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津药药业:收到化学原料药上市申请批准通知书
Xin Lang Cai Jing· 2025-08-29 09:02
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]
中国医药上半年净利润2.94亿元;治疗不孕不育长效注射液获批
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]
津药药业股价下跌4.22% 子公司获批国内首仿滴眼液
Jin Rong Jie· 2025-08-27 19:22
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]
津药药业:子公司获得药品注册证书
Zheng Quan Ri Bao Wang· 2025-08-27 12:42
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]
破除垄断 为民监管——医药领域反垄断执法成效纪实
Zhong Guo Jing Ji Wang· 2025-08-27 09:54
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]
津药药业:“二氟泼尼酯滴眼液”取得注册证
Mei Ri Jing Ji Xin Wen· 2025-08-27 09:01
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]
津药药业(600488) - 津药药业股份有限公司关于参加2025年天津辖区上市公司投资者网上集体接待日活动的公告
2025-08-27 07:53
关于参加 2025 年天津辖区上市公司 投资者网上集体接待日活动的公告 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。 证券代码:600488 证券简称:津药药业 编号:2025-055 津药药业股份有限公司 2025 年 8 月 27 日 1 / 1 特此公告。 津药药业股份有限公司董事会 为进一步加强与投资者的互动交流,津药药业股份有限公司(以 下简称"公司")将参加由天津证监局指导、天津上市公司协会与深 圳市全景网络有限公司联合举办的"2025 年天津辖区上市公司投资 者网上集体接待日活动",现将有关事项公告如下: 本次活动将采用网络远程的方式举行,投资者可登录"全景路演" 网站(http://rs.p5w.net);或关注微信公众号(名称:全景财经); 或下载全景路演 APP,参与本次互动交流。活动时间为 2025 年 9 月 11 日(周四)15:00-17:00。 届时公司董事长徐华先生、总经理李书箱先生、独立董事边泓先 生、独立董事陈喆女士、首席财务官朱立延先生、董事会秘书刘博先 生将在线就公司 2025 ...
津药药业(600488) - 津药药业股份有限公司关于子公司获得药品注册证书的公告
2025-08-27 07:53
证券代码:600488 证券简称:津药药业 编号:2025-054 津药药业股份有限公司 关于子公司获得药品注册证书的公告 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。 近日,津药药业股份有限公司(以下简称"公司")子公司津药和平(天津)制 药有限公司(以下简称"津药和平")收到国家药品监督管理局核准签发的二氟泼尼 酯滴眼液(以下简称 "该药品"或"本品")的《药品注册证书》。现将相关情况公告 如下: 1 / 2 药品名称 二氟泼尼酯滴眼液 剂型 眼用制剂 注册分类 化学药品 3 类 药品注册标准编号 YBH19822025 规格 0.05%(5ml:2.5mg) 受理号 CYHS2101727 国 证书编号 2025S02532 药品批准文号 国药准字 H20255163 申请事项 药品注册(境内生产) 上市许可持有人 名称:津药和平(天津)制药有限公司 地址:天津开发区黄海路 221 号 生产企业 名称:津药和平(天津)制药有限公司 地址:天津开发区黄海路 221 号 审批结论 根据《中华人民共和国药品管理法》及有 ...
津药药业:子公司津药和平获二氟泼尼酯滴眼液药品注册证书
Xin Lang Cai Jing· 2025-08-27 07:44
Core Viewpoint - Tianjin Pharmaceutical Industry announced that its subsidiary, Tianjin Yaohe Pharmaceutical Co., Ltd., has received the drug registration certificate for Difluprednate Eye Drops from the National Medical Products Administration, marking it as the first generic version in China [1] Group 1: Product Development - The drug is primarily used for treating inflammation and pain related to eye surgeries [1] - The total research and development investment for this project has reached approximately 53.27 million yuan [1] Group 2: Market Potential - The projected global sales for Difluprednate Eye Drops are estimated to be 33 million USD in 2023 and 24 million USD in 2024 [1]
津药药业2025年半年报:净利润下滑超65% 反垄断罚单与主业承压拖累业绩
Core Viewpoint - Tianjin Pharmaceutical Industry (津药药业) reported significant pressure on its operating performance in the first half of 2025, with a net profit attributable to shareholders dropping by 65.28% year-on-year to 49.30 million yuan, primarily due to revenue contraction and a substantial antitrust fine [1][2]. Financial Performance - The company achieved operating revenue of 1.588 billion yuan, a decrease of 11.81% from 1.801 billion yuan in the same period last year, indicating challenges in market demand and sales capabilities [2]. - Total profit for the period was 100 million yuan, down 48.45% year-on-year, while the net profit attributable to shareholders was only 49.30 million yuan, a decline of 65.28% compared to 142 million yuan last year, highlighting a significant deterioration in profitability [2]. - Basic and diluted earnings per share were both 0.045 yuan, a decrease of 65.38% from 0.130 yuan in the previous year, which directly weakened shareholder returns [2]. Antitrust Fine Impact - On April 30, 2025, the Tianjin Market Supervision Administration issued an administrative penalty against the company for monopolistic behavior related to dexamethasone phosphate raw materials, resulting in a fine of 69.19 million yuan, which significantly impacted net profit [3]. - This fine was recorded as an extraordinary expense, revealing major deficiencies in the company's antitrust compliance and internal control systems, posing future compliance risks [3]. Operational Challenges - In response to performance pressures, the company has made adjustments in its sales strategy, transferring non-U.S. raw material business to Tianjin Pharmaceutical (Singapore) Co., Ltd. to leverage geographical and foreign exchange advantages, although market development and channel integration will take time [3]. - Cost-saving measures, such as collective procurement of packaging materials, have been implemented to achieve nearly 40 million yuan in cost reductions, but the impact on profit is limited due to revenue contraction [3]. Potential Risks - The company faces multiple potential risks, including fluctuations in raw material and energy prices, supply chain disruptions, and increased environmental compliance costs due to stricter VOCs regulations [4]. - Safety risks associated with hazardous chemicals used in production, as well as exchange rate fluctuations affecting export profits, particularly since over 60% of steroid hormone raw materials are exported, further complicate the operational landscape [4].