FUSEN PHARM(01652): Approval of clinical trial application for innovative traditional Chinese medicine "SY 617" in Class 1 drugs.

FUSEN PHARM (01652) announced that its wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has been approved by the China National Medical Products Administration to conduct clinical trials for "SY 617" (Approval Number: 2024LP 02103). The main functions of SY 617 are to dispel wind, detoxify, clear dampness, and treat wind-heat dampness syndrome in the context of epidemic influenza. Symptoms include fever, oppressive headache, sore throat, aversion to wind, cough, aching limbs, chest tightness, epigastric discomfort, red tongue with greasy white or yellow coating, and slippery or rapid pulse. According to Minet data, in 2022, the top three categories of drugs for respiratory diseases were: antipyretic and detoxifying drugs, antitussive and expectorant drugs, and cold drugs, with the market size of cold drugs ranking third. In 2022, the market sales of cold drugs in hospitals reached approximately 8.5 billion RMB, and the sales in the first half of 2023 exceeded 4.5 billion RMB. Influenza, caused by the influenza virus, is a highly contagious, high-incidence acute respiratory disease with high variability and recurrent infections. Currently, the main antiviral drugs recommended internationally and available in China have certain limitations and may lead to drug resistance, necessitating the search for other effective treatment options. Traditional Chinese medicine has unique advantages in alleviating flu symptoms, enhancing patient recovery capabilities, and preventing complications. SY 617 is a new innovative traditional Chinese medicine drug developed from two internally formulated drugs with years of historical use at Chengdu University of Traditional Chinese Medicine Affiliated Hospital (Sichuan Provincial TCM Hospital). Under the guidance of TCM theory, it underwent conversion research through effective combination and was selected as a major TCM technology project by the Sichuan Provincial Administration of Traditional Chinese Medicine. This drug belongs to Class 1.1 prescription with a composition that aligns with TCM theory and has clinical experience with the use of traditional Chinese medicine. According to the specific regulations for the registration of traditional Chinese medicine, SY 617 does not need to undergo Phase I clinical trials and can directly apply for Phase II clinical trials, which has been approved by the China National Medical Products Administration (Approval Number: 2024LP 02103). This milestone approval holds significant importance. SY 617 has shown promising prospects in the treatment of wind-heat dampness syndrome in epidemic influenza diagnosis. SY 617 is another milestone traditional Chinese medicine product following the success of Shuanghuanglian oral liquid and injection, further enriching the group's product pipeline in the field of traditional Chinese medicine treatments for influenza. This product will provide more treatment options for patients with wind-heat dampness syndrome in epidemic influenza upon its market launch.