Core Viewpoint - The approval of the chemical raw material drug application for Ferric Succinylate by the National Medical Products Administration marks a significant advancement for the company in the raw material drug sector, enhancing its strategic development and product structure [1] Group 1: Company Developments - The company’s subsidiary, Harbin Pharmaceutical Group Sanjing Ming Water Pharmaceutical Co., Ltd., received the approval notice for Ferric Succinylate [1] - This approval is a crucial step in the company's strategy to achieve self-control over its raw material drugs [1] - The approval will further solidify the company's integrated development strategy of raw materials and formulations, benefiting the diversification of its product structure [1]

Core Viewpoint - The approval of the chemical raw material drug application for Ferric Succinate by the National Medical Products Administration marks a significant advancement for the company in the raw material drug sector, enhancing its strategic development and product structure [1] Group 1: Regulatory Approval - The company’s subsidiary, Harbin Pharmaceutical Group Sanjing Ming Water Pharmaceutical Co., Ltd., received the approval notice for Ferric Succinate from the National Medical Products Administration [1] - The approval number for the application is 2026YS00100 [1] Group 2: Strategic Implications - The approval signifies an important step in the company's layout within the raw material drug field, allowing for greater autonomy and control over its raw material production [1] - This development will further solidify the company's integrated strategy of raw material and formulation development, benefiting the diversification of its product offerings [1]

Core Viewpoint - Harbin Pharmaceutical Group announced the approval of its oral solution of ferric succinate for the treatment of iron deficiency anemia by the National Medical Products Administration of China [1][3] Group 1: Product Approval - The oral solution of ferric succinate is a non-prescription drug used to treat iron deficiency anemia caused by insufficient iron intake, absorption issues, chronic blood loss, and conditions during pregnancy and lactation [1] - As of the announcement date, there are a total of 10 domestic drug approval numbers and 1 import drug approval number for the oral solution of ferric succinate [1] Group 2: Sales Projections - According to the Minet database, the projected annual sales for the oral solution of ferric succinate in domestic hospitals for 2024 is approximately 626.2 million yuan, with sales of 490.34 million yuan for the first three quarters of 2025 [1] - The Zhongkang database indicates that the projected retail sales for the oral solution of ferric succinate in 2024 is around 114 million yuan, with sales of 83 million yuan for the first three quarters of 2025 [1] Group 3: R&D Investment - The company has invested approximately 4.851 million yuan in research and development for the oral solution of ferric succinate project as of the announcement date (unaudited) [2]

证券代码：600664 证券简称：哈药股份 编号：2026-006 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性 陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，哈药集团股份有限公司（以下简称"公司"）所属企业哈 药集团制药总厂（以下简称"哈药总厂"）收到国家药品监督管理局 颁发的关于注射用头孢哌酮钠舒巴坦钠（1:1）和注射用头孢哌酮钠舒 巴坦钠（2:1）的《药品补充申请批准通知书》【编号：2026B00587、 2026B00592、2026B00590、2026B00591】，以上两个药品共 4 个规 格通过仿制药质量和疗效一致性评价。现将有关情况公告如下： 哈药集团股份有限公司 关于所属企业药品通过仿制药一致性评价的公告 一、药品的基本情况 （一）注射用头孢哌酮钠舒巴坦钠（1:1） 药品名称：注射用头孢哌酮钠舒巴坦钠 剂型：注射剂 规格：1.0g（C25H27N9O8S2 0.5g 与 C8H11NO5S 0.5g） 1.5g（C25H27N9O8S2 0.75g 与 C8H11NO5S 0.75g） 上市许可持有人：哈药集团制药总厂 原药品批准文号：国药准字 ...

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. (哈药股份) announced that its subsidiary, Harbin Pharmaceutical Group Pharmaceutical Factory (哈药总厂), received approval from the National Medical Products Administration for two formulations of injectable cefoperazone sodium and sulbactam sodium, indicating successful completion of the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The company received approval for two formulations: injectable cefoperazone sodium and sulbactam sodium in two ratios (1:1 and 2:1) [1] - A total of four specifications for these drugs have passed the consistency evaluation [1]

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. (哈药股份) has received approval from the National Medical Products Administration for two formulations of injectable cefoperazone sodium and sulbactam sodium, indicating a significant advancement in its product portfolio and compliance with quality and efficacy standards for generic drugs [1] Group 1 - The company’s subsidiary, Harbin Pharmaceutical Group Pharmaceutical Factory, has been granted a "Drug Supplement Application Approval Notice" for two formulations of injectable cefoperazone sodium and sulbactam sodium [1] - The approved products include four specifications that have passed the consistency evaluation of quality and efficacy for generic drugs [1]

Core Viewpoint - Harbin Pharmaceutical Group has received approval from the National Medical Products Administration for two formulations of injectable cefoperazone sodium and sulbactam sodium, indicating a successful evaluation of the consistency of quality and efficacy for these generic drugs [1] Group 1 - The company has obtained a supplement approval notice for injectable cefoperazone sodium sulbactam sodium (1:1) and (2:1) [1] - A total of four specifications for these drugs have passed the consistency evaluation [1]

Group 1 - The company has received the drug registration certificate for the oral solution of protein succinyl iron, which will enhance its product variety and market competitiveness [1][3] - The drug is classified as a non-prescription medication for treating iron deficiency anemia caused by insufficient iron intake, absorption issues, chronic blood loss, and conditions during pregnancy and lactation [2] - The company has invested approximately RMB 4.851 million in the research and development of the protein succinyl iron oral solution project [2] Group 2 - The domestic annual sales for the protein succinyl iron oral solution are projected to be RMB 62.62 million in 2024, with RMB 49.034 million in sales recorded for the first three quarters of 2025 [2] - The retail sales for the same product are expected to reach RMB 11.4 million in 2024, with RMB 8.3 million in sales for the first three quarters of 2025 [2] - The approval of the drug registration certificate is expected to provide valuable experience for the company's future product development efforts [3]

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. (哈药股份) has received approval from the National Medical Products Administration for its oral solution of ferric succinate, indicating a significant advancement in its product portfolio aimed at treating iron deficiency anemia [1] Group 1: Product Approval - The oral solution of ferric succinate has been granted a drug registration certificate with the number 2026S00300 [1] - This product is classified as an over-the-counter medication [1] Group 2: Medical Indication - The oral solution is intended for the treatment of iron deficiency anemia, which can result from insufficient iron intake, absorption issues, chronic blood loss, and conditions related to pregnancy and lactation [1]

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. (哈药股份) has received approval from the National Medical Products Administration for its oral solution of ferric succinate, which is now registered as a non-prescription drug for treating iron deficiency anemia [1] Group 1 - The product, ferric succinate oral solution, is indicated for treating iron deficiency anemia caused by insufficient iron intake, absorption issues, chronic blood loss, and conditions related to pregnancy and lactation [1]