SIHUAN PHARM(00460)

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四环医药(00460):渼颜空间自主研发的注射用聚己内酯微球面部填充剂获得国家药监局批准
智通财经网· 2025-04-02 11:06
智通财经APP讯,四环医药(00460)发布公告,集团旗下渼颜空间生物科技(吉林)有限公司自主研发的注 射用聚己内酯微球面部填充剂正式获得中国国家药品监督管理局批准第三类医疗器械注册证。标志着四 环医药在医美领域的重大突破,也为国内再生医美材料市场注入了新的活力。 集团研发的这款"少女针"由预灌封注射器、一次性使用无菌注射针和封装在注射器中的凝胶颗粒悬液组 成,设计精巧,使用便捷。其适用于注射到鼻唇沟部位皮下层,以纠正中到重度鼻唇沟皱纹,能有效提 升面部整体年轻感。 除上述已获批的注射用聚己内酯微球面部填充剂(少女针)外,渼颜空间在再生材料领域还有多款产品布 局,管线中还包括聚乳酸面部填充剂(童颜针)、新型再生材料注射用聚羟基脂肪酸酯微球(PHA)填充 剂、注射用羟基磷酸钙微球面部填充剂、丝素蛋白类填充剂、以及更具独特工艺的液态再生材料等重磅 产品。 注射用聚己内酯微球面部填充剂,市场简称"少女针",是一种再生注射类材料,并以其独特的作用机理 使其在医美市场中备受瞩目。该产品注射到皮下组织后,其中的聚己内酯凝胶载体可起到即时填充的效 果,能迅速改善面部凹陷问题。而在凝胶载体被降解吸收后,聚己内酯微球可持续刺激 ...
四环医药(00460.HK)4月2日收盘上涨8.2%,成交5137.72万港元
搜狐财经· 2025-04-02 08:33
4月2日,截至港股收盘,恒生指数下跌0.02%,报23202.53点。四环医药(00460.HK)收报0.66港元/ 股,上涨8.2%,成交量8070.56万股,成交额5137.72万港元,振幅9.84%。 最近一个月来,四环医药累计涨幅3.39%,今年来累计跌幅7.58%,跑输恒生指数15.69%的涨幅。 2025年3月28日,2024财年年报归属股东应占溢利-2.167亿人民币,同比下降301.1%,基本每股收 益-0.0234人民币 (以上内容为金融界基于公开消息,由程序或算法智能生成,不作为投资建议或交易依据。) 来源:金融界 机构评级方面,目前暂无机构对该股做出投资评级建议。 行业估值方面,药品及生物科技行业市盈率(TTM)平均值为12.42倍,行业中值4.93倍。四环医药市 盈率-24.25倍,行业排名第95位;其他精优药业(00858.HK)为0.68倍、金斯瑞生物科技(01548.HK) 为1.2倍、百信国际(00574.HK)为1.49倍、东瑞制药(02348.HK)为3倍、帝王国际投资 (00928.HK)为3.98倍。 资料显示,四环医药控股集团有限公司成立於2001年。经过十几年的持续 ...
多重利好催化,四环医药(00460)“创新药+医美”双轮驱动战略成效显著
智通财经网· 2025-04-01 01:19
2024年财报发布,四环医药(00460)可谓捷报频传:全年实现总收益19.01亿元,同比上升约2.2%,一改 此前下降颓势,出现明确业绩拐点。 其中,医美板块延续24年上半年的增长趋势,收入高增66.4%,收入占比接近四成,已形成公司新的营 收支柱,产品管线和营销网络加速完善; 创新药板块取得388.1%的迅猛增速,肿瘤、糖尿病等热门领域多款重磅单品处于密集上市阶段,有望 持续贡献业绩增量。 两大业务板块的高速增长,表明四环医药向"医美+创新药"双轮驱动战略转型卓有成效。对此,四环医 药亦在业绩会上透露,公司转型战略已取得积极成果,25年有望实现盈亏平衡,26年有望进入正面盈利 阶段。 从市场层面来看,具备消费属性的医美行业仍然长坡厚雪,具备强势的长期增长逻辑;在政策红利释放 与技术创新共振下,港股创新药板块也已显现出回暖迹象。在"医美+创新药"双重布局初步形成的当 下,四环医药即将迎来价值重估的契机。 医美板块增长强劲 业务规模快速提升 在医美板块,得益于多款产品商业化进展积极及营销战略取得阶段性成功,带动业绩高速增长。报告期 内,公司医美分部业务收入约7.44亿元,同比增长约65.4%,收入增速在业界处 ...
