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10款1类新药首次在中国获批临床!来自翰森制药(03692)等
智通财经网· 2025-04-19 02:29
Core Insights - A total of 10 first-class innovative drugs have received clinical trial approval in China from April 14 to April 19, covering various types including small molecules, antibody-drug conjugates (ADC), gene therapy, and cell therapy, targeting conditions such as advanced solid tumors, type 1 diabetes, spinal cord injury, Duchenne muscular dystrophy (DMD), and paroxysmal nocturnal hemoglobinuria [1] Group 1: Company-Specific Developments - Hansoh Pharmaceutical's HS-10529, a KRAS G12D small molecule inhibitor, has been approved for clinical trials to treat advanced solid tumors with KRAS G12D mutations, showing good preclinical efficacy and safety [2] - Kanghong Pharmaceutical's KH815, a TROP2-targeted dual-payload ADC, has received clinical approval for treating advanced solid tumors, demonstrating potential to overcome drug resistance [3] - Innovent Biologics' IBI3020, a CEACAM5-targeted dual-payload ADC, has been approved for clinical trials aimed at treating unresectable, locally advanced, or metastatic solid tumors [4] - Xinneng Pharmaceutical's BBM-D101, an AAV gene therapy drug, has been approved for clinical trials to treat Duchenne muscular dystrophy (DMD), aiming for long-term efficacy with a single administration [5] - Zhixin Haosheng's E-islet 01, a universal allogeneic islet regeneration product, has received clinical approval for treating type 1 diabetes, utilizing advanced cell reprogramming techniques [6] - Shizhe Biotechnology's XS228, an iPSC-derived neural precursor cell injection, has been approved for clinical trials to treat subacute spinal cord injury (SCI) [7] - Baili Pharmaceutical's BL-M09D1, an ADC drug, has been approved for treating locally advanced or metastatic solid tumors, sharing technology with another ADC [8] - Renfu Innovation's HWS116, a biological product, has received clinical approval for treating advanced solid tumors, although specific mechanisms are not yet disclosed [9]
中证港股通生物科技主题指数报1134.61点,前十大权重包含翰森制药等
Jin Rong Jie· 2025-04-18 09:18
Group 1 - The core index of the CSI Hong Kong Stock Connect Biotechnology Theme Index closed at 1134.61 points, with a decline of 3.59% over the past month, an increase of 24.05% over the past three months, and a year-to-date increase of 20.15% [1] - The index consists of 50 listed companies involved in biopharmaceuticals, pharmaceuticals, and biotechnology services, reflecting the overall performance of biotechnology theme companies within the Hong Kong Stock Connect [1] - The index was established on December 28, 2018, with a base point of 1000.0 [1] Group 2 - The top ten weighted companies in the index include: BeiGene (15.69%), WuXi Biologics (11.81%), Innovent Biologics (10.68%), CanSino Biologics (8.36%), CSPC Pharmaceutical Group (6.36%), China Biologic Products (5.81%), Hansoh Pharmaceutical (3.68%), Zai Lab (3.48%), 3SBio (3.22%), and WuXi AppTec (2.82%) [1] - The index's holdings are entirely composed of companies listed on the Hong Kong Stock Exchange, with a 100% allocation [1] Group 3 - In terms of industry composition, biopharmaceuticals account for 52.00%, chemical drugs for 25.67%, pharmaceutical and biotechnology services for 19.19%, and medical devices for 3.14% [2] - The index samples are adjusted semi-annually, with adjustments occurring on the next trading day after the second Friday of June and December each year, with a sample adjustment ratio generally not exceeding 20% [2] - Special adjustments may occur under certain circumstances, such as delisting or significant corporate actions like mergers or acquisitions [2]
翰森制药恒沐20余项成果亮相APASL 2025,长期疗效及安全性再获验证
Zhong Guo Jing Ji Wang· 2025-04-10 04:12
