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华熙生物:通过美国FDA现场检查
news flash· 2025-07-09 08:13
华熙生物公告,公司于2025年3月24日至2025年3月28日接受了美国食品药品监督管理局(FDA)的cGMP 现场检查,涵盖质量体系、设施与设备、物料系统、生产系统、实验室系统、包装与标签六大系统,检 查产品范围为玻璃酸钠原料药。近日,公司收到FDA出具的检查报告,以零缺陷("0-483")通过本次现场 检查。此次是公司继2012年首次参与美国FDA现场检查以来,第五次通过FDA现场检查,表明公司高质 量生产制造规范持续获得国际权威机构的认可。本次"零缺陷通过"为FDA对药品生产质量体系合规性的 最高认可,标志着公司质量管理体系达到国际高标准。 ...
全球首个非动物源肝素平台落成!光明科学城合成生物大动作
【SynBioCon】 获 悉,7月7日上午,全球透明质酸产业领导者 华熙生物 旗下企业 华熙唐安生物科技(深圳)有限公司 (简称"华熙唐安")落地光明 科学城。 这是华熙生物在透明质酸领域之外实现多元化发展及合成生物技术应用的重大战略部署,也是华熙生物在粤港澳大湾区建立的 全球首个非动物源肝素全产 业链平台 。 据了解,华熙生物以合成生物为驱动,聚焦 糖生物学和细胞生物学 ,已拥有生物活性物原料、药品及医疗器械、皮肤科学创新转化及营养科学创新转化四 大业务板块,旗下诞生了润致、润百颜、夸迪、米蓓尔、BM肌活等消费品牌。 依托华熙生物优势产业基础, 华熙唐安已在全酶合成肝素领域实现多维度技术突破与产业革新,相关产品在化妆品、药品、医疗器械等领域具有广泛应用 ,临床上更是预防和治疗血栓栓塞性疾病、心肌梗死、心血管手术抗凝等场景的关键药物。 华熙唐安的落地,将吸引集聚更多医美、化妆品细分领域上下游企业,助力光明打造具有科学城特色的产业集群,建设具有国际影响力与竞争力的合成生 物产业创新高地。 ▌ 参考信息: 本 文部分 素 材 来 自光明科学城 。由 作 者重新 编写,系作者个人观点,本平台发布仅为了传达一种不同 ...
华熙生物: 北京市通商律师事务所关于华熙生物科技股份有限公司差异化分红事项之专项法律意见书
Zheng Quan Zhi Xing· 2025-07-07 11:19
Core Viewpoint - The legal opinion issued by Tongshang Law Firm confirms that Huaxi Biological Technology Co., Ltd.'s differentiated dividend distribution plan for 2024 complies with relevant laws and regulations, ensuring no harm to the interests of the company and its shareholders [3][6]. Group 1: Differentiated Dividend Distribution - The reason for the differentiated dividend distribution is due to the company's share repurchase plan, which will result in a discrepancy between the total share capital and the shares participating in profit distribution [3][4]. - Huaxi Biological plans to distribute a cash dividend of RMB 0.11 per share (tax included) based on the total share capital minus the shares held in the repurchase account, with no capital reserve conversion or bonus shares [4][5]. - As of the date of the legal opinion, the total share capital of Huaxi Biological is 481,678,242 shares, with 3,315,538 shares in the repurchase account, leading to a total of 478,362,704 shares eligible for the cash dividend distribution, amounting to a total of RMB 52,619,897.44 (tax included) [5]. Group 2: Calculation Basis for Dividend Distribution - The calculation for the ex-dividend reference price is based on the formula: (previous closing price - cash dividend) ÷ (1 + change in circulating shares ratio), with the circulating shares ratio being 0 since only cash dividends are distributed [5]. - The closing price of the stock on June 23, 2025, was RMB 50.67 per share, leading to an ex-dividend reference price of RMB 50.56 per share after accounting for the cash dividend [5][6]. - The impact of the differentiated dividend on the ex-dividend reference price is less than 1%, indicating a minimal effect [6]. Group 3: Legal Compliance and Conclusion - The legal opinion asserts that the differentiated dividend distribution does not violate the Company Law, Securities Law, or self-regulatory guidelines, and does not harm the interests of the company or its shareholders [6].
华熙生物: 华熙生物2024年年度权益分派实施公告
Zheng Quan Zhi Xing· 2025-07-07 11:12
证券代码:688363 证券简称:华熙生物 公告编号:2025-025 每股现金红利0.11元(含税) ? 相关日期 股权登记日 除权(息)日 现金红利发放日 一、 通过分配方案的股东大会届次和日期 本次利润分配方案经公司2025 年 6 月 11 日的2024年年度股东大会审议通过。 二、 分配方案 华熙生物科技股份有限公司 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: ? 是否涉及差异化分红送转:是 ? 每股分配比例 截至股权登记日下午上海证券交易所收市后,在中国证券登记结算有限责任 公司上海分公司(以下简称"中国结算上海分公司")登记在册的除华熙生物科技 股份有限公司回购专用证券账户外的本公司全体股东。 (1) 差异化分红送转方案 根据公司 2024 年年度股东大会审议通过的《关于公司 2024 年度利润分配预 案的议案》,公司 2024 年度利润分配方案为:以实施权益分派股权登记日登记的 总股本扣除公司回购专用证券账户中股份数为基数,每股派发现金红利 0.11 元(含 税),不进行资本公积转增股本, ...
