Workflow
褪黑素颗粒
icon
Search documents
1月8日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-08 10:30
Group 1 - Jinli Permanent Magnet expects a net profit of 660 million to 760 million yuan for 2025, representing a year-on-year growth of 127% to 161% [1] - Wens Foodstuffs anticipates a net profit of 5 billion to 5.5 billion yuan for 2025, a decrease of 40.73% to 46.12% compared to the previous year [2] - New Open Source plans to repurchase shares worth 40 million to 50 million yuan, with a maximum repurchase price of 25.77 yuan per share [3] Group 2 - Fosun Pharma's subsidiary has had a drug registration application accepted for a new drug targeting ALK-positive non-small cell lung cancer [4] - Leike Film reported a net profit of -86 million yuan for the first three quarters of 2025, indicating a potential annual loss [5] - Crown Stone Technology's application for a specific issuance of A-shares has been accepted by the Shanghai Stock Exchange [6] Group 3 - Dongxin Technology has completed the business registration change for its subsidiary, Lishuan Technology, and has invested 211 million yuan in it [7] - Tianci Materials has increased its commodity futures hedging business limit from 150 million to 300 million yuan [8] - Gaode Infrared's actual controller has reduced his shareholding by 0.54%, bringing his stake down to 62.95% [9] Group 4 - Tianyong Intelligent expects a net profit of 10 million to 15 million yuan for 2025, marking a turnaround from losses [10][11] - China Merchants Energy anticipates a net profit of 6 billion to 6.6 billion yuan for 2025, an increase of 17% to 29% year-on-year [18] - Guangdong Electric Power A's Huizhou Power Plant's Unit 5 has been put into commercial operation, with an investment of 8.05 billion yuan [19] Group 5 - Jianghuai Automobile reported a 42.24% year-on-year increase in sales volume for December 2025 [25] - China Pharmaceutical's subsidiary has received a drug registration certificate for a new medication [26] - TianNeng Co. plans to use up to 12 billion yuan of its own funds for entrusted wealth management [27] Group 6 - Luoyang Huizhong reported a 10.55% month-on-month decrease in sales revenue from live pigs for December 2025 [28] - Baolidi expects a net profit of 145 million to 152 million yuan for 2025, a year-on-year increase of 27.17% to 33.30% [30] - Changchun High-tech's subsidiary has had a melatonin granule registration application accepted [31] Group 7 - Zhongmin Energy reported a 4.46% year-on-year decrease in cumulative on-grid electricity for 2025 [32] - Huaxin Electronics reported a 7.79% year-on-year decrease in consolidated operating revenue for December 2025 [35] - Xiamen Airport reported a 2.79% year-on-year increase in passenger throughput for December 2025 [36] Group 8 - Baiyun Airport reported a 12.27% year-on-year increase in passenger throughput for December 2025 [37] - Pulaike has received a new veterinary drug registration certificate for a chewable tablet [38] - Yunnan Energy Holdings' subsidiary has reduced its stake to 84% after a capital increase [39] Group 9 - Gansu Energy Chemical's new thermal power project has successfully completed trial operation [41] - Zhenghong Technology reported a significant decrease in sales revenue from live pigs for December 2025 [42] - Huasheng Lithium Battery is planning to issue H-shares for listing on the Hong Kong Stock Exchange [43] Group 10 - Jincheng Mining has signed a mining production contract with an estimated total price of approximately 510 million yuan [44] - Microchip Biotech has received approval for clinical trials of a new drug for pancreatic cancer [45] - Yahon Pharmaceutical has completed the first patient enrollment for a Phase I clinical trial of its drug [46]
长春高新子公司褪黑素颗粒上市申请获受理
Zhi Tong Cai Jing· 2026-01-08 08:48
长春高新(000661.SZ)公告,公司控股子公司——长春金赛药业有限责任公司("金赛药业")收到国家药品 监督管理局核准签发的《受理通知书》,金赛药业褪黑素颗粒的境内生产药品注册上市许可申请获得受 理。 长春高新(000661.SZ)公告,公司控股子公司——长春金赛药业有限责任公司("金赛药业")收到国家药品 监督管理局核准签发的《受理通知书》,金赛药业褪黑素颗粒的境内生产药品注册上市许可申请获得受 理。 公告显示,褪黑素颗粒是金赛药业研发的一款儿童神经精神领域产品,属于化学药品4类,能够通过激活 视交叉上核的MT1及MT2受体来调节视交叉上核的神经活动,显示出诱导睡眠的作用。拟用于改善儿童 期伴随神经性发育障碍的入睡困难。 ...