Core Insights - The 34th Asia-Pacific Association for the Study of the Liver (APASL 2025) conference highlighted the academic achievements of Hansoh Pharmaceutical's oral antiviral drug, TMF (Amitriptyline), which is the first original research drug for hepatitis B in China [1][2] - TMF demonstrated significant efficacy in chronic hepatitis B patients, with a 95% cumulative HBV DNA suppression rate and a 68% HBeAg seroconversion rate over five years, the highest among current NAs [1] - The drug's safety profile remained stable, with no new drug-related adverse events reported during the study period [1] Group 1 - TMF's Phase IV study showed sustained benefits for chronic hepatitis B patients, particularly in virological response and HBeAg seroconversion [1] - The cumulative incidence of virological resistance after five years of treatment with TMF was 0% [1] - The immunological mechanism study indicated TMF's potential to modulate T cell responses and reduce viral load, contributing to its antiviral efficacy [1] Group 2 - Over 20 additional studies related to TMF were presented, covering its application in various subpopulations, including the elderly, pregnant women, and patients with liver cirrhosis and liver cancer [2] - A systematic review and network meta-analysis indicated TMF's superiority in ALT normalization and delaying liver fibrosis progression compared to other new-generation NAs [2] - TMF was shown to have good maternal-fetal safety and efficacy in treating hepatitis B in pregnant women, successfully preventing HBV mother-to-child transmission [2]
《国际分子科学杂志》:翰森制药孚来美通过双重机制加速糖尿病伤口愈合
Zhong Guo Jing Ji Wang· 2025-03-31 05:48
Core Insights - The study published in the International Journal of Molecular Sciences reveals that the GLP-1 receptor agonist, polyethylene glycol-liraglutide (brand name: Fulaimei), accelerates diabetic wound healing through a dual mechanism: systemic anti-inflammatory regulation and restoration of endothelial progenitor cell (EPC) function [1][2]. Group 1: Research Findings - Diabetes is a leading cause of death and disability globally, with vascular complications such as chronic wound healing delays posing significant clinical challenges [1]. - The research utilized a mouse model to compare wound healing in diabetic mice treated with Fulaimei, untreated diabetic mice, and normal mice, demonstrating that Fulaimei improves metabolic disorders, accelerates wound healing, regulates systemic inflammation, and restores EPC function [2]. - Previous in vitro studies indicated that liraglutide can improve EPC damage and mitochondrial dysfunction via the SIRT3/Foxo3 signaling pathway [2]. Group 2: Clinical Implications - The study provides theoretical support for the use of Fulaimei in treating diabetic vascular complications and offers a new strategy for chronic wound treatment in diabetes [2]. - The findings expand the clinical application prospects of GLP-1 receptor agonists, suggesting potential use in other diseases related to mitochondrial dysfunction [2]. - Future research will further explore the efficacy and molecular regulatory networks of Fulaimei in human subjects [2].
仿创转型熬出头,翰森制药创新药收入占比超77%
Guo Ji Jin Rong Bao· 2025-03-28 08:57
Core Insights - Hansoh Pharmaceutical reported a total revenue of approximately 12.261 billion RMB for 2024, representing a year-on-year growth of about 21.3%, and a net profit attributable to shareholders of 4.372 billion RMB, up 33.4% year-on-year [1] - The proportion of innovative drugs in total revenue increased significantly from less than 20% at the time of the company's Hong Kong listing to 77.3% in 2024, highlighting the successful transition to an innovation-driven pharmaceutical company [1][5] - The company achieved revenue of 9.477 billion RMB from innovative drugs and collaborative products, marking a year-on-year increase of 38.1% [1] Revenue Breakdown - In 2024, revenue from various therapeutic areas included approximately 8.122 billion RMB from oncology, 1.464 billion RMB from anti-infection, 1.379 billion RMB from central nervous system disorders, and 1.296 billion RMB from metabolic and other diseases, accounting for 66.2%, 11.9%, 11.3%, and 10.6% of total revenue respectively [1] R&D Investment - The company invested 2.702 billion RMB in R&D, which accounted for 22% of total revenue, focusing on major disease areas such as oncology, central nervous system disorders, metabolism, and autoimmune diseases [2] - Key products in development include the lung cancer treatment Amelot, which has three indications entering NDA stage, and other drugs like HS-20094 and HS-10374 progressing to Phase III clinical trials [2] Business Development (BD) Cooperation - In 2024, revenue from BD cooperation reached 1.573 billion RMB, including a 185 million USD upfront payment from GSK for HS-20093 [4] - The company secured a global exclusive license for an oral GLP-1 small molecule from Merck, receiving an upfront payment of 112 million USD and potential milestone payments of up to 1.9 billion USD [4] - Collaborations with international pharmaceutical companies like GSK and Merck are aimed at accelerating global market expansion [4] Strategic Direction - The company aims to continue its transformation from generics to innovative drugs, leveraging R&D and international strategies while enhancing BD cooperation to optimize its global market presence [5]
