自願公告 創新藥安奈拉唑鈉用於反流性食管炎的新適應症 III期臨床完成首例受試者入組 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） 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。 關於軒竹生物 軒 竹 生 物 是 四 環 醫 藥 旗 下 的 創 新 藥 子 公 司，是 一 家 根 植 於 中 國、具 有 全 球 化 視 野 的 創 新 型 制 藥 企 業，聚 焦 於 消 化、腫 瘤 及 非 酒 精 性 脂 肪 性 肝 炎 等 重 大 疾 病 領 域，致 力 於 研 發、生 產 及 商 業 化 具 有 核 心 自 主 知 識 產 權 的1類 新 藥。公 司 擁 有 一 流 的 研 發 團 隊，核 心 人 員 均 具 有 多 年 新 藥 研 發 經 驗。公 司 同 時 具 備 小 ...

Core Viewpoint - Four Seasons Pharmaceutical has launched three self-developed aesthetic products, becoming the only compliant dual regeneration injection holder in China [1] Group 1: Product Launch and Innovation - The newly launched products include: 1) PLLA Youthful Injection, which is divided into two variants based on microsphere particle size: Sifuyan (larger particles for deep injection) and Huiyan Zhen (finer particles for dermal applications) [1] - 2) PCL Tinging, which features uniform particle size and high dispersion to avoid local irritation, enhancing support and viscoelasticity during injection [1] - The company is transitioning from single products to comprehensive aesthetic treatment solutions, addressing the evolving consumer demand for more complete aesthetic plans [1] Group 2: Market Position and Strategy - The core barriers for aesthetic enterprises lie in high-quality pipelines (underlying R&D capabilities) and B2B2C channel management (commercialization capabilities) [2] - Four Seasons Pharmaceutical has built a product matrix of over 60 products through self-research and business development, with its core product, Letibao Botulinum Toxin, covering over 6,200 aesthetic institutions across more than 370 cities in China [2] - The launch of the three regeneration products significantly strengthens the company's pipeline synergy, with expectations for performance growth through collaboration with existing products and mature channel systems [2] Group 3: Financial Performance and Forecast - The company is expected to achieve revenues of 2.32 billion, 3.44 billion, and 4.73 billion yuan in 2025-2027, with growth rates of 22%, 48%, and 37% respectively [2] - The net profit attributable to the parent company is projected to be 60 million, 530 million, and 780 million yuan for the same period, with a corresponding PE of 22 times for 2026 [2] - The adjustment in revenue forecasts reflects the strengthening of pipeline synergy and performance realization from the new aesthetic products [2]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative price increase of over 20% within the next six months [19]. Core Viewpoints - The launch of new regenerative products positions the company as the only compliant holder of dual regenerative injectables in China [2]. - The company is transitioning from single product offerings to comprehensive aesthetic treatment solutions, addressing the evolving demands in the aesthetic medicine market [4]. - The company has established a robust product pipeline and distribution network, with over 60 products developed and a presence in more than 6,200 aesthetic institutions across 370 cities [5]. - The traditional pharmaceutical business is stabilizing, with a focus on innovative drugs, including the upcoming launches of key products [6]. Financial Performance and Forecast - Revenue projections for 2025-2027 are adjusted to 2.32 billion, 3.44 billion, and 4.73 billion RMB, respectively, with growth rates of 22%, 48%, and 37% [6]. - The net profit forecast for the same period is 63 million, 528 million, and 783 million RMB, with corresponding growth rates of 129%, 736%, and 48% [6]. - The expected price-to-earnings ratio for 2026 is 22 times, reflecting a positive outlook on profitability [6].

Core Insights - The medical beauty injection market is rapidly transforming the industry landscape, driven by minimally invasive procedures, quick recovery, and broad applicability, making it the most promising segment in the medical beauty field [1] - The regenerative injection market in mainland China is projected to maintain a high compound annual growth rate of 54.73%, with an expected market size exceeding 11.52 billion yuan by 2027, reflecting explosive consumer demand and accelerated technological innovation [1] Company Developments - Four Seasons Pharmaceutical's stock price has risen against the trend, primarily due to strong growth signals from its dual focus on medical beauty and innovative drugs [2] - The company launched three new regenerative medical beauty products, which are expected to fill clinical technology gaps and rapidly capture market share, thus injecting new momentum into its medical beauty business [2] - The innovative drug sector is also progressing, with the approval of a CDK4/6 inhibitor for late-stage breast cancer, enhancing market confidence and supporting the company's valuation [2] Industry Trends - The regenerative medical beauty sector is entering a "new product explosion period," marked by a surge in regulatory approvals and innovations [1][2] - The industry is shifting towards a comprehensive service system that combines aesthetic and psychological value, moving beyond mere external improvements [5] Product Innovations - The newly launched products, including 回颜臻® (Youthful Needle), 斯弗妍® (Youthful Needle), and 倾研® (Youthful Needle), are designed to activate the skin's collagen regeneration system, offering long-lasting effects rather than temporary solutions [11][12] - These products utilize advanced technologies to ensure precise targeting and effective results, transforming the approach to anti-aging treatments [11][12] Strategic Vision - Four Seasons Pharmaceutical emphasizes a commitment to continuous innovation and technological breakthroughs, aiming to redefine the boundaries of anti-aging aesthetics [15] - The company is focused on creating a comprehensive ecosystem for skin rejuvenation, integrating various treatment modalities to meet diverse consumer needs [7][8]

