Shanghai Serum Bio-technology Co., Ltd. (hereinafter referred to as the "Company") has passed the approval of the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, the lead organization of the Phase II Clinical Study of Anti-Viper Venom Serum Injection, and obtained the ethical review approval document. The relevant information is announced as follows:

The results of the completed Phase I clinical trial study of Anti-Viper Venom Serum Injection (Registration No. CRT20202621) showed that good safety and tolerability were observed in healthy subjects given different dose groups of Anti-Viper Venom Serum. The results of drug dose, drug concentration, and correlation analysis with effect indicated that the efficacy of the anti-viper venom serum (ability to neutralize viper venom in vitro) was well correlated and dependent on the dose of the test drug administered, and the concentration of the drug in the blood. Based on the positive safety results obtained in the Phase I clinical trial, the Company will cooperate with the First Affiliated Hospital of Guangzhou Medical University and other research institutes to conduct a randomized, double-blind, positive drug-parallel-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of the anti-viper venom serum in subjects with round-spotted viper bites. The Phase II clinical study protocol received ethical review approval from the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University.

Anti-viper venom serum is a passive immune preparation independently developed by the Company that can specifically neutralize round-spotted viper toxin, and belongs to the category 1 innovative drugs of biological products that are not marketed both domestically and internationally. in April 2019, the Company received the "Notice of Clinical Trial" issued by the State Drug Administration, agreeing to the application for the clinical trial of the anti-viper venom serum; and in the first half of 2022, the Phase Ⅰ clinical study of the project passed the acceptance.

The round-spotted viper is a blood venomous snake, one of the top ten venomous snakes in China, which is mainly distributed in Fujian, Guangdong, Guangxi and other places. Patients are injured after the onset of acute, easy to cause a series of complications, in the snake bite fatality rate is high, the current lack of specific serum for viper bite poisoning, clinical use of antipit viper venom serum or combined with anti-five-step viper venom serum treatment of viper bite, but the clinical effect is not obvious, clinical treatment is more difficult, which leads to viper bite incident death risk increases. Therefore, the development of specific anti-viper venom serum as soon as possible is the key to the treatment of viper bite poisoning.

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