翰森制药(03692):创新转型成效显著,国际化持续提速
Hua Yuan Zheng Quan· 2025-03-28 08:54
Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company has shown significant results in its innovative transformation, with internationalization accelerating. The revenue from innovative products is growing rapidly, and the core product, Amivantamab, is expected to reach peak sales of 8 billion yuan. The company continues to benefit from overseas licensing agreements, contributing positively to its performance [5][8]. Financial Performance Summary - For the fiscal year 2024, the company reported total revenue of 12.261 billion yuan, a year-on-year increase of 21.3%. Product sales revenue was 10.688 billion yuan, while collaboration and licensing income was 1.573 billion yuan. The net profit attributable to shareholders was 4.372 billion yuan, reflecting a year-on-year growth of 33.4% [6]. - The company’s operating income and profit both achieved double-digit year-on-year growth, with product sales revenue increasing by 13.65% compared to 9.403 billion yuan in 2023 [6]. Revenue and Profit Forecast - The company’s revenue forecast for 2025 is 13.604 billion yuan, with a projected growth rate of 10.95%. The net profit attributable to shareholders is expected to be 4.421 billion yuan, with a growth rate of 1.14% [7]. - The earnings per share (EPS) for 2025 is projected to be 0.74 yuan, with a return on equity (ROE) of 13.4% [7]. Innovative Product Performance - The revenue from innovative drugs grew by 38.1% year-on-year, reaching 9.477 billion yuan in 2024, accounting for 77.3% of total revenue. The sales of innovative drugs, excluding licensing income, are expected to reach approximately 8 billion yuan, reflecting a year-on-year increase of 28.5% [8]. - The company has a rich pipeline of innovative products, with several expected to be approved soon, providing long-term support for its innovative transformation [8]. Market Position and Future Outlook - The company is well-positioned for future growth, with expectations that the proportion of revenue from innovative drugs will exceed 80% by 2025. The sales of Amivantamab are projected to reach 6 billion yuan, with an upward revision of peak sales to 8 billion yuan [8].
翰森制药:肿瘤药引领业绩快速增长,产品出海进展顺利-20250326
中泰国际证券· 2025-03-26 03:27
Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 25.00 [6][8][17] Core Insights - The company's revenue for 2024 is expected to increase by 21.3% to RMB 12.26 billion, with a net profit growth of 33.4%, exceeding expectations [1][6] - The oncology drug segment is projected to contribute 61.2% of the total product sales revenue in 2024, driven by strong performance from the core product Amelot, which is expected to see sales growth of 19.9% [2] - The company has established a partnership with Merck for the development and commercialization of a GLP-1 receptor agonist, which is expected to enhance its capabilities in the metabolic field [4] - The company is currently developing 40 innovative drugs, with several in late-stage clinical trials, indicating a promising pipeline for future growth [5] Financial Summary - The company's revenue is projected to grow from RMB 10.10 billion in 2023 to RMB 12.26 billion in 2024, with a compound annual growth rate (CAGR) of 21.3% [7][14] - Shareholder net profit is expected to rise from RMB 3.28 billion in 2023 to RMB 4.37 billion in 2024, reflecting a growth rate of 33.4% [7][14] - The gross margin is anticipated to improve by 1.2 percentage points, while sales and administrative expenses as a percentage of product sales revenue are expected to decrease [1][7] Product and Market Developments - The oncology drug business is expected to grow from approximately RMB 6.55 billion in 2024 to RMB 10.97 billion by 2027, with a CAGR of 18.8% [2] - The anti-infection drug revenue is projected to increase by 15.0% to RMB 1.46 billion in 2024, primarily driven by the strong sales of the hepatitis drug Hengmu [3] - The company has received multiple recommendations for its products in clinical guidelines, which is expected to support future sales growth [3]
