证券日报网讯 12月8日晚间，福安药业发布公告称，2025年12月7日，国家医保局、人力资源社会保障 部发布了《关于印发 （2025年）的通知》【医保发〔2025〕33号）】，药品名称：帕拉米韦注射液。 （文章来源：证券日报） ...

福安药业（300194）(300194.SZ)公告，据国家医保局、人力资源社会保障部发布《关于印发 <国家基本 医疗保险 生育保险和工伤保险药品目录="生育保险和工伤保险药品目录"> (2025年)的通知》，公司下 属子公司产品帕拉米韦注射液被纳入《国家医保药品目录》。 ...

智通财经APP讯，福安药业(300194.SZ)公告，据国家医保局、人力资源社会保障部发布《关于印发<国 家基本医疗保险、生育保险和工伤保险药品目录>(2025年)的通知》，公司下属子公司产品帕拉米韦注 射液被纳入《国家医保药品目录》。 ...

格隆汇12月8日丨福安药业(300194.SZ)公布，国家医保局、人力资源社会保障部发布了《关于印发<国 家基本医疗保险、生育保险和工伤保险药品目录>（2025年）的通知》【医保发〔2025〕33号）】，福 安药业（集团）股份有限公司下属子公司产品新纳入药品名称：帕拉米韦注射液。新版《国家医保药品 目录》将于2026年1月1日起正式执行，药品纳入《医保目录》将对相关产品销售有积极作用，但对公司 未来业绩的影响暂无法准确估计，药品未来销售情况受医药行业政策变动、市场环境变化等影响，具有 不确定性。 ...

福安药业(300194)12月8日公告，下属子公司产品帕拉米韦注射液新纳入2025年《国家医保药品目 录》，用于治疗甲型或乙型流行性感冒。 ...

Core Viewpoint - The company has a subsidiary that holds the production approval for Palivizumab injection, which is used for the treatment of influenza A and B. However, due to multiple factors such as centralized procurement policies and changes in the competitive market environment, the current sales volume of Palivizumab injection is very low, and it does not have a significant impact on the company's overall revenue and operating performance [1]. Group 1 - The company’s subsidiary possesses the production approval for Palivizumab injection [1] - Palivizumab injection is indicated for the treatment of influenza A and B [1] - Sales volume of Palivizumab injection is currently very low [1] Group 2 - The low sales volume is influenced by centralized procurement policies and market competition changes [1] - The current sales situation does not significantly affect the company's overall revenue [1] - The company's operating performance remains largely unaffected by the low sales of Palivizumab injection [1]

Group 1 - The company is developing a new product, Palivizumab injection, aimed at treating influenza A or B, specifically targeting the H3N2 subtype, which is a prevalent seasonal flu strain in humans [2] - The company confirmed that the Palivizumab injection is being researched as a next-generation product to address resistance to Oseltamivir and severe cases of influenza [2] - The company will continue to advance the progress of its research and development products [2]

Core Points - The National Organization for Drug Procurement has canceled the procurement qualification of Ningbo Dahongying Pharmaceutical's fluorouracil injection due to quality issues, placing the company and its contract manufacturer on a violation list, prohibiting them from participating in national drug procurement from October 15, 2025, to April 14, 2027 [1][5] - This incident highlights ongoing quality control issues within the pharmaceutical industry, despite existing regulations and oversight mechanisms [2][8] - The cancellation of procurement qualifications serves as a warning to other companies about the importance of maintaining drug quality to avoid losing market share and damaging brand reputation [2][8] Industry Impact - The fluorouracil injection, a widely used chemotherapy drug, had a market size of approximately $30 million in the U.S. and about 550 million yuan in China in 2023 [4] - The competitive landscape for fluorouracil injection saw seven companies successfully bid in the tenth national procurement, with Ningbo Dahongying's bid price being 2.97 yuan for a 10ml:0.25g specification [4] - The cancellation of procurement qualifications for multiple products indicates a broader trend of quality issues affecting various pharmaceutical companies, including Jiangxi Jingrui and Shanxi Yanghe [5][6] Regulatory Environment - The regulatory framework for drug procurement has been evolving, with the upcoming eleventh batch of national drug procurement set to impose stricter quality control measures, including requiring companies to have at least two years of experience in producing similar formulations [8][9] - The emphasis on quality in the procurement process is expected to benefit companies with stable production processes and strict quality controls, potentially raising the overall quality standards in the industry [9][10] Strategic Recommendations - Companies are encouraged to balance quality and cost-effectiveness by optimizing production processes, increasing R&D investment, expanding market reach, and establishing stable supply chains [10] - Engaging in national drug procurement with a focus on quality assurance and reasonable pricing strategies can help companies gain market share and build patient trust [10]