长春高新(000661.SZ)子公司褪黑素颗粒上市申请获受理
智通财经网· 2026-01-08 08:41
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. ("Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the domestic production drug registration application of melatonin granules, indicating progress in its product development in the pediatric neuropsychiatric field [1]. Group 1 - The melatonin granules are developed by Jinsai Pharmaceutical and are classified as a Category 4 chemical drug [1]. - The product aims to improve sleep difficulties associated with neurodevelopmental disorders in children by activating the MT1 and MT2 receptors in the suprachiasmatic nucleus [1]. - The indication for the product is specifically targeted at children experiencing sleep onset issues due to neurodevelopmental disorders [1].
长春高新:子公司褪黑素颗粒上市申请获得受理
Mei Ri Jing Ji Xin Wen· 2026-01-08 08:37
(文章来源:每日经济新闻) 每经AI快讯,1月8日,长春高新(000661.SZ)公告称,公司控股子公司金赛药业收到国家药品监督管理 局核准签发的《受理通知书》,金赛药业褪黑素颗粒的境内生产药品注册上市许可申请获得受理。褪黑 素颗粒是金赛药业研发的儿童神经精神领域产品,属于化学药品4类,能够通过激活视交叉上核的MT1 及MT2受体来调节视交叉上核的神经活动,显示出诱导睡眠的作用。拟用于改善儿童期伴随神经性发育 障碍的入睡困难。金赛药业研发的褪黑素颗粒已经完成了受试制剂与参比制剂对比的BE研究,并递交 了仿制药上市申请(ANDA)。本品的申报上市将增加褪黑素颗粒在儿童中使用的选择性,更好的满足 临床需求。 ...
长春高新(000661.SZ):子公司褪黑素颗粒上市申请获得受理
Ge Long Hui A P P· 2026-01-08 08:34
格隆汇1月8日丨长春高新(000661.SZ)公布,控股子公司——长春金赛药业有限责任公司(简称"金赛药 业")收到国家药品监督管理局核准签发的《受理通知书》,金赛药业褪黑素颗粒的境内生产药品注册 上市许可申请获得受理,褪黑素颗粒是金赛药业研发的一款儿童神经精神领域产品,属于化学药品4类, 能够通过激活视交叉上核的MT1及MT2受体来调节视交叉上核的神经活动,显示出诱导睡眠的作用。拟 用于改善儿童期伴随神经性发育障碍的入睡困难。 ...
长春高新:子公司褪黑素颗粒上市申请获受理
Xin Lang Cai Jing· 2026-01-08 08:34
长春高新公告,控股子公司长春金赛药业有限责任公司收到国家药品监督管理局核准签发的《受理通知 书》,金赛药业褪黑素颗粒的境内生产药品注册上市许可申请获得受理。褪黑素颗粒是金赛药业研发的 一款儿童神经精神领域产品,属于化学药品4类,能够通过激活视交叉上核的MT1及MT2受体来调节视 交叉上核的神经活动,显示出诱导睡眠的作用。拟用于改善儿童期伴随神经性发育障碍的入睡困难。 ...
亿帆医药股份有限公司2025年第三季度报告
Core Viewpoint - The company reported a stable growth in operating revenue and a decrease in net profit attributable to shareholders by 25.64% compared to the same period last year, primarily due to reduced income from the transfer of drug agency rights and government subsidies [3]. Financial Performance - The company did not need to restate previous accounting data, indicating stability in financial reporting [3]. - The net profit attributable to shareholders decreased by 25.64% year-on-year, attributed to a reduction in income from non-recurring gains [3]. - The company reported a total asset impairment provision of 44.31 million yuan for the first three quarters of 2025, impacting the net profit by 37.50 million yuan [15][19]. Shareholder Information - The employee stock ownership plan held 6.7754 million shares, representing 0.56% of the total share capital as of the reporting period [10]. Corporate Governance - The company held its eighth board meeting and elected new board members and senior management on September 5, 2025, completing the board renewal process [11]. Subsidiary Developments - The company’s subsidiary received multiple drug registration approvals from the National Medical Products Administration, including for oral medications and injections, indicating ongoing product development and market expansion [6][7][8].
