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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 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
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].
美诺华子公司获得利奥西呱片药品注册证书
Zhi Tong Cai Jing· 2026-01-12 09:27
Core Viewpoint - Meihua (603538.SH) announced that its wholly-owned subsidiary, Ningbo Meihua Tiankang Pharmaceutical Co., Ltd., has received the drug registration certificate for Liosiguat tablets from the National Medical Products Administration, indicating a significant regulatory approval for a new treatment option in the market [1] Group 1 - The drug Liosiguat is indicated for the treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) [1]
美诺华(603538.SH)子公司获得利奥西呱片药品注册证书
智通财经网· 2026-01-12 09:24
Core Viewpoint - Meihua (603538.SH) announced that its wholly-owned subsidiary, Ningbo Meihua Tiankang Pharmaceutical Co., Ltd., has received the drug registration certificate for Liosiguat tablets from the National Medical Products Administration, indicating a significant regulatory approval for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) [1] Group 1 - The drug Liosiguat is approved for the treatment of CTEPH and PAH, which are serious conditions affecting pulmonary circulation [1]
美诺华(603538.SH):全资子公司获得利奥西呱片药品注册证书
Ge Long Hui A P P· 2026-01-12 08:45
Group 1 - The core point of the article is that Meinuohua's subsidiary has received approval from the National Medical Products Administration for the registration of Liosiguap tablets, enhancing the company's market competitiveness and product pipeline [1][3]. Group 2 - The drug is indicated for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) [2]. - Liosiguap acts as a soluble guanylate cyclase (sGC) agonist, which plays a crucial role in the pulmonary circulation system by catalyzing the synthesis of cyclic guanosine monophosphate (cGMP) [2]. - The company has invested approximately RMB 6.8671 million in the research and development of Liosiguap tablets as of the announcement date [2].
美诺华:全资子公司获得利奥西呱片药品注册证书
Xin Lang Cai Jing· 2026-01-12 08:37
Core Viewpoint - Meheco's wholly-owned subsidiary, Meheco Tiankang, has received the drug registration certificate for Liosiguat tablets from the National Medical Products Administration, enhancing the company's market competitiveness in the treatment of chronic thromboembolic pulmonary hypertension and arterial pulmonary hypertension [1] Group 1: Company Developments - The drug Liosiguat acts as a soluble guanylate cyclase (sGC) agonist, expanding blood vessels through the NO-sGC-cGMP pathway [1] - Meheco Tiankang is now qualified to produce and sell Liosiguat tablets in the domestic market following the approval [1] - The approval marks a significant milestone for Meheco Tiankang, as it joins two other approved companies, Qilu Pharmaceutical and Jiangsu Huayang Pharmaceutical, in the domestic market [1] Group 2: Market Potential - The global sales forecast for Liosiguat tablets in 2024 is approximately $494.16 million, with expected sales in China around $10.38 million [1] - The approval of Liosiguat tablets is expected to enhance the company's product competitiveness in a growing market [1] Group 3: Future Considerations - Future sales of Liosiguat tablets may be influenced by various uncertainties, including policy changes, market demand, and competition from similar drugs [1]