业绩会议直击:四环医药(00460.HK)医美业务爆发式增长,创新药管线进入商业化拐点
格隆汇· 2025-03-31 05:38
此前,在今年2月初四环医药已经在市场公告盈警,而近日其年度成绩单正式出炉,至此财报靴子落 地。 01 财报亮点透视,"双引擎"驱动价值重估 当下四环医药无疑是站在了"医美爆发"和"创新药拐点"两个黄金赛道的交汇点。 梳理公司这份年度财报的亮点如下: 1、医美业务增长强劲。 医美业务实现收入7.44亿元,同比增长65.4%。新产品持续获批并贡献收入,推动医美业务利润率进一 步提升。 2、创新药业务快速发展。 创新药及其他药品收入约5760万元,同比上升388.1%。轩竹生物自研的一类新药安奈拉唑钠获批上市 并贡献收入,同时多款创新药和首仿药密集获批。 3、研发投入成效显著。 研发开支约4.74亿元,同比下降18.0%,但仍保持高强度投入。研发管线进展顺利,多款产品完成三期 临床试验,十余款药物研发注册稳步推进。 4、商业合作与市场拓展良好。 司美格鲁肽减重管线授权合作、SGLT-2抑制剂创新药脯氨酸加格列净片与华东医药达成战略联盟等, 加速创新药新品落地及市场渗透。医保目录的纳入与集采中选提升了产品的可及性,同时全产业链的协 同发展能力持续加强。 结合这份财报,不论是稳健的业务基本盘,良好的现金流状况来看,其释 ...
四环医药(00460)“医美+创新药”双轮驱动战略成效显著 2024年总收益同比上升约2.2%至19.01亿元
智通财经网· 2025-03-28 04:23
智通财经APP讯,四环医药(00460)公布2024年业绩,总收益约为人民币19.01亿元(单位下同),同比上升 约2.2%。毛利约为12.42亿元,整体研究及开发开支约为4.74亿元,同比下降18.0%。年内经营活动的现 金流量流入净额约为2.44亿元。 其中,来自医美业务的销售收益约为7.44亿元,同比上升约65.4%,主要由于年内产品获得市场的高度 认可,从而推动医美销售收入大幅增长,叠加新产品销售带来的新增收入。 来自创新药及其他药品的收益约为5760万元,同比上升约388.1%。主要由于轩竹生物自研的一类新药 安奈拉唑钠于 2023年下半年获批上市并开始产生收入。以上销售收益的变动趋势符合国内当前的"创新 驱动,腾笼换鸟"的行业政策趋势。 虽然在集采降价等行业政策动态调整的影响下,该集团的仿制药业务的经营性指标呈现阶段性调整态 势,但也正是在市场变革创新的背景下,该集团在以"创新驱动+资源整合"为核心下实现多项业务突 破,包括:医美平台通过独家代理射频治疗仪SylfirmX获批上市及续签肉毒毒素乐提葆®独家代理权, 产品优势持续巩固。旗下创新药平台惠升生物制药股份有限公司、轩竹生物等子公司全年推动十 ...