Core Viewpoint - The company Sihuan Pharmaceutical (00460.HK) is pursuing the independent listing of its subsidiary Xuan Zhu Bio-Tech, which has faced challenges in its previous attempts to list on the STAR Market and is now targeting the Hong Kong Stock Exchange for its IPO [1][4]. Group 1: Listing Attempts - Sihuan Pharmaceutical initially planned to spin off Xuan Zhu Bio-Tech for a listing on the STAR Market in March 2022, but the IPO was halted in March 2023 and ultimately withdrawn in May 2024 due to strategic considerations and market conditions [4]. - Following the withdrawal from the A-share market, Sihuan Pharmaceutical initiated a new plan to list Xuan Zhu Bio-Tech on the Hong Kong Stock Exchange, with a second application submitted in June 2024 [4]. Group 2: Product Development - Xuan Zhu Bio-Tech has successfully launched its core product KBP-3571, which is used for treating duodenal ulcers and is expanding its indications to include gastroesophageal reflux disease [6][8]. - The company has over ten drug assets in active development, targeting diseases such as digestive system disorders, tumors, and non-alcoholic fatty liver disease [6]. Group 3: Financial Performance - Despite the launch of KBP-3571, Xuan Zhu Bio-Tech reported continuous losses, with projected losses increasing in 2024. Revenue figures for 2023 and 2024 show a significant decline, with losses reported at 300 million yuan for 2023 and 556 million yuan for 2024 [9]. - The company's R&D expenditures have decreased in 2024, with a notable drop in the proportion of R&D spending relative to total operating expenses, attributed to increased administrative and sales expenses [10]. Group 4: Future Outlook - Xuan Zhu Bio-Tech plans to continue investing heavily in the clinical development of its core products, particularly KBP-3571, which is entering Phase III trials, and other products targeting breast cancer and lung cancer [11].

Core Viewpoint - The global ESG investment is accelerating towards mainstream adoption, with investors recognizing that companies with strong ESG performance tend to have better innovation capabilities and long-term resilience, leading to more stable and sustainable investment returns [1] Group 1: Medical Aesthetics Business Growth - The medical aesthetics business of the company is experiencing explosive growth, with projected revenue of 744 million yuan in 2024, representing a year-on-year increase of 65.4% [3] - The growth is supported by continuous investment in product innovation compliance and channel deepening [3] Group 2: Product Innovation and Quality - The company has developed a product matrix for medical aesthetics, including self-developed injectable products that have received regulatory approval, focusing on quality stability, clinical efficacy, and safety [4] - The company is expanding its product line with potential new products expected to be approved in the next 1 to 3 years, including collagen and water light needles [4] Group 3: Channel Expansion and Internationalization - The company has established a dual-track model of "direct sales + agency," covering over 370 cities and collaborating with more than 6,200 medical aesthetic institutions [6] - The company is accelerating its international expansion, with successful registrations of some products in Indonesia and Malaysia, and plans to enter markets in Brazil and the Middle East [6] Group 4: Innovation in Pharmaceuticals - The company is recognized for its deep engagement in innovative drugs and biopharmaceuticals, focusing on improving drug accessibility and addressing unmet clinical needs [7] - The company has multiple innovative drugs approved for various therapeutic areas, including oncology and diabetes, with significant market potential [12] Group 5: Financial Outlook and Growth Strategy - The company aims to achieve approximately 2.3 billion yuan in revenue by 2025, with a goal of turning overall operating profit positive [13] - With a cash reserve of nearly 4 billion yuan, the company is well-positioned to support the commercialization of its new products and drive further value enhancement [13]

