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仿制药质量和疗效一致性评价
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亚宝药业: 亚宝药业集团股份有限公司关于获得药品补充申请批准通知书的公告
Zheng Quan Zhi Xing· 2025-05-16 12:15
Group 1 - The company received the approval notice for the supplementary application of Propranolol Hydrochloride Tablets, indicating that the product has passed the consistency evaluation of generic drug quality and efficacy [1][2] - Propranolol Hydrochloride Tablets were first launched in Japan in October 1966 under the brand name Inderal, with a specification of 10mg [2] - The indications for the drug include secondary prevention of myocardial infarction mortality, hypertension treatment, control of various types of arrhythmias, and management of hyperthyroidism-related tachycardia [2] Group 2 - In 2023, the domestic sales amount of Propranolol Hydrochloride Tablets was approximately 82.18 million RMB, with public medical market sales accounting for about 57.76 million RMB and retail pharmacy sales around 24.42 million RMB [2] - As of the announcement date, six other companies in China have also passed the consistency evaluation for this drug [2] - The company has invested approximately 2.6 million RMB in the research and development of this project [2]
上海现代制药股份有限公司2025年第一季度报告
Core Viewpoint - The company, Shanghai Modern Pharmaceutical Co., Ltd., announced that its wholly-owned subsidiary, National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has received approval for potassium chloride injection to pass the consistency evaluation of generic drug quality and efficacy, which is expected to enhance market expansion and sales potential for the product [6][7]. Financial Data - The quarterly financial report for the first quarter of 2025 has not been audited [3]. - The company has invested approximately RMB 1.6354 million in the research and development of potassium chloride injection [8]. Drug Information - Potassium chloride injection is a commonly used medication for supplementing potassium in the body, primarily used to treat and prevent hypokalemia, especially when oral supplementation is not possible [7]. - The sales revenue of potassium chloride injection in public medical institutions across China was RMB 619 million in 2023 [7]. Regulatory Approval - The approval was granted based on various regulations, including the Drug Administration Law of the People's Republic of China and related announcements regarding the consistency evaluation of generic drugs [6].
华润双鹤药业股份有限公司关于全资子公司华润紫竹药业有限公司地夸磷索钠滴眼液通过GMP符合性检查的公告
Group 1: GMP Compliance Announcement - Company’s subsidiary, China Resources Zizhu Pharmaceutical Co., Ltd., received GMP compliance notice for Diquafosol Sodium Eye Drops from Beijing Drug Administration [1] - The GMP inspection was conducted from March 12 to March 14, 2025, confirming compliance with the 2010 revised Drug Production Quality Management Standards [1][2] - The production capacity for Diquafosol Sodium Eye Drops is designed at 80 million bottles per year, with no additional investment made for the inspection [2] Group 2: Market Situation of Diquafosol Sodium Eye Drops - Diquafosol Sodium Eye Drops are used for treating dry eye patients with diagnosed tear film abnormalities, developed by Santen Pharmaceutical Co., Ltd. and launched in Japan in April 2010 [2][3] - In 2023, global sales of Diquafosol Sodium Eye Drops reached $161.3 million, with the product marketed as "Diquas" in Japan and "Liaisi" in China [2][3] - In China, 39 companies have approved production of Diquafosol Sodium Eye Drops, with the total sales in the domestic market amounting to 228 million RMB in 2023 [3] Group 3: Impact on Company - The successful GMP compliance indicates that the company can maintain stable product quality and production capacity to meet market demand [4] - The inspection results are not expected to have a significant impact on the company's financial performance [4] Group 4: Vitamin B6 Injection Announcement - The company’s subsidiary, China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., received approval for Vitamin B6 Injection's consistency evaluation from the National Medical Products Administration [13] - The Vitamin B6 Injection is used for preventing and treating Vitamin B6 deficiency and related conditions, with a cumulative R&D investment of 3.89 million RMB [14][15] - In 2023, the total sales of Vitamin B6 Injection in the domestic market reached 453 million RMB, with the top five companies holding significant market shares [15]
新赣江:向不特定合格投资者公开发行股票并在北京证券交易所上市招股说明书
2023-01-19 09:36
江西省吉安市吉州区云章路 36 号 江西新赣江药业股份有限公司 江西新赣江药业股份有限公司招股说明书 证券简称: 新赣江 证券代码: 873167 保荐人(主承销商) (浙江省杭州市西湖区天目山路 198 号财通双冠大厦西楼) 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证券交易所主要 服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风险高等特点,投资者面临较 大的市场风险。投资者应充分了解北京证券交易所市场的投资风险及本公司所披露的风险因素,审 慎作出投资决定。 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表明 其对注册申请文件及所披露信息的真实性、准确性、完整性作出保证,也不表明 其对发行人的盈利能力、投资价值或者对投资者的收益作出实质性判断或者保证。 任何与之相反的声明均属虚假不实陈述。 根据《证券法》的规定,股票依法发行后,发行人经营与收益的变化,由发 行人自行负责;投资者自主判断发行人的投资价值,自主作出投资决策,自行承 担股票依法发行后因发行人经营与收益变化或者股票价格变动引致的投资风险。 1-1-1 声明 发行人及全体董事、监事、高级管理人员 ...
新赣江:招股说明书(注册稿)
2023-01-09 23:12
证券简称: 新赣江 证券代码: 873167 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证券交易所主要 服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风险高等特点,投资者面临较 大的市场风险。投资者应充分了解北京证券交易所市场的投资风险及本公司所披露的风险因素,审 慎作出投资决定。 保荐人(主承销商) (浙江省杭州市西湖区天目山路 198 号财通双冠大厦西楼) 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表明 其对注册申请文件及所披露信息的真实性、准确性、完整性作出保证,也不表明 其对发行人的盈利能力、投资价值或者对投资者的收益作出实质性判断或者保证。 任何与之相反的声明均属虚假不实陈述。 根据《证券法》的规定,股票依法发行后,发行人经营与收益的变化,由发 行人自行负责;投资者自主判断发行人的投资价值,自主作出投资决策,自行承 担股票依法发行后因发行人经营与收益变化或者股票价格变动引致的投资风险。 1-1-1 声明 江西省吉安市吉州区云章路 36 号 江西新赣江药业股份有限公司 江西新赣江药业股份有限公司招股说明书(申报稿) 本公司的发行申请尚未经中国 ...