四环医药(00460) - 2024 - 年度业绩
2025-03-28 04:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明,並 明 確 表 示 概 不 就 因 本 公 告 全 部 或 任 何 部 份 內 容 而 產 生 或 因 倚 賴 該 等 內 容 而 引 致 之 任 何 損 失 承 擔 任 何 責 任。 Sihuan Pharmaceutical Holdings Group Ltd. 截至二零二四年十二月三十一日止年度的 全年業績公告 四環醫藥控股集團有限公司 (於百慕達註冊成立的有限公司) (股份代號:0460) 四 環 醫 藥 控 股 集 團 有 限 公 司(「四環醫藥」或「本公司」)董 事(「董 事」)會(「董事會」) 謹 此 宣 佈 本 公 司 及 其 附 屬 公 司(統 稱「本集團」或「集 團」)截 至 二 零 二 四 年 十 二 月 三 十 一 日 止 年 度(「本年度」或「年 內」)的 綜 合 業 績 連 同 去 年 的 比 較 數 字。 本集團財務摘要 – 1 – • 年內本集團取得總收益約為人民幣1,901.1百 萬 元(二 零 二 三 年:人 民 幣 1,860. ...
四环医药(00460) - 2024 - 中期财报
2024-09-23 08:31
澳 空 问题: 50 a persnica Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 (incorporated in Bermuda with limited liability) ( 於 百 慕 達 註 冊 成 立 之 有 限 公 司 ) Stock Code 股份代號:0460 门冬颜岛景注射准 Huisheng Pharm INTERIM REPORT 中 期 報 告 D 2 安奈拉唯铁颐湖片 轩竹生物 四环医药 SihuanPharm Gen PDF一定要壓細 10M內 Gen PDF一定要壓細 10M內 公司簡介 CORPORATE PROFILE 四環醫藥控股集團有限公司(「四環醫藥」或「本 公司」,連同其附屬公司為「本集團」)(股份代號: 00460.HK)創立於二零零一年,二零一零年於 香港聯合交易所有限公司主板上市,是一家以 創新為引領,堅持創新驅動,擁有獨立領先的 自主生產、研究與開發(「研發」)技術平台,具 備豐富的全球化產品管線和成熟卓越銷售體系 的國際化醫美及生物製藥企業。四環醫藥聚焦 醫美、腫瘤、代謝、糖尿病、心 ...
四环医药(00460) - 2024 - 中期业绩
2024-08-30 04:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明,並 明 確 表 示,概 不 對 因 本 公 告 全部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責 任。 SihuanPharm Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 (於百慕達註冊成立的有限公司) (股份代號:0460) 截至二零二四年六月三十日止六個月 中期業績公告 四 環 醫 藥 控 股 集 團 有 限 公 司(「四環醫藥」或「本公司」)董 事(「董 事」)會(「董事會」) 謹 此 公 佈 本 公 司 及 其 附 屬 公 司(統 稱「本集團」)截 至 二 零 二 四 年 六 月 三 十 日 止 六 個 月(「期 內」)的 未 經 審 核 綜 合 業 績 連 同 截 至 二 零 二 三 年 六 月 三 十 日 止 六 個 月 的 比 較 數 字。該 中 期 簡 明 綜 合 財 務 資 料 已 經 由 本 公 司 的 外 部 核 數 師 安 永 會 計師事務所根據國際審計和核證準 ...
