Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Minoxidil lotion, which is expected to enhance the company's product portfolio and overall competitiveness [1] Company Summary - The Minoxidil lotion was approved for registration in August 2025, indicating a future expansion in the company's product offerings [1] - This approval is anticipated to strengthen the company's market position and competitive edge in the pharmaceutical industry [1]

山东新华制药（000756）股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"新华制 药"或"本公司")收到国家药品监督管理局核准签发的沙库巴曲缬沙坦钠片(以下简称"该产品")《药品注 册证书》。 沙库巴曲缬沙坦钠片用于射血分数降低的慢性心力衰竭(NYHAⅡ-Ⅳ级，LVEF≤40%)成人患者，降低心 血管死亡和心力衰竭住院的风险。沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂(ACEI)或血管紧 张素Ⅱ受体拮抗剂(ARB)，与其他心力衰竭治疗药物合用。沙库巴曲缬沙坦钠片也可用于治疗原发性高 血压。 本品作为血管紧张素II拮抗剂的复方药物，属于《国家基本医疗保险、工伤保险和生育保险药品目录 (2025年)》乙类品种。根据相关统计数据，2024年中国公立医疗机构沙库巴曲缬沙坦钠片销售额约为人 民币49亿元。 新华制药的沙库巴曲缬沙坦钠片于2025年8月取得药品注册证书，有利于丰富本公司心血管疾病治疗药 物，提升公司综合竞争优势。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Clarithromycin suspension, which is expected to enhance the company's product offerings in the anti-infection drug category and improve its overall competitiveness [1][2]. Group 1: Product Approval - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin suspension by the National Medical Products Administration [1]. - The application for the marketing authorization of Clarithromycin suspension was submitted in December 2023 and was accepted, with the registration certificate obtained in August 2025 [1]. Group 2: Indications and Market Potential - Clarithromycin is indicated for treating infections caused by pathogens sensitive to it, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [2]. - The estimated sales revenue for Clarithromycin in public medical institutions in China is approximately RMB 1.123 billion in 2024 [2]. - The approval of Clarithromycin suspension will enrich the company's anti-infection drug portfolio [2].

格隆汇8月26日丨山东新华制药股份(00719.HK)发布公告，近日，公司收到国家药品监督管理局核准签 发的沙库巴曲缬沙坦钠片《药品注册证书》。沙库巴曲缬沙坦钠片用于射血分数降低的慢性心力衰竭 (NYHA Ⅱ-Ⅳ级，LVEF≤40%)成人患者，降低心血管死亡和心力衰竭住院的风险。沙库巴曲缬沙坦钠片 可代替血管紧张素转化酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗剂(ARB)，与其他心力衰竭治疗药物合 用。沙库巴曲缬沙坦钠片也可用于治疗原发性高血压。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Clarithromycin Dry Suspension from the National Medical Products Administration [1] Company Summary - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., is responsible for the newly approved product [1] - The approval of the drug registration certificate signifies a potential expansion in the company's product offerings and market presence [1] Industry Summary - The approval of Clarithromycin Dry Suspension aligns with the ongoing trends in the pharmaceutical industry towards expanding antibiotic options [1] - Regulatory approvals such as this are crucial for companies in the pharmaceutical sector to enhance their competitive edge and meet market demands [1]

Group 1 - Shandong Xinhua Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Clarithromycin suspension from the National Medical Products Administration [1] - The application for the marketing authorization of Clarithromycin suspension was submitted in December 2023 and accepted, with the registration certificate granted in August 2025 [1] - The approval of Clarithromycin suspension will enhance the company's portfolio of anti-infective drugs and improve its overall competitiveness [2] Group 2 - Clarithromycin is indicated for treating infections caused by pathogens sensitive to it, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [2] - The estimated sales of Clarithromycin in public medical institutions in China for 2024 is approximately RMB 1.123 billion [2]

本品作为血管紧张素II拮抗剂的复方药物，属于《国家基本医疗保险、工伤保险和生育保险药品目录 (2025年)》乙类品种。根据相关统计数据，2024年中国公立医疗机构沙库巴曲缬沙坦钠片销售额约为人 民币49亿元。 新华制药的沙库巴曲缬沙坦钠片于2025年8月取得药品注册证书，有利于丰富本公司心血管疾病治疗药 物，提升公司综合竞争优势。 智通财经APP讯，山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"新 华制药"或"本公司")收到国家药品监督管理局核准签发的沙库巴曲缬沙坦钠片(以下简称"该产品")《药 品注册证书》。 沙库巴曲缬沙坦钠片用于射血分数降低的慢性心力衰竭(NYHA Ⅱ-Ⅳ级，LVEF≤40%)成人患者，降低心 血管死亡和心力衰竭住院的风险。沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂(ACEI)或血管紧 张素Ⅱ受体拮抗剂(ARB)，与其他心力衰竭治疗药物合用。沙库巴曲缬沙坦钠片也可用于治疗原发性高 血压。 ...

Core Viewpoint - The announcement indicates that the company's subsidiary has received regulatory approval for a new drug, which is expected to enhance its product portfolio and market presence in the pharmaceutical industry [1] Group 1 - The full subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin dry suspension by the National Medical Products Administration [1] - Clarithromycin is indicated for the treatment of infections caused by pathogens sensitive to the drug, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Minoxidil lotion, which is expected to enhance the company's product portfolio and overall competitiveness [1] Company Summary - The Minoxidil lotion received its registration certificate, which is a significant milestone for the company [1] - The approval date for the Minoxidil lotion is set for August 2025, indicating a future expansion in product offerings [1] Industry Summary - The approval of new pharmaceutical products like Minoxidil lotion contributes to the diversification of product categories within the pharmaceutical industry [1] - Enhanced product offerings are likely to improve competitive positioning in the market [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. reported a decline in revenue and net profit for the first half of 2025, indicating challenges in the market despite some growth in specific segments [1] Financial Performance - The company's operating revenue was approximately 4.639 billion yuan, a year-on-year decrease of 1.98% [1] - Net profit attributable to shareholders was about 224 million yuan, down 15.69% year-on-year [1] - Basic earnings per share stood at 0.32 yuan [1] Product Development and Market Position - The company launched 10 new formulation products in the first half of the year [1] - A total of 19 products across 25 specifications were awarded national procurement bids [1] - The formulation processing and export business maintained stable growth, with significant development in self-operated formulation exports [1] Production and Innovation - The company focused on cost reduction and leveraged its production advantages in key raw materials, resulting in increased production of 11 key raw materials such as ibuprofen and aspirin, thereby expanding market share [1] - Sales of specialty raw materials experienced rapid growth [1] - In the first half of the year, the company obtained 21 drug approvals, including 19 new formulation products and 2 raw material drug approvals [1] - The company initiated Phase II clinical work for a Class I innovative drug OAB-14 for Alzheimer's treatment [1] - The company received 18 authorized patents, including 8 invention patents [1] - One project was awarded the Shandong Province 2024 Science and Technology Progress Award, and another was included in the 2025 provincial major science and technology innovation project [1]