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悦康药业:自愿披露关于头孢丙烯片通过仿制药一致性评价的公告
2024-12-05 07:56
证券代码:688658 证券简称:悦康药业 公告编号:2024-053 悦康药业集团股份有限公司 自愿披露关于头孢丙烯片 通过仿制药一致性评价的公告 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。 注册分类:化学药品 原药品批准文号:国药准字 H20184107 上市许可持有人:悦康药业集团股份有限公司 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药品医 疗器械审评审批制度的意见》(国发〔2015〕44 号)和《关于仿制药质量和疗 效一致性评价工作有关事项的公告》(2017 年第 100 号)的规定,经审查,本 品通过仿制药质量和疗效一致性评价。 二、药品的相关信息 近日,悦康药业集团股份有限公司(以下简称"公司")收到国家药品监督 管理局核准签发的关于头孢丙烯片(规格:0.25g)的《药品补充申请批准通知 书》(通知书编号:2024B05594),该药品通过仿制药质量和疗效一致性评价。 一、上述药品的基本情况 药品名称:头孢丙烯片 剂型:片剂 规格:0.25g(按 C₁₈H₁₉N₃O₅S 计) 常见病菌具 ...
悦康药业:北京天驰君泰律师事务所关于悦康药业集团股份有限公司2024年第二次临时股东大会的法律意见书
2024-11-21 09:56
中国北京市朝阳区北辰东路八号 北辰汇宾大厦 A 座六层 邮编:100101 F6/A,North Star HuiBin Plaza, No.8 BeiChen East Road, ChaoYang District, BeiJing 100101 China 北京天驰君泰律师事务所 关于悦康药业集团股份有限公司 2024 年第二次临时股东大会 的 法律意见书 北京 上海 广州 深圳 天津 长春 南京 郑州 成都 福州 Beijing, Shanghai, Guangzhou, Shenzhen, Tianjin, Changchun, Nanjing, Zhengzhou, Chengdu, Fuzhou, 北京天驰君泰律师事务所 关于悦康药业集团股份有限公司 2024 年第二次临时股东大会的法律意见书 致:悦康药业集团股份有限公司 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人 民共和国证券法》等相关法律、行政法规,以及中国证券监督管理委员会发布 的中国证券监督管理委员会公告〔2022〕13 号《上市公司股东大会规则》 (2022 年修订)(以下简称"《股东大会规则》")等规范性文件以 ...
悦康药业:2024年第二次临时股东大会决议公告
2024-11-21 09:56
本公司董事会及全体董事保证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。 重要内容提示: 本次会议是否有被否决议案:无 一、 会议召开和出席情况 (一) 股东大会召开的时间:2024 年 11 月 21 日 (二) 股东大会召开的地点:北京市北京经济技术开发区科创七街 11 号悦康创 新药物国际化产业园一楼会议室。 证券代码:688658 证券简称:悦康药业 公告编号:2024-052 悦康药业集团股份有限公司 2024 年第二次临时股东大会决议公告 (三) 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况: | 1、出席会议的股东和代理人人数 | 147 | | --- | --- | | 普通股股东人数 | 147 | | 2、出席会议的股东所持有的表决权数量 | 76,195,992 | | 普通股股东所持有表决权数量 | 76,195,992 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比例 | 17.1427 | | (%) | | | 普通股股东所持有表决权数量占公司表决权数量的比例( ...
悦康药业:携手华为召开数字化转型顶设项目宣贯会
证券时报e公司讯,11月18日,悦康药业数字化转型顶设项目宣贯暨数字化转型建设项目动员会召开。 本次大会标志着悦康药业数字化转型战略的执行落地迎来重大里程碑。 华为制造行业总裁杨萍等华为领导、专家团队,与悦康药业集团董事长于伟仕及集团管理层干部共同出 席大会。 会上,华为专家宣贯了悦康数字化转型顶层设计项目的成果。 华为制造行业总裁杨萍表示,华为将持续为悦康提供人才、技术、资源及方法论支持,携手悦康将数字 化转型进行到底。 ...