Core Points - The National Organization for Drug Procurement Office has announced the cancellation of the selection qualification for Ningbo Dayang Pharmaceutical Co., Ltd. for its fluorouracil injection, placing both Ningbo Dayang and Heilongjiang Fuhe Pharmaceutical Group Co., Ltd. on a "violation list" and suspending their eligibility to participate in national drug procurement from October 15, 2025, to April 14, 2027 [2][3] Group 1: Company Actions and Penalties - Ningbo Dayang Pharmaceutical was penalized for producing substandard fluorouracil injection, leading to the confiscation of illegal products and fines as per the Zhejiang Provincial Drug Administration's administrative penalty [2] - The announcement indicates that the main supply provinces for fluorouracil injection, where Ningbo Dayang is the primary supplier, will initiate a replacement procedure with backup suppliers taking over the supply responsibilities [3] Group 2: Industry Context - Fluorouracil injection is an anti-cancer drug included in the tenth batch of national drug procurement, with a winning bid price of 2.97 yuan for a 10ml:0.25g vial, supplied to provinces including Beijing, Zhejiang, Anhui, Guizhou, and Xinjiang [3] - Since 2025, the National Organization for Drug Procurement Office has repeatedly canceled the selection qualifications of multiple pharmaceutical companies in the tenth batch of procurement, indicating a trend of strict enforcement of compliance and quality standards in the industry [4][5][6]

Core Viewpoint - The article highlights the cancellation of the procurement qualification of Ningbo Dayang Pharmaceutical Co., Ltd. for its fluorouracil injection due to violations of quality standards, emphasizing the increasing scrutiny on drug quality in the national centralized procurement process [2][4]. Group 1: Company Overview - Ningbo Dayang Pharmaceutical, founded in 1956, is a comprehensive pharmaceutical company involved in manufacturing, research, and sales, and is currently controlled by Haier Shijie Biomedical Co., Ltd. since 2013 [3]. - Fluorouracil is a widely used first-generation antimetabolite chemotherapy drug, applicable in treating various cancers, including gastrointestinal, gynecological, head and neck, lung, liver, and bladder cancers [3]. Group 2: Procurement and Regulatory Actions - The National Organization for Drug Procurement Office announced the cancellation of Dayang Pharmaceutical's qualification for fluorouracil injection, which was part of the tenth batch of national centralized procurement, due to the production of substandard drugs [2][4]. - Dayang Pharmaceutical's bid price for fluorouracil injection was 2.97 yuan per 10ml (0.25g), which was relatively high compared to other bidders, as there were seven companies that won the bid [3]. - Since the implementation of the tenth batch of national drug procurement, there has been a trend of increased regulatory scrutiny on the production quality of selected drugs, with four companies, including Dayang Pharmaceutical, being disqualified due to quality issues [4][5]. Group 3: Industry Implications - The article indicates that three out of the four disqualified companies are classified as pure B-license enterprises, which lack production capabilities and rely on contract manufacturing [5]. - The regulatory challenges posed by the increasing participation of pure B-license enterprises in the bidding process highlight the need for stricter quality oversight in the pharmaceutical industry [5].