证券日报网讯 9月12日晚间，诚意药业发布公告称，近日，公司收到国家药品监督管理局核准签发的 《药品补充申请批准通知书》，公司生产的盐酸多巴酚丁胺注射液已通过仿制药质量和疗效一致性评 价。 （编辑 楚丽君） ...

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for its supplementary application, confirming that its product, Dobutamine Hydrochloride Injection, has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Dobutamine Hydrochloride Injection, is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome following cardiac surgery, serving as a short-term supportive treatment [1]

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for its supplemental drug application, indicating that its product, Dobutamine Hydrochloride Injection, has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Dobutamine Hydrochloride Injection, is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease [1] - The drug is also indicated for short-term support treatment in cases of low cardiac output syndrome following cardiac surgery [1]

诚意药业9月12日公告，近日，公司收到国家药品监督管理局核准签发的《药品补充申请批准通知 书》，公司生产的盐酸多巴酚丁胺注射液已通过仿制药质量和疗效一致性评价。盐酸多巴酚丁胺注射液 主要用于器质性心脏病时心肌收缩力下降引起的心力衰竭，包括心脏直视手术后所致的低排血量综合 征，作为短期支持治疗。 ...

Group 1 - The company announced that its product, Dopamine Hydrochloride Injection, has passed the consistency evaluation for generic drug quality and efficacy [1] - This drug is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome after cardiac surgery, serving as a short-term supportive treatment [1] - As of the announcement date, there are a total of 31 manufacturers that have passed the consistency evaluation for Dopamine Hydrochloride Injection by the National Medical Products Administration [1]

Group 1 - Shanghai Municipal Medical Procurement Management Office has suspended the procurement qualifications for two drugs due to non-compliance with price adjustment requirements: hydrochloride dobutamine injection produced by Anhui Changjiang Pharmaceutical Co., Ltd. and hydrochloride arginine injection produced by Jilin Huinan Changlong Biochemical Pharmaceutical Co., Ltd [1] - Both drugs are classified as shortage drugs, with multiple companies having obtained approval numbers for these products in China [1] - The national average price for hydrochloride dobutamine injection (2ml:20mg) is reported at 3.53 yuan per unit, while hydrochloride arginine injection (20ml:5g) is at 11.68 yuan per unit [1] Group 2 - The management mechanism for shortage drugs in China is improving, with the State Council issuing opinions in 2019 to ensure the supply and price stability of these drugs [2] - The average delivery rate for drugs on the national shortage list has increased from approximately 60% before 2019 to 90% currently [2] - New issues have emerged, including some companies creating artificial shortages to justify price increases, particularly at the local level [2] Group 3 - In August 2024, several national departments issued a notice to strengthen monitoring of production reserves for shortage drugs and those selected for centralized procurement [3] - A total of 109 shortage drug formulations, 60 raw materials, and 240 nationally selected drugs are under production reserve monitoring, with dynamic adjustments to the monitoring list [3] - The National Medical Insurance Administration has issued guidelines for risk management of shortage drug prices, focusing on price information disclosure, analysis, and monitoring [3]

Core Viewpoint - The suspension of procurement qualifications for two critical shortage drugs, Dobutamine Hydrochloride Injection and Arginine Hydrochloride Injection, due to failure to reduce prices, highlights the ongoing challenges in ensuring supply and stabilizing prices in the shortage drug market [1][2][10]. Group 1: Drug Details - Dobutamine Hydrochloride Injection, produced by Anhui Changjiang Pharmaceutical, is essential for treating acute heart failure and is packaged in 2ml:20mg vials [3][4]. - Arginine Hydrochloride Injection, produced by Jilin Province Huinan Changlong Biochemical Pharmaceutical, is crucial for treating hepatic encephalopathy and is packaged in 20ml:5g vials [3][4]. - The average national price for Dobutamine Hydrochloride Injection is reported at 3.53 yuan per unit, while Arginine Hydrochloride Injection is at 11.68 yuan per unit [9]. Group 2: Market Dynamics - The recent price increases for shortage drugs, including the significant rise in the price of the rare disease drug Hydrocortisone Acetate Tablets, reflect ongoing supply and demand imbalances, regulatory challenges, and regional price disparities [2][10][12]. - The production of Dobutamine Hydrochloride Injection is not limited to Anhui Changjiang Pharmaceutical; other companies like Hainan Puli Pharmaceutical and Shandong Xinhua Pharmaceutical have also entered the market, enhancing competition [5][6]. - The procurement suspension serves as a warning to pharmaceutical companies that they must consider drug accessibility and price rationality in their pricing strategies to avoid market constraints [9][11]. Group 3: Regulatory Environment - The regulatory landscape for shortage drugs has evolved from self-pricing to risk management, with recent policies allowing companies to set reasonable prices while emphasizing the need to prevent unreasonable price hikes and monopolistic practices [11][12]. - Various regions, including Chongqing and Guangdong, are exploring centralized procurement for shortage and emergency drugs to stabilize prices and ensure supply [12].

Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for its product, Dopamine Hydrochloride Injection, which is expected to enhance the company's product line and market competitiveness [1][2]. Group 1: Drug Registration Details - The Drug Registration Certificate pertains to Dopamine Hydrochloride Injection, classified as a Class 3 chemical drug and a prescription medication [1][2]. - The product specifications include a dosage form of injection with a concentration of 100 mg in a 5 ml vial [1]. - The approval number for the registration is CYHS2303423, and the certificate number is 2025S01492 [1]. Group 2: Market Context and Financial Impact - The Dopamine Hydrochloride Injection is used for treating heart failure due to decreased myocardial contractility in organic heart disease, with a reported sales figure of 444 million RMB in 2024 [2]. - The company has invested approximately 7 million RMB in research and development for this product as of the announcement date [2]. - The acquisition of the Drug Registration Certificate is not expected to have a significant impact on the company's recent operating performance [2]. Group 3: Company Development - The company has obtained a total of 7 production licenses and 1 clinical license in 2025 [2]. - The approval of the Drug Registration Certificate signifies that the product has passed the consistency evaluation of generic drug quality and efficacy [2].

Core Viewpoint - The article discusses the impact of the recent drastic price cuts in the pharmaceutical industry, particularly focusing on the implications of the tenth batch of centralized procurement and the challenges faced by companies involved in the production of generic drugs [1][2]. Group 1: Centralized Procurement and Price Cuts - The tenth batch of centralized procurement has led to unprecedented price cuts, with some drugs like the injection of isopropyl phenol being bid at extremely low prices, raising concerns about quality and sustainability [2][4]. - The price of isopropyl phenol injection was bid at 0.22 yuan per unit, a 92.36% drop from the highest effective bid of 2.8805 yuan, highlighting the aggressive competition among 36 companies [4][5]. - The involvement of B-class pharmaceutical companies, which often outsource production and have minimal investment in R&D, has increased significantly, leading to a more competitive and potentially unstable market environment [10][11]. Group 2: Regulatory Challenges and Company Responses - Two companies, Haimeizhisun and Sichuan Taiji, faced penalties for failing to meet quality standards, resulting in an 18-month suspension from national procurement, indicating the regulatory scrutiny in the industry [2][3][4]. - The rapid increase in B-class companies, from 140 in January 2021 to 1172 by November 2023, reflects a shift in the industry where many companies prioritize low-cost production over quality assurance [10][11]. - The article notes that many B-class companies lack adequate quality management, leading to potential risks in drug production and compliance with regulatory standards [11][12]. Group 3: Market Dynamics and Competitive Pressures - The intense competition has forced companies to shorten drug development cycles, with some projects being completed in as little as 12 months, raising concerns about the thoroughness of research and development [18][19]. - Companies are increasingly focusing on cost control, with a shift towards using domestic raw materials to reduce expenses, reflecting the pressure to maintain profitability amid price cuts [21][22]. - The article highlights a trend where companies are reducing R&D budgets and personnel, leading to a decline in innovation and a potential long-term impact on the industry [22][23].

凤凰网《风暴眼》出品 文｜玲子 2024 年底，北方一家制药公司的办公室里，几位研发、采购人员围坐一圈，在稿纸上、白板上疾笔写下一串串数字。 3 分钱 / 片的阿司匹林肠溶 片、 0.22 元 / 支的间苯三酚注射液，按照理论成本，无论换多少种计算方法，他们也算不出这个价格。此时，第十批集采的中标价刚刚出炉，整个 医药圈都骚动起来。 "至少需要五六毛！"有人把笔一搁，最后一轮演算，成本价最多还是只能压到这里。研发主管郭青沉思片刻，试图给出合理解释："估计是为了打出 品牌"。马上有人附和："如果企业技术很厉害，应该有更好的方式控制成本吧……" 郭青在仿制药研发领域摸爬滚打了七年，经手过 50 余个研发项目。他所在的公司曾参与集采竞标，有几款产品顺利中标。通常，他会遇到两三毛钱 的压价，觉得这在预期范围之内，规模效应带来的持续订单和利润，与暂时的让价相比，总是更有诱惑力的。但第十批集采的激烈厮杀，他却前所未 见。 而近期，就在第十批集采落地前夕，饱受争议的超低价中标药间苯三酚注射液忽然被曝出不符合要求，两家涉事药企遭同步重罚 —— 委托方四川海 梦智森生物制药有限公司（下称"海梦智森"）与受托方太极集团四川太极制 ...