悦康药业:2024年第二次临时股东大会会议资料
2024-11-13 07:34
悦康药业集团股份有限公司 2024 年第二次临时股东大会会议资料 悦康药业集团股份有限公司 2024 年第二次临时股东大会 会议资料 2024 年 11 月 | 2024 | 年第二次临时股东大会会议须知 2 | | --- | --- | | 2024 | 年第二次临时股东大会会议议程 4 | | 2024 | 年第二次临时股东大会会议议案 6 | 悦康药业集团股份有限公司 2024 年第二次临时股东大会会议资料 悦康药业集团股份有限公司 2024 年第二次临时股东大会会议须知 为了维护全体股东的合法权益,确保股东大会的正常秩序和议事效率,保证 大会的顺利进行,根据《公司法》、《证券法》、《上市公司股东大会规则》以 及《悦康药业集团股份有限公司章程》(以下简称"《公司章程》")的相关规定, 认真做好召开股东大会的各项工作,特制定本须知: 一、为保证股东大会的严肃性和正常秩序,切实维护股东的合法权益,除出 席会议的股东及股东代表、董事、监事、公司高级管理人员、公司聘任律师及中 介机构外,公司有权依法拒绝其他人员入场。 二、请出席会议的股东及股东代表在会议召开前 20 分钟到达会议现场办理 签到手续。大会工作人 ...
悦康药业:子公司在国际知名期刊发表AI快速高效设计和筛选药物的学术论文
近日,悦康药业集团股份有限公司(代码:688658,以下简称"公司")子公司北京悦康科创医药科技股 份有限公司在国际知名期刊《Viruses》在线发表了题为"Antiviral Peptide-Generative Pre-trained Transformer (AVP-GPT): A Deep Learning-Powered Model for Antiviral Peptide Design with HighThroughput Discovery and Exceptional Potency"的AI药物研发学术论文。 据介绍,多肽药物是由氨基酸组成的短链分子,介于小分子药物和大分子生物药物之间。由于其独特的 生物学特性和药理作用,多肽药物在治疗多种疾病方面显示出巨大的潜力。而传统的多肽等药物设计依 赖于昂贵而耗时的人工库构建和筛选。公司基于自主创新的一系列AI算法模型,结合独创的多肽片断 相互作用研究新理念,抓住膜融合过程蛋白动态相互作用本质,开发了一种更为先进的深度学习AI模 型:AVP-GPT。AVP-GPT利用Transformer语言模型和多模态架构,专为多肽新药开发而设计,包含了 多肽 ...
悦康药业:Q3利润超预期,多款中药创新药有望陆续获批
GOLDEN SUN SECURITIES· 2024-11-07 07:30
Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Views - The company's Q3 profit exceeded expectations, with several innovative traditional Chinese medicine products expected to be approved soon [1][2]. - Revenue growth has continued throughout 2024, with Q3 showing a year-on-year increase of 37.47% and a quarter-on-quarter increase of 6.07%, primarily driven by sales growth in cardiovascular and digestive products [1]. - The company has returned to normal operating conditions after previous low-price competition and inventory adjustments in 2023 [1]. Financial Performance Summary - For the first three quarters of 2024, the company achieved revenue of 2.992 billion yuan, a year-on-year increase of 1.15%, and a net profit attributable to shareholders of 210 million yuan, a year-on-year increase of 37.73% [1]. - Q3 2024 revenue reached 1.042 billion yuan, a year-on-year increase of 37.47%, with a net profit of 91.17 million yuan, compared to a loss of 54.80 million yuan in the same period of 2023 [1]. - The company's sales expense ratio for Q1-3 2024 was 36.01%, down 8.01 percentage points year-on-year, while the R&D expense ratio was 8.73%, up 0.89 percentage points year-on-year [1]. Future Outlook - The company expects steady growth from ginkgo leaf extract injections and anticipates the approval of three innovative traditional Chinese medicine products in the first half of 2025 [2]. - The small RNA platform is being strengthened, with FDA and CDE clinical approvals for PCSK9 siRNA, and more small RNA pipelines are expected to enter IND [2]. - The peptide platform has completed Phase II clinical studies for the membrane fusion inhibitor aerosolized peptide YKYY017, which is expected to advance to Phase III [2]. Profit Forecast and Valuation - The forecasted net profits for 2024-2026 are 302 million yuan, 392 million yuan, and 460 million yuan, representing growth rates of 63.2%, 30.1%, and 17.1% respectively [2]. - The expected EPS for the same period is 0.67 yuan, 0.87 yuan, and 1.02 yuan, with corresponding P/E ratios of 34x, 26x, and 22x [2].
