Group 1 - The core point of the article is that Tianyao Pharmaceutical (600488) announced the approval of its subsidiary Tianyao Heping for the injection of compound potassium hydrogen phosphate by the National Medical Products Administration, indicating that the product has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2 - The approval signifies a significant milestone for the company, enhancing its product portfolio in the pharmaceutical market [1] - The successful completion of the consistency evaluation may lead to increased market competitiveness and potential revenue growth for the company [1] - This development reflects the ongoing regulatory support for generic drugs in the industry, which may encourage further investments and innovations [1]

Core Viewpoint - Tianyao Pharmaceutical (600488.SH) announced that its subsidiary Tianyao Peace (Tianjin) Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration for the potassium hydrogen phosphate injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval - The potassium hydrogen phosphate injection is a phosphorus supplement used to correct hypophosphatemia in adults and children when oral or enteral nutrition is not feasible, insufficient, or contraindicated [1] - The product is also indicated for parenteral nutrition in adults and children under similar conditions [1] Group 2: Research and Development - In July 2024, Tianyao Peace submitted a supplementary application for the consistency evaluation of the potassium hydrogen phosphate injection to the National Medical Products Administration, which has been accepted [1] - The cumulative R&D investment in the potassium hydrogen phosphate injection project by Tianyao Peace is approximately 9.21 million yuan [1]

复合磷酸氢钾注射液作为磷补充剂，主要用于：(1)当口服或肠内营养无法进行、不足或有禁忌时，用 于纠正成人和儿童患者的低磷血症;(2)当口服或肠内营养无法进行、不足或有禁忌时，用于成人和儿童 患者的肠外营养。2024年7月津药和平向国家药品监督管理局药品审评中心提交复合磷酸氢钾注射液一 致性评价补充申请并获受理。截至目前，津药和平在复合磷酸氢钾注射液项目上累计研发投入约921万 元。 智通财经APP讯，津药药业(600488.SH)发布公告，近日，公司子公司津药和平(天津)制药有限公司(简 称"津药和平")收到国家药品监督管理局核准签发的复合磷酸氢钾注射液的《药品补充申请批准通知 书》，批准本品通过仿制药质量和疗效一致性评价。 ...

Core Insights - The company reported a significant decline in revenue and net profit for the first three quarters of 2025, with revenue at 2.23 billion yuan, down 13.2% year-on-year, and net profit at 69.54 million yuan, down 62.8% [1] - The sharp drop in net profit is attributed to a hefty administrative fine of 69.19 million yuan due to monopolistic practices, alongside reduced sales prices and volumes due to intensified market competition and changes in drug procurement policies [1][2] - The company has faced multiple penalties for monopolistic behavior in recent years, indicating systemic issues in compliance and corporate governance [2][3] Financial Performance - For Q3 2025, the company experienced a 16.6% year-on-year decline in revenue and a 54.7% drop in net profit [1] - The net cash flow from operations for the first three quarters was only 33.39 million yuan, a staggering decrease of 92.7% compared to the previous year, primarily due to extended payment cycles from hospitals and the payment of the aforementioned fine [2] Business Challenges - The company's product line includes steroid hormones and amino acid raw materials, but faces significant pricing pressure on core products due to normalized bulk procurement and heightened industry competition [3] - Frequent penalties for monopolistic practices not only lead to direct financial losses but also damage the company's brand image and market trust [3] - The company must address deeper operational and governance risks, focusing on compliance, cash flow quality, and rebuilding competitive advantages in a tightening regulatory environment [3]

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酒石酸布 托啡诺注射液（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： | 药品名称 | 酒石酸布托啡诺注射液 | | | --- | --- | --- | | 剂型 | 注射剂 | | | 注册分类 | 化学药品 3 类 | | | 药品注册标准编号 | YBH26532025 | | | 规格 | 1ml：1mg 2ml：4mg | | | 受理号 | CYHS2302751 CYHS2302752 | | | 证书编号 | 2025S03254 2025S03255 | | | 药品批准文号 | 国药准字 国药准字 H20255802 | H20255803 | | 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 号 221 | | | 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 ...

