■ 证券代码：600062 证券简称：华润双鹤 公告编号：临2026－012 华润双鹤药业股份有限公司 关于全资子公司西安京西双鹤药业 有限公司平衡盐冲洗液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法律责任。 近日，华润双鹤药业股份有限公司(以下简称"公司")全资子公司西安京西双鹤药业有限公司(以下简 称"京西双鹤")收到了国家药品监督管理局(以下简称"国家药监局")颁发的平衡盐冲洗液(以下简称"该药 品")《药品注册证书》。现将相关情况公告如下： 一、药品注册证书主要内容 二、药品相关情况 平衡盐冲洗液为无菌电解质水溶液，适用于外科冲洗。 京西双鹤于2022年1月启动该药品的仿制药研发工作，于2024年4月26日向国家药监局提交上市许可申 请，于2024年5月21日获得受理通知书，并于2026年2月10日获得国家药监局批准上市。根据国家相关政 策规定，本次获得《药品注册证书》视同通过一致性评价。 截至本公告日，公司针对该药品累计研发投入为人民币365.31万元(未经审计)。 三、同类药品的市场状况 平衡盐冲 ...

Group 1: Product Matrix and Market Position - The company has established a clear and advantageous external product matrix, with significant exclusive and medical insurance advantages in key varieties. Approved products include: Loxoprofen Sodium Gel Patch, Ketoprofen Gel Patch, Anti-inflammatory Pain Relief Patch, Lidocaine Gel Patch, Strong Waist and Bone Strengthening Patch, and Daiwen Moxibustion Patch [2] - The Ketoprofen Gel Patch is a key exclusive product with significant market competitiveness, while the Daiwen Moxibustion Patch holds both traditional Chinese medicine exclusivity and medical insurance exclusivity, showcasing distinct advantages [2] Group 2: Brand Development Strategies - The company has implemented a series of systematic and innovative measures to enhance brand influence and market recognition, including expanding into retail pharmacies and online platforms [3] - A brand upgrade event was held on December 6, 2025, introducing the "JiuDian Pain Relief Expert" symbol and the slogan "Change to JiuDian for Pain Relief Patches," aimed at addressing consumer pain points and enhancing brand communication and market competitiveness [3] Group 3: Sales and Procurement Expectations - The 11th batch of national centralized procurement results will be executed nationwide starting February 2026, with procurement cycles lasting until December 31, 2028 [3] - The company is optimistic about the market prospects for the Ketoprofen Gel Patch, which was approved for listing in 2023 and successfully entered the national medical insurance directory [3] Group 4: Innovation in Drug Development - The company is undergoing a comprehensive transformation towards innovative drug research and development, utilizing a strategy of multiple R&D centers and various drug forms [4] - Two innovation drug R&D centers are being established in central and Yangtze River Delta regions, leveraging local clinical resources and cost advantages [4] - The company is focusing on various tumor and chronic disease indications, employing small molecule drugs, peptide drugs, PDC, and ADC formats [4] Group 5: New Drug Advantages - The newly introduced small molecule pain relief innovative drug YJ2301 is designed to overcome limitations of existing neurogenic pain medications, such as limited efficacy and significant side effects [4] - Clinical pre-research data for YJ2301 shows superior pain relief effects and the potential to address issues like drowsiness and tolerance, providing a new solution for neurogenic pain management [4]

Group 1 - The core announcement is that Yongtai Technology's wholly-owned subsidiary, Binhai Meikang Pharmaceutical Co., Ltd., has received the drug registration certificate for Lidocaine and Prilocaine Cream from the National Medical Products Administration [2] Group 2 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio in the pharmaceutical sector [2] - This development may lead to increased market opportunities and revenue growth for Yongtai Technology in the future [2]

Core Viewpoint - Yongtai Technology (002326.SZ) has received approval from the National Medical Products Administration for the registration of its compound drug, Ropivacaine and Lidocaine Cream, which is intended for local anesthesia in specific medical procedures [1] Group 1: Product Approval - Yongtai Technology's wholly-owned subsidiary, Binhai Meikang Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Ropivacaine and Lidocaine Cream by the National Medical Products Administration [1] - The cream is a compound formulation of Lidocaine and Ropivacaine, designed for local anesthesia in various situations [1] Group 2: Indications for Use - The cream is indicated for local anesthesia in procedures such as needle punctures (e.g., catheter insertion or blood sampling) [1] - It is also used for superficial surgical procedures, including those involving the genital mucosa and for cleaning/debridement of leg ulcers [1]

Core Viewpoint - Yongtai Technology (002326.SZ) announced that its wholly-owned subsidiary, Binhai Meikang Pharmaceutical Co., Ltd., has recently received the drug registration certificate for Lidocaine and Prilocaine Cream from the National Medical Products Administration [1] Group 1: Product Approval - The drug registration certificate pertains to a compound formulation of Lidocaine and Prilocaine, intended for local anesthesia in specific skin conditions [1] - Indications for the use of the cream include: 1. Needle punctures, such as catheter insertion or blood sampling; 2. Superficial surgical procedures, such as mucosal anesthesia before superficial surgery or infiltration anesthesia; and cleaning/debridement of leg ulcers [1]

