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翰森制药(03692) - 自愿公告 - 昕越(伊奈利珠单抗注射液)第二项适应症获国家药品监督管理局...
2025-09-01 14:39
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份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Hansoh Pharmaceutical Group Company Limited 翰森製藥集團有限公司 (於開曼群島註冊成立的有限公司) (股份代號:3692) 於本公告日期,董事會成員包括主席兼執行董事鍾慧娟女士、執行董事孫遠女士 及呂愛鋒博士;及獨立非執行董事林國強先生、陳尚偉先生及楊東濤女士。 昕越® (伊奈利珠單抗注射液)第二項適應症 獲國家藥品監督管理局簽發藥品註冊證書 翰森製藥集團有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董 事會」)欣然宣佈,於二零二五年八月二十六日,創新藥昕越® (伊奈利珠單抗注射 液)(「該產品」)獲中國國家藥品監督管理局(「NMPA」)簽發的藥品註冊證書,批 准增加適應症:適用於免疫球蛋白G4相關性疾病(IgG4-RD)成人患者。此為昕越® 獲批的第二項適應症,該適應症曾於二零二五年二月八日獲NMPA納入優先審評 審批程序。 關於該產品 伊奈 ...
全球首次!翰森制药CD19单抗新适应症获批上市
Group 1 - The National Medical Products Administration (NMPA) has approved a new indication for Hansoh Pharmaceutical's (03692.HK) Inalizumab injection for the treatment of Immunoglobulin G4-related disease (IgG4-RD), which was previously prioritized for review by the Center for Drug Evaluation (CDE) [1] - Inalizumab is a targeted CD19B cell-depleting antibody, and it was first approved by the NMPA in March 2022, making this the second indication for the drug [1] - The approval is based on positive results from the global pivotal Phase III trial MITIGATE, which was conducted in 22 countries, including China, and is the first randomized, double-blind, placebo-controlled study in IgG4-related disease [1] Group 2 - In the 52-week placebo-controlled period, the risk of relapse for IgG4-RD patients treated with Inalizumab was significantly reduced by 87% compared to the placebo group [2] - Among 68 patients treated with Inalizumab, only 7 experienced a relapse, while 40 out of 67 patients in the placebo group relapsed [2] - 57.4% of patients treated with Inalizumab achieved complete remission without relapse or treatment by week 52, compared to 22.4% in the placebo group [2] Group 3 - Inalizumab is currently the only approved CD19 monoclonal antibody for IgG4-RD globally, highlighting its unique position in the market [3]
港股创新药ETF(159567)涨2.67%,成交额19.85亿元
Xin Lang Cai Jing· 2025-09-01 12:19
Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 2.67% on September 1, with a trading volume of 1.985 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1] - As of August 29, 2024, the fund's latest share count was 6.686 billion, with a total size of 6.403 billion yuan, reflecting a year-to-date increase of 1591.03% in shares and 1594.74% in size compared to the end of 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 91.54% during the tenure [2] - The top holdings of the fund include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant weightings in the portfolio [2] - The fund's liquidity is strong, with a cumulative trading amount of 34.181 billion yuan over the last 20 trading days, averaging 1.709 billion yuan per day [1]
港股异动 | 医药股再度走强 上半年药企业绩整体表现稳健 机构看好创新药长期向好逻辑
Zhi Tong Cai Jing· 2025-09-01 06:38
Group 1 - Pharmaceutical stocks in Hong Kong have shown strong performance, with notable gains in companies such as 加科思-B (up 23.18%), 三叶草生物-B (up 22.09%), and others [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with 恒瑞医药 achieving record high revenue and profit, and 翰森制药 exceeding revenue expectations [1] - Upcoming major conferences, including the World Lung Cancer Conference (WCLC) and the European Society for Medical Oncology (ESMO), will showcase research results from innovative domestic drugs [1] Group 2 - 海通国际 maintains a positive outlook on Hong Kong pharmaceutical companies due to their stable cash flow, rich R&D pipelines, and normalizing external licensing revenues [2] - The recent slight pullback in the Hong Kong pharmaceutical sector is attributed to rapid fund rotation, with expectations of short-term fluctuations [2] - The long-term value reassessment logic in the pharmaceutical industry remains unchanged, supported by the engineer dividend and a rich catalyst environment in the innovative drug industry [2]
2025港交所上市公司多元包容指数DIIndex研究报告与100强榜单
Sou Hu Cai Jing· 2025-09-01 00:35
