Group 1 - The core point of the article is that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration certificate of Entacapone tablets, indicating a significant development for the company [1] Group 2 - Xinhua Pharmaceutical's stock closed at 15.15 yuan on March 4 [1] - The product name approved is "Entacapone tablets," which suggests potential new revenue streams for the company [1]

本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或 重大遗漏。 近日，山东新华制药股份有限公司（以下简称"本公司"）之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沙格列汀二甲双胍缓释片(Ⅰ)、(Ⅲ) （以下简称"本品"）《药品注册证书》。现将相关情况公告如下： 一、基本情况 药品名称：沙格列汀二甲双胍缓释片(Ⅰ)、(Ⅲ) 剂型：片剂 规格：沙格列汀二甲双胍缓释片(Ⅰ)：每片含沙格列汀5mg和盐酸二甲双胍1000mg。 沙格列汀二甲双胍缓释片(Ⅲ)：每片含沙格列汀2.5mg和盐酸二甲双胍1000mg。 证券代码：000756 证券简称：新华制药 公告编号：2026-05 山东新华制药股份有限公司 关于子公司获得沙格列汀二甲双胍缓释片药品注册证书的公告 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关 要求，批准注册，发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企 业应当符合药品生产质量管理规范要求方可生产销售。 二、其他相关信息 2024年6月，新达制药向国家药品监督管 ...

证券代码：000756 证券简称：新华制药 公告编号：2026-06 山东新华制药股份有限公司 关于获得恩他卡朋片药品注册证书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述 或重大遗漏。 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 理局核准签发的恩他卡朋片（以下简称"本品"）《药品注册证书》。现将相关情况公告如下： 一、基本情况 药品名称：恩他卡朋片 剂型：片剂 规格：0.2g 药品分类：处方药 注册分类：化学药品4类 申请人：山东新华制药股份有限公司 申请事项：药品注册（境内生产） 受理号：CYHS2403452 药品批准文号：国药准字H20263454 证书编号：2026S00543 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关 要求，批准注册，发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企 业应当符合药品生产质量管理规范要求方可生产销售。 二、其他相关信息 2024年10月，新华制药向国家药品监督管理局药品审评中心（CDE）递交恩他卡朋片上市许可注 册申 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Entacapone tablets, which will enhance the company's product portfolio and competitive strength in the pharmaceutical market [1] Group 1: Product Approval - The company has obtained the drug registration certificate for Entacapone tablets, which can be used as an adjunct therapy for Parkinson's disease when standard medications are insufficient [1] - Entacapone tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] Group 2: Market Potential - The estimated sales revenue for Entacapone tablets in Chinese public medical institutions is approximately RMB 286 million in 2024 [1] - The approval of Entacapone tablets will further enrich the company's formulation product series, contributing to an increase in overall competitiveness [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical's subsidiary has received approval for a new diabetes medication, which is expected to enhance the company's competitive position in the market [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for the Saxagliptin Metformin Extended-Release Tablets (I) and (III) by the National Medical Products Administration [1] - The medication is intended for adult patients with type 2 diabetes to improve blood sugar control and is not suitable for type 1 diabetes or diabetic ketoacidosis patients [1] Group 2: Market Potential - The Saxagliptin Metformin Extended-Release Tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The projected sales revenue for Saxagliptin Metformin Extended-Release Tablets in Chinese public medical institutions is approximately RMB 419 million in 2024 [1] Group 3: Strategic Implications - The approval of this medication will enrich the company's range of hypoglycemic agents, thereby enhancing its overall competitiveness in the pharmaceutical market [1]

格隆汇3月4日丨山东新华制药股份(00719.HK)公布，近日，公司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沙格列汀二甲双胍缓释片(Ⅰ)、(Ⅲ)(以下简 称"本品")《药品注册证书》。 药品名称：沙格列汀二甲双胍缓释片(Ⅰ)、(Ⅲ) 剂型：片剂 规格：沙格列汀二甲双胍缓释片(Ⅰ)：每片含沙格列汀5mg和盐酸二甲双胍1000mg。沙格列汀二甲双胍 缓释片(Ⅲ)：每片含沙格列汀2.5mg和盐酸二甲双胍1000mg。药品分类：处方药 注册分类：化学药品4类 申请事项：药品注册(境内生产) 受理号：CYHS2401958、CYHS2401959 药品批准文号：国药准字H20263398、国药准字H20263445 证书编号：2026S00469、2026S00534 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册，发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企业应当符 合药品生产质量管理规范要求方可生产销售。 申请人：山东淄博新达制药有限公司 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Entacapone tablets, which can be used as an adjunct therapy for Parkinson's disease when standard medications are insufficient [1] Company Summary - The approved product, Entacapone tablets, is indicated for use alongside standard medications such as Levodopa/Benserazide or Levodopa/Carbidopa [1] - The indication for Entacapone includes treatment for Parkinson's disease and symptom fluctuations that are not controlled by existing therapies [1]

格隆汇3月4日丨山东新华制药股份(00719.HK)公布，近日，公司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沙格列汀二甲双胍缓释片(Ⅰ)、(Ⅲ)(以下简 称"本品")《药品注册证书》。 药品名称：沙格列汀二甲双胍缓释片(Ⅰ)、(Ⅲ) 剂型：片剂 规格：沙格列汀二甲双胍缓释片(Ⅰ)：每片含沙格列汀5mg和盐酸二甲双胍1000mg。沙格列汀二甲双胍 缓释片(Ⅲ)：每片含沙格列汀2.5mg和盐酸二甲双胍1000mg。药品分类：处方药 注册分类：化学药品4类 申请人：山东淄博新达制药有限公司 申请事项：药品注册(境内生产) 受理号：CYHS2401958、CYHS2401959 药品批准文号：国药准字H20263398、国药准字H20263445 证书编号：2026S00469、2026S00534 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册，发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企业应当符 合药品生产质量管理规范要求方可生产销售。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Saxagliptin Metformin Extended-Release Tablets, which will enhance its diabetes treatment product line and improve its overall competitiveness in the market [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Saxagliptin Metformin Extended-Release Tablets (I) and (III) from the National Medical Products Administration [1] - This product is indicated for adult patients with type 2 diabetes to improve blood glucose control when used in conjunction with diet and exercise [1] Group 2: Market Potential - The product is not intended for patients with type 1 diabetes or diabetic ketoacidosis [1] - Saxagliptin Metformin Extended-Release Tablets are 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 Saxagliptin Metformin Extended-Release Tablets in Chinese public medical institutions is approximately RMB 419 million in 2024 [1] Group 3: Strategic Implications - The approval of Saxagliptin Metformin Extended-Release Tablets will enrich the company's diabetes medication portfolio [1] - This development is expected to enhance the company's comprehensive competitiveness in the pharmaceutical industry [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Entacapone tablets, which will enhance the company's product portfolio and competitive strength in the pharmaceutical market [1] Group 1: Product Approval - The company has obtained the drug registration certificate for Entacapone tablets, which can be used as an adjunct therapy for Parkinson's disease when standard medications are insufficient [1] - Entacapone tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2025) [1] Group 2: Market Potential - The estimated sales revenue for Entacapone tablets in Chinese public medical institutions is approximately RMB 286 million in 2024 [1] - The approval of Entacapone tablets will further enrich the company's formulation product series, contributing to an increase in overall competitiveness [1]