“睡不着”的中国失眠药研发商
3 6 Ke· 2025-10-10 01:29
Core Viewpoint - The Chinese insomnia medication market is poised for rapid growth and transformation, driven by increasing awareness of sleep disorders and government initiatives to enhance sleep health services [2][3][12]. Group 1: Market Overview - Approximately 1/4 of the Chinese population suffers from sleep deprivation, with nearly 40% experiencing nighttime awakenings, indicating a significant market potential for insomnia treatments [3]. - The insomnia medication market in China is projected to reach 350 billion RMB by 2025, reflecting a growing demand for effective sleep aids [6][15]. - The recent approval of new insomnia medications, such as Fazamorexant and Daliresp, marks a shift in the market, with companies like Yangtze River Pharmaceutical Group and Xiansheng Pharmaceutical leading the charge [8][9]. Group 2: Industry Challenges - The Chinese insomnia medication market has faced a 16-year gap in new drug approvals, primarily due to stringent regulatory policies governing psychotropic medications [12]. - Traditional insomnia medications often come with significant side effects, leading to a dilemma for patients seeking effective treatment options [13][14]. - There is a lack of specialized sleep medicine departments in hospitals, complicating the diagnosis and treatment process for insomnia patients [14]. Group 3: Opportunities for Innovation - The increasing prevalence of insomnia, particularly among the aging population, presents a substantial opportunity for pharmaceutical companies to develop innovative treatments [15]. - Advances in technology, such as AI-assisted drug development and digital therapies, are expected to shorten research timelines and expand treatment options [15]. - The government's "Healthy China 2030" initiative aims to integrate insomnia interventions into primary healthcare services, potentially increasing market penetration for insomnia medications [15].
医药生物行业双周报(2025、7、25-2025、8、7):第十一批集采开始报量-20250808
Dongguan Securities· 2025-08-08 07:38
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry, expecting the industry index to outperform the market index by over 10% in the next six months [32]. Core Insights - The SW pharmaceutical and biotechnology industry outperformed the CSI 300 index, rising by 1.80% from July 25, 2025, to August 7, 2025, exceeding the CSI 300 index by approximately 2.62 percentage points [12]. - Most sub-sectors within the industry recorded positive returns during the same period, with the medical research outsourcing and chemical preparation sectors leading with increases of 6.32% and 4.33%, respectively [13]. - Approximately 61% of stocks in the industry achieved positive returns, with notable performers such as Lide Man, which saw a weekly increase of 71.70% [14][17]. - The overall industry valuation remains stable, with a PE (TTM) of approximately 52.61 times as of August 7, 2025, which is relatively low compared to historical levels [18]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry outperformed the CSI 300 index, with a rise of 1.80% from July 25, 2025, to August 7, 2025, surpassing the CSI 300 by about 2.62 percentage points [12]. - Most sub-sectors recorded positive returns, particularly medical research outsourcing and chemical preparations, which increased by 6.32% and 4.33%, while hospitals and vaccines saw declines of 1.88% and 1.76% [13]. - About 61% of stocks in the industry posted positive returns, with Lide Man leading at a 71.70% increase [14][17]. 2. Industry News - The 11th batch of national drug procurement officially began reporting on August 6, 2025, with key deadlines for data submission and review set for August 25 and August 27, respectively [24]. 3. Company Announcements - Yifan Pharmaceutical announced that its subsidiary received a drug registration acceptance notice for melatonin granules, marking a significant milestone as the first domestic application for this product [25]. 4. Weekly Industry Perspective - The report maintains an "Overweight" rating for the industry, highlighting the continuous outperformance of the pharmaceutical and biotechnology sector against the CSI 300 index, driven by new business development (BD) authorizations and positive earnings forecasts from medical research outsourcing companies [26][28].
亿帆医药:褪黑素颗粒境内生产药品注册上市许可申请获受理
Zheng Quan Ri Bao Wang· 2025-08-06 07:12
Core Viewpoint - Yifan Pharmaceutical (002019) announced that its wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., received the acceptance notice for the registration and listing application of melatonin granules from the National Medical Products Administration on August 5, 2025. This drug is intended to improve sleep difficulties in children aged 6-15 with neurodevelopmental disorders, marking the first domestic generic application in this category [1]. Company Summary - Yifan Pharmaceutical's subsidiary has received regulatory approval for a new product aimed at a specific pediatric demographic [1]. - The melatonin granules are classified under Category 4 for chemical drug registration, indicating a significant step in the company's product development pipeline [1]. - This product represents a pioneering effort in the domestic market for generic drugs targeting sleep issues in children with neurodevelopmental disorders [1].