Recently, the National Medical Products Administration approved the marketing of Zihua Wenfei Zhike Granules , a Class 1.1 innovative traditional Chinese medicine submitted by Guangzhou Yuekang Biopharmaceutical Co., Ltd., a subsidiary of Yuekang Pharmaceutical , for the treatment of cough due to wind-cold lingering in the lungs .
Cough is a common symptom of respiratory diseases, and post-infectious cough is particularly troublesome due to its prolonged course. Zihua Wenfei Zhike Granules are specifically indicated for cough due to wind-cold lingering in the lungs, providing a new medication option for patients with this syndrome whose illness lasts 3 to 6 weeks.
From the perspective of the formulation, the product prescription is derived from an empirical formula that has been clinically verified over a long period of time . It is composed of six medicinal materials: Aster tataricus, Tussilago farfara, Belamcanda chinensis, dried ginger, mango kernel, and Schizonepeta tenuifolia. These herbs complement each other to achieve the effects of relieving wind and cough, warming the lungs and resolving phlegm. It is a vivid practice of "inheriting the essence and upholding the correctness while innovating" in traditional Chinese medicine.
As a Class 1.1 innovative traditional Chinese medicine in China, Zihua Wenfei Zhike Granules have passed the rigorous testing of modern evidence-based medicine in terms of efficacy and safety . Its Phase III clinical trial was led by West China Hospital of Sichuan University, in collaboration with 15 clinical centers across the country, including the China-Japan Friendship Hospital, enrolling a total of 480 patients. Professor Lai Kefang, the drafter of the Chinese Guidelines for the Diagnosis and Treatment of Cough, served as the DMC chairman, with Professor Mao Bing and Professor Jiang Hongli from West China Hospital of Sichuan University as principal investigators, and more than 100 clinical experts participating in the trial.
Data shows that as early as November 2023, the nationwide multicenter Phase III clinical trial of this drug for treating post-infectious cough (wind-cold lingering in the lungs syndrome) had already met its primary endpoint, demonstrating superior efficacy in the primary efficacy endpoint of 14-day cough relief rate (a reduction of 50% or more in cough VAS score) , and exhibiting a good safety profile with no new safety warnings reported. In March 2024, the drug's marketing application was accepted, and after going through various review and approval stages, it was finally successfully approved.
It is understood that Yuekang Pharmaceutical has been continuously promoting its innovation-driven R&D strategy and has already deployed a number of Class 1 innovative drug research and development projects in the fields of high-end chemical drugs, innovative traditional Chinese medicine, small nucleic acid drugs, mRNA vaccines and peptide drugs.
With the addition of Zihua Wenfei Zhike Granules, Yuekang Pharmaceutical's product portfolio in the respiratory system field has been further improved. Relying on its mature marketing network and market access system, it is expected to accelerate the benefit to a wider range of patients.

Source: https://news.yaozh.com/archive/49191.html