HUADONG MEDICINE(000963)
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华东医药(000963.SZ):控股子公司获得美国FDA新药临床试验批准通知
Ge Long Hui A P P· 2026-01-14 13:00
Core Viewpoint - East China Pharmaceutical (000963.SZ) announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd. (referred to as "Daor Bio"), has received notification from the U.S. Food and Drug Administration (FDA) that its clinical trial application for the drug DR10624 injection has been approved, allowing clinical trials to be conducted in the U.S. for the indication of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) [1] Group 1 - East China Pharmaceutical's subsidiary Daor Bio has received FDA approval for clinical trials of DR10624 injection [1] - The approved indication for the clinical trial is Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) [1]
1月14日晚间公告 | 紫光国微拟购买瑞能半导并复牌;彩讯股份拟募资逾16亿用于Agent开发项目等
Xuan Gu Bao· 2026-01-14 12:12
Group 1: Resumption of Trading - Unisplendour plans to acquire 100% equity of Ruineng Semiconductor from 14 parties through share issuance and cash payment, leading to stock resumption [1] - Minmetals Development's board approved major asset replacement proposals, resulting in stock resumption [2] - Huibo's actual controller will change to Tianjin State-owned Assets Supervision and Administration Commission, with stock resuming tomorrow [3] Group 2: Private Placement - Lante Optics intends to raise no more than 1.055 billion yuan for AR optical product industrialization, production capacity enhancement of glass aspheric lenses, micro-nano optical components R&D, and working capital [4] Group 3: Equity Transfer - Jinhai High-tech's controlling shareholder, Huitou Holdings, plans to transfer 5% of shares at a price of 12.72 yuan per share through an agreement [4] Group 4: External Investment and Daily Operations - Hongda Electronics' subsidiary plans to invest 1 billion yuan in Wuxi High-tech Development Zone for semiconductor special device chip research, design, production, and testing [5] - Caixun plans to issue convertible bonds to raise no more than 1.46 billion yuan for intelligent computing center construction, Rich AIBox platform R&D upgrades, and enterprise-level AI applications [5] - Dingtong Technology intends to issue convertible bonds to raise no more than 930 million yuan for company expansion, high-speed communication and liquid cooling production, new energy BMS production, and working capital [5] - East China Pharmaceutical's subsidiary received FDA approval for clinical trials of DR10624 injection [6] - Xizi Clean Energy reported a cumulative new order of 5.998 billion yuan for 2025 [7] - Tianli Lithium Energy's subsidiary is expected to reduce production by 1,500 to 2,000 tons due to maintenance [8] Group 5: Performance Changes - CITIC Securities expects a net profit of 30.051 billion yuan in 2025, a year-on-year increase of 38.46% [9] - Four-dimensional Map expects a net profit of 90.0925 million to 117 million yuan in 2025, turning profitable due to the booming market for automotive assisted driving [9] - Jinhai Tong expects a net profit of 160 million to 210 million yuan in 2025, a year-on-year increase of 103.87% to 167.58% due to growing demand in the semiconductor packaging and testing equipment sector [9] - Shanghai Silicon Industry anticipates a net loss of 1.53 billion to 1.28 billion yuan in 2025 [10] - Jiamei Packaging expects a net profit of 85.4371 million to 104 million yuan in 2025, a year-on-year decrease of 43.02% to 53.38% due to a "small year" in the beverage industry [10]
华东医药(000963) - 关于控股子公司获得美国FDA新药临床试验批准通知的公告
2026-01-14 10:30
近日,华东医药股份有限公司(以下简称"公司") 控股子公 司浙江道尔生物科技有限公司(以下简称"道尔生物")收到美国食 品药品监督管理局(以下简称"美国 FDA")通知,由道尔生物申 报的 DR10624 注射液药品临床试验申请已获得美国 FDA 批准,可在 美国开展临床试验,适应症为代谢相关脂肪性肝病(Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD)。现将有关 详情公告如下: 一、该药物基本信息 证券代码:000963 证券简称:华东医药 公告编号:2026-002 华东医药股份有限公司 关于控股子公司获得美国FDA新药临床试验批准通知的公 告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 药物名称:DR10624 注射液 IND 编号:180034 适应症:代谢相关脂肪性肝病(Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD) 申请事项:临床试验 DR10624 是道尔生物自主研发的全球首创(Fir ...
