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联环药业(600513.SH):茚达特罗莫米松吸入粉雾剂(II)获得药物临床试验批准通知书
Ge Long Hui A P P· 2026-01-22 08:55
格隆汇1月22日丨联环药业(600513.SH)公布,公司于近日收到国家药品监督管理局核准签发的关于茚达 特罗莫米松吸入粉雾剂(II)(称"该药品")的《药物临床试验批准通知书》,并将于近期开展临床试 验,茚达特罗莫米松吸入粉雾剂(II)适用于成人和12岁及以上青少年哮喘的维持治疗。包括:(1)使用 吸入性糖皮质激素未能充分控制的患者;(2)或使用长效β2受体激动剂和低剂量吸入性糖皮质激素未能充 分控制的患者。 ...
联环药业:公司获得药物临床试验批准通知书
Xin Lang Cai Jing· 2026-01-22 08:43
联环药业公告,近日收到国家药监局核准签发的关于茚达特罗莫米松吸入粉雾剂(II)的《药物临床试 验批准通知书》,并将于近期开展临床试验。茚达特罗莫米松吸入粉雾剂(II)适用于成人和12岁及以 上青少年哮喘的维持治疗。截至本公告披露日,公司2026年已获得2个临床批件。 ...
联环药业:茚达特罗莫米松吸入粉雾剂(II)获得药物临床试验批准通知书
人民财讯1月22日电,联环药业(600513)1月22日公告,公司于近日收到国家药品监督管理局核准签发 的关于茚达特罗莫米松吸入粉雾剂(II)的《药物临床试验批准通知书》,该药品将开展用于哮喘的临床 试验。 ...
联环药业:茚达特罗莫米松吸入粉雾剂(II)获临床试验批准
南财智讯1月22日电,联环药业公告,联环药业收到国家药品监督管理局核准签发的关于茚达特罗莫米 松吸入粉雾剂(II)的《药物临床试验批准通知书》,同意该药品开展用于哮喘的临床试验。该药品适 用于成人和12岁及以上青少年哮喘的维持治疗,包括使用吸入性糖皮质激素未能充分控制的患者,或使 用长效β2受体激动剂和低剂量吸入性糖皮质激素未能充分控制的患者。截至公告披露日,该项目公司 累计研发投入约为人民币2,213.57万元(未经审计)。根据相关规定,该药品还需完成临床试验并经审 评审批后方可生产上市,预计在未来相当一段时间内不会对公司的营业收入和经营业绩产生重大影响。 ...
1月16日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-16 10:19
Group 1 - Xianghe Industrial signed a contract worth 43.1041 million yuan with China Railway 15th Bureau, accounting for approximately 6.5% of the company's projected revenue for 2024 [1] - Dayu Water-saving's subsidiary won a bid for a project valued at 133 million yuan, with a construction period of 545 days [2] - China National Materials International's subsidiary signed a contract worth 299 million Canadian dollars for engineering design and procurement services [3] Group 2 - Baoland expects a net loss of approximately 75 million yuan for 2025, compared to a loss of 58.7224 million yuan in the previous year [4] - Changhong High-tech received an administrative regulatory decision due to inadequate internal controls and improper revenue recognition [5] - Debon Stock will be suspended from trading on January 21, 2026, pending a decision on its delisting [6] Group 3 - Haitai Technology anticipates a net profit increase of 226.86% to 323.97% for 2025, with an expected profit of 51.5 million to 66.8 million yuan [7] - Fushun Special Steel expects a net loss of 770 million to 870 million yuan for 2025, compared to a profit of 112 million yuan in the previous year [8] - Rejing Bio forecasts a net loss of 210 million to 230 million yuan for 2025, compared to a loss of 191 million yuan in the previous year [10] Group 4 - Sanyou Chemical expects a net profit of approximately 91 million yuan for 2025, a decrease of about 82% compared to the previous year [11] - Lianhuan Pharmaceutical received approval for clinical trials of a new drug for benign prostatic hyperplasia [12] - Samsung New Materials anticipates a net loss for 2025, indicating a decline in operational performance [13] Group 5 - Jinggong Technology expects a net profit increase of 36.1% to 70.13% for 2025, with an estimated profit of 200 million to 250 million yuan [14] - Zhongsheng Pharmaceutical's subsidiary signed a licensing agreement for the production and commercialization of RAY1225 injection, with total payments expected to reach 1 billion yuan [15] - Hengshuai shares saw a reduction of 600,000 convertible bonds held by its controlling shareholder [16] Group 6 - Buchang Pharmaceutical plans to repurchase shares worth 60 million to 120 