Core Viewpoint - Tianjin Pharmaceutical Industry Co., Ltd. (津药药业) announced that its subsidiary, Tianjin Pharmaceutical Peace Co., Ltd. (津药和平), has received the drug registration certificate for Butorphanol Tartrate Injection from the National Medical Products Administration (NMPA) [1] Group 1: Product Development - Butorphanol Tartrate Injection is classified as a second-class psychoactive drug under the national regulations and is indicated for the treatment of various cancer-related pain and postoperative pain [1] - The application for the drug's domestic production registration was submitted to the NMPA in October 2023 and was accepted [1] - The drug registration certificate was officially granted in October 2025, with a total research and development investment of approximately 22 million yuan (around 3.1 million USD) in the Butorphanol Tartrate Injection project to date [1]

Core Viewpoint - Tianyao Pharmaceutical (600488) announced the approval of its subsidiary Tianyao Heping for the drug registration certificate of Butorphanol Tartrate Injection by the National Medical Products Administration, indicating a significant advancement in its product portfolio aimed at treating various cancer-related and postoperative pain [1] Company Summary - Tianyao Pharmaceutical's subsidiary Tianyao Heping has received regulatory approval for Butorphanol Tartrate Injection, which is intended for the treatment of cancer pain and postoperative pain [1]

Core Viewpoint - Tianyao Pharmaceutical (600488.SH) announced that its subsidiary Tianyao Heping received the drug registration certificate for Butorphanol Tartrate Injection from the National Medical Products Administration, which is expected to enhance the company's product pipeline in the narcotic and psychotropic drug sector and positively impact its operating performance [1] Summary by Category Product Approval - The Butorphanol Tartrate Injection is classified as a second-class psychotropic drug, indicated for the treatment of various cancer-related pain and postoperative pain [1] Investment and Development - Tianyao Heping has invested approximately 22 million yuan in the research and development of this product [1] Market Potential - According to data from Minet, the domestic sales revenue for Butorphanol Tartrate Injection is projected to be 1.965 billion yuan in 2023 and 1.899 billion yuan in 2024 [1]

Core Viewpoint - Tianjin Pharmaceutical Industry Co., Ltd. (津药药业) announced that its subsidiary, Tianjin Yaohe Pharmaceutical Co., Ltd. (津药和平), has received the drug registration certificate for Butorphanol Tartrate Injection from the National Medical Products Administration (NMPA) [1] Company Summary - The main component of Butorphanol Tartrate Injection is Butorphanol Tartrate, classified as a second-class psychoactive drug under the national regulations on narcotic and psychotropic drugs [1] - The drug is indicated for the treatment of various cancer-related pain and postoperative pain [1] - In October 2023, Tianjin Yaohe submitted the application for domestic production drug registration to the NMPA, which was accepted [1] - The drug registration certificate was officially granted in October 2025 [1] - To date, Tianjin Yaohe has invested approximately 22 million yuan in the research and development of Butorphanol Tartrate Injection [1]

Core Viewpoint - Tianjin Pharmaceutical Industry (津药药业) announced that its subsidiaries, Tianjin Peace Pharmaceutical Co., Ltd. and Hubei Tian Pharmaceutical Co., Ltd., participated in the 11th national centralized drug procurement organized by the National Organization for Drug Procurement Office, with seven products expected to be selected for this procurement [1] Group 1 - The subsidiaries involved in the procurement are Tianjin Peace Pharmaceutical and Hubei Tian Pharmaceutical [1] - The seven products proposed for selection include Betamethasone Sodium Phosphate Injection, Ambroxol Hydrochloride Injection, Metoclopramide Hydrochloride Injection, Theophylline Injection, Isoniazid Injection, Adrenaline Hydrochloride Injection, and Famotidine Injection [1]