Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing of Fumarate Bisoprolol Tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Summary by Category Product Approval - The approval includes the issuance of a Drug Registration Certificate for Fumarate Bisoprolol Tablets [1] - The product is intended for use under medical supervision alongside ACE inhibitors, diuretics, and selectively used cardiac glycosides [1] Indications - Fumarate Bisoprolol Tablets are indicated for the treatment of: - Hypertension - Coronary heart disease (angina) - Chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Fumarate Bisoprolol Tablets, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The Fumarate Bisoprolol Tablets are indicated for the treatment of hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication requires adherence to medical advice, including the use of ACE inhibitors, diuretics, and selectively using cardiac glycosides [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The approval is for Fumarate Bisoprolol Tablets, which are indicated for hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 2: Treatment Guidelines - The use of Fumarate Bisoprolol Tablets should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1]

Core Viewpoint - The announcement indicates that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Fumarate Bisoprolol tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 1 - The approved drug, Fumarate Bisoprolol, targets specific cardiovascular conditions [1] - The estimated sales revenue for Fumarate Bisoprolol tablets in Chinese public medical institutions is approximately RMB 1.228 billion in 2024 [1]

证券代码：000756 证券简称：新华制药 公告编号：2025-59 山东新华制药股份有限公司 关于获得富马酸比索洛尔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（"新华制药"或"本公司"）收到国家药品监督 管理局核准签发的富马酸比索洛尔片（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：富马酸比索洛尔片 剂型：片剂 规格：5mg；2.5mg 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：CYHS2400705、CYHS2400706 药品批准文号：国药准字H20255640；国药准字H20255641 证书编号：2025S03071；2025S03072 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 2 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, enhancing its cardiovascular product line and providing more options for clinical medication [1]. Group 1 - The company has been approved for the registration of Fumarate Bisoprolol Tablets [1]. - This approval enriches the company's cardiovascular product offerings [1]. - The new product provides additional choices for clinical medication [1].

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Fumaric Acid Bisoprolol Tablets, indicating a significant advancement in its product portfolio and potential market impact [1] Group 1: Product Approval and Registration - The company has been granted a drug registration certificate for Fumaric Acid Bisoprolol Tablets, confirming compliance with the relevant drug registration requirements [1] - The registration process included submission of application materials to the Center for Drug Evaluation (CDE) in February 2024, with approval granted in October 2025 [1] Group 2: Indications and Usage - Fumaric Acid Bisoprolol Tablets are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1] Group 3: Market Potential - The drug is classified as a Category A product in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024 edition) [1] - Estimated sales for Fumaric Acid Bisoprolol Tablets in Chinese public medical institutions are projected to be approximately RMB 1.228 billion in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Fumaric Acid Bisoprolol Tablets, enhancing its cardiovascular product line and providing more options for clinical medication [1] Company Summary - The approval of Fumaric Acid Bisoprolol Tablets enriches the company's cardiovascular product offerings [1] - This development indicates the company's commitment to expanding its portfolio in the cardiovascular sector [1] Industry Summary - The approval reflects ongoing regulatory support for new pharmaceutical products in the cardiovascular market [1] - The introduction of new medications can lead to increased competition and innovation within the cardiovascular treatment landscape [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. will hold a board meeting on October 24, 2025, to review and approve the unaudited performance for the nine months ending September 30, 2025, along with any other applicable matters [1] Summary by Category - **Company Meeting Details** - The board meeting is scheduled for October 24, 2025, at 9:30 AM [1] - Location of the meeting is at the company's conference room in Zibo High-tech Zone, Shandong Province, China [1] - **Performance Review** - The meeting will include the review and approval of the unaudited performance of the company and its subsidiaries for the nine months ending September 30, 2025 [1] - **Other Matters** - The agenda may include any other applicable matters as necessary [1]

Core Insights - Vitamin B12, also known as cobalamin, is essential for human health, playing a critical role in nerve function and preventing pernicious anemia. It is used in the treatment of various diseases such as cerebral hemorrhage, Alzheimer's disease, and acute myelitis. The market demand for Vitamin B12 supplements is increasing due to rising health awareness among consumers. The market size of the cobalamin industry in China is projected to reach 1.4 billion yuan in 2024, representing a year-on-year growth of 6% [1][10]. Industry Overview - Cobalamin, or Vitamin B12, is the only vitamin that contains a metal element. It is a red crystalline powder that is water-soluble and plays multiple indispensable roles in the human body, including maintaining a healthy nervous system and promoting red blood cell production [3][10]. - The primary sources of Vitamin B12 are animal products, with some plant sources like soybeans containing lower amounts. The vitamin is crucial for protein and amino acid synthesis, especially in infants [3]. Market Dynamics - China is a major supplier of Vitamin B12 globally, with significant export volumes. The export quantity of unblended Vitamin B12 and its derivatives is expected to grow from 355.08 tons in 2020 to 498.08 tons by 2024 [10]. - The competition in the cobalamin market is intensifying due to limited market size and high domestic production capacity. Major players include Hebei Huaron, Yuxing Bio, Ningxia Jinyi, and Jiutian Pharmaceutical [10][11]. Production Methods - The cobalamin industry primarily utilizes microbial fermentation methods for production, as chemical synthesis is complex and costly. The fermentation process mainly involves anaerobic fermentation using Propionibacterium and aerobic fermentation using Pseudomonas [8]. Industry Trends - The cobalamin industry is expected to see continuous technological innovation, focusing on refining extraction methods and enhancing product stability. The use of biotechnological advancements will likely lead to higher activity and lower impurity levels in cobalamin products [12]. - There is a trend towards high-end and diversified product offerings to meet varying consumer needs, including specialized products for anemia treatment and a wider range of dosage forms [13]. - The industry is moving towards environmentally sustainable practices, including green sourcing of raw materials and energy-efficient extraction processes [14].