Core Viewpoint - Recently, China Resources Double Crane (华润双鹤) announced that its subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., received the drug registration certificate for Oxcarbazepine tablets from the National Medical Products Administration (NMPA), which is expected to enhance the company's product line and market competitiveness [1][2]. Group 1: Drug Registration and Market Potential - The Oxcarbazepine tablets are indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 and above [1]. - The research and development of this generic drug began in August 2021, with the application for market approval submitted in July 2024 and the approval expected in November 2025 [1]. - The global sales of Oxcarbazepine tablets are projected to reach $351 million in 2024, with the brand "Trileptal" accounting for $162 million of that total [1]. Group 2: Competitive Landscape - In the Chinese market, there are 10 approved manufacturers of Oxcarbazepine tablets, with 9 having passed or deemed to have passed the consistency evaluation [2]. - The total sales of Oxcarbazepine tablets in the domestic medical and retail markets are estimated at 738 million yuan in 2024, with Novartis holding a market share of 74.17%, followed by Beijing Four Ring Pharmaceutical at 13.78% and Wuhan Renfu Pharmaceutical at 11.85% [2]. Group 3: Company Overview and Financial Performance - China Resources Double Crane operates 24 subsidiaries and employs 13,000 staff, focusing on new drug research and development, formulation production, drug sales, and active pharmaceutical ingredient production [2]. - The company reported a third-quarter revenue of 2.542 billion yuan, a year-on-year decrease of 2.96%, while net profit increased by 6.71% to 374 million yuan [3]. - For the first three quarters of 2025, the total revenue was 8.283 billion yuan, down 3.1% year-on-year, with net profit declining by 3.4% to 1.35 billion yuan [3]. Group 4: Recent Drug Approvals - Recently, the company has received multiple drug registration certificates for its subsidiaries, including Bosentan dispersible tablets for pulmonary arterial hypertension and a new injection for acute coronary syndrome [4].

Core Viewpoint - China Resources Double Crane Pharmaceutical Co., Ltd. has received a drug registration certificate for Oxcarbazepine tablets from the National Medical Products Administration, indicating a significant regulatory milestone for the company [2]. Group 1 - The announcement was made on the evening of November 18, highlighting the company's progress in drug registration [2]. - The drug registration certificate was issued to Hunan Xiangzhong Pharmaceutical Co., Ltd., a subsidiary of China Resources Double Crane [2].

Group 1 - Shengxin Lithium Energy signed a framework agreement with Huayou Cobalt for the procurement of 221,400 tons of lithium salt products over five years [1] - Wehua New Materials' subsidiary plans to acquire 70% of He Yutai for 154 million yuan [1] - Xiamen Tungsten plans to invest 600 million yuan to establish a wholly-owned subsidiary for a project with an annual production capacity of 50,000 tons of high-performance battery materials [1][2] Group 2 - *ST Songfa's subsidiary signed a shipbuilding contract worth approximately 200-300 million USD for two VLCCs [3] - Hailianxun's stock will resume trading on November 19 after the end of the acquisition request period [5] - Yunnan Energy Investment obtained the development rights for a 25,000 kW wind power project [7] Group 3 - China Resources Double Crane's subsidiary received a drug registration certificate for Oxcarbazepine tablets [8] - Jincheng Pharmaceutical's subsidiary received a CEP certificate for glutathione raw materials [9] - Jinkong Electric plans to transfer 51% of Tongying Thermal Power to an affiliate for 266 million yuan [9] Group 4 - Clean Technology's subsidiary won a bid for a waste incineration power generation project in Thailand with a total investment of up to 4.27 million USD [12] - Tonglian Precision's shareholders set the transfer price for shares at 43.67 yuan each [13] - Hu Nong Commercial Bank's executives collectively purchased 259,100 shares of the company [13] Group 5 - Huatai Medical's subsidiary obtained a medical device registration certificate for polyethylene embolization microspheres [13] - Fosun Pharma's subsidiary's drug registration application was accepted by the National Medical Products Administration [13] - Xianhui Technology signed contracts worth 796 million yuan with multiple subsidiaries of CATL [15] Group 6 - Ningbo Fangzheng signed a strategic cooperation agreement with Huaxiang Qiyuan for the development of various robotic technologies [15] - Ruida Futures' vice president resigned for personal reasons [16] - Samsung Medical is expected to win contracts worth approximately 125 million yuan from the State Grid [17] Group 7 - Tianjin Pharmaceutical's injectable methylprednisolone sodium succinate received registration from Panama's Ministry of Health [19] - Yaxing Anchor Chain plans to invest up to 300 million yuan in a project for deep-sea floating equipment [20] - Zejing Pharmaceutical's clinical trial for ZG006 was approved by the National Medical Products Administration [21] Group 8 - Weiye Co., Ltd. won a bid for a project worth approximately 2.086 billion yuan [23] - Ruimao Tong plans to sell 8.5794 million repurchased shares [25] - Guangge Technology's shareholders plan to reduce their holdings by up to 3.99% [26] Group 9 - Hongsheng Development signed a debt restructuring contract for a total of 2 billion yuan [27][28] - Yatai Co., Ltd. plans to reduce its holdings by up to 1% [30] - Dexin Technology's shareholder plans to reduce its holdings by up to 1% [31] Group 10 - Yaji International's shareholder plans to reduce its holdings by up to 1% [33] - Shenzhen New Star's subsidiary received approval for trial production of a boron trifluoride project [35] - Shengyi Electronics plans to raise up to 2.6 billion yuan through a private placement [36]

Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of ensuring the quality and safety of drugs selected through centralized procurement, highlighting the need for strict compliance and quality control by selected companies [1] Group 1: Regulatory Oversight - The NMPA will implement comprehensive production inspections and product sampling for selected drugs, ensuring full coverage in regulatory practices [1] - Regulatory bodies will optimize work mechanisms and explore risk monitoring to enhance oversight and prevent potential risks [1] Group 2: Company Responsibilities - Selected companies are required to strictly fulfill their primary responsibilities, focusing on quality control, drug vigilance, and information traceability [1] - Continuous compliance in production practices is mandated for companies involved in centralized procurement [1]

| 药品名称 | 药品通用名称：奥卡西平片 英文名/拉丁名：Oxcarbazepine Tablets | | --- | --- | | 剂型 | 片剂 | | 注册分类 | 化学药品 类 4 | | 规格 | 0.3g | | 编号 | 2025S03399 | | 药品批准文号 | 国药准字 H20255934 | | 申请事项 | 药品注册(境内生产) | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定， 经审查，本品符合药品注册的有关要求，批准注 | | | 册，发给药品注册证书。质量标准、说明书、标 | | | 签及生产工艺照所附执行。药品生产企业应当符 合药品生产质量管理规范要求方可生产销售。 | | --- | --- | | 上市许可持有人 | 名称：湖南省湘中制药有限公司 | | 生产企业 | 名称：湖南省湘中制药有限公司 | 二、药品相关情况 证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－097 华润双鹤药业股份有限公司 关于控股子公司湖南省湘中制药有限公司 奥卡西平片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 ...

Core Points - China Resources Double Crane (600062.SH) announced that its subsidiary Hunan Xiangzhong Pharmaceutical Co., Ltd. has received the drug registration certificate for Oxcarbazepine Tablets from the National Medical Products Administration [1] Company Summary - The drug Oxcarbazepine Tablets is indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 years and older, with or without secondary generalized seizures [1]

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., received the drug registration certificate for Oxcarbazepine Tablets from the National Medical Products Administration (NMPA) [1] Group 1: Drug Registration and Approval - The drug, Oxcarbazepine Tablets, is indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 years and older [1] - The research and development of this generic drug began in August 2021, with the application for market authorization submitted on July 26, 2024, and acceptance notification received on August 14, 2024 [1] - The drug is expected to be approved for market launch on November 12, 2025, and the registration certificate is considered equivalent to passing the consistency evaluation according to national policies [1] Group 2: Financial Investment and Market Impact - The total R&D investment for this drug has reached RMB 14.2164 million (approximately 2.1 million USD) as of the announcement date [1] - The approval of the drug registration certificate will enhance the company's product line, improve market competitiveness, and provide valuable experience for future product development [1]

Core Viewpoint - China Resources Double Crane Pharmaceutical Co., Ltd. has received a drug registration certificate for Oxcarbazepine tablets from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Company Summary - The company’s subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., is responsible for the receipt of the drug registration certificate [1] - Oxcarbazepine tablets are indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 years and older [1]

Core Viewpoint - China Resources Double Crane announced that its subsidiary, Xiangzhong Pharmaceutical, received the drug registration certificate for Oxcarbazepine Tablets from the National Medical Products Administration, indicating a significant milestone in the company's product development pipeline [1] Group 1: Product Development - The drug is intended for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 years and older [1] - Xiangzhong Pharmaceutical initiated the research and development of Oxcarbazepine in August 2021 and submitted the application for marketing authorization on July 26, 2024 [1] - The drug was approved for market launch on November 12, 2025, following a cumulative R&D investment of 14.2164 million yuan [1]

Core Viewpoint - The company announced that its subsidiary, Xiangzhong Pharmaceutical, has received the Drug Registration Certificate for Oxcarbazepine Tablets from the National Medical Products Administration [1] Group 1 - The approval of Oxcarbazepine Tablets is a significant milestone for the company, indicating progress in its pharmaceutical product offerings [1] - This development may enhance the company's market position in the pharmaceutical industry, particularly in the neurology segment where Oxcarbazepine is utilized [1]