Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Lianxi Guo tablets, enhancing its market competitiveness and product pipeline [1][4]. Group 1: Drug Information - Drug Name: Lianxi Guo tablets - Dosage Form: Tablets - Specifications: 0.5mg, 1mg, 2.5mg - Application Matter: Drug registration (domestic production) - Registration Category: Chemical drug category 4 - Acceptance Numbers: CYHS2402749, CYHS2402750, CYHS2402751 - Drug Approval Numbers: National Drug Approval H20263049, H20263050, H20263051 - Validity of Drug Approval Numbers: Until January 4, 2031 - Marketing Authorization Holder: Ningbo Meinuo Hua Tiankang Pharmaceutical Co., Ltd. - Manufacturing Enterprise: Ningbo Meinuo Hua Tiankang Pharmaceutical Co., Ltd. [4] Group 2: Drug Mechanism and Indications - Indications: Suitable for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) - Mechanism of Action: Lianxi Guo is a soluble guanylate cyclase (sGC) agonist that enhances the sensitivity of sGC to endogenous NO and directly stimulates sGC through different binding sites, increasing cGMP production and causing vasodilation [2]. Group 3: Market Context - As of the announcement date, three domestic companies have been approved for Lianxi Guo tablets, including Qilu Pharmaceutical Co., Ltd., Jiangsu Huayang Pharmaceutical Co., Ltd., and Ningbo Meinuo Hua Tiankang Pharmaceutical Co., Ltd. [3] - The global sales of Lianxi Guo tablets in 2024 are projected to be approximately $49.42 million, with sales in China estimated at $1.04 million [3].
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