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悦康药业:筹划发行H股股票并在香港联合交易所有限公司上市。
Xin Lang Cai Jing· 2025-12-05 09:25
悦康药业:筹划发行H股股票并在香港联合交易所有限公司上市。 ...
Nature子刊:悦康药业siRNA新药,有望实现乙肝的功能性治愈
生物世界· 2025-12-03 04:04
撰文丨王聪 编辑丨王多鱼 排版丨水成文 据估计,全球范围内约有 3.25 亿 人慢性感染了 乙型肝炎病毒 (HBV) ,尽管已有有效疫苗,HBV 仍导致了每年近 100 万人死亡。HBV 的慢性感染会对肝细 胞造成长期损伤,使感染者面临进展性肝病风险,近一半的 肝细胞癌 是因为 HBV 慢性感染所致。 目前,针对慢性乙型肝炎病毒 (HBV) 感染的治疗方法效果不佳,原因是高循环水平的乙型肝炎表面抗原 (HBsAg) 导致了免疫耗竭。 2025 年 12 月 1 日, 悦康药业 宋更申 团队在 Nature 子刊 Nature Communications 上发表了题为: An RNA interference therapeutic potentially achieves functional cure of chronic hepatitis B virus infection 的研究论文。 该研究表明,靶向 乙型肝炎病毒 S 区的 siRNA 药物 KC13-M2G2 ,有望实现慢性乙型肝炎病毒感染的功能性治愈。 这种名为 KC13-M2G2 的 siRNA 制剂在体外对所有乙型肝炎病毒 (HBV) 基 ...
悦康药业YKYY018雾化吸入剂获得临床试验批准;中国药品价格登记系统发布|医药早参
Mei Ri Jing Ji Xin Wen· 2025-12-03 00:16
Group 1 - The core point of the news is that Baihua Pharmaceutical's controlling shareholder and actual controllers have their agreement to act in concert expire, which will not adversely affect the company's management or change its controlling shareholder [1] - The expiration of the agreement is a routine corporate governance action, and the company confirms that it will not impact daily operations [1] - Such agreements not being renewed after expiration is common in the A-share market [1] Group 2 - YKYY018 aerosol inhalation agent from Yuyuan Pharmaceutical has received clinical trial approval from both Chinese and U.S. regulatory authorities for the prevention and treatment of respiratory syncytial virus (RSV) infections [2] - This product addresses a significant clinical need, particularly in high-risk populations, and utilizes an innovative aerosol inhalation delivery method [2] Group 3 - HeYu Pharmaceutical's oral small molecule KRAS G12D inhibitor, ABSK141, has received IND approval from the U.S. FDA for treating patients with advanced solid tumors carrying the KRAS G12D mutation [3] - This drug targets a common oncogenic mutation associated with several cancers, including pancreatic and colorectal cancer, indicating a pressing clinical demand [3] Group 4 - The China Drug Price Registration System has been officially launched, aimed at providing authoritative and accurate drug price information to support the internationalization of pharmaceutical companies [4] - This system is a key step towards establishing a scientific and transparent pricing system for innovative drugs in China, facilitating high-quality development in the pharmaceutical industry [4]
悦康药业(688658) - 关于自愿披露子公司YKYY018雾化吸入剂获得国家药品监督管理局临床试验批准的公告
2025-12-02 08:30
证券代码:688658 证券简称:悦康药业 公告编号:2025-050 悦康药业集团股份有限公司 关于自愿披露子公司 YKYY018 雾化吸入剂获得国家 药品监督管理局临床试验批准的公告 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、准确性和完整性依法承担法律责任。 悦康药业集团股份有限公司(以下简称"公司")全资子公司北京悦康科创 医药科技股份有限公司(以下简称"悦康科创")于近日获得国家药品监督管理 局(以下简称"NMPA")核准签发的关于同意 YKYY018 雾化吸入剂用于与呼 吸道合胞病毒患者接触后的暴露后预防和用于 RSV 感染的治疗的两份《药物临 床试验批准通知书》,公司将开展本品 I 期临床试验。现将相关情况公告如下: 3、申请适应症分别为: (1)与呼吸道合胞病毒患者接触后的暴露后预防 (2)RSV 感染的治疗 4、申请人:北京悦康科创医药科技股份有限公司 5、申报阶段:临床试验 6、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, 分别于 2025 年 10 月 28 日和 2025 年 10 月 27 日受理的 YKYY ...