四环医药(00460) - 2023 - 年度财报
2024-04-26 08:33
Product Approvals and Market Penetration - Four new non-PVC dual-chamber bag products were included in the 2023 National Medical Insurance Catalogue, which is expected to enhance patient usage willingness and accelerate market penetration in China [14]. - The proton pump inhibitor innovative drug Anjowei® (sodium anaprazole enteric-coated tablets) developed by Xuan Bamboo Biotechnology Co., Ltd. was also included in the 2023 National Medical Insurance Catalogue, facilitating faster hospital access and positive impact on company performance [14]. - Insulin aspart injection, insulin aspart 30 injection, and insulin aspart 50 injection developed by Huisheng Biopharmaceutical Co., Ltd. received drug registration approval from the National Medical Products Administration, marking the first approved insulin (analog) product to meet various clinical needs of diabetes patients [14]. - In November 2023, Sihuan Pharmaceutical's Azithromycin for Suspension and Dopamine Hydrochloride Injection won the bid for the ninth batch of national centralized procurement, which will enhance market share for these products [19]. - In December 2023, Xuanzhu Biopharm's Anaprazole Sodium Enteric-coated Tablets were included in the National Reimbursement Drug List, expected to lead to rapid sales growth and positively impact company performance [17]. - In December 2023, Huisheng Biopharm's Insulin Aspart Injection products received New Drug Application approval, addressing diverse clinical needs for diabetic patients [18]. - The inclusion of four non-PVC solid-liquid dual chamber bag products in the National Reimbursement Drug List in December 2023 is expected to increase market penetration and sales [16]. - Xuanzhu Biopharm's Anaprazole Sodium is recognized as the first and only PPI fully developed in China, highlighting the company's innovative capabilities [29]. - The NDA for Birociclib, a Class 1 new drug, was presented at the ASCO Annual Meeting in June 2023, showing potential efficacy in HR+ breast cancer patients resistant to endocrine therapy [33]. - The NDA for insulin degludec injection and Janagliflozin has been accepted by NMPA [53]. - The NDA for Anaprazole Sodium Enteric Dissolve Tablets has been accepted by the NMPA [54]. Clinical Trials and Research Developments - Xuanzhu Biopharm's Birociclib monotherapy for HR+/HER2- advanced breast cancer was accepted by the NMPA in October 2023, marking a significant advancement in treatment options for this patient group [20]. - The phase II clinical trial results of Birociclib demonstrated significant statistical differences compared to the control group, indicating its potential effectiveness in treating advanced breast cancer [26]. - In October 2023, Huisheng Biopharm's Insulin Degludec and Liraglutide Injection received approval to initiate clinical studies for type 2 diabetes, enhancing the company's product pipeline [25]. - The phase II clinical trial for Anaprazole Sodium Enteric-coated Tablets, developed by Xuanzhu Biopharm, completed patient enrollment in April 2023, targeting reflux esophagitis treatment [36]. - The completion of the phase III clinical trial for Birociclib in combination with fulvestrant reached its primary endpoint, indicating progress in advanced breast cancer treatment [36]. - The GLP-1 receptor agonist Semaglutide Injection is currently in clinical phase III for glucose-lowering indication, with weight-loss indication expected to file for IND in the second half of 2024 [151]. - Clinical research for Pyrotinib in HR+/HER2- advanced breast cancer has been accepted for NDA submission, with results recognized at major oncology conferences [179]. Financial Performance and Market Strategy - The Group recorded total revenue of approximately RMB1,860.5 million, a year-on-year decrease of approximately 14.7% compared to RMB2,181.2 million in the same period of 2022 [196]. - The medical aesthetics segment achieved revenue of approximately RMB449.9 million, representing a year-on-year increase of approximately 200.3% due to the easing of pandemic controls and recovery of consumer demand [197]. - The generic medicine segment reported revenue of approximately RMB1,398.8 million, a year-on-year decrease of approximately 29.0% due to price reductions from centralized procurement and declines in sales volumes [198]. - Revenue from innovative drugs and other drugs was approximately RMB11.8 million, reflecting a year-on-year decrease of 80.6% primarily due to the divestment of certain API companies [199]. - The Group invested approximately RMB577.7 million in R&D, a year-on-year decrease of 38.3%, as several products completed phase III clinical trials [200]. - The Group's pharmaceutical business achieved