本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，株洲千金药业股份有限公司（以下简称"公司"）下属子公司湖南千金湘江药业股份有限公司（以 下简称"千金湘江药业"）收到国家药品监督管理局核准签发的铝碳酸镁咀嚼片《药品注册证书》。现将 相关情况公告如下： 一、药品基本信息 药品名称：铝碳酸镁咀嚼片 剂型：片剂 规格：0.5g 注册分类：化学药品4类 药品批准文号：国药准字H20263134 株洲千金药业股份有限公司 2026年1月27日 铝碳酸镁咀嚼片为消化系统一线用药，具有抗酸、抗胆汁、保护黏膜的功效，三效合一整体治疗上消化 道疾病。该产品适用于广泛治疗多种胃部疾病：1.急、慢性胃炎；2.胃、十二指肠溃疡；3.反流性食管 炎；4.与胃酸有关的胃部不适症状，如胃痛、胃灼热、酸性嗳气、饱胀等；5.预防非甾体类药物的胃黏 膜损伤。可广泛用于消化科、急诊科、耳鼻喉科、神经内科等科室。其主药铝碳酸镁为不溶于水的结晶 性粉末，呈层状网络结构，口服之后不被胃肠道吸收，安全性高。根据摩熵医药数据显示，2024年铝碳 酸镁咀嚼片国内医疗市场和 ...

Group 1 - The core announcement is that Fosun Pharma's subsidiary, Suzhou Erye Pharmaceutical Co., Ltd., has had its drug registration application for injectable lactulose erythromycin accepted by the National Medical Products Administration [1] - The drug is intended for use when oral administration is not feasible or when a rapid high serum concentration of erythromycin is required for treating infections caused by specific sensitive microbial strains, as well as for preventing rheumatic fever and bacterial endocarditis [1] - As of December 2025, the cumulative R&D investment for this drug by the group is approximately RMB 6.33 million (unaudited) [1] Group 2 - According to the latest data from IQVIA CHPA, the sales revenue for injectable lactulose erythromycin in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 170 million in 2024 [1]

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].

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].

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of L-Carnitine Injection, which is intended for treating complications arising from secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis [1] Group 1 - The L-Carnitine Injection is classified as a Class 4 chemical drug, which is equivalent to passing the consistency evaluation, enhancing the company's market competitiveness [1] - The company has invested approximately 4.69 million yuan in the research and development of the L-Carnitine Injection project [1] - The projected domestic market sales for L-Carnitine Injection are estimated to reach approximately 508 million yuan in the first half of 2025 [1]

Core Viewpoint - The company BoHui Innovation (300318.SZ) announced that its subsidiary BoHui Biopharmaceutical (Hebei) Co., Ltd. has received the Drug Registration Certificate from the National Medical Products Administration for its product Human Coagulation Factor VIII, which is significant for treating hemophilia A and acquired Factor VIII deficiency [1] Group 1 - The newly approved Human Coagulation Factor VIII is designed to correct coagulation dysfunction caused by a lack of this factor, primarily used for the prevention and treatment of bleeding symptoms in hemophilia A patients [1] - The approval of the Drug Registration Certificate enhances the company's product line and is a crucial step for BoHui Biopharmaceutical in improving plasma utilization efficiency [1]

Core Viewpoint - Qianjin Pharmaceutical (600479.SH) has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, which is used for the treatment of schizophrenia, enhancing the company's product pipeline and supporting sustainable development [1] Company Summary - Qianjin Xiangjiang Pharmaceutical, a subsidiary of Qianjin Pharmaceutical, has invested a total of 6.3294 million yuan in the research and development of Lurasidone Hydrochloride Tablets [1] - The approval of Lurasidone Hydrochloride Tablets signifies that the product has passed the consistency evaluation, which is a positive development for the company's product offerings [1] Industry Summary - Other companies that have received the drug registration certificate for Lurasidone Hydrochloride Tablets include Jiangsu Hengrui Medicine Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., and Zhejiang Haizheng Pharmaceutical Co., Ltd. [1] - The production and sales of the drug are subject to significant uncertainties due to factors such as national policies and market environment changes [1]

Core Viewpoint - Pro Pharmaceutical (000739.SZ) announced that its subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., has received the drug registration certificate for L-carnitine injection from the National Medical Products Administration of China [1] Group 1: Product Information - L-carnitine injection is indicated for patients with chronic renal failure undergoing long-term hemodialysis, addressing secondary carnitine deficiency and related complications such as cardiomyopathy, skeletal myopathy, arrhythmias, hyperlipidemia, hypotension, and muscle cramps during dialysis [1] - The projected market size for L-carnitine injection in China's hospital market for 2024 is estimated at 103 million units, with a sales value of 965 million yuan [1] Group 2: Financial Investment - The total research and development expenses incurred for L-carnitine injection up to the date of the announcement amount to 3.7629 million yuan [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Canagliflozin tablets, which are primarily used to improve blood sugar control in adults with type 2 diabetes [1] Summary by Relevant Sections Product Development - Canagliflozin tablets are expected to generate approximately 370 million yuan in sales in the domestic market by 2024, according to data from Meini Network [1] - The company has invested around 5.64 million yuan in the research and development of this drug [1] Market Impact - The approval of the registration certificate will enrich the company's product line and enhance its market competitiveness [1] - The introduction of Canagliflozin tablets is anticipated to have a positive impact on the company's operating performance [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a drug registration acceptance notice from the National Medical Products Administration (NMPA) for edaravone tablets, aimed at treating acute ischemic stroke [1][3]. Drug Information - Drug Name: Edaravone Tablets - Application: Domestic production drug registration and marketing license - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: To improve neurological symptoms and functional impairments caused by acute ischemic stroke (AIS) and enhance daily living capabilities [1]. R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage [3]. - The injectable form of edaravone has been approved in Japan and China for AIS treatment, but it requires intravenous administration, limiting patient compliance [3]. - The oral formulation, TTYP01, developed by Shanghai Aozong Biotechnology, is a modified new drug that allows for self-administration and room temperature storage, enhancing convenience and compliance [3][4]. - The clinical trial for TTYP01 was completed in June 2024, showing efficacy and safety comparable to the injectable form while improving patient adherence [3]. Impact on the Company - The approval of edaravone tablets is expected to enrich the company's cardiovascular product pipeline and create synergies with existing products [6]. - The drug is anticipated to meet the urgent clinical needs of stroke patients, potentially becoming a significant product in the treatment field [5][6]. - The company has invested approximately 100.81 million yuan in the development of edaravone tablets [5]. Future Considerations - Following the acceptance notice, the drug will undergo review by the NMPA's drug evaluation center, with the approval timeline and market competition remaining uncertain [6].