悦康药业(688658.SH):子公司YKYY018雾化吸入剂获得国家药品监督管理局临床试验批准
Ge Long Hui A P P· 2025-12-02 08:25
YKYY018雾化吸入剂是悦康科创依托全流程AI平台,自主开发的一款国际原创的膜融合抑制剂药物, 用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗。该产品具有全新的作用机制, YKYY018能够与呼吸道合胞病毒融合蛋白(F蛋白)F1亚基的七肽重复序列区1(HR1)特异性结合, 抑制病毒自身HR1与HR2结构域之间同源6-HB的形成,阻断病毒与宿主细胞的融合过程,实现抗病毒效 果,兼具治疗和预防的双重功能。公司已获得该产品的核心专利授权,并拥有其全球独占权益。 格隆汇12月2日丨悦康药业(688658.SH)公布,公司全资子公司北京悦康科创医药科技股份有限公司(简 称"悦康科创")于近日获得国家药品监督管理局(简称"NMPA")核准签发的关于同意YKYY018雾化吸 入剂用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准 通知书》,公司将开展本品I期临床试验。 ...
悦康药业(688658.SH)子公司YKYY018雾化吸入剂获临床试验批准
智通财经网· 2025-12-02 08:24
智通财经APP讯,悦康药业(688658.SH)发布公告,公司全资子公司北京悦康科创医药科技股份有限公 司(简称"悦康科创")于近日获得国家药品监督管理局(简称"NMPA")核准签发的关于同意YKYY018雾化 吸入剂用于与呼吸道合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批 准通知书》,公司将开展本品I期临床试验。 ...
悦康药业子公司YKYY018雾化吸入剂获临床试验批准
Zhi Tong Cai Jing· 2025-12-02 08:19
悦康药业(688658.SH)发布公告,公司全资子公司北京悦康科创医药科技股份有限公司(简称"悦康科创") 于近日获得国家药品监督管理局(简称"NMPA")核准签发的关于同意YKYY018雾化吸入剂用于与呼吸道 合胞病毒患者接触后的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准通知书》,公司将 开展本品I期临床试验。 ...
悦康药业:子公司YKYY018雾化吸入剂获国家药监局临床试验批准
Xin Lang Cai Jing· 2025-12-02 08:18
悦康药业公告称,其全资子公司悦康科创近日获国家药监局核准签发的关于YKYY018雾化吸入剂两份 《药物临床试验批准通知书》,同意用于与呼吸道合胞病毒患者接触后的暴露后预防和RSV感染的治 疗,公司将开展I期临床试验。该产品是国际原创的膜融合抑制剂药物,已获核心专利授权及全球独占 权益,近日也获美国FDA临床试验批准函告。不过,药品研发存在周期长、环节多、风险高的特点,公 司提醒投资者注意风险。 ...
悦康药业:YKYY018雾化吸入剂获临床试验批准
人民财讯12月2日电,悦康药业(688658)12月2日公告,公司全资子公司北京悦康科创医药科技股份有限 公司近日获得国家药监局核准签发的关于同意YKYY018雾化吸入剂用于与呼吸道合胞病毒患者接触后 的暴露后预防和用于RSV感染的治疗的两份《药物临床试验批准通知书》,公司将开展本品I期临床试 验。 ...
开源晨会-20251130
KAIYUAN SECURITIES· 2025-11-30 14:45
Macro Economic Overview - Manufacturing and construction sectors show signs of low-level recovery, while the service sector is weakening, as indicated by the November PMI data [3][5] - The PMI for manufacturing increased by 0.3 percentage points to 50.0%, with improvements in new orders and export orders [3][4] - The construction PMI improved by 0.5 percentage points to 49.6%, supported by the acceleration of special bond issuance [5][6] Corporate Profit Trends - In the first ten months of 2025, the cumulative profit of large-scale industrial enterprises increased by 1.9% year-on-year, down from 3.2% [8][9] - October saw a significant decline in profits, with a year-on-year drop of 5.5%, attributed to a high base effect and rising costs [9][10] - The profit structure indicates a shift, with midstream profits increasing while upstream profits are declining [11][41] Investment Strategies - The report suggests early positioning for the upcoming spring market rally, with December being a crucial macroeconomic window [14][15] - Growth style is expected to continue, with a focus on technology and cyclical sectors [19][27] - The report highlights the potential of small-cap stocks, particularly in a liquidity-rich environment [18][22] Sector-Specific Insights - The real estate sector is seeing a shift towards infrastructure REITs, with a notable performance in affordable housing REITs [3][5] - The coal mining sector is experiencing price stability, with coal prices expected to remain firm [3][5] - The pharmaceutical sector is advancing rapidly in clinical trials for PD-1/VEGF dual antibodies, with four candidates entering registration trials [3][5] ETF and Index Performance - The report discusses the core investment value of the China Securities 2000 Enhanced Strategy ETF, emphasizing its growth potential and resilience [20][21] - The index is characterized by high growth and elasticity, particularly benefiting from liquidity easing and stimulus policies [21][22] Financial Engineering and Asset Allocation - The report recommends a multi-asset allocation strategy favoring short-term bonds, undervalued convertible bonds, and gold assets [55][56] - The bond market is expected to experience upward pressure on yields, with a shift in asset allocation from safe-haven assets to risk assets [43][48]