Core Viewpoint - Recently, Xinhua Pharmaceutical (000756) announced the approval of several drug registration certificates by the National Medical Products Administration, indicating a positive development for the company's product portfolio [1] Group 1 - Xinhua Pharmaceutical received the drug registration certificate for Sacubitril/Valsartan Sodium Tablets and Minoxidil Lotion [1] - The wholly-owned subsidiary, Xinda Pharmaceutical, received the drug registration certificate for Clarithromycin Dry Suspension [1]

南财智讯8月26日电，新华制药发布2025年半年度报告，报告期实现营业收入46.39亿元，同比下降 1.98%；归属上市公司股东的净利润2.24亿元，同比下降15.69%；扣除非经常性损益后的归属于上市公 司股东的净利润2.11亿元，同比下降15.44%；基本每股收益0.32元。 ...

Core Viewpoint - Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the Minoxidil topical solution, which is intended for the treatment of male pattern baldness and alopecia areata [1] Group 1: Product Approval - The approval of Minoxidil topical solution enhances the product portfolio of Xinhua Pharmaceutical [1] - This product is expected to contribute to the company's competitiveness in the market [1] Group 2: Market Potential - The estimated sales revenue for Minoxidil in Chinese public medical institutions is approximately RMB 2.36 billion in 2024 [1] - The approval aligns with the growing demand for treatments related to hair loss in the healthcare sector [1]

新华制药公告，2025年上半年营业收入46.39亿元，同比下降1.98%。净利润2.24亿元，同比下降 15.69%。公司计划不派发现金红利，不送红股，不以公积金转增股本。 ...

山东新华制药股份有限公司 二零二五年半年度报告 二零二五年八月 | 章节 | 内容 | 页码 | | --- | --- | --- | | | 释 \' | 2 | | | 公司基本情况 · | ব | | ー | 会计数据和业务指标摘要 ……………………… | 5 | | 111 | 股本变动及股东情况 …………………………… | 7 | | 四 | 董事、监事、高级管理人员及员工情况 …………………… | 10 | | 五 | 董事长报告 … | 13 | | 六 | 经营管理研讨与分析 ……………………………………………………… | 15 | | 七 | 环境和社会责任 … | 24 | | 八 | 重要事项……………………………………………………… | 25 | | 九 | 公司管治 | 31 | | 十 | 财务报告 | 32 | | + | 备查文件 …………………………………… | 157 | 释义 | 释义项 | 指 | 释义内容 | | --- | --- | --- | | 公司、本公司 | 指 | 山东新华制药股份有限公司 | | 华鲁控股 | 指 | 华鲁控股集团有限公司，本公司之控 ...

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]