million yuan for employee stock ownership plans [17] - Baike Bio expects a net loss of 220 million to 280 million yuan for 2025, marking a shift from profit to loss [18] - Weishi Electronics anticipates a net profit decrease of 53.27% to 61.61% for 2025, with expected profits of 21.49 million to 26.16 million yuan [19] Group 7 - China Automotive Research expects a net profit increase of 17.85% for 2025, with a projected profit of 1.06 billion yuan [20] - Hualan Biological's controlling shareholder raised the upper limit of its shareholding plan to 86.66 yuan per share [22] - Nasda anticipates a net loss for 2025, indicating a decline in financial performance [23] Group 8 - Haizheng Pharmaceutical received a warning letter from the Zhejiang Securities Regulatory Commission for financial data inaccuracies [24] - Mengguli received an administrative regulatory decision for accounting errors in its financial reports [25] - Zhongguancun's subsidiary received acceptance for a drug application for a heart-related treatment [26] Group 9 - Hosheng Silicon Industry was ordered to correct information disclosure violations by the Zhejiang Securities Regulatory Commission [27] - Meiteng Technology expects a net profit decrease of 22.4551 million to 28.5285 million yuan for 2025, a reduction of 55.21% to 70.14% [28] - Sanwei Co. received a warning letter for financial irregularities related to related party transactions [29] Group 10 - Ganyue Expressway expects a net profit increase of 3.18% for 2025, with a projected profit of 1.32 billion yuan [30] - Xinhang New Materials plans to acquire 51% of Hairete for 12.8826 million yuan [31] - China Software anticipates a net loss of 41 million to 49 million yuan for 2025, an improvement from the previous year's loss [32] Group 11 - Rongsheng Development expects a net loss for 2025, with losses not exceeding the previous year's audited net assets [33] - Northern Rare Earth anticipates a net profit increase of 117% to 135% for 2025, with expected profits of 2.176 billion to 2.356 billion yuan [34] - Energy-saving Wind Power received renewable energy subsidies totaling 1.507 billion yuan, a 122.74% increase from the previous year [35] Group 12 - Dongzhu Ecology expects a net loss of 935 million to 1.135 billion yuan for 2025, compared to a loss of 630 million yuan in the previous year [36] - Jingneng Real Estate anticipates a net loss of 986 million to 1.315 billion yuan for 2025, compared to a loss of 109 million yuan in the previous year [37] - Hailu Heavy Industry signed new orders worth 1.941 billion yuan for 2025, with total orders on hand amounting to 3.597 billion yuan [38] Group 13 - Dalian Thermal Power expects a net loss of 92 million to 112 million yuan for 2025, compared to a loss of 146 million yuan in the previous year [39] - Jiangsu Sop expects a net profit decrease of 52.99% to 62.4% for 2025, with profits projected between 8 million to 10 million yuan [40] - Lian Technology plans to initiate preparations for issuing H-shares and listing on the Hong Kong Stock Exchange [42] Group 14 - Zhenyang Development expects a net profit decrease of 58.13% to 64.94% for 2025, with profits projected between 67 million to 80 million yuan [43] - Sheneng Co. reported a 1.7% decrease in power generation for 2025, with total generation of 57.654 billion kWh [44] - XGIMI Technology's subsidiary received a development notification from a well-known domestic automotive manufacturer [45] Group 15 - Wanhua Chemical's MDI Phase II facility resumed production after maintenance [46] - Daqing Energy expects a net loss of 1 billion to 1.3 billion yuan for 2025, with a reduction in losses compared to the previous year [47]