Core Viewpoint - Yongtai Technology (002326.SZ) announced that its wholly-owned subsidiary, Binhai Meikang Pharmaceutical Co., Ltd., has received the drug registration certificate for Lidocaine and Prilocaine Cream from the National Medical Products Administration [1] Group 1 - The drug, Lidocaine and Prilocaine Cream, is a compound formulation of Lidocaine and Prilocaine [1] - It is indicated for local anesthesia in the following situations: 1. Needle punctures, such as catheter insertion or blood sampling; 2. Superficial surgical procedures, such as mucosal anesthesia before superficial surgery or infiltration anesthesia; and cleaning/debridement of leg ulcers [1]

Core Viewpoint - The company, Tibet Weixin Kang Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of Lidocaine and Dicaine Cream, which is intended for local anesthesia in adult skin surgeries [1][2]. Drug Basic Information - Drug Name: Lidocaine and Dicaine Cream - Dosage Form: Cream - Specification: Each gram contains 70mg of Lidocaine and 70mg of Dicaine - Application: Clinical trial approval - Acceptance Number: CYHL2500168 - Approval Conclusion: The clinical trial application meets the requirements for drug registration and is approved for use in local anesthesia for intact skin prior to adult skin surgeries [1]. Other Relevant Information - The drug was developed by Zars Company and was approved by the FDA in the U.S. on June 29, 2006, under the brand name Pliaglis [2]. - Currently, there are no domestic listings for this product, but four companies have received clinical trial approvals: Jiangsu Yingke Biological Pharmaceutical Co., Ltd., Zhejiang Funuo Pharmaceutical Co., Ltd., Beijing Nobot Biological Technology Co., Ltd., and Kedi Biopharmaceuticals (Wuxi) Co., Ltd. [2]. - The company has invested approximately RMB 8.9453 million in the research and development of this drug as of October 2025 [3]. - The total sales amount for similar products, including Compound Lidocaine Cream and Dapiprazole Cream, in urban public hospitals and county-level public hospitals in China was approximately RMB 422 million in 2024 [3].

Policy Developments - The National Health Commission will hold a press conference on November 27, 2025, to discuss the progress and effectiveness of grassroots medical and health services [1] Industry Initiatives - Beijing's Economic and Information Technology Bureau, along with six departments, has introduced measures to accelerate the promotion of artificial intelligence-assisted diagnostic technologies, including financial support of up to 50 million yuan for selected projects [2] Regulatory Approvals - Saikexide has obtained registration for three medical device products, enhancing its product range in the in vitro diagnostic field [3] - Xinhua Pharmaceutical has received a drug registration certificate for a compound local anesthetic cream, with an estimated sales revenue of 615 million yuan in 2024 [4] - Heng Rui Medicine has received approval for clinical trials of its innovative anti-tumor drug HRS-8364, with a cumulative R&D investment of approximately 21.65 million yuan [5] Capital Market Activities - Suzhou High-tech plans to sell a 47% stake in its medical device subsidiary for 604 million yuan [6] - Shanghai DeYin Technology has completed a Pre-A round financing of several million yuan, backed by listed company Songlin Technology [8] Industry News - Novartis China has responded to rumors of dissolving its county-level team, stating it will adjust its operational model while continuing to serve the county medical market [9] - Samsung Medical's subsidiary has been recommended as a candidate for a procurement project with a total expected amount of approximately 107 million yuan [10] Legal Matters - Foreign companies have filed a Section 337 investigation request against specific antibody-drug conjugates, alleging infringement of trade secrets, involving companies from the US, Netherlands, and China [11] Shareholder Actions - Bid Pharma's shareholder plans to reduce their stake by up to 0.16% between December 17, 2025, and March 16, 2026, due to funding needs [12]

Group 1 - Shandong Xinhua Pharmaceutical (000756) shares increased by over 4%, currently trading at 7.49 HKD with a transaction volume of 95.1843 million HKD [1] - The company received approval from the National Medical Products Administration for the registration of Lidocaine and Prilocaine Cream, which is expected to generate approximately 615 million CNY in sales for public medical institutions in China in 2024 [1] - The current season is seeing a rise in demand for flu medications such as Oseltamivir and Marbofloxacin, with sales of Oseltamivir increasing by 237% and Marbofloxacin by 180% over the past week [1] Group 2 - Xinhua Pharmaceutical is a significant global supplier of antipyretic and analgesic medications, with a product portfolio that includes Ibuprofen, Aspirin, and Meloxicam [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has seen its stock price increase by over 4%, currently trading at 7.49 HKD, following the approval of its drug registration certificate for a new compound anesthetic cream by the National Medical Products Administration of China [1] Company Summary - The newly approved drug, Lidocaine and Prilocaine Cream, is intended for local skin anesthesia and is projected to generate sales of approximately 615 million CNY in public medical institutions in China by 2024 [1] - Xinhua Pharmaceutical is a significant global supplier of antipyretic and analgesic medications, with a product portfolio that includes Ibuprofen, Aspirin, and Meloxicam [1] Industry Summary - The current season is marked by a surge in respiratory infectious diseases, leading to increased demand for antiviral medications such as Oseltamivir and Marbofloxacin, with sales growth rates of 237% and 180% respectively over the past week [1]