悦康药业:集采影响逐步出清,三季度业绩超预期
Huafu Securities· 2024-11-05 10:22
Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 20% relative to the market benchmark index within the next six months [13]. Core Insights - The company has turned a profit in Q3 2024, exceeding 90 million, with a notable performance excluding impairment losses. Revenue for Q1-Q3 2024 reached 2.99 billion, a year-on-year increase of 1%, while net profit attributable to shareholders was 210 million, up 38% year-on-year [1]. - The company is focusing on its core product, Ginkgo biloba extract, with traditional products' negative impacts from centralized procurement gradually clearing, leading to improved profitability [1]. - Several potential blockbuster products are nearing market readiness, including "Hydroxy Safflower Yellow A" for stroke treatment, which has completed Phase III clinical trials and is awaiting NDA approval [1]. - The company is actively investing in cutting-edge fields such as small nucleic acids and peptides, with promising developments in drug candidates for primary liver cancer [1]. Financial Performance Summary - For 2024, the company is projected to achieve revenues of 4.35 billion, with a growth rate of 4%. Net profits are expected to reach 300 million, reflecting a significant growth rate of 63% [2][11]. - The financial metrics indicate a recovery trajectory, with a gross margin of 64.3% in Q3 2024, up 5.9 percentage points year-on-year [1]. - The company’s sales expenses for Q3 2024 were 400 million, a 20% increase year-on-year, while R&D expenses decreased by 10% to 80 million [1]. Future Projections - Revenue forecasts for 2024, 2025, and 2026 are 4.35 billion, 4.78 billion, and 5.40 billion respectively, with growth rates of 4%, 10%, and 13% [2][11]. - Net profit projections for the same years are 300 million, 410 million, and 510 million, with growth rates of 63%, 35%, and 27% respectively [2][11].
悦康药业:重磅产品进展顺利,小核酸平台值得期待
申万宏源· 2024-11-01 06:43
Investment Rating - The investment rating for the company is "Buy" (maintained) [2][5] Core Views - The company has shown steady progress in its key products, particularly in the small nucleic acid platform, which is expected to yield significant results in the future [5] - The company reported a revenue of 2.992 billion yuan for the first three quarters of 2024, reflecting a year-on-year growth of 1.15%, with a notable increase in net profit [4][5] - The company is focusing on cost reduction and efficiency improvements, with a decrease in sales and management expense ratios [5] Financial Performance - For the first three quarters of 2024, the company achieved a net profit of 210 million yuan, a year-on-year increase of 37.73% [4] - The third quarter of 2024 saw a revenue of 1.042 billion yuan, up 37.47% year-on-year, and a net profit of 91 million yuan, up 266.37% year-on-year [4] - The company maintains a healthy financial position with a debt-to-asset ratio of 38.84% and a net asset value per share of 8.14 yuan [3] Product Development - The company is advancing its key product, Hydroxy A, which is expected to be approved for market by 2025, potentially becoming a blockbuster product with a market size of 2 billion yuan [5] - Other products, such as Compound Ginkgo Leaf Tablets and Purple Flower Cough Relief Granules, are in the NDA review stage, while the first small interfering RNA drug YKYY015 has received IND approval in the US [5] Earnings Forecast and Valuation - The company is projected to achieve net profits of 306 million yuan, 410 million yuan, and 506 million yuan for 2024, 2025, and 2026 respectively, with corresponding EPS of 0.68 yuan, 0.91 yuan, and 1.12 yuan [5][7] - The expected growth rates for net profit are 65.6%, 33.9%, and 23.5% for the years 2024 to 2026 [5][7]
悦康药业:自愿披露关于子公司YKYY015注射液获得国家药品监督管理局临床试验批准的公告
2024-10-31 08:11
证券代码:688658 证券简称:悦康药业 公告编号:2024-051 悦康药业集团股份有限公司 自愿披露关于子公司 YKYY015 注射液获得国家药品 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")全资子公司杭州天龙药业 有限公司(以下简称"杭州天龙")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 YKYY015 注射液用于治疗以 LDL-C 升高为特征的 原发性(家族性和非家族性)高胆固醇血症或混合型高脂血症的患者的《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: 一、《药物临床试验批准通知书》主要内容: 1、药品名称:YKYY015 注射液 2、受理号:CXHL2400819 3、通知书编号:2024LP02464 4、申请适应症:以 LDL-C 升高为特征的原发性(家族性和非家族性)高 胆固醇血症或混合型高脂血症的患者 4、申请人:杭州天龙药业有限公司 6、审批结论:根据《中华人民 ...