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Source: Sihuan Pharmaceutical Holdings Group Ltd.
Sihuan Pharmaceutical (0460.HK): Huisheng Biopharmaceutical's Drug Semaglutide Injection Obtained Approval For Clinical Trial

HONG KONG, July 5, 2023 - (ACN Newswire) - Sihuan Pharmaceutical Holdings Group Ltd. (the "Company" or "Sihuan Pharmaceutical", together with its subsidiaries, the "Group", HKEX stock code: 0460) is pleased to announce that, Huisheng Biopharmaceutical, Co., Ltd. ("Huisheng Biopharmaceutical"), a non-wholly owned subsidiary of the Group, has been approved for clinical trials from the National Medical Products Administration (the "NMPA") of China of Semaglutide Injection for the treatment of type 2 diabetes. In addition, Thioctic Acid Injection, a peripheral neuropathy (PN) drug developed by Huisheng Biopharmaceutical, has recently obtained the drug registration approval from NMPA, which is deemed to have passed the consistency evaluation on quality and efficacy of generic drugs.

Semaglutide is a long-acting GLP-1 receptor agonist (GLP-1RA) injected once a week, which not only has the potential to potently lower glucose, but also to significantly reduce weight, lower blood pressure, improve lipid profiles and reduce the risk of major cardiovascular adverse events, thereby increasing patient compliance and improving quality of life over the classic GLP-1 receptor agonist drug liraglutide. It is recommended for use in patients with type 2 diabetes mellitus (T2DM), cardiovascular disease or patients at very high cardiovascular risk. Semaglutide injection was first launched in the US in December 2017 and by 2022, global sales had exceeded US$10 billion.

Lipoic Acid is an antioxidant that inhibits lipid peroxidation, increases blood flow to neurotrophic vessels, improves neurological Na+-K+-ATPase activity, directly scavenges reactive oxygen clusters and free radicals, and protects vascular endothelial function. It can be used to treat diabetic peripheral neuropathy and is recommended in the "Expert Consensus on the Management of Diabetic Neuropathy (2021 Edition)".

The number of Diabetic Peripheral Neuropathy (DPN) patients in China accounts for more than 50% of diabetes patients, and at present, there are about 140 million diabetes patients in China. Thioctic Acid Injection is a Category B drug under the National Reimbursement Drug List (2022 Edition). According to IQVIA data, the sample hospitals' sales volume of Lipoic Acid injections in 2011 exceeded RMB1 billion in China.

The two products developed by Huisheng Biopharmaceutical were approved for clinical trials and drug registration approvals respectively, which is another milestone in the development of Huisheng Biopharmaceutical, and also shows that its products have taken a step forward in the process of commercialization, with more comprehensive coverage diabetes products. Huisheng Biopharmaceutical strives to become a leading biopharmaceutical company with full product coverage in the field of diabetes and complications in China, and to achieve continuous amplification of value.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, "Semaglutide injection was approved for entry into the PRC market in 2021 and was included in the national medical insurance catalogue in the same year. Sales in the Greater China region exploded in 2022 with US$311 million in sales. As the product has obtained approval for the clinical trial, we believe that it will help the Group to further strengthen the provision of providing diabetic patients with a full range of comprehensive and integrated treatment solutions for the diabetic patients."


Topic: Press release summary
Source: Sihuan Pharmaceutical Holdings Group Ltd.

Sectors: BioTech, Healthcare & Pharm
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