华熙生物(688363) - 华熙生物2024年年度权益分派实施公告
2025-07-07 11:00
证券代码:688363 证券简称:华熙生物 公告编号:2025-025 华熙生物科技股份有限公司 2024年年度权益分派实施公告 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: | 股权登记日 | 除权(息)日 | 现金红利发放日 | | --- | --- | --- | | 2025/7/11 | 2025/7/14 | 2025/7/14 | 一、 通过分配方案的股东大会届次和日期 本次利润分配方案经公司2025 年 6 月 11 日的2024年年度股东大会审议通过。 二、 分配方案 1. 发放年度:2024年年度 2. 分派对象: 截至股权登记日下午上海证券交易所收市后,在中国证券登记结算有限责任 公司上海分公司(以下简称"中国结算上海分公司")登记在册的除华熙生物科技 股份有限公司回购专用证券账户外的本公司全体股东。 3. 差异化分红送转方案: (1) 差异化分红送转方案 根据公司 2024 年年度股东大会审议通过的《关于公司 2024 年度利润分配预 由于公司本次进行差异化分红送转,上述公式中现金 ...
2025年中国医疗美容细分市场分析:轻医美市场贡献过半
Qian Zhan Wang· 2025-07-07 04:14
Core Insights - The light medical beauty market in China has surpassed half of the overall medical beauty market, becoming the mainstream beauty method by 2024, with significant contributions from non-invasive and minimally invasive procedures [1][2] Market Overview - Light medical beauty is defined as professional medical beauty projects that fall between surgical procedures and lifestyle beauty, utilizing non-invasive or minimally invasive methods for skin management, contour modification, and anti-aging effects [1] - The rapid growth of the light medical beauty market is attributed to its advantages such as minimal trauma, quick recovery, significant results, and relatively low risks, aligning with modern consumers' dual demands for beauty and quality of life [2] Consumer Trends - The penetration rate of the light medical beauty market is increasing, with 34% of consumers planning to engage in light medical beauty services in the coming year, marking a 36% increase from the previous year [4] - Among the interested consumer group, over one-third are new entrants, injecting fresh growth vitality into the Chinese medical beauty industry [4] Popular Products - Injectable and photothermal products are the main attractions for light medical beauty consumers, with ultrasound-based products (e.g., ultrasound scalpel) rapidly gaining popularity [5] Consumption Behavior - Consumers are increasingly rational in their light medical beauty choices, prioritizing needs-based combinations of projects and products, with over half selecting options based on specific needs [7] - The average planned consumption has increased to 2.4 projects per consumer, reflecting a 14% year-on-year growth [7] Consumer Demographics - The consumer base for light medical beauty exhibits high retention and strong growth, with seasoned consumers making up 35% of the existing market, indicating their essential role in the market [10] - Among the new consumer group, high-end novices represent 38%, characterized by high standards for beauty and a willingness to pay, with a focus on facial anti-aging solutions [10]
衡美健康北交所IPO受理 市场总局助推保健食品企业风险防控能力【一周财经】
Sou Hu Cai Jing· 2025-07-06 01:27
源头创新开辟营养健康新赛道 7月2日,国家卫生健康委员会发布《关于D-阿洛酮糖等20种"三新食品"》的公告,对D-阿洛酮糖等5种物质申请作为新食品原料,氨基肽酶等9种物质申请 作为食品添加剂新品种,月桂酸铵等6种物质申请作为食品相关产品新品种。 #03-官方释放保健食品三大信号! 下一风口锁定中药复方 SHUZHENG 关注行业每天发生的变化,是把握行业脉络、锻炼专业素养、培养商业敏锐度的必经之路。庶正康讯为大家按类别整合一周财经新闻,希望有所帮助。 何为商业广告? 总局发文厘清边界 7月4日,市场监管总局发布《〈中华人民共和国广告法〉适用问题执法指南(一)》,直击当下广告执法中"何为商业广告"的核心争议,阐释《广告法》 调整范围。 #02-D-阿洛酮糖等5种新原料获批! 国家市场监督管理总局公开多个对两会代表的提案建议案答复,其中对保健食品有诸多表态,也让我们可以更加清晰的把握到中国保健食品法规发展的脉 络。 #04-闯关资本局! 2025H1营养健康赛道投融资扫描 据港交所2025年6月30日披露,Yangtuo Technology Inc.已正式向港交所主板提交上市申请,中信证券担任独家保荐人。此次I ...
