Group 1 - The core point of the article is that Xinhua Pharmaceutical (000756.SZ) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration [1] - The drug is indicated for the treatment of cholesterol gallstones (which must be X-ray penetrable stones and the gallbladder must have normal contraction function) [1] - It is also used for cholestatic liver diseases (such as primary biliary cirrhosis) and bile reflux gastritis [1]

Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval for the registration of Ursodeoxycholic Acid Capsules from the National Medical Products Administration [1] - Xinhua Pharmaceutical's revenue composition for the first half of 2025 is as follows: 44.36% from chemical drug formulation manufacturing, 32.11% from chemical raw material manufacturing, and 23.53% from pharmaceutical intermediates and others [1] - As of the report, Xinhua Pharmaceutical has a market capitalization of 11.6 billion yuan [1]

Core Viewpoint - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Company Summary - Xinda Pharmaceutical, a wholly-owned subsidiary of Xinhua Pharmaceutical, has been approved for Ursodeoxycholic Acid Capsules, which are used to treat cholesterol gallstones, cholestatic liver disease, and bile reflux gastritis [1] - The drug is classified as a Class A item in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024, enhancing its market accessibility [1] Industry Summary - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately 2.155 billion yuan in 2024, indicating a substantial market opportunity for the newly approved drug [1] - Xinda Pharmaceutical submitted the application for marketing authorization in January 2024 and received approval in September 2025, reflecting the regulatory timeline for new drug approvals in the industry [1]

Group 1 - The company announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration [1] - The drug is indicated for the treatment of cholesterol gallstones, cholestatic liver disease, and bile reflux gastritis [1] - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately RMB 2.155 billion in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical's subsidiary, Shandong Zibo Xinda Pharmaceutical, has received approval for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, enhancing the company's product offerings in the digestive system medication sector [1] Group 1: Regulatory Approval - The company submitted the application for Ursodeoxycholic Acid Capsules to the Center for Drug Evaluation in January 2024, which was accepted [1] - The product received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Ursodeoxycholic Acid Capsules are indicated for the treatment of cholesterol gallstones, cholestatic liver diseases, and bile reflux gastritis [1] Group 3: Market Potential - The product is classified as a Category A drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately RMB 2.155 billion in 2024 [1] Group 4: Strategic Impact - The approval of Ursodeoxycholic Acid Capsules is expected to enrich the company's product variety in digestive system medications and enhance its overall competitiveness [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Sildenafil Citrate Orally Disintegrating Tablets, which is expected to enhance the company's market competitiveness and open new market opportunities [1]. Company Summary - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, and the application was accepted [1]. - The drug received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1]. - The product is indicated for the treatment of erectile dysfunction, a market that generated approximately RMB 5.2 billion in sales for related formulations in public medical institutions in China in 2024 [1]. Industry Summary - The approval of Sildenafil Citrate Orally Disintegrating Tablets is expected to contribute positively to the market landscape for erectile dysfunction treatments in China [1]. - The significant sales figure of RMB 5.2 billion in 2024 indicates a robust demand for erectile dysfunction medications within the public healthcare sector [1].

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Sildenafil Citrate Orally Disintegrating Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1] Group 1: Company Developments - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, which was accepted [1] - The drug registration certificate was granted in September 2025, with the evaluation conclusion being approval for registration [1] Group 2: Market Context - Sildenafil Citrate Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction [1] - In 2024, the sales revenue of Sildenafil-related formulations in public medical institutions in China is estimated to be approximately RMB 5.2 billion [1]

格隆汇9月16日丨山东新华制药股份(00719.HK)发布公告，近日，公司的全资子公司山东淄博新达制药 有限公司(以下简称"新达制药")收到国家药品监督管理局核准签发的熊去氧胆酸胶囊《药品注册证 书》。本品用于治疗胆囊胆固醇结石(必须是X射线能穿透的结石，同时胆囊收缩功能须正常)；胆汁淤 积性肝病(如：原发性胆汁性肝硬化)；胆汁反流性胃炎。 ...

本品用于治疗胆囊胆固醇结石(必须是X射线能穿透的结石，同时胆囊收缩功能须正常);胆汁淤积性肝病 (如：塬发性胆汁性肝硬化);胆汁反流性胃炎。 本品属于《国家基本医疗保险、工伤保险和生育保险药品目录(2024年)》甲类品种。根据相关统计数 据，2024年中国公立医疗机构熊去氧胆酸销售额约为人民币21.55亿元。 公告称，新达制药申报的熊去氧胆酸胶囊于2025年9月获得批准，有利于丰富公司消化系统用药品种， 提升公司综合竞争力。 智通财经APP讯，山东新华制药股份(00719)公布，近日，公司的全资子公司山东淄博新达制药有限公司 (以下简称"新达制药")收到国家药品监督管理局核准签发的熊去氧胆酸胶囊《药品注册证书》。 2024年1月，新达制药向国家药品监督管理局药品审评中心(CDE)递交熊去氧胆酸胶囊上市许可申报资 料并获受理，2025年9月获得《药品注册证书》，审评结论为：批准注册。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Sildenafil Citrate Orally Disintegrating Tablets, which is expected to enhance the company's market competitiveness and open new market opportunities [1]. Company Summary - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, and the application was accepted [1]. - The drug received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1]. - The product is indicated for the treatment of erectile dysfunction, a market segment with significant sales potential [1]. Industry Summary - In 2024, the sales revenue of Sildenafil-related formulations in Chinese public medical institutions is estimated to be approximately RMB 5.2 billion [1]. - The approval of this new formulation is expected to contribute positively to the overall market dynamics for erectile dysfunction treatments in China [1].