津药药业(600488.SH)公告称，公司子公司津药和平收到国家药品监督管理局核准签发的复方氨基酸 （15）双肽（2）注射液的《药品注册证书》。该药品适用于不能口服或经肠道补给营养的患者，尤其 适用于中度至重度分解代谢状况的患者。津药和平在该项目上已累计投入研发费用约1888万元。根据米 内网数据，该药品2023年、2024年国内销售额分别为3.29亿元和2.34亿元。该药品注册证书的取得将对 公司业绩带来积极影响，但药品研发、生产和销售受政策、市场等因素影响，存在不确定性。 ...

Core Viewpoint - JYSW003 project by Tianjin Pharmaceutical Industry Co., Ltd. shows promising efficacy and safety for psoriasis treatment, with ongoing exploratory research [1] Group 1 - The JYSW003 project is an innovative drug initiative commissioned by Tianjin Pharmaceutical's innovation research institute [1] - Preliminary research results indicate significant drug efficacy and superior safety characteristics [1] - The company plans to establish an innovation research institute in 2024 to focus on drug design, discovery, and incubation [1] Group 2 - Current projects in the innovative drug pipeline are in the early exploratory research phase [1] - The company aims to enhance its product pipeline, accelerate diversified development, and concentrate resources on high-value products [1] - The strategy includes continuous project initiation to build product advantages and expand market space for optimized product structure [1]

Group 1 - The company has received the approval notice for the listing application of the chemical raw material drug Difluprednate from the National Medical Products Administration (NMPA) [1][3] - Difluprednate is a topical corticosteroid used to suppress inflammation caused by various irritants, primarily available in the form of eye drops for treating inflammation and pain related to eye surgeries [2][3] - The global sales figures for Difluprednate formulations are projected to be $49 million in 2023 and $41 million in 2024, indicating a potential market opportunity for the company [3] Group 2 - The approval of the raw material drug will enhance the company's product portfolio and leverage its integrated advantages in raw material and formulation production, aiding in business expansion [4] - The company has invested approximately 2.6 million yuan in the research and development of the Difluprednate raw material project [3]

证券代码：600488 证券简称：津药药业 编号：2025-056 津药药业股份有限公司 关于公司收到化学原料药上市申请批准通知书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，对公告的虚假 记载、误导性陈述或者重大遗漏负连带责任。 近日，津药药业股份有限公司（以下简称"公司"）收到国家药 品监督管理局（以下简称"国家药监局"）核准签发的二氟泼尼酯《化 学原料药上市申请批准通知书》。现将相关情况公告如下： 三、对上市公司的影响及风险提示 公司此次二氟泼尼酯原料药获得《化学原料药上市申请批准通知 书》，表明该原料药符合国家药品注册的有关规定要求，可销售至国 内市场，将进一步丰富公司的产品结构，充分发挥原料药制剂一体化 优势，有助于拓展公司业务领域。 由于医药产品的行业特点，该药品的投产及未来投产后在国内市 场的销售时间、销售规模及后续拓展进度具有不确定性，敬请广大投 资者谨慎决策，注意防范投资风险。 申请事项：境内生产化学原料药上市申请 审批结论：经审查，本品符合药品注册的有关要求，批准本品 生产，同意本品在关联制剂二氟泼尼酯滴眼液（CYHS2101727）中使 用。 二、药物相关信息 二氟泼尼酯 ...

Core Viewpoint - The company Tianyao Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Difluprednate, a topical corticosteroid drug that can inhibit inflammation caused by various irritants [1] Group 1: Product Information - Difluprednate is primarily available in the form of eye drops and is used to treat inflammation and pain associated with eye surgeries [1] - According to the IQVIA database, the global sales of Difluprednate formulations are projected to be $49 million in 2023 and $41 million in 2024 [1]

Policy Developments - The State Council aims to develop the China (Jiangsu) Pilot Free Trade Zone into a globally influential biopharmaceutical industry hub, with a plan that includes 18 key tasks for integrated innovation across the entire industry chain by 2030 [1] Drug Approvals - China Resources Double Crane announced that its subsidiaries received drug registration certificates for three products, which will enhance the company's product line and market competitiveness [2] - Tianyao Pharmaceutical's subsidiary received a drug registration certificate for a new eye drop product, which is expected to positively impact the company's domestic market expansion and performance [3] Financial Reports - China National Pharmaceutical Group reported a revenue of 17.076 billion yuan for the first half of 2025, a decrease of 6.71% year-on-year, with a net profit of 294 million yuan, down 16.19% [4] - Jiahe Meikang reported a revenue of 219 million yuan for the first half of 2025, a decline of 27.22%, resulting in a net loss of 116 million yuan [5] - Renfu Pharmaceutical reported a revenue of 12.064 billion yuan, a decrease of 6.20%, but a net profit increase of 3.92% to 1.155 billion yuan [6] Investment Activities - Tibet Pharmaceutical plans to invest 60 million USD in Accuredit Therapeutics Limited, acquiring a 40.82% stake, focusing on gene editing technologies [7] Industry Developments - The first long-acting injection for infertility treatment has been approved, providing a more efficient and convenient option for patients compared to traditional daily injections [8] - A study revealed a protein linked to infertility and cancer, suggesting potential new treatment avenues for both conditions [9] Shareholder Actions - Dabo Medical announced a plan for a shareholder to reduce their stake by up to 2% of the company's shares [10] - Kangchen Pharmaceutical's executive plans to sell up to 87,500 shares due to personal financial needs [11]

