Zhuohe Pharmaceutical’s “Category 1.1 innovative traditional Chinese medicine” was approved for marketing

February 26, 2024  Source: drugdu 52

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On February 21, the National Medical Product Administration approved the marketing application pf the innovative traditional Chinese medicine Category 1.1 drug Jiuwei Cough Oral Liquid applied by Zhuohe Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Zhuohe Pharmaceutical").

According to the NMPA official website, a randomized, double-blind, placebo and active drug parallel controlled multi-center clinical trial has been conducted. The results show that in terms of the main efficacy indicators: cough disappearance rate and cough disappearance time the test group is better than the placebo group and non-inferior to the positive drug group.

This medicine is used for relieving lungs and cough, acute tracheobronchitis and cough that belongs to wind-heat syndrome according to traditional Chinese medicine. The launch of this drug provides more treatment option for patients with acute tracheobronchitis cough.

Anti-rheumatic, anti-tumor…

According to Zhuohe Pharmaceutical’s public information, the company has professional R&D and innovation capabilities in multiple disciplines such as drug synthesis, pharmaceutical preparations, drug analysis and intellectual property management. The R&D center’s ongoing projects involve anti-rheumatism, immune regulation, anti-tuberculosis, Cancer, infection, cardiovascular and cerebrovascular diseases and other fields.

According to the CDE official website, Zhuohe Pharmaceutical has applied for two types of traditional Chinese medicines. Among them, Zhuohe Pharmaceutical submitted a marketing application for the new category 1.1 traditional Chinese medicine Fengye Kechuanping Oral Liquid in 2022.

According to the "Randomized double-blind multi-center clinical study of Fengye Kechuanping Mixture in the treatment of acute bronchitis cough (wind-heat affecting the lungs)" (2014) [1], Fengye Kechuanping Mixture is derived from Professor Zou Xuexi's clinical experience prescription, using for the treatment of acute bronchitis with wind-heat cough syndrome, the prescription consists of Aidi tea, loquat leaves, ephedra, bitter almond, mint, tangerine peel, bamboo root, Houttuynia cordata and Zhigancao.

Conclusion

In recent years, in order to promote the inheritance, innovation and development of traditional Chinese medicine, the National Health Commission, the Food and Drug Administration and other relevant departments have issued a series of policies to support innovative research and development of traditional Chinese medicine and speed up the review and approval process. Based on this, many traditional Chinese medicine companies have entered the innovative development of traditional Chinese medicine. At the same time, they have persisted in innovative research and technological innovation, and have achieved many innovative fruits.

As another innovative traditional Chinese medicine approved for marketing, Jiuwei Zhike Oral Liquid is expected to become another milestone in the road of traditional Chinese medicine innovation.

https://news.yaozh.com/archive/41930.html

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