Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Valsartan capsules, which will enhance the company's cardiovascular disease treatment product line and improve its overall competitiveness [1] Group 1 - The company has been granted a drug registration certificate for Valsartan capsules, which is expected to be effective from December 2025 [1] - The approval of Valsartan capsules is part of the company's strategy to diversify its product offerings in the cardiovascular disease sector [1] - This development is anticipated to strengthen the company's market position and competitive edge in the pharmaceutical industry [1]

Group 1 - The core point of the article is that Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of its injection product, Isopropylphenol [1] - The product is indicated for the treatment of acute spasmodic pain caused by digestive system and biliary dysfunction, as well as acute spasmodic pain in the urinary tract, bladder, and kidney, and gynecological spasmodic pain [1] - The product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] Group 2 - In July 2024, the company submitted the registration application for the domestic production of Isopropylphenol injection, which was accepted by the National Medical Products Administration [1] - The product received its registration certificate in December 2025, with the review conclusion being approval for registration [1] - The estimated sales revenue for Isopropylphenol injection in Chinese public medical institutions is approximately RMB 900 million in 2024 [1]

Group 1 - The core point of the article is that Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Valsartan capsules, which are used to treat mild to moderate primary hypertension [1] Group 2 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio in the cardiovascular medication market [1] - Valsartan is a well-known medication in the treatment of hypertension, indicating a strategic move by the company to address a significant health issue [1] - The introduction of Valsartan capsules may lead to increased revenue opportunities for the company in the pharmaceutical sector [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of its Isopropylphenol Injection, marking a significant milestone for the company in expanding its product offerings in the pharmaceutical market [1] Group 1: Product Approval and Registration - The company submitted the registration application for Isopropylphenol Injection to the Center for Drug Evaluation (CDE) in July 2024, which was accepted [1] - The product received its registration certificate in December 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Isopropylphenol Injection is indicated for the treatment of acute spasmodic pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1] Group 3: Market Potential - The product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The estimated sales revenue for Isopropylphenol Injection in Chinese public medical institutions is approximately RMB 900 million in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Valsartan capsules from the National Medical Products Administration, which is expected to enhance the company's product portfolio for cardiovascular disease treatment and improve its overall competitiveness [1]. Group 1 - The drug registration certificate for Valsartan capsules was approved and issued on December 2025 [1]. - The approval of Valsartan capsules will enrich the company's product line for treating cardiovascular diseases [1]. - This development is anticipated to strengthen the company's comprehensive competitiveness in the pharmaceutical industry [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 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 12 月 30 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得間苯三酚注射液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12月29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 ...

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 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 12 月 30 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得缬沙坦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。 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 | 寧先生 | 凌沛學先生 | | ...

Core Viewpoint - Xinhua Pharmaceutical has received the drug registration certificate for Oseltamivir Phosphate Suspension from the National Medical Products Administration, indicating a significant regulatory approval for the company [1] Group 1 - The company announced the approval of Oseltamivir Phosphate Suspension, which is a key product in its portfolio [1] - The registration certificate signifies compliance with national drug regulations, enhancing the company's market position [1] - This approval may lead to increased sales and market share in the antiviral medication segment [1]

Core Viewpoint - Xinhua Pharmaceutical has received the drug registration certificate for Oseltamivir Phosphate Dry Suspension from the National Medical Products Administration, indicating a significant advancement in its product offerings for influenza treatment and prevention [1] Group 1: Product Approval - The drug is approved for the treatment of influenza A and B in patients aged 2 weeks and older [1] - It can also be used for the prevention of influenza A and B in individuals aged 1 year and above [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Oseltamivir Phosphate Oral Suspension, which is indicated for the treatment of influenza A and B in patients aged 2 weeks and older [1] Group 1 - The product is effective in treating both influenza A and B, although clinical application data for influenza B is limited [1] - Patients are advised to use the product within 48 hours of the onset of symptoms [1] - The product can also be used for the prevention of influenza A and B in individuals aged 1 year and older [1]