Sihuan Pharmaceutical Holdings Group Ltd. announced that the supplementary application for the new strength (2.5mg) of Rivaroxaban Tablets developed by the Group's subsidiary Jilin Sihuan Pharmaceutical Co. Ltd. (the "Jilin Sihuan") has been approved by the National Medical Products Administration (the " NMPA") of the People's Republic of China (the "China"). The combination of Rivaroxaban TableTS (strength:2.5mg) and Aspirin can be seen as a new product, with different indications to the already marketed Rivaroxaban Tablets (strength:10mg and 15mg) (used for adult venous thromboembolism (VTE), deep venous thrombosis (DVT), pulmonary embolism (PE), and non-valvular atrial fibrillation).

The indication of Rivaroxaban Tablet (strength:2.5 mg) is that Rivaroxaban Tablets combined with Aspirin (ASA) is used in adult patients with coronary artery disease (CAD) or peripheral arterial disease (PAD) at high risk of ischemic events, to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke). It is deemed to have passed the consistency evaluation on quality and efficacy of generic drugs. For Rivaroxaban Tablets (" strength:2.5mg), Sihuan Pharmaceutical is the third domestic company approved for marketing.

Rivaroxaban is a Class B drug under the National Reimbursement Drug List (NRDL), and it's a new type of oral anticoagulant drug widely used clinically. It has the advantages of rapid onset, low incidence of intracranial hemorrhage, and no need for routine coagulation monitoring and dose adjustment. The combination of Rivaroxab and Aspirin can significantly improve the prognosis of CAD/PAD patients, and it is recommended by authoritative guidelines in Europe, United States, and China.

In the first half of 2023, among the top 10 sales of antithrombotic drugs in China, Rivaroxaban is the only oral anticoagulant Drug. According to public data, there are approximately 11 million CAD patients and 45.3 million PAD patients in China currently. The cardiovascular and cerebrovascular field is one of the key focus area of the Group.

Sihuan Pharmaceutical's Rivaroxaban Tablets(strength: 10mg, 15mg) were approved in China in March 2021 and were included in the national volume-based procurement in June 2021. The approval of Rivaroxaban Tableting (strength: 2.5mg) will further benefit patients and add another significant variety to the Group's pipeline in cardiovascular and cerebrovascular fields, which will benefit the future market sales and competition of this product, and will have a positive impact on the operating results of the Group.