宁波美诺华药业股份有限公司关于全资子公司获得利奥西呱片药品注册证书的公告

Core Viewpoint - The announcement highlights that Ningbo Meinuo Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Ningbo Meinuo TianKang Pharmaceutical Co., Ltd., has received the drug registration certificate for Lianxiqiao tablets from the National Medical Products Administration, allowing for domestic production and sales of the drug [1][4]. Drug Information - Drug Name: Lianxiqiao Tablets [3] - Dosage Form: Tablets [3] - Specifications: 0.5mg, 1mg, 2.5mg [3] - Registration Classification: Chemical Drug Class 4 [3] - Approval Number: National Drug Approval Numbers H20263049, H20263050, H20263051 [1][3] - Validity of Approval: Until January 4, 2031 [3] Drug Mechanism and Indications - Indications: Suitable for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) [2] - Mechanism: Lianxiqiao acts as a soluble guanylate cyclase (sGC) agonist, enhancing the sensitivity of sGC to endogenous NO and directly stimulating sGC through different binding sites, leading to increased cGMP production and vasodilation [2]. Market Context - As of the announcement date, three domestic companies have been approved for Lianxiqiao tablets, including Qilu Pharmaceutical Co., Ltd. and Jiangsu Huayang Pharmaceutical Co., Ltd. [4] - Global sales of Lianxiqiao tablets in 2024 are projected to be approximately $49.42 million, with sales in China estimated at $1.04 million [4]. Impact on Company - The approval of Lianxiqiao tablets enhances the company's market competitiveness and enriches its product pipeline, contributing positively to its operational development [4].