimmune diseases, and metabolic disorders. Notably, at the start of 2026, domestically produced Class 1 new drugs have already made substantial progress in clinical trials and market approvals.
 

　　New Adaptation Application for Class 1 Innovative Drug Ruvoltine® Accepted
 

On January 8, Luye Pharma announced that the Center for Drug Evaluation of the China National Medical Products Administration has officially accepted the new indication application for market approval of the Class 1 innovative drug Roxenlin® (Toluroxidine Venlafaxine Hydrochloride Sustained-Release Tablets), intended for the treatment of Generalized Anxiety Disorder (GAD).
 

The new indication application for Ruoxinlin® is based on an 8-week, multi-center, randomized, double-blind, placebo-controlled Phase III clinical study. The results showed that Ruoxinlin® can rapidly and comprehensively improve anxiety symptoms, with an efficacy rate of over 80% and a remission rate of approximately 50%. It demonstrated good overall safety and tolerability, with no significant impact on weight or glucose-lipid metabolism. The incidence of adverse reactions such as drowsiness, insomnia, fatigue, and sexual dysfunction was low.
 

　　Innovative Drug Class 1 Relafusp Alpha Injection Launched
 

On January 7, Hengrui Pharma announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received notification from the National Medical Products Administration (NMPA) approving the listing of the company's self-developed Class 1 innovative drug, Relafusp Alfa Injection (brand name: Aizeli).
 

This drug can exert its anti-tumor effects by specifically blocking the interaction between PD-1 and PD-L1, while neutralizing TGF-β in the tumor microenvironment. After inquiry, there are no similar products approved for marketing domestically or internationally.
 

Class 1 Innovative RTX-117 Approved for Clinical Trials
 

On January 7, Crystal Tech Holdings announced that its incubated company, ReviR Therapeutics, had received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for the small molecule pipeline RTX-117 intended to treat Charcot-Marie-Tooth disease (CMT). A Phase I clinical trial is planned to commence in the first quarter of 2026.
 

According to reports, RTX-117 is a Class 1 innovative drug pipeline for CMT and also the first project to enter clinical trials after the in-depth collaboration between ReviR and Crystal Clear Holdings. Previously, this pipeline had received the IND approval and Orphan Drug Designation from the U.S. FDA, qualifying it for priority review and a longer market exclusivity period overseas.
 

　　New Drug F-652 Granted Clinical Trial Approval for Additional Indications
 

On January 5, Yifan Pharmaceutical Co., Ltd. announced that its controlling subsidiaries, Yifan Biopharmaceuticals Development (Shanghai) Co., Ltd. and Yifan Biopharmaceuticals (Beijing) Co., Ltd., received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving Yifan Biopharmaceuticals to conduct a Phase II clinical trial for the treatment of Graft-versus-Host Disease (GVHD) with its investigational product Recombinant Human Interleukin 22-Fc Fusion Protein for Injection (F-652).
 

The drug is registered as a Class 1 therapeutic biologic. Currently, no products with the same target have been approved for marketing either in China or globally, and no products with the same target are currently undergoing clinical development for GVHD indications.
 

Overall, at the beginning of 2026, China's innovative drug sector has already shown a positive trend characterized by "significant product launches, strategic expansions, and technological breakthroughs." In the future, as pharmaceutical companies continue to deepen and implement innovation, the momentum of high-quality development in the industry will become increasingly evident.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.