phased results with one innovative drug and three biopharmaceutical products receiving NDA approvals during the year [170]. - The Group is developing a pipeline of over 100 medical aesthetics and biopharmaceutical products, aiming to accelerate product industrialization and value amplification [200]. Awards and Recognition - Sihuan Pharmaceutical was recognized as one of the "2023 Top 100 Chinese Pharmaceutical Innovative Enterprises," highlighting its competitive advantages in the innovative drug field [88]. - Sihuan Pharmaceutical won the "Transformation Pioneer Enterprise of the Year 2023" award for its innovative business strategy, focusing on medical aesthetics and innovative drugs [90]. - The company received the "Best Innovation Value Award of the Year" for its innovative business strategies, showcasing its achievements in innovation [94]. - Sihuan Pharmaceutical was awarded the "Most Valuable Pharmaceutical and Medical Company," reflecting its strong corporate governance and stable value return for investors [97]. - The Chief Financial Officer, Ms. Miao Guili, was recognized as the "Best CFO," emphasizing the company's financial leadership [97]. - Sihuan Pharmaceutical won the "Best ESG Award," indicating its commitment to environmental, social, and governance performance [100]. - The company was also awarded the "ESG Pioneer Enterprise Award" at the 2023 ESG Summit, recognizing its efforts in ESG system construction and information disclosure [103]. - Xuanzhu Biopharm was recognized as one of the "Top 10 Most Growing Enterprises of Small Molecule Innovative Drugs" at the 2023 China Biomedical Technology Innovation Value List ceremony [113]. - Xuanzhu Biopharm was also rated as one of the "2023 China Top 100 Companies with Comprehensive Drug R&D Ability" based on extensive analysis of R&D-related data [116]. - Xuanzhu Biopharm received the title of "Top 50 Scientific and Innovative Leaders of China's Pharmaceutical Enterprises in 2023" for its outstanding R&D capabilities [120]. - Xuanzhu Biopharm was included in the "Forbes China Unicorn Enterprises" list, highlighting its innovation-driven approach and core proprietary intellectual property [123]. Strategic Focus and Future Plans - The Group intends to divest and dispose of some generic drugs and non-core pharmaceutical or healthcare businesses to focus on medical aesthetics and biopharmaceuticals, enhancing resource allocation efficiency [47]. - The company aims to transform towards medical aesthetics and innovative drugs, capitalizing on the growing market demand in the post-pandemic era [140]. - The light medical aesthetics industry in China is expected to experience explosive growth in 2024, transitioning from a luxury market to a mass consumer market [143]. - The company aims to enhance its global competitiveness while focusing on unmet clinical needs and developing innovative drugs [123]. - The company plans to expedite the NDA of innovative drugs and achieve product iteration of generic drugs through innovative drugs [155]. - The Group's strategic focus on registration, production, and sales capabilities is designed to create a solid competitive advantage in the pharmaceutical market [192]. - The Group is divesting non-core pharmaceutical and healthcare assets to focus on innovative drug development, aligning with its long-term strategic goals [191].
四环医药(00460) - 2023 - 年度业绩
2024-03-28 04:17
Financial Performance - The total revenue for the year was approximately RMB 1,860.5 million, a decrease of about 14.7% compared to RMB 2,181.2 million in the previous year[2]. - Revenue from generic drug sales was approximately RMB 1,398.8 million, down 29.0% from RMB 1,970.5 million, primarily due to price reductions and volume declines[3]. - Gross profit for the year was approximately RMB 1,295.6 million, a decrease of 12.9% from RMB 1,487.6 million, with a gross margin of 69.6%, up from 68.2%[3]. - Operating profit for the year was approximately RMB 161.7 million, a significant improvement from an operating loss of RMB 1,830.7 million in the previous year[3]. - The net loss for the year was approximately RMB 257.7 million, a reduction from RMB 2,283.3 million in the previous year[4]. - Cash flow from operating activities was approximately RMB 199.5 million, with cash and cash equivalents totaling approximately RMB 4,610.5 million as of December 31, 2023[4]. - Financial expenses increased by 27.5% to approximately RMB 269.3 million, primarily due to interest expenses related to redeemable liabilities[3]. - The company’s loss attributable to owners was approximately RMB 54.0 million, a decrease of 97.2% from RMB 1,914.9 million in the previous year[4]. Research and Development - Research and development expenses were approximately