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悦康药业(688658) - 对外担保管理制度(草案)
2025-12-05 09:31
悦康药业集团股份有限公司 (H 股发行上市后适用) 1 第一章 总 则 第二章 担保原则 第三章 担保对象的审查 2 第一条 为规范悦康药业集团股份有限公司(以下简称"公司")对外担保行为, 有效防范公司对外担保风险,现根据《中华人民共和国公司法》《中华人 民共和国证券法》《中华人民共和国民法典》《上市公司监管指引第 8 号 ——上市公司资金往来、对外担保的监管要求》《上海证券交易所科创板 股票上市规则》《上海证券交易所科创板上市公司自律监管指引第 1 号— —规范运作》《香港联合交易所有限公司证券上市规则》等相关法律、行 政法规和规范性文件、公司股票上市地证券监管规则以及《悦康药业集团 股份有限公司章程》(以下简称"公司章程")的规定,特制定本制度。 第二条 本制度所称担保是指公司以第三人身份为他人银行债务或其它债务提供 担保责任,包括为其控股子公司提供担保,担保方式包括但不限于保证、 抵押或质押。具体种类可能是银行借款担保、银行开立信用证和银行承兑 汇票担保、开具保函的担保等。 第三条 本制度所称的控股子公司是指公司对其拥有实际控制权的控股子公司。 第四条 以公司本部或控股子公司名义进行的所有担保,均由公 ...
悦康药业(688658) - 信息披露事务管理制度(草案)
2025-12-05 09:31
信息披露事务管理制度 (草案) (H股发行上市后适用) 1 总 则 鉴于公司同时在上海证券交易所和境外证券市场上市,公司及相关信息披 露义务人在境外证券交易所披露的信息,应当同时在符合条件的媒体按照 中国证监会及上海证券交易所相关规定披露;公司及相关信息披露义务人 在境外市场进行信息披露时,不在上海证券交易所规定的信息披露时段内 的,应当在上海证券交易所最近一个信息披露时段内披露。 公司及相关信息披露义务人就同一事项向境外证券交易所提供的报告和 公告应当与向上海证券交易所提供的内容一致。出现重大差异时,公司及 相关信息披露义务人应向上海证券交易所作出专项说明,并披露更正或者 补充公告。 根 据 《 香 港 联 交 所 上 市 规 则 》 , 公 司 于 香 港 联 交 所 指 定 网 站 "www.hkexnews.hk"所披露的所有公告、通函及其他文件应同时在公司官 方网站上登载。 悦康药业集团股份有限公司 第三条 本制度所称信息披露义务人是指:公司及其董事、高级管理人员、股东、 实际控制人,收购人,重大资产重组、再融资、重大交易有关各方等自然 人、单位及其相关人员,破产管理人及其成员,以及法律、行政法规、 ...
悦康药业(688658) - 关于制定公司于H股发行上市后适用的《公司章程(草案)》及修订、制定相关内部治理制度的公告
2025-12-05 09:30
证券代码:688658 证券简称:悦康药业 公告编号:2025-053 悦康药业集团股份有限公司 《公司章程(草案)》须经股东会审议通过,并将于本次公司发行 H 股股 票自香港联交所上市之日起生效,在此之前,现行《公司章程》继续有效。 二、关于修订、制定 H 股发行上市后适用的公司治理制度的情况 基于公司本次发行上市需要,按照《公司法》《证券法》《境内企业境外 发行证券和上市管理试行办法》《上市公司章程指引》以及《香港联交所上市 规则》等境内外法律、法规、规范性文件的要求,并结合公司实际情况,董事 会修订、制定了如下公司于 H 股发行上市后适用的相关内部治理制度,具体如 下: | 序 | 制度 | 修订/ | 是否需要股东 | | --- | --- | --- | --- | | 号 | | 制定 | 大会审议 | | 1 | 股东会议事规则(草案) | 制定 | 是 | | 2 | 董事会议事规则(草案) | 制定 | 是 | | 3 | 信息披露事务管理制度(草案) | 修订 | 否 | | 4 | 关联(连)交易决策制度(草案) | 修订 | 是 | | 5 | 独立董事工作制度(草案) | 修订 | ...
悦康药业:拟发行H股
Ge Long Hui· 2025-12-05 09:30
Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its competitive edge and international brand image while diversifying financing channels [1] Group 1: Company Strategy - The company aims to improve its overall competitiveness and better utilize international capital markets [1] - The issuance of H-shares is part of a strategy to enhance the company's international brand image [1] Group 2: Regulatory Compliance - The company will comply with relevant laws and regulations, including the Company Law, Securities Law, and the Management Measures for the Overseas Issuance of Securities and Listing by Domestic Enterprises [1] - The listing will adhere to the rules of the Hong Kong Stock Exchange [1] Group 3: Shareholder Consideration - The company will consider the interests of existing shareholders when determining the timing and window for the H-share issuance [1] - The decision will be valid for 24 months from the date of the shareholders' meeting resolution, with the possibility of extension [1]
悦康药业(688658.SH)筹划发行H股股票并在香港联交所上市
Zhi Tong Cai Jing· 2025-12-05 09:25
智通财经APP讯,悦康药业(688658.SH)发布公告,为进一步提高公司综合竞争力,提升公司国际品牌 形象,同时更好地利用国际资本市场,多元化融资渠道,公司拟在境外发行股份(H股)并在香港联合交 易所有限公司(简称"香港联交所")主板上市。 ...
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
Core Viewpoint - The article discusses a promising new treatment for chronic hepatitis B virus (HBV) infection, highlighting the potential of the siRNA drug KC13-M2G2 to achieve functional cure, outperforming existing therapies [3][4][7]. Group 1: Background on HBV - Approximately 325 million people globally are chronically infected with HBV, leading to nearly 1 million deaths annually despite the availability of effective vaccines [2]. - Chronic HBV infection poses significant risks, including progressive liver disease and is responsible for nearly half of liver cancer cases [2]. Group 2: Research Findings - The research published by the team from悦康药业 in Nature Communications presents KC13-M2G2, an siRNA drug targeting the HBV S region, which aims to significantly suppress HBsAg levels and restore host immunity [3][6]. - KC13-M2G2 demonstrated strong antiviral efficacy against all HBV genotypes in vitro and showed rapid and sustained reductions in HBsAg and HBV DNA levels in multiple mouse models, with serological conversion of HBsAb [7]. - In toxicology studies on rats and crabs monkeys, KC13-M2G2 exhibited satisfactory biosafety, indicating its potential for clinical application [7].
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
Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) has received approval from the National Medical Products Administration (NMPA) for its YKYY018 aerosol inhalation agent, which is intended for post-exposure prophylaxis and treatment of respiratory syncytial virus (RSV) infections, and will initiate Phase I clinical trials [1] Group 1 - YKYY018 is developed by Yuyuan's subsidiary, Beijing Yuyuan Kechuang Pharmaceutical Technology Co., Ltd., utilizing a full-process AI platform [1] - The drug is an international original membrane fusion inhibitor with a novel mechanism of action, specifically binding to the F protein of the respiratory syncytial virus [1] - YKYY018 has dual functions for both treatment and prevention of RSV infections, and the company holds core patent rights with global exclusivity [1]