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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]
医药生物行业跟踪周报:海外小核酸进入收获期,关注国内悦康、前沿、福元等-20251130
Soochow Securities· 2025-11-30 14:15
证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 海外小核酸进入收获期,关注国内悦康、前 沿、福元等 增持(维持) [Table_Tag] [Table_Summary] 投资要点 2025 年 11 月 30 日 证券分析师 朱国广 执业证书:S0600520070004 zhugg@dwzq.com.cn 行业走势 -13% -10% -7% -4% -1% 2% 5% 8% 11% 14% 17% 20% 2024/12/2 2025/4/1 2025/7/30 2025/11/27 医药生物 沪深300 相关研究 《药店现金流稳健、估值低,重点推 荐益丰药房、大参林等》 2025-11-23 《医药行业 2025Q3 总结报告:CXO 及科研服务收入持续高增长,有望延 续》 2025-11-17 东吴证券研究所 1 / 28 请务必阅读正文之后的免责声明部分 ◼ 本周、年初至今 A 股医药指数涨幅分别为 2.67%、16.72%,相对沪深 300 的超额收益分别为 1.03%、1.68%;本周、年初至今恒生生物科技 指数涨跌幅分别为 4.30%、81.69%,相对于恒生科技指数跑赢 0.52 ...
投资策略专题:开源金股,12月推荐
KAIYUAN SECURITIES· 2025-11-28 09:12
Group 1 - The report suggests that after the recent market adjustment, growth stocks are expected to continue to outperform, with a focus on sectors such as military, media (gaming), AI applications, Hong Kong internet, and power equipment [3][12] - The financial engineering team has developed a sector rotation model, recommending a December industry portfolio that includes beauty care, social services, home appliances, oil and petrochemicals, retail, communication, transportation, automotive, media, and food and beverage [4][15] - Alibaba (9988.HK) is highlighted for its significant investment in AI infrastructure, which is expected to accelerate cloud business growth, alongside increased user traffic and revenue from e-commerce technology services [4][17] Group 2 - Zhongji Xuchuang (300308.SZ) is recognized as a global leader in optical modules, with a strong focus on cutting-edge research and commercial applications, gaining wide recognition from clients [4][20] - Yuekang Pharmaceutical (688658.SH) has several innovative drugs entering critical clinical or approval stages, indicating potential breakthroughs from research to commercialization [4][22] - Ximai Co., Ltd. (002956.SZ) continues to focus on the oat category, driving high growth through product structure adjustments and category innovations, benefiting from falling raw material prices [4][24] Group 3 - China Life Insurance (601628.SH) is expected to exceed expectations in its life insurance segment, with ongoing high growth in the bancassurance channel and improved investment returns [4][27] - Shangmei Co., Ltd. (2145.HK) is leveraging a multi-brand strategy and strong operational capabilities, with promising performance during the Double Eleven shopping festival [4][30] - Giant Network (002558.SZ) is anticipated to achieve new highs in key metrics due to seasonal events and successful game titles, indicating strong growth potential [4][33] Group 4 - Northern Huachuang (002371.SZ) is positioned to benefit from the growth of domestic semiconductor equipment and is expected to see significant order growth in 2026 [4][35] - Zhuoyi Information (688258.SH) is focusing on AI programming and related trends, with promising commercial prospects for its new products [4][37] - Midea Group (000333.SZ) is experiencing high growth in its ToB business and significant retail sales increases in its high-end brand strategy, contributing to sustained performance [4][40]
悦康药业(688658):公司信息更新报告:加大研发投入,创新管线逐步迈入收获期
KAIYUAN SECURITIES· 2025-11-28 07:30
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has increased its R&D investment, and its innovative pipeline is gradually entering a harvest period. The FDA has approved the clinical trial for the YKYY018 aerosol inhalation agent for the prevention and treatment of RSV infections. Despite facing pressure on its operating performance in 2025, the company is optimistic about its long-term growth potential due to its innovative layout and small nucleic acid technology platform [3][4] Financial Performance Summary - For the first three quarters of 2025, the company achieved revenue of 1.759 billion yuan, a year-on-year decrease of 41.20%. The net profit attributable to the parent company was -148 million yuan, down 170.56% year-on-year. The non-recurring net profit attributable to the parent company was -168 million yuan, a decrease of 182.95% year-on-year [3][4] - The company has adjusted the price of its "Ginkgo Leaf Extract Injection" at the end of 2024, which has impacted its performance. The R&D expenses have increased significantly, contributing to the net profit decline [3][4] - The sales expense ratio for the first three quarters of 2025 was 28.64%, down 7.37 percentage points; the management expense ratio was 10.67%, up 5.18 percentage points; the R&D expense ratio was 18.00%, up 9.27 percentage points; and the financial expense ratio was 0.59%, up 0.47 percentage points [3][4] Earnings Forecast - The revised earnings forecast for the company indicates net profits attributable to the parent company of -183 million yuan, -53 million yuan, and 69 million yuan for 2025, 2026, and 2027 respectively. The original forecasts were 51 million yuan, 206 million yuan, and 561 million yuan [3][4] - The expected EPS for 2025, 2026, and 2027 is -0.41 yuan, -0.12 yuan, and 0.15 yuan respectively, with the current stock price corresponding to P/E ratios of -60.6, -208.5, and 161.2 times [3][4] Innovative Pipeline Progress - The company is advancing its innovative drug pipeline, with key traditional Chinese medicine (TCM) drugs in the final review stage for NDA. The small nucleic acid innovative drugs YKYY015 and YKYY029 have received approval for clinical trials in the US and China, with ongoing Phase I trials domestically [4] - The RSV mRNA vaccine YKYY025 and VZV mRNA vaccine YKYY026 have also received approval for clinical trials in the US. The company has completed the Phase IIa clinical trial for its first domestic antisense nucleic acid drug for primary liver cancer [4]