RMB 577.7 million, down 38.3% from RMB 936.6 million, due to the completion of several clinical trials[3]. - The company has made significant progress in the research and development of innovative drugs, with multiple self-developed products achieving substantial advancements[11]. - The innovative drug Anaprazole Sodium Enteric-Coated Tablets received approval from the National Medical Products Administration in June 2023 and was included in the National Medical Insurance Catalog[11]. - The company has submitted NDA applications for two indications of Pyrotinib, which have been accepted, and the clinical research results were presented at major oncology conferences[12]. - The company has advanced three globally leading innovative drugs into clinical stages, including XZP-KM501, XZP-6877, and XZP-KM602, with the latter receiving FDA approval for clinical trials in September 2023[12]. Market and Business Strategy - The management noted a significant slowdown in the Chinese consumer market, impacting the medical beauty sector and indicating a shift in consumer behavior[5]. - The company is committed to a dual-driven strategy of "innovative drugs + medical aesthetics," which has proven effective in enhancing its market position[8]. - The ongoing medical reform in China continues to drive the pharmaceutical industry, despite challenges such as volume-based procurement and economic downturns[7]. - The company is gradually divesting non-core pharmaceutical and health-related businesses to focus on innovative drug development[14]. - The company aims to improve cash flow generation capabilities while adhering to the dual-driven strategy of "medical aesthetics + innovative drugs" to maximize shareholder value[58]. Medical Aesthetics Segment - The medical aesthetics segment saw a substantial recovery in sales revenue, driven by the successful upgrade of the 3.0 version of the sales platform, resulting in a significant increase in sales[9]. - The medical aesthetics platform, Meiyan Space, expanded its sales channels to cover a total of 4,700 medical beauty institutions across the country, achieving 100% coverage of the top 500 institutions[9]. - The company has launched multiple products in the medical aesthetics sector, including Botulinum Toxin and Hyaluronic Acid, which have received positive recognition from consumers and medical institutions[10]. - The aesthetic medicine segment achieved revenue of approximately RMB 449.9 million, a significant increase of about 200.3% due to the lifting of pandemic restrictions and recovery in consumer demand[16]. - The company aims to build a leading position in the Chinese aesthetic medicine market through a robust product matrix and diverse marketing channels[20]. Awards and Recognition - The company has been recognized with several awards, including the "Outstanding Enterprise Award" at the 2023 China Medical Beauty Industry Awards and the "Annual Botulinum Toxin Brand Award" at the 3rd Light Chasing Awards[10]. - The company has been recognized with multiple awards, including "Forbes China's Unicorn Enterprise" and "Top 10 Most Growth-Oriented Small Molecule Innovative Drug Enterprises" in 2023[12]. Financial Position and Liabilities - The group maintained a stable financial position with cash and cash equivalents totaling approximately RMB 4,610.5 million as of December 31, 2023, after deducting interest-bearing bank loans[18]. - The group's borrowings to equity ratio was 25.6%, indicating a moderate level of leverage[18]. - The total liabilities increased to RMB 4,106,802 thousand from RMB 2,533,000 thousand in the previous year[62]. - The company reported a total impairment loss on non-current assets was RMB (1,291,043) thousand, with significant losses attributed to innovative drugs and other pharmaceuticals[78]. Operational Efficiency - The company has implemented a comprehensive operational transformation, integrating sales, planning, production, and logistics through an online ERP expansion module[49]. - The company has enhanced its production capacity to over 10 million units and improved internal operational efficiency and R&D effectiveness through production line upgrades[49]. - The company is focusing on optimizing its generic drug business while accelerating the divestiture of non-core traditional pharmaceutical assets[51]. Future Outlook - The company aims to achieve better performance in 2024 through a dual model of direct sales and agency management for its new product line, Meiyan Space[34]. - The company is actively pursuing market expansion and new strategies in drug development and commercialization[37]. - The company aims to expand its product portfolio with innovative therapies targeting cardiovascular and chronic kidney diseases[45].