Gelonghui March 28th 丨Hengrui Pharmaceutical (600276.SH) announced that recently, Fujian Shengdi Pharmaceutical Co., Ltd., a subsidiary of the company, received approval from the China Drug Administration (“China Drug Administration”) to issue the “Drug Clinical Trial Approval Notice” for HRS-5635, and will conduct clinical trials in the near future.

Approval conclusion: According to the “Drug Administration Law of the People's Republic of China” and related regulations, the HRS-5635 injection received on January 9, 2023 met the relevant requirements for drug registration, and it was agreed to carry out clinical trials for chronic hepatitis B in accordance with the submitted plan.

HRS-5635 is a Class 1 innovative drug independently developed by the company. Non-clinical efficacy studies have shown that HRS-5635 shows excellent antiviral activity in all HBV genotypes and can exert an effective and long-lasting antiviral effect in the body. Non-clinical safety evaluation studies have shown that HRS-5635 has no off-target activity and is highly safe. According to inquiries, no similar products have been approved for listing at home or abroad. Up to now, a total of about 69.58 million yuan has been invested in R&D projects related to HRS-5635 injection.