Group 1 - The stock price of Tianyao Pharmaceutical closed at 4.31 yuan on August 27, down 0.19 yuan or 4.22% from the previous trading day [1] - The company operates in the chemical pharmaceutical industry, focusing on the research, production, and sales of steroid hormone and amino acid raw materials and formulations [1] - Tianyao Pharmaceutical is recognized as a national high-tech enterprise and is a global leader in amino acid raw material manufacturing [1] Group 2 - On the evening of August 27, Tianyao Pharmaceutical announced that its subsidiary Tianyao Heping received approval from the National Medical Products Administration for the registration certificate of Difluprednate Eye Drops, which is the first generic version in China [1] - The drug is primarily used for treating inflammation and pain related to eye surgeries, with a cumulative R&D investment of approximately 53.27 million yuan [1] - According to IQVIA data, the global sales for this drug are projected to be 33 million USD in 2023 and 24 million USD in 2024 [1] Group 3 - On August 27, the net inflow of main funds into Tianyao Pharmaceutical was 7.69 million yuan, accounting for 0.16% of the circulating market value [1] - Over the past five days, the net inflow of main funds totaled 34.99 million yuan, representing 0.74% of the circulating market value [1]

Group 1 - The core point of the article is that Tianjin Pharmaceutical Co., Ltd. (津药药业) announced the approval of its subsidiary Tianjin Peace Pharmaceutical Co., Ltd. for the drug registration certificate of Difluprednate Eye Drops by the National Medical Products Administration [1] Group 2 - The approval signifies a significant milestone for the company in expanding its product portfolio in the pharmaceutical market [1] - Difluprednate is a corticosteroid used for the treatment of inflammation and pain associated with eye surgery, indicating potential market demand [1] - The registration certificate allows the company to market and sell the product, which could enhance its revenue streams [1]

Core Points - The Chinese government emphasizes that modernity is fundamentally linked to public health, with a focus on affordable and essential medications for the population [1] - The market regulatory authorities have intensified anti-monopoly enforcement in the pharmaceutical sector, resulting in significant price reductions for essential drugs [2][3] - Recent anti-monopoly cases have restored market competition and reduced both patient medication costs and insurance expenditures [3][4] Summary by Sections Anti-Monopoly Enforcement - The market regulatory authorities have taken strong actions against pharmaceutical monopolies, with penalties totaling 6.23 billion yuan in the first half of the year [4] - Specific cases include the price manipulation of dexamethasone phosphate sodium, where the price surged from 8,000 yuan per kilogram to 13,000 yuan, leading to a 282-fold increase in the injection price [2][3] - The authorities have implemented a "punishment to individuals" approach, holding both companies and responsible individuals accountable for anti-competitive practices [5] Market Impact - The crackdown on monopolistic practices has led to a nearly 94% price reduction for dexamethasone phosphate sodium injection, from 7.2 yuan to 0.45 yuan [2][3] - The enforcement actions have also addressed other critical drugs, ensuring their availability and affordability for patients [3][4] Regulatory Framework - The market regulatory authorities are developing clearer anti-monopoly guidelines for the pharmaceutical sector, with a focus on enhancing compliance and preventing future violations [6][7] - The shift from punitive measures to proactive compliance strategies aims to foster a competitive environment that benefits public health [6][7] Industry Response - Pharmaceutical companies are increasingly recognizing the importance of compliance with anti-monopoly regulations as essential for their survival and competitiveness [7] - Training programs are being implemented to enhance awareness and understanding of anti-monopoly laws among industry professionals [7]

Group 1 - Tianjin Pharmaceutical Industry announced that its subsidiary, Tianjin He Ping Pharmaceutical Co., Ltd., received the drug registration certificate for Difluprednate Eye Drops from the National Medical Products Administration [1] - The product is officially named "Difluprednate Eye Drops" [1] Group 2 - The pet industry is experiencing significant growth, with a market size of 300 billion yuan, leading to a surge in stock prices for related listed companies [1]