近日，津药药业股份有限公司（以下简称"公司"）收到天津市药品监督管理局签发的《药品GMP符合 性检查告知书》（编号：2025011），现将相关信息公告如下： 一、 基本情况 本公司董事会及全体董事保证本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个别及连带责任。 （二）涉及主要产品的市场情况 ■ 企业名称：津药药业股份有限公司 检查地址：天津开发区西区新业九街19号 检查范围：1.原料药(泼尼松)，生产车间:107车间，生产线:泼尼松生产B线；2.原料药(甲泼尼龙)，生产 车间:113车间，生产线:甲泼尼龙生产B线；3.原料药(氢化可的松琥珀酸钠)，生产车间:106车间，生产 线:氢化可的松琥珀酸钠生产线;4.原料药(富马酸福莫特罗)，生产车间:108车间，生产线:富马酸福莫特 罗生产线。 检查时间：2025年05月13日-2025年05月16日 检查依据：《药品生产质量管理规范》(2010年修订) 检查结论：符合要求 二、其他相关情况 （一）本次检查所涉及生产线及主要产品情况 ■ 注: 1.以上部分数据来源为国家药品监督管理局官方网站； 2.上述统计结果可能不 ...

Core Viewpoint - Tianjin Pharmaceutical Industry (津药药业) has received a GMP compliance inspection notice from the Tianjin Drug Administration, indicating that its production facilities for certain raw materials meet regulatory requirements, which is expected to support stable production capacity and leverage the integrated advantages of raw materials and formulations [2] Group 1 - The company received a GMP compliance inspection notice for its production facilities related to raw materials including prednisone, methylprednisolone, hydrocortisone sodium succinate, and formoterol fumarate [2] - The inspection concluded that the production facilities meet the required standards, which is beneficial for maintaining stable production capacity [2] - The integrated advantages of raw materials and formulations will help the company meet market demand [2] Group 2 - Future sales of the products may be influenced by changes in the market environment, indicating potential uncertainties [2]

Core Viewpoint - AstraZeneca and Merck have announced that the National Medical Products Administration (NMPA) has approved the use of the PARP inhibitor Olaparib in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer carrying germline or somatic BRCA mutations [1] Group 1: Approval and Clinical Data - The NMPA's approval is based on the results of the PROpel Phase III trial, which included global and Chinese cohort subgroup analyses [1] - Data from the global cohort of patients with BRCA mutations showed a significant improvement in imaging progression-free survival with the combination of Olaparib and Abiraterone compared to Abiraterone monotherapy [1] - Although the sample size of the Chinese cohort was small and interpretation was limited, the study data also indicated improvements consistent with global cohort trends, with no new safety issues identified [1] Group 2: Expert Commentary - Professor Ye Dingwei, a leading researcher of the PROpel study in China, emphasized that patients with BRCA mutation metastatic castration-resistant prostate cancer have poor prognoses and unmet clinical needs [1] - He stated that the PROpel study results allow for earlier use of Olaparib in treatment, improving patient outcomes and highlighting the potential of this innovative therapy to become a new treatment standard [1] Group 3: Company Strategy - Dr. He Jing, AstraZeneca's Global Senior Vice President and Head of Global R&D in China, expressed excitement over the PROpel study results and indicated that the company will continue to leverage both in-house research and external collaborations to enrich its pipeline for the benefit of more cancer patients [1]

Core Viewpoint - Merck has received approval from the National Medical Products Administration of China for its PARP inhibitor, Olaparib, in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) [1] Group 1 - The approval of this combination therapy will provide advanced treatment options for more prostate cancer patients [1]

Group 1 - Merck announced that the National Medical Products Administration of China has officially approved its PARP inhibitor, Lapatinib (Olaparib), in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) [1]

Core Viewpoint - Merck has received approval from the National Medical Products Administration of China for its PARP inhibitor, Lynparza (olaparib), in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline or somatic BRCA mutations [1] Group 1 - The approval is specifically for adult patients with mCRPC who have either germline BRCA mutations (gBRCAm) or somatic BRCA mutations (sBRCAm) [1] - This combination therapy represents a significant advancement in the treatment options available for mCRPC patients in China [1] - The collaboration between Merck and AstraZeneca highlights the ongoing efforts to enhance cancer treatment through innovative drug combinations [1]

Core Viewpoint - The approval of the clinical trial for HDM2005 marks a significant advancement in the company's drug development process, enhancing its core competitiveness in the oncology treatment sector [1] Group 1: Clinical Trial Approval - The company's wholly-owned subsidiary, Hangzhou Sino-American East Pharmaceutical Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration for HDM2005 [1] - HDM2005 is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), used in combination with rituximab, cyclophosphamide, doxorubicin (or epirubicin), and prednisone (R-CHP) for treating previously untreated diffuse large B-cell lymphoma (DLBCL) [1] Group 2: Clinical Trial Progress - The drug has received approval for clinical trials in both China and the United States, with indications for advanced malignancies [1] - Currently, the drug is in the I phase of clinical trials in China, having completed the first four dose escalations without any dose-limiting toxicities (DLT), and is now in the fifth dose escalation stage [1] Group 3: Regulatory Milestones - In February 2025, HDM2005 received orphan drug designation from the FDA for the indication of mantle cell lymphoma (MCL) [1] - The approval of this clinical trial is a crucial step in the product's development, which is expected to strengthen the company's position in the oncology market [1]