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].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited （於中華人民共和國註冊成立之股份有限公司） （股份代碼：00719） 海外監管公告 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2025 年 9 月 17 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得枸櫞酸西地那非口崩片藥品註冊證書的公告》, 茲載列有關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2025年9月16日 於本公告日期，本公司董事會之成員如下： | 執行董事： | | 獨立非執行董事： | | --- | --- | --- | | 賀同慶先生（董事長） | | 潘廣成先生 | | 徐文輝先生 | | 朱建偉先生 | | 侯 | 寧先 ...

（股份代碼：00719） 海外監管公告 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited （於中華人民共和國註冊成立之股份有限公司） 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條作出。 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2025 年 9 月 17 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於子公司獲得熊去氧膽酸膠囊藥品註冊證書的公告》, 茲載列有關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2025年9月16日 於本公告日期，本公司董事會之成員如下： | 執行董事： | | 獨立非執行董事： | | --- | --- | --- | | 賀同慶先生（董事長） | | 潘 ...

Group 1 - The core point of the article is the resignation of Zheng Zhonghui, the Deputy General Manager of XinHua Pharmaceutical, due to personal reasons, effective September 5, 2025 [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 11.4 billion yuan [1]

Core Viewpoint - The resignation of the Vice President of Shandong Xinhua Pharmaceutical Co., Ltd. is officially announced, and it is stated that this will not impact the company's normal operations [1] Group 1: Resignation Announcement - The company received a written resignation report from Vice President Zheng Zhonghui on September 5, 2025, due to personal reasons [1] - Zheng Zhonghui will not hold any executive position in the company after his resignation [1] - The resignation is effective immediately upon delivery to the board of directors [1] Group 2: Impact on Company Operations - As of the announcement date, Zheng Zhonghui has no outstanding commitments that he has failed to fulfill [1] - His resignation will not affect the company's normal production and operational activities [1] - There were no disagreements between Zheng Zhonghui and the board during his tenure [1] Group 3: Shareholding Information - Zheng Zhonghui holds 397,550 A shares of the company, and he will continue to manage his shares according to relevant laws and regulations after his resignation [1] - The board expresses gratitude for Zheng Zhonghui's contributions during his tenure [1]