四环医药(00460.HK)旗下利伐沙班片获批上市 为国产第三家获批上市

Sihuan Pharm (00460.HK) subsidiary's rivaroxaban tablet has been approved for listing, becoming the third domestic company to receive approval for listing.

Gelonghui Finance ·  Jun 11 12:16

Sihuan Pharm (00460.HK) announced on June 11th that the supplemental application for a new dosage (2.5mg) of levosimendan tablet, developed by its subsidiary Jilin Sihuan Pharmaceutical Co., Ltd. ("Jilin Sihuan"), has been approved by the China National Medical Products Administration. Levosimendan tablet with a dosage of 2.5mg combined with aspirin is equivalent to a new product, which is different from the already marketed dosages of 10mg and 15mg (used for adult venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE), and non-valvular atrial fibrillation). Levosimendan tablet (2.5mg) is indicated for adults with coronary artery disease (CAD) or peripheral artery disease (PAD) who are at high risk of ischemic events and need to reduce their risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) when combined with aspirin. It is considered to be equivalent to the quality and efficacy of generic drugs. The levosimendan tablets with a dosage of 2.5mg, are the third domestic product approved for marketing by Sihuan Pharma.

Levosimendan is a new type of oral anticoagulant drug that is widely used clinically and is a national health insurance category B drug. It has the advantages of rapid onset, low incidence of intracranial bleeding, and no need for routine coagulation monitoring and dose adjustments. The combination of levosimendan and aspirin can significantly improve the prognosis of CAD/PAD patients and is recommended by authoritative guidelines at home and abroad, such as in Europe, the United States, and China.

In the first half of 2023, levosimendan was the only oral anticoagulant drug on the TOP10 list of antithrombotic drug sales in China. According to public data, there are currently approximately 11 million CAD patients and 45.3 million PAD patients in China. The cardiovascular field is a key area of focus for the group, and Sihuan Pharma's levosimendan tablets (dosages: 10mg, 15mg) was approved for marketing in China in March 2021 and was included in the national procurement in June 2021. The approval of levosimendan tablets with a dosage of 2.5mg will further benefit a large number of patients and add an important variety to the group's cardiovascular drug pipeline, which is conducive to the future market sales and market competition of this product and has a positive impact on the group's operational performance.

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