2025年中国医疗美容用户画像分析:男性医美需求激增,出境医美趋热
Qian Zhan Wang· 2025-07-03 08:54
Group 1 - The majority of consumers in the medical beauty market spend between 10,000 to 50,000 yuan annually, indicating a diverse range of services from basic skincare to moderately complex cosmetic procedures [1] - First-tier cities dominate the medical beauty consumption market, accounting for approximately 69% of total spending, driven by concentrated medical resources and advanced consumer capabilities [3] - The average age of consumers in the medical beauty sector is around 35 years, with over 72% of high-end consumers aged 30 and above, reflecting a mature and stable consumption mindset [5][7] Group 2 - There is a notable increase in male consumers seeking medical beauty services, with 43% planning to increase their spending in this area, highlighting a shift in self-image management among men [7][8] - The demand for outbound medical beauty services is rising, particularly in Japan and South Korea, with about 31% of middle to high-income consumers planning to seek these services abroad in 2024 [10]
蹲点调查|探寻透明质酸产业发展的“第二增长曲线”
Da Zhong Ri Bao· 2025-07-03 05:47
Group 1 - The Shandong provincial government has implemented a plan to boost consumption, focusing on six key tasks and 20 specific measures, including the enhancement of health consumption and the development of health-related industries such as health tourism and biomedicine [2] - The hyaluronic acid industry in Shandong, led by companies like Huaxi Bio and Furuida, has formed a trillion-level industrial cluster, responding to rapidly changing consumer aesthetics and demands [2][14] - Huaxi Bio has emphasized the importance of establishing scientific and unified testing standards for the industry, following a public dispute with competitor Juzhi Bio regarding product quality and testing methods [3][6] Group 2 - The competition between Huaxi Bio and Juzhi Bio has highlighted the challenges in the hyaluronic acid market, with Huaxi Bio accusing Juzhi Bio of misleading research that undermines the hyaluronic acid industry [6][8] - Despite the ongoing competition, the hyaluronic acid market is experiencing a decline in product prices, with some high-end products dropping to as low as 10% of their previous prices [9][10] - The three major players in the hyaluronic acid sector, including Huaxi Bio, have reported negative growth in revenue and net profit in recent quarters, contrasting with the strong performance of companies in the recombinant collagen sector [10][11] Group 3 - Huaxi Bio has maintained a leading position in the global hyaluronic acid market, holding a 44% share of global sales in 2021 and actively participating in the development of industry standards [16] - The company is undergoing a strategic upgrade, investing over 100 million yuan in innovative business areas such as regenerative medicine and nutritional science [16] - Furuida is also expanding into the recombinant collagen market, recognizing the need for transformation and innovation in response to industry pressures [19][20] Group 4 - Experts suggest that the hyaluronic acid industry has reached maturity and needs to explore a "second growth curve" to maintain competitiveness and sustainable development [21] - The relationship between hyaluronic acid and collagen is viewed as complementary rather than competitive, with both having unique advantages in various applications [20] - The industry is focusing on developing new business models and products that align with consumer health trends, including functional foods and personalized raw materials [19][20]
被华熙生物暗指“伪科学”!巨子生物回应:不作评价
Nan Fang Du Shi Bao· 2025-07-02 15:23
Core Viewpoint - Huaxi Biological asserts that claims exempt from scientific verification are inherently pseudoscientific, emphasizing the necessity of measurable and verifiable scientific methods in the industry [1][2]. Group 1: Huaxi Biological's Position - Huaxi Biological argues that the absence of standardized testing methods does not negate the existence of scientific methods for validation, using their product "Runbaiyan" as an example of verifiable testing results for recombinant collagen [2][5]. - The company highlights the use of High-Performance Liquid Chromatography-High-Resolution Mass Spectrometry (HPLC-HRMS) as a reliable method to accurately measure recombinant collagen content, claiming it effectively avoids complex matrix interference [5][12]. Group 2: Response from Juzhi Biological - Juzhi Biological acknowledged the limitations of their existing quality standards and testing methods in a statement, indicating a need for continuous optimization to meet industry advancements [6][9]. - The company plans to collaborate with research institutions to enhance the qualitative and quantitative detection methods for recombinant collagen in cosmetics, aiming for greater transparency and industry standardization [9][10]. Group 3: Testing Method Controversy - The debate over testing methods arose when beauty blogger Dazui Doctor (Hao Yu) questioned the recombinant collagen content in a product, using a high-precision HPLC amino acid quantification method, which Juzhi Biological claimed was not included in industry standards [10][11]. - Experts noted that both HPLC amino acid quantification and HPLC-HRMS methods have their unique applications and challenges, particularly in detecting low concentrations of collagen in complex cosmetic formulations [12][13].