翰森制药(03692):创新产品主导业绩高速增长,对外合作彰显全球竞争力
CMS· 2025-03-25 07:04
Investment Rating - The report maintains a "Strong Buy" investment rating for the company [3][7]. Core Insights - The company achieved a revenue of 12.261 billion CNY in 2024, representing a year-on-year growth of 21.3%, and a profit of 4.372 billion CNY, up 33.4% year-on-year [1][2]. - The sales revenue from innovative drugs and collaborative products reached 9.477 billion CNY in 2024, a 38.1% increase, accounting for 77.3% of total revenue [7]. - The company has shown strong cost control, with a gross margin of 91% in 2024, an increase of 1.2 percentage points year-on-year [7]. - The company is actively pursuing global collaborations, enhancing its competitive edge, with significant partnerships established in 2024 [7]. Financial Data and Valuation - The company’s projected revenues for 2025-2027 are 13.714 billion CNY, 15.395 billion CNY, and 17.378 billion CNY, with respective year-on-year growth rates of 12%, 12%, and 13% [2][9]. - The projected net profits for 2025-2027 are 4.588 billion CNY, 5.152 billion CNY, and 5.930 billion CNY, with growth rates of 5%, 12%, and 15% respectively [7][9]. - The company’s PE ratios for 2025-2027 are projected to be 24.6, 21.9, and 19.1 [9]. Shareholder Information - The total market capitalization of the company is 120.5 billion HKD, with a total share capital of 5,936 million shares [3]. - The major shareholder, Sunrise Investment Advisors Limited, holds a 65.7% stake in the company [3]. Performance Metrics - The company’s return on equity (ROE) is reported at 15.2% for 2024, with a projected increase to 15.4% by 2027 [9]. - The asset-liability ratio is notably low at 9.4% in 2024, indicating strong financial stability [9].
翰森制药:创新成果显著,看好稳定增长和BD-20250324
HTSC· 2025-03-24 02:50
Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 23.82 [8][9]. Core Insights - The company reported a revenue of RMB 12.261 billion for 2024, representing a year-on-year growth of 21.3%, and a net profit of RMB 4.372 billion, up 33.4% year-on-year. The revenue from innovative drugs reached RMB 9.477 billion, growing 38.1% year-on-year, and accounting for 74% of total revenue, which aligns with expectations [1][2]. - The growth in revenue is driven by strong performance in oncology and anti-infection segments, with revenues of RMB 8.122 billion and RMB 1.464 billion respectively, reflecting increases of 31.7% and 15.4% year-on-year. The gross margin improved to 91%, while the R&D expense ratio increased to 22%, indicating ongoing investment in innovation [2][3]. - The company has seven innovative drugs and nine indications included in the national medical insurance catalog as of 2024, with over 40 new molecular entities in more than 60 clinical trials. The company completed three license-in agreements in 2024, generating R&D expenses of RMB 247 million [3][4]. Summary by Sections Financial Performance - For 2024, the company achieved revenues of RMB 12.261 billion, with a year-on-year growth of 21.35%. The net profit for the same year was RMB 4.372 billion, reflecting a growth of 33.39% [7][19]. - The projected net profits for 2025 and 2026 are RMB 4.400 billion and RMB 4.179 billion respectively, with an expected EPS of RMB 0.74 for 2025 [5][19]. Research and Development - The company has a robust pipeline with 40 new molecular entities and over 60 clinical trials ongoing. Key drugs like Amatinib are expected to generate significant sales, projected to reach RMB 6 billion by 2025 [4][5]. - The company is actively expanding into autoimmune diseases and has multiple assets in development for skin diseases and kidney diseases [4][5]. Valuation - The company is valued at HKD 1,414 billion, with the innovative drug segment valued at HKD 1,378 billion and the generic drug segment at HKD 36 billion. The target price reflects an increase from the previous valuation of HKD 22.28 [5][9].
