| 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]

Core Viewpoint - The company, through its subsidiary Shuanghe Tianan Pharmaceutical, has received a GMP compliance inspection notice from the Guizhou Provincial Drug Administration, confirming that its production quality management meets GMP requirements, which is crucial for maintaining product quality and production capacity [1][4]. GMP Inspection Information - The inspected entity is Shuanghe Tianan Pharmaceutical, located in Guizhou, with the inspection conducted from October 15 to October 17, 2025, focusing on the production line for Metformin and Empagliflozin Tablets (I) [1][2]. - The production line has a designed capacity of 500 million tablets per year [2]. Product and Market Situation - Metformin and Empagliflozin Tablets (I) are used for improving blood sugar control in adults with type 2 diabetes and were developed by Boehringer Ingelheim, launched in the EU and the US in 2015, and in China in 2019 [2]. - The global sales for Metformin and Empagliflozin Tablets (I) are projected to reach $103 million in 2024, with the product "SYNJARDY" generating sales of approximately $43.31 million [2]. - In the Chinese market, there are 22 approved manufacturers for Metformin and Empagliflozin Tablets (I), with Shuanghe Tianan included, and the total sales in the domestic market are estimated at 341 million RMB in 2024 [3]. Impact on the Company - The successful GMP compliance inspection indicates that the company can maintain stable product quality and production capacity, which is essential for meeting market demand [4]. - The inspection results are not expected to have a significant impact on the company's financial performance [4].

Group 1: Company Performance - SMIC reported a revenue of 17.162 billion yuan in Q3 2025, a year-on-year increase of 9.9%, with a net profit of 1.51 billion yuan, up 43.1% year-on-year. For the first three quarters, revenue reached 49.51 billion yuan, growing 18.2%, and net profit was 3.81 billion yuan, an increase of 41.1% year-on-year [1] - BoRui Pharma's BGM1812 injection has received clinical trial approval for weight loss indications, with no similar targeted formulations approved globally [2] - Li Zhong Group's subsidiaries received project confirmations for aluminum alloy wheels from major international automotive manufacturers, with expected total sales of approximately 1.135 billion yuan [4] Group 2: Corporate Actions - Kanda New Materials announced the termination of the acquisition of equity in North One Semiconductor due to unmet progress expectations and lack of consensus among parties [3] - Lide Man plans to acquire 70% of Xiansheng Xiangrui for 1.733 billion yuan, aiming to enter the bioproducts industry [9] - Arctech's controlling shareholder CSIQ expects total revenue of 1.3 to 1.5 billion USD in Q4 2025, with a gross margin of 14% to 16% [6] Group 3: Market Activity - Taihe Technology's VC project phase two construction will be adjusted based on phase one market expansion, indicating some uncertainty [5] - Hezhong China has experienced significant stock price fluctuations, with a cumulative increase of 230.84% over 12 out of 13 trading days, leading to potential application for trading suspension if abnormal price increases continue [7][8]

证券日报网讯11月13日晚间，华润双鹤（600062）发布公告称，近日，华润双鹤药业股份有限公司(以 下简称"公司")控股子公司双鹤天安药业(贵州)股份有限公司(以下简称"双鹤天安")收到贵州省药品监督 管理局颁发的《药品GMP符合性检查告知书》。 ...

Group 1 - China Pacific Insurance's subsidiary, China Pacific Life, reported a cumulative premium income of 241.32 billion yuan for the first ten months, a year-on-year increase of 9.9% [1] - China Pacific Property Insurance, another subsidiary, achieved a cumulative premium income of 173.57 billion yuan, with a year-on-year growth of 0.4% [1] - Nocera Biopharma reported a net loss of 64.41 million yuan for the first three quarters, despite a revenue increase of 59.85% to 1.115 billion yuan [1] Group 2 - Founder Securities received approval from the China Securities Regulatory Commission to issue short-term corporate bonds not exceeding 5 billion yuan [1] - Haicheng Bonda's director plans to reduce his stake by up to 0.97%, equating to 198,400 shares [1] - Yuyuan Group intends to repurchase shares worth between 200 million and 300 million yuan, with a maximum price of 8.60 yuan per share [1] Group 3 - Huaren Shuanghe's subsidiary passed the GMP compliance inspection for a specific diabetes medication [4] - Lichong Group received project notifications from three international automotive manufacturers, with expected sales amounting to approximately 1.135 billion yuan [6] - Deyang Co. is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy [7] Group 4 - Longxin General announced the transfer of its entire stake in a subsidiary for 105.6 million yuan, and also plans to divest another stake for 1 yuan due to poor performance [16] - Kangda New Materials decided to terminate the acquisition of a semiconductor company due to unsatisfactory due diligence progress [17] - Lu'an Environmental reported a 3.28% year-on-year increase in coal sales for October, totaling 3.78 million tons [18] Group 5 - Shanghai Port Group plans to invest 2 billion yuan to establish a new holding company with several state-owned enterprises [20] - Borui Pharmaceutical's new drug for obesity treatment has received clinical trial approval [23] - Silver Dragon Co. has completed the registration of a new energy industry fund focusing on high-growth potential projects [24] Group 6 - Hengrui Medicine received approval for a clinical trial of a prostate cancer drug [11] - Baiji Shenzhou reported a net profit of 1.139 billion yuan for the first three quarters, marking a turnaround from losses [36] - Huasheng Pharmaceutical's special medical food product has received registration certification [60]