华东医药:DR10624注射液药品临床试验申请已获FDA批准
Xin Lang Cai Jing· 2026-01-14 10:27
Core Viewpoint - The company has received FDA approval for a clinical trial of its drug DR10624, aimed at treating metabolic-associated fatty liver disease [1] Group 1 - The company's subsidiary, Zhejiang Daor Biotechnology Co., Ltd., is responsible for the drug application [1] - The FDA notification indicates that the clinical trial can now proceed in the United States [1] - The approved indication for the drug is metabolic-associated fatty liver disease [1]
华东医药:控股子公司DR10624注射液获得美国FDA新药临床试验批准通知
Mei Ri Jing Ji Xin Wen· 2026-01-14 10:25
Core Viewpoint - The announcement highlights that Zhejiang Daer Biotechnology, a subsidiary of Huadong Medicine, has received FDA approval for the clinical trial application of the drug DR10624, aimed at treating Metabolic Associated Steatotic Liver Disease (MASLD) [1] Group 1 - The drug DR10624 is a globally innovative long-acting tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, developed independently by Daer Biotechnology [1] - DR10624 has successfully completed Phase II clinical trials for severe hypertriglyceridemia, achieving positive top-line results [1] - The approval for the clinical trial will not have a significant impact on the company's recent performance [1]
华东医药:目前公司吲哚布芬晶型专利状态仍为有效
Zheng Quan Ri Bao Wang· 2026-01-13 09:13
Core Viewpoint - East China Pharmaceutical (华东医药) is actively pursuing legal action against Zhejiang Tongwu Biopharmaceutical Co., Ltd. for patent infringement related to its indobufen crystal form patent, which remains valid [1] Group 1: Patent Status and Legal Actions - The company's patent for "Indobufen Crystal Form D and its preparation method" (Patent No: ZL202211596913.5) is still effective [1] - The company has filed an administrative ruling request with the Hangzhou Intellectual Property Bureau against Zhejiang Tongwu for patent infringement, which resulted in a ruling to cease infringement [1] - During the first instance of the administrative litigation, Zhejiang Tongwu disclosed that its raw material source is from a company in Sichuan, leading to the Hangzhou Intellectual Property Bureau revoking its previous ruling due to new facts [1] Group 2: Ongoing Legal Proceedings - The administrative ruling application process regarding the raw material source from the Sichuan company is currently under normal acceptance [1] - The infringement fact remains unchanged, and the company will continue to monitor the case's progress and take necessary legal measures to protect its rights [1]
2025年1-11月中国化学药品原药产量为335.8万吨 累计增长1.8%
Chan Ye Xin Xi Wang· 2026-01-13 03:03
Core Viewpoint - The report highlights the growth trends in China's chemical pharmaceutical raw materials industry, indicating a steady increase in production and market dynamics from 2025 to 2032 [1] Industry Summary - In November 2025, China's chemical pharmaceutical raw material production reached 331,000 tons, reflecting a year-on-year growth of 1.5% [1] - From January to November 2025, the cumulative production of chemical pharmaceutical raw materials in China was 3,358,000 tons, with a cumulative growth of 1.8% [1] - The report by Zhiyan Consulting provides insights into the supply and demand dynamics of the chemical pharmaceutical industry in China, projecting future trends from 2026 to 2032 [1] Company Summary - Listed companies in the sector include Heng Rui Medicine, East China Pharmaceutical, Lizhu Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical [1]
创新药概念股走强,相关ETF涨超2%
Mei Ri Jing Ji Xin Wen· 2026-01-13 02:33
Group 1 - The core viewpoint of the news highlights a strong performance in innovative drug concept stocks, with notable increases in companies such as WuXi AppTec and Kanglong Chemical, which rose over 7%, and others like Xinlitai, which increased over 3% [1] - The innovative drug-related ETFs also saw significant gains, with an overall increase of over 2% [1] Group 2 - Specific ETF performance includes the Innovative Drug Industry ETF rising by 2.59% to 0.633, and other ETFs like the Innovative Drug ETF and the EasyGo Innovative Drug ETF also showing increases of 2.45% and 2.40% respectively [2] - Analysts indicate that core assets in innovative drugs are expected to continue rising, with new opportunities emerging in areas such as small nucleic acids and in vivo CAR technologies [2] - The long-term trend of innovative drug business development (BD) is seen as a pathway for China's innovative drug capabilities to gain recognition on the global stage, with core assets licensed to multinational corporations (MNCs) expected to realize value as clinical progress continues [2]
华东医药:2026年公司将有十余项IND申报计划
Zheng Quan Ri Bao Wang· 2026-01-12 11:41
证券日报网讯1月12日,华东医药(000963)在互动平台回答投资者提问时表示,2026年公司将有十余 项IND申报计划,覆盖肿瘤、代谢/内分泌、自免等核心治疗领域。 ...
1月12日重要公告一览
Xi Niu Cai Jing· 2026-01-12 02:36
Group 1 - Defu Technology plans to acquire at least 51% of Huiru Technology through cash purchase and capital increase, making Huiru a subsidiary [1] - Huiru Technology specializes in the research, production, and sales of high-performance electrolytic copper foil, including lithium battery copper foil and electronic circuit copper foil [1] Group 2 - Medike's shareholder plans to reduce holdings by no more than 1% of the company's shares, amounting to approximately 410.93 million shares [2] - Huadong Medicine's subsidiary, Daor Biotechnology, has its product DR10624 included in the list of breakthrough therapeutic varieties, targeting severe hypertriglyceridemia [3] Group 3 - Fangsheng Pharmaceutical received a notice of non-compliance from the Hunan Provincial Drug Administration regarding its raw material drug production [4] - Yanjing Co. is planning a major asset restructuring, leading to a temporary suspension of its stock [5] - Xianle Health intends to issue H-shares and apply for listing on the Hong Kong Stock Exchange [6] Group 4 - Huate Gas shareholders plan to collectively reduce their holdings by no more than 2% of the company's shares [7] - Hangyu Technology plans to sell up to 752,800 repurchased shares to supplement working capital [8] Group 5 - Sichuan Electronics expects a net loss of between 265 million to 340 million yuan for the year 2025 [10] - Jinzongzi Wine anticipates a net loss for the 2025 fiscal year, although the loss is expected to narrow compared to the previous year [11] - Hebang Bio forecasts a net loss for 2025 due to anticipated asset impairment provisions [12] Group 6 - Dechang Co. expects a net profit decrease of 51% to 61% for 2025, estimating a profit of 160 million to 200 million yuan [13] - Kosen Technology and Weiyuan Co. both project net losses for 2025 [14][15] - Xiantan Co. reported a chicken product sales revenue of 530 million yuan in December 2025, with a year-on-year increase of 9.41% [16] Group 7 - Shangluo Electronics' application for issuing convertible bonds has been accepted by the Shenzhen Stock Exchange [17] - Zhongheng Group anticipates a net loss for 2025 [18]