翰森制药(03692) - 2024 - 年度业绩
2025-03-21 09:30
Financial Performance - The company reported revenue of approximately RMB 12.261 billion for the year ending December 31, 2024, representing a year-on-year growth of approximately 21.3%[4] - Profit for the same period was approximately RMB 4.372 billion, an increase of about 33.4% compared to the previous year[15] - Basic earnings per share were approximately RMB 0.74, an increase of approximately 33.3% compared to the previous year[4] - Revenue for the year ended December 31, 2024, reached RMB 12,260,814 thousand, a 21.4% increase from RMB 10,103,806 thousand in 2023[77] - Gross profit for 2024 was RMB 11,155,406 thousand, up from RMB 9,072,943 thousand in 2023, reflecting a significant growth in profitability[77] - Net profit for the year was RMB 4,371,825 thousand, representing a 33.4% increase compared to RMB 3,277,503 thousand in 2023[79] - The group's profit before tax rose to RMB 3,327,665,000 in 2024, compared to RMB 2,680,840,000 in 2023, reflecting a growth of 24.2%[90] Revenue Breakdown - Sales revenue from innovative drugs and collaborative products reached approximately RMB 9.477 billion, an increase of approximately 38.1% year-on-year, accounting for about 77.3% of total revenue[4] - Revenue from the oncology segment was approximately RMB 8.122 billion, making up about 66.2% of total revenue[18] - The anti-infection segment generated revenue of approximately RMB 1.464 billion, contributing about 11.9% to total revenue[18] - The central nervous system segment reported revenue of approximately RMB 1.379 billion, representing about 11.3% of total revenue[18] - The metabolic and other diseases segment achieved revenue of approximately RMB 1.296 billion, accounting for about 10.6% of total revenue[18] Research and Development - Research and development expenses amounted to approximately RMB 2.702 billion, up approximately 28.8% year-on-year, representing about 22.0% of total revenue[4] - Over 60 clinical trials for innovative drugs are currently ongoing, with 8 new candidates entering clinical research stages during the reporting period[37] - The company has published multiple research findings on ShengLuoLai® in prestigious journals and conferences, focusing on its mechanism of action and clinical studies[33] Product Approvals and Developments - The company received clinical trial approval for the innovative drug HS-10501, intended for the treatment of type 2 diabetes and adult obesity[6] - The innovative drug Amelot® received its third NDA acceptance from NMPA for use in NSCLC patients with specific mutations[9] - The innovative drug Amelotin® has been approved for three indications and was successfully included in the 2024 National Medical Insurance Directory[21] - The product XinYue® (Inalizumab injection) received NMPA approval for treating adult patients with AQP4 antibody-positive NMOSD on March 14, 2022, and was included in the national medical insurance catalog in January 2023[25] - HS-20093, a B7-H3 targeted ADC, has entered Phase III clinical trials for small cell lung cancer and has shown strong anti-tumor activity in preliminary studies[40][41] Licensing Agreements - A licensing agreement was established with Zhuhai Pumis Biotechnology Co., granting the company exclusive rights to develop and commercialize HS-20117 globally[6] - The company entered into a global exclusive licensing agreement with Merck Sharp & Dohme LLC for the development of the investigational GLP-1 receptor agonist HS-10535[13] - The company has entered into a licensing agreement with Promis to develop and commercialize the bispecific antibody HS-20117 globally, currently in Phase I clinical trials[49] - The company has secured a licensing agreement with LUPON Pharmaceuticals for HS-10561, a BTK inhibitor, with clinical trials for chronic spontaneous urticaria expected to commence in February 2025[51] Corporate Governance and Sustainability - The company maintained an MSCI ESG rating of AA and was included in the S&P Global Sustainable Development Yearbook 2025, ranking first in the Chinese pharmaceutical industry[13] - The company plans to continue reviewing and enhancing its corporate governance practices to ensure compliance with the corporate governance code[110] - The audit committee, consisting of three independent non-executive directors, reviewed the audited performance for the year ending December 31, 2024[112] Cash Flow and Financial Position - The group reported a net cash inflow from operating activities of RMB 3.862 billion for the year ending December 31, 2024[62] - As of December 31, 2024, the group had cash and bank deposits totaling RMB 22.622 billion, an increase from RMB 22.435 billion as of December 31, 2023[63] - The group's asset-liability ratio was approximately 9.4% as of December 31, 2024, a decrease from 21.9% as of December 31, 2023[63] - Total assets less current liabilities increased to RMB 28,962,631 thousand in 2024 from RMB 26,176,230 thousand in 2023, indicating a stronger financial position[81] Dividends and Shareholder Returns - The declared final dividend for 2023 was RMB 768,760,000, significantly higher than RMB 268,852,000 for 2022, representing a 186.5% increase[96] - The company announced a final dividend of HKD 0.1353 per share for the year ending December 31, 2024, down from HKD 0.1422 in 2023[115] - The total dividend for the year 2024, including the interim dividend, amounts to HKD 0.3363 per share[115]