SIHUAN PHARM(00460)

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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].
四环医药(00460) - 2023 - 中期财报
2023-09-26 08:30
Hulsheng Pharm 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 2023 Interim Report 中期報告 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 的自主研究與開發(「研發」)技術平台,具備豐 富的全球化產品管線,強大的產品註冊能力, 高效率及低成本的全劑型生產平台和成熟卓越 銷售體系的國際化醫美及生物製藥企業。四環 醫藥一直秉承「堅持全速推進四環醫美及生物製 藥雙輪驅動戰略」的整體戰略目標來打造中國領 先的醫美及生物製藥企業。 Founded in 2001 and listed on the Main Board of The ...
四环医药(00460) - 2023 - 中期业绩
2023-08-29 04:01
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) 截至二零二三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 三 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 二 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 計和核證準則委員會頒佈的國際審閱業務準則第2410號「由 實 體 的 獨 立 核 數 師 審 閱 中 期 財 務 資 ...
四环医药(00460) - 2022 - 年度业绩
2023-05-23 13:30
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。 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) 補充公告 有關二零二二年年報之補充資料 茲 提 述 四 環 醫 藥 控 股 集 團 有 限 公 司(「本公司」,及 其 附 屬 公 司,「本集團」)於 二 零 二 三 年 四 月 二 十 七 日 刊 發 之 截 至 二 零 二 二 年 十 二 月 三 十 一 日 止 年 度(「本年度」)之 年 度 報 告(「二零二二年年報」)。除 另 有 界 定 外,本 公 告 所 用 詞 彙 與 二 零 二 二 年 年 報 所 界 定者具有相同涵義。 除二零二二年年報提供的資料外,本公司謹此就減值虧損的詳情提供以下補充資料。 截至二零二二年十二月三十一日止年度之減值虧損 誠如二零二二年年報所披露,於本年度內,本集團把物業、廠房及設 ...
四环医药(00460) - 2022 - 年度财报
2023-04-27 08:36
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 2022 Annual Report 年度報告 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、心腦血管、現 代中藥及工業大麻等高增長治療領域,一直秉 承「堅持全速推進四環醫美及生物製藥雙輪驅動 戰略」的整體戰略目標來打造中國領先的醫美及 生物製藥企業。 Founded in 2001 and listed on the Main Board of The ...
四环医药(00460) - 2022 - 年度业绩
2023-03-24 04:11
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。 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) 截至二零二二年十二月三十一日止年度的 全年業績公告 及 建議修訂細則 及 採納新細則 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 二 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 | --- | --- | |---------------------------------------------------------------------------- ...