联环药业(600513) - 联环药业关于公司获得2类改良新药临床试验批准通知书的公告
2026-01-16 10:16
药品名称:LH-2417 片 剂型:片剂 申请事项:临床试验 证券代码:600513 证券简称:联环药业 公告编号:2026-003 江苏联环药业股份有限公司 关于公司获得 2 类改良新药临床试验批准通知书的公告 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。 江苏联环药业股份有限公司(以下简称"公司")于近日收到国家药品监督 管理局(以下简称"国家药监局")核准签发的关于 2 类改良新药 LH-2417 片 (以下简称"本品"或"该药品")的《药物临床试验批准通知书》,并将于近 期开展临床试验,现将相关情况公告如下: 一、药品基本情况 受理号:CXHL2501239、CXHL2501240、CXHL2501241 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,2025 年 11 月 11 日受理的 LH-2417 片临床试验申请符合药品注册的有关要求,同意 本品开展临床试验。 二、药品的其他情况 公司 2 类改良新药 LH-2417 片用于前列腺肥大的男性良性前列腺增生的体 征和症状的初始治疗。 截至本公告披露 ...
联环药业:2类改良新药LH-2417片临床试验获批
Core Viewpoint - The company, Lianhuan Pharmaceutical, has received approval from the National Medical Products Administration for its Class 2 modified new drug LH-2417 tablets, which will soon enter clinical trials for the treatment of benign prostatic hyperplasia in men [1]. Group 1 - The drug LH-2417 is intended for the initial treatment of symptoms associated with benign prostatic hyperplasia in men [1]. - The clinical trial approval marks a significant step in the drug development process for the company [1].
联环药业(600513.SH):获得2类改良新药临床试验批准通知书
Xin Lang Cai Jing· 2026-01-16 08:49
Core Viewpoint - Company Lianhuan Pharmaceutical (600513.SH) has received approval from the National Medical Products Administration for the clinical trial of its Class 2 improved new drug LH-2417, aimed at treating benign prostatic hyperplasia in men [1] Group 1: Drug Development - The drug LH-2417 is intended for the initial treatment of symptoms associated with benign prostatic hyperplasia in men [1] - The company currently has other prostate treatment drugs, including the marketed Class 1 new drug Aipulete Tablets (brand name: Chuanliu) and two Class 2 improved new drugs, LH-2103 Capsules and Rilugolix Tablets, which are in clinical trial stages [1] - As of the announcement date, the cumulative R&D investment for this project is approximately RMB 1.3678 million (unaudited) [1] Group 2: Regulatory Milestones - The approval for LH-2417 marks the company's first clinical approval obtained in 2026 [1]
联环药业:获得2类改良新药LH-2417片临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2026-01-16 08:39
每经AI快讯,1月16日,联环药业(600513.SH)公告称,公司于近日收到国家药监局核准签发的关于2类 改良新药LH-2417片的《药物临床试验批准通知书》,并将于近期开展临床试验。该药品用于前列腺肥 大的男性良性前列腺增生的体征和症状的初始治疗。截至公告披露日,公司累计研发投入约为136.78万 元。由于改良新药的前期研发以及产品从研制到投产的周期长,容易受到不确定因素影响,预计短期内 不会对公司营业收入和经营业绩产生重大影响。 (文章来源:每日经济新闻) ...
联环药业:公司获得2类改良新药临床试验批准通知书
Xin Lang Cai Jing· 2026-01-16 08:36
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of the new drug LH-2417, aimed at treating benign prostatic hyperplasia in men [1] Group 1 - The drug LH-2417 is classified as a type 2 modified new drug [1] - The clinical trial will focus on the initial treatment of symptoms associated with benign prostatic hyperplasia [1] - The company plans to commence clinical trials in the near future [1]