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福森药业(01652.HK):1.1类中药创新药"SY617"临床试验申请获得批准

Fusen Pharm (01652.HK): Application for clinical trial of type 1.1 traditional Chinese medicine innovative drug "SY617" approved.

Gelonghui Finance ·  Sep 19 09:27

Fusen Pharm announced on September 19 that "SY617", developed by its wholly-owned subsidiary Jiaheng (Zhuhai Hengqin) Medical Technology Co., Ltd., has been approved by the China National Medical Products Administration for clinical trials (Approval No.: 2024LP02103). SY617 is mainly used for dispelling wind and detoxification, clearing epidemic dampness, and treating wind-heat cold dampness syndrome of influenza. Symptoms include fever, heavy head, sore throat, aversion to wind, cough, body aches, chest stuffiness, epigastric fullness, red tongue with greasy white or yellow coating, and slippery or rapid or floating pulse.

According to data from Minet.com, in 2022, the top three Chinese patent medicines for respiratory system diseases are heat-clearing and detoxification, antitussive expectorants and bronchodilators, and cold medicines. Chinese patent cold medicines rank third in the market size of Chinese patent cold medicines. In 2022, the sales revenue of Chinese patent cold medicines in hospital channels was about 8.5 billion yuan, exceeding 4.5 billion yuan in the first half of 2023 in hospital channels.

Influenza, commonly known as the flu, is an acute respiratory disease caused by the influenza virus, characterized by highly contagious, high incidence, high variability, and recurrent infections. Currently, the main antiviral drugs recommended internationally and listed in China have certain limitations and may lead to drug resistance, prompting the urgent need to find other effective treatment options. Traditional Chinese medicine has unique advantages in alleviating flu symptoms, enhancing patients' ability to recover from the disease, and preventing complications.

SY617 is a proprietary formulation with years of historical use at the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine). Guided by traditional Chinese medicine theory, under effective compatibility and transformation research, it was selected as a major traditional Chinese medicine technology project by the Sichuan Provincial Administration of Traditional Chinese Medicine. This product belongs to Class 1.1 prescription composition, in line with traditional Chinese medicine theory, an innovative Chinese herbal medicine with human experience. According to the "Special Regulations for the Registration and Management of Traditional Chinese Medicine", SY617 does not need to conduct Phase I clinical trials, thus directly applying for Phase II clinical trials, which have been approved by the China National Medical Products Administration (Approval No.: 2024LP02103). The approval of this application marks a milestone. SY617 has shown very promising prospects in the treatment of conditions like wind-heat cold dampness syndrome in influenza.

After Shuanghuanglian Oral Liquid and Shuanghuanglian Injection, SY617 is another heavyweight traditional Chinese medicine anti-flu product, further enriching the Group's product pipeline in the field of Chinese patent medicine treatment for flu. After its launch, this product will provide more treatment options for patients with wind-heat cold dampness syndrome in influenza.

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
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