Group 1 - The core point of the article is that Sihuan Pharmaceutical's subsidiary, Xuan Bamboo Biotech, has received acceptance for a new drug application (NDA) for the innovative drug Palbociclib (brand name: Xuan Yue Ning®) for a new indication in treating HR+/HER2- advanced breast cancer patients [1][2] - The new indication involves using Palbociclib in combination with aromatase inhibitors as initial endocrine therapy and as subsequent treatment for patients who have progressed after tamoxifen or toremifene adjuvant therapy [1] - Palbociclib is a CDK4/6 inhibitor with a unique multi-target synergistic mechanism that significantly reduces hematological toxicity compared to traditional CDK4/6 inhibitors, enhancing patient tolerance to treatment [1] Group 2 - Breast cancer is the most common malignant tumor among women globally, with 2.3 million new cases reported in 2022, and projections indicate 3.2 million new cases by 2050, with approximately 70% being HR+/HER2- subtype, indicating a substantial treatment demand [2] - The global market for CDK4/6 inhibitors is expected to reach nearly $13 billion in 2024, reflecting an approximate 18% year-on-year growth [2] - The acceptance of the NDA for the new indication of Palbociclib demonstrates the company's strong innovative research capabilities and commitment to providing more effective treatment options for breast cancer patients [2]

Core Viewpoint - The stock performance of pharmaceutical companies, particularly SiHuan Pharmaceutical, has been notably strong following the approval of its innovative drug, Pyrotinib tablets, for treating advanced breast cancer [1][3][4]. Company Overview - SiHuan Pharmaceutical operates in various segments including aesthetic medicine, innovative drugs, and generic drugs, with a focus on multiple therapeutic areas such as diabetes, oncology, and digestive diseases [3]. - The company has developed over 60 aesthetic medicine products and more than 40 innovative and biological drug pipelines [3]. Recent Developments - On May 15, SiHuan Pharmaceutical announced that its subsidiary, XuanZhu Biotechnology, received approval from the National Medical Products Administration of China for its innovative drug Pyrotinib tablets for two indications related to HR+/HER2- advanced breast cancer [3][4]. - Pyrotinib is the only approved CDK4/6 inhibitor in China for this specific indication, marking a significant milestone for XuanZhu Biotechnology [4]. Market Context - Breast cancer is the most common malignancy among women globally, with an estimated 2.3 million new cases in 2022, projected to rise to 3.2 million by 2050 [5]. - Approximately 70% of breast cancer patients are HR+ subtype, indicating a substantial treatment demand [5]. - The global sales of CDK4/6 inhibitors exceeded $10 billion in 2023, with China's sales reaching approximately RMB 2.2 billion, expected to grow to RMB 13 billion by 2032 [5]. Financial Performance - SiHuan Pharmaceutical has faced declining performance in recent years, with revenues of RMB 2.181 billion in 2022, projected to be RMB 1.861 billion in 2023 and RMB 1.901 billion in 2024 [8]. - The company reported significant losses, with shareholder profits of -RMB 1.915 billion in 2022 and -RMB 0.54 billion in 2023 [8]. - The generic drug segment saw a revenue decline of approximately 21.4% in 2024, while the aesthetic medicine segment grew by about 65.4% [9]. Future Outlook - The approval of Pyrotinib is expected to positively impact SiHuan Pharmaceutical's financial performance, although the extent of this impact remains to be seen [10]. - The aesthetic medicine segment shows promising growth and could significantly contribute to the company's overall performance moving forward [10].

财务数据显示，截至2024年12月31日，四环医药实现营业总收入19.01亿元，同比增长2.18%；归母净利 润-2.17亿元，同比减少301.1%；毛利率65.32%，资产负债率53%。 机构评级方面，目前暂无机构对该股做出投资评级建议。 5月19日，截至港股收盘，恒生指数下跌0.05%，报23332.72点。四环医药（00460.HK）收报0.78港元/ 股，上涨16.42%，成交量4.59亿股，成交额3.55亿港元，振幅17.91%。 行业估值方面，药品及生物科技行业市盈率（TTM）平均值为6.09倍，行业中值5.87倍。四环医药市盈 率-26.38倍，行业排名第92位；其他精优药业（00858.HK）为0.68倍、金斯瑞生物科技（01548.HK）为 0.96倍、东瑞制药（02348.HK）为2.86倍、正大企业国际（03839.HK）为3.52倍、联康生物科技集团 （00690.HK）为5.55倍。 最近一个月来，四环医药累计涨幅6.35%，今年来累计涨幅1.52%，跑输恒生指数16.38%的涨幅。 资料显示，四环医药控股集团有限公司成立於2001年。经过十几年的持续发展,现已成为中国处方药市 场领 ...

港股收盘，恒指收跌0.05%，恒生科技指数收跌0.50%，四环医药(00460.HK)收涨16.42%，阿里巴巴 (09988.HK)收跌3.4%。 ...