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FDA临床试验批准的公告
Core Viewpoint - YKYY018 aerosol inhalation agent developed by the company has received FDA approval for clinical trials aimed at preventing and treating respiratory syncytial virus (RSV) infections, highlighting a significant advancement in the company's drug development capabilities [1][4]. Group 1: FDA Approval and Clinical Trials - The FDA has granted approval for the clinical trial of YKYY018 aerosol inhalation agent, allowing the company to proceed with the study as per the submitted protocol [1]. - The IND number for the clinical trial is 178457, and the application is specifically for the prevention and treatment of RSV infections [4]. Group 2: RSV Infection Overview - RSV is a highly infectious RNA virus that primarily affects children, the elderly, and immunocompromised individuals, with approximately 90% of children infected by the age of two [2]. - Globally, RSV is the leading cause of lower respiratory tract infections in children under five, resulting in about 3.6 million hospitalizations and approximately 100,000 deaths annually [2]. - In 2024, it is estimated that 91.4 million children under five will be infected with RSV worldwide, with 13.4 million cases in China [2]. Group 3: YKYY018 Product Details - YKYY018 is an innovative membrane fusion inhibitor developed using a full-process AI platform, designed to prevent and treat RSV infections [3]. - The drug works by specifically binding to the F protein of RSV, blocking the fusion process between the virus and host cells, thus providing both therapeutic and preventive effects [3]. - The company holds core patent rights for YKYY018, granting it global exclusive rights [3]. Group 4: Preclinical Research Findings - Preclinical studies have shown that YKYY018 effectively inhibits various RSV strains and clinical isolates, demonstrating significant antiviral activity [5]. - In animal models, the drug significantly reduced viral loads and alleviated lung tissue damage, indicating its potential efficacy [5]. - Safety assessments in animal trials revealed no significant adverse effects on respiratory function or other health indicators, suggesting good safety and tolerability [5].
悦康药业YKYY018雾化吸入剂获美国FDA临床试验批准
Bei Jing Shang Bao· 2025-11-27 10:43
Core Viewpoint - Yuyuan Pharmaceutical's subsidiary has received FDA approval for clinical trials of YKYY018 aerosol inhalation solution aimed at preventing and treating respiratory syncytial virus (RSV) infections [1] Group 1: Company Developments - Yuyuan Pharmaceutical announced that its wholly-owned subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., has obtained FDA consent for clinical trials of YKYY018 [1] - The drug YKYY018 is a membrane fusion inhibitor that specifically binds to the HR1 region of the RSV fusion protein, blocking the fusion process between the virus and host cells [1] Group 2: Product Details - YKYY018 aerosol inhalation solution has dual functions for both treatment and prevention of RSV infections [1] - The mechanism of action involves inhibiting the formation of the homologous 6-HB structure between HR1 and HR2 domains of the virus [1]
11月27日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-27 10:37
Group 1 - Hekang New Energy's subsidiary received a government subsidy of 6 million yuan, accounting for 58.27% of the company's latest audited net profit attributable to shareholders [1] - Anhui Construction won two major EPC projects with a total bid price of 2.603 billion yuan [2] - Tianrun Dairy's wholly-owned subsidiary received a government subsidy of 7.9094 million yuan, representing 18.12% of the company's audited net profit for 2024 [2] Group 2 - Yunnan Gold's subsidiary obtained a mining license for the Xinxiao County Tanxi Tungsten Mine, with a production capacity of 990,000 tons per year [5][22] - Yanzhou Coal Energy plans to acquire 100% equity of a high-end support company for 345 million yuan [6] - Heng Rui Pharmaceutical received approval for multiple drug clinical trials, including Sulfate Amexitin tablets [8] Group 3 - Huazhi Jie plans to invest 157 million yuan to establish five wholly-owned subsidiaries to expand its global strategy [1] - Junting Hotel's controlling shareholder is planning a change of control, leading to a continued suspension of trading [4] - Funi Technology's shareholder plans to reduce its stake by up to 1.68% [10] Group 4 - Midea Group's subsidiary received a government subsidy of 6 million yuan, which is 58.27% of the company's latest audited net profit [1] - Hunan Gold's subsidiary obtained a mining license for tungsten, iron, and silver, with a production scale of 990,000 tons per year [5][22] - Xin Hua Pharmaceutical received approval for the listing application of Acetate Prednisone raw material [24][25] Group 5 - Zhejiang Pharmaceutical plans to spin off its subsidiary for a listing on the Hong Kong Stock Exchange [28] - Kesheng Technology plans to invest 61.2 million yuan to acquire 51% of Shenzhen Guanding [30] - Tian Shan Aluminum's 1.4 million tons electrolytic aluminum green low-carbon energy efficiency improvement project has commenced production [38]