在成本收缩策略下，公司研发费用同比下降24.65%，至6317万元，但仍有3款新药获批上市，包括治疗 呼吸疾病的富马酸福莫特罗吸入溶液。 两大因素成为主要拖累。一方面，公司受药品集采、国际市场竞争加剧影响，核心产品销售收入与利润 空间持续承压，甾体激素类、氨基酸类等主力产品营收均同比下滑，其中氨基酸类产品收入降幅达 9.01%，其他品类收入下降22.09%（其中制剂收入下降22.01%）。另一方面，公司因反垄断事项收到天 津市市场监督管理委员会《行政处罚决定书》，因操控地塞米松磷酸钠原料药价格，被没收违法所得 4276.44万元、罚款2642.79万元，合计罚没款6919.24万元。该笔支出直接计入营业外支出，导致本期营 业外支出同比暴增31905.46%，进一步侵蚀利润。 经营活动现金流净额从去年同期的3.16亿元下降至2020万元，降幅达93.6%。应收账款激增92.6%，至 5.61亿元，占流动资产比例攀升至27%，显示销售回款效率恶化。公司解释称，除反垄断罚款的现金支 出外，下游客户延长付款周期、部分制剂产品进入集采后结算滞后共同加剧了资金压力。 南方财经8月26日电，津药药业（600488.SH）近 ...

Policy Developments - The Central Committee and State Council issued an opinion to improve the adjustment mechanism for the basic medical insurance drug catalog and to establish an innovative drug catalog for commercial health insurance [2] - The opinion aims to promote the sharing of high-quality medical resources and enhance the capacity of grassroots medical institutions [2] - The commercial health insurance sector is becoming a crucial lever for the high-quality development of commercial health insurance, helping to address the payment challenges for innovative drugs [3] Medical Device Approvals - DaAn Gene obtained a medical device registration certificate for six nucleic acid test kits for respiratory pathogens, expanding its product portfolio [5] - BGI Innovation received a medical device registration certificate for a human papillomavirus genotyping test kit, classified as Class III [6] - Shanghai Pharmaceuticals received approval for the production of Formoterol Fumarate inhalation solution, which is used for the maintenance treatment of chronic obstructive pulmonary disease [7] Corporate Transactions - Pilin Bio announced the resumption of trading after China National Pharmaceutical Group acquired 21.03% of its shares, changing the controlling shareholder [8] - China General Nuclear Power Corporation plans to inject 500 million yuan into its subsidiary for proton medical research and development [9] - Zhonghui Pharmaceutical completed two rounds of financing totaling nearly 50 million yuan, which will be used for the construction of a hollow microneedle medical device production base [10] Industry Developments - Dongxing Medical's subsidiary signed two contracts with Shanghai Jiao Tong University for synthetic biology technology development, totaling 6 million yuan [11] Regulatory Alerts - Huahai Pharmaceutical received a warning letter from the FDA regarding its production facility, which may affect future ANDA applications but will not significantly impact current performance [12]

Core Viewpoint - Shanghai Pharmaceuticals has received approval for the production of Formoterol Fumarate Inhalation Solution, which is intended for the maintenance treatment of chronic obstructive pulmonary disease (COPD) [1][2]. Group 1: Drug Information - The drug is classified as a Class 3 chemical drug and is registered under the approval number H20254361 [1]. - The formulation is an inhalation solution with a specification of 2ml:20μg [1]. - The drug is indicated for maintaining airway obstruction in COPD patients, including chronic bronchitis and emphysema, to be administered twice daily [2]. - The product was originally developed by Mylan Specialty L.P. and was first approved in the U.S. in May 2007 under the brand name PERFOROMIST [2]. - As of the announcement date, the company has invested approximately RMB 4.4055 million in the research and development of this drug [2]. - The projected procurement amount for Formoterol Fumarate Inhalation Solution in Chinese hospitals for 2024 is RMB 461.55 million [2]. Group 2: Market Impact - The approval of this drug is expected to enhance market share and competitiveness for Shanghai Pharmaceuticals, as new registered generic drugs will receive greater support in medical insurance and procurement [3]. - The experience gained from this approval will be valuable for the company in future generic drug applications [3].

Core Viewpoint - The company has reported its first-quarter financial results for 2025, highlighting significant developments in product approvals and strategic initiatives aimed at enhancing operational efficiency and shareholder returns [12][28]. Financial Data - The company achieved a revenue of 3.215 billion yuan and a net profit attributable to shareholders of 133 million yuan in 2024 [12]. - The company plans to distribute a cash dividend of 0.98 yuan per 10 shares for the 2024 fiscal year, totaling approximately 107 million yuan, maintaining a cash dividend ratio of 80.18% [15]. Product Approvals and Market Expansion - The company received approval for the active pharmaceutical ingredient (API) Fumarate Formoterol and the inhalation solution from the National Medical Products Administration, which is expected to enhance its market presence [5]. - The company’s Dexamethasone Sodium Phosphate API has been approved for sale in Brazil, which will aid in expanding its international market footprint [5]. - The company obtained a production license for special dietary foods covering 26 amino acids, enhancing its operational capabilities [5]. Research and Development - In 2024, the company invested 248 million yuan in R&D, representing 7.7% of its main business revenue, and achieved significant milestones in drug approvals [16]. - The company plans to focus on six key areas, including ophthalmology and dermatology, to enhance its product pipeline and market competitiveness [17]. Compliance and Governance - The company is committed to enhancing its compliance management systems and has implemented various measures to improve operational efficiency and risk management [18][22]. - The company has revised its governance documents to align with regulatory requirements and improve its response to public sentiment [22]. Investor Relations - The company emphasizes the importance of information disclosure and has actively engaged with investors through various channels, including regular reports and investor education initiatives [20][21]. - The company has received a B-level rating for information disclosure from the Shanghai Stock Exchange, reflecting its commitment to transparency [20].