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福森药业(01652):1.1类中药创新药“SY 617”临床试验申请获得批准

Fusen Pharm (01652): The clinical trial application for the class 1.1 innovative Chinese medicine "SY 617" has been approved

Zhitong Finance ·  Sep 19 21:27

Fusen Pharmaceutical (01652) announced that Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of the Group...

According to Zhitong Finance App, Fussen Pharmaceutical (01652) announced that “SY 617” developed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of the Group, has been approved by the China National Drug Administration for clinical trials (approval number: 2024LP 02103). The function of SY 617 is to relieve wind and detoxify, clean and dehumidify. It is used to treat influenza as evidence of wind fever and wetness. Symptoms include fever, heavy head, sore throat, bad wind, cough, body aches, chest tightness, burning, red tongue, white or yellowish moss, wet or slippery or floating.

According to data from the Mi Intranet, the top three proprietary Chinese medicines for respiratory diseases in 2022 are those that clear heat and detoxify, medicines to relieve cough and expectoration and relieve asthma, and medicines for colds, which rank third in the market size of proprietary Chinese medicines for colds. In 2022, sales of proprietary Chinese medicines for colds were about 8.5 billion yuan in hospital channels, and sales in hospital channels exceeded 4.5 billion yuan in the first half of 2023.

Influenza (influenza for short) is an acute respiratory disease caused by the influenza virus that is highly contagious, high incidence, high variability, and repeated infections. Currently, neuraminidomycin inhibitors, the mainstream drug recommended by international guidelines and marketed in China, have certain limitations and may develop drug resistance. There is an urgent need to find other effective treatments. Traditional Chinese medicine has unique advantages in eliminating influenza symptoms, improving patients' ability to resist disease and recover, and preventing complications.

SY 617 is two in-hospital preparations from the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Hospital of Traditional Chinese Medicine) with many years of history of use. Under the theoretical guidance of traditional Chinese medicine, translational research was carried out through effective integration, and was selected as a major traditional Chinese medicine science and technology project by the Sichuan Provincial Administration of Traditional Chinese Medicine. This product is an innovative traditional Chinese medicine with a 1.1 prescription composition that conforms to the theory of traditional Chinese medicine and has human experience. According to the “Special Provisions on the Registration Administration of Traditional Chinese Medicines”, SY 617 does not need to carry out phase I clinical trials. It has been approved by the China National Drug Administration (approval number: 2024LP 02103). The approval of this application is a landmark. SY 617 has shown very favorable prospects in treating influenza, such as the diagnosis of wind fever and humidity.

SY 617 is another major traditional Chinese medicine resistance product after Shuanghuanglian Oral Solution and Shuanghuanglian Injection, further enriching the Group's product pipeline in the field of proprietary Chinese medicine treatment for anti-sensitivity. After the product is launched, it will provide more treatment options for influenza diagnosis and patients with wind fever and wet symptoms.

The translation is provided by third-party software.


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