Group 1 - The report by Zhong Chengxin Certification Research provides a comprehensive quantitative assessment of the diversity and inclusion (D&I) performance of 760 companies listed on the Hong Kong Stock Exchange with a market capitalization exceeding HKD 5 billion, using a framework that integrates ISO 30415:2021 standards and HKEX ESG guidelines [1][12][14] - The overall D&I performance of Hong Kong listed companies shows a pattern of "initial development with significant differentiation," with an average score of 48.52 out of 100 and a median score of 47.11, indicating that most companies are still in the early stages of D&I practices [1][13][41] - 28% of companies scored below 40, while 51% scored between 40 and 60, and only 7% exceeded a score of 70, highlighting the need for improvement in D&I practices across the market [1][41][44] Group 2 - Leading companies in D&I performance are primarily in the financial sector, with HSBC Holdings scoring 85.3 and AIA Group scoring 83.7, attributed to their strong governance, high levels of internationalization, and significant investment in human capital [1][13][52] - The report identifies common issues across the market, such as the lack of substantial equity indicators like "gender pay ratio" and low disclosure rates for data on employees with disabilities, indicating a gap in transparency and accountability [1][2][13] - The financial industry leads with an average score of 65.8, followed by non-bank financial services at 62.5, while sectors like real estate and electronics lag behind with scores of 45.6 and 43.2, respectively, reflecting significant industry disparities in D&I performance [2][13][56] Group 3 - The report suggests that companies should adopt ISO 30415 as a guideline to strengthen governance commitments, data-driven decision-making, and enhance transparency in disclosures [2][14] - Investors are encouraged to incorporate D&I assessments into their investment frameworks and conduct industry comparisons, as D&I performance is expected to become a key non-financial indicator of investment value in the Hong Kong capital market [2][14] - The findings indicate that the Hong Kong market is at a critical transition period for D&I practices, moving from mere compliance to creating strategic value, which is essential for gaining investor trust [2][14]
多家创新药企业绩大涨
Core Viewpoint - The performance of innovative pharmaceutical companies in China for the first half of 2025 has been impressive, with significant revenue and profit growth driven by innovative drug sales, indicating a potential recovery in the pharmaceutical industry [1][6][15]. Group 1: Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, with a net profit of 4.45 billion yuan, up 29.67%. Innovative drug sales accounted for 60.66% of total revenue [3][9]. - BeiGene reported total revenue of 17.52 billion yuan, a 46.0% increase year-on-year, with a net profit of 450 million yuan, marking a turnaround from losses [3][6]. - China Biopharmaceutical's revenue reached 17.57 billion yuan, a 10.7% increase, with innovative product revenue of 7.8 billion yuan, up 27.2%, representing 44.4% of total revenue [3][6]. - XinDa Biopharmaceutical achieved revenue of 5.95 billion yuan, a 50.6% increase, and a net profit of 1.21 billion yuan, turning a loss from the previous year [7][8]. - Xiansheng Pharmaceutical reported a revenue increase of 15.1% to 3.58 billion yuan, with innovative drug revenue surpassing 75% of total revenue [8]. Group 2: Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies suggests a shift towards innovation-driven strategies, indicating a growing market for innovative drugs in China [6][8][15]. - The second-tier market is experiencing a prosperous phase, leading to speculation about a potential "spring" for the pharmaceutical industry, although the primary market remains challenging [4][15]. - The demand for high-quality products that can compete globally is increasing, with a focus on "best-in-class" products [4][15]. Group 3: Business Development (BD) Contributions - Business development (BD) activities are becoming crucial for the growth of innovative pharmaceutical companies, with significant deals contributing to revenue [9][10]. - Heng Rui Pharmaceutical's BD activities included a $1.97 billion contract with Merck and a partnership with GSK, highlighting the increasing global engagement of Chinese innovative drug companies [10][11]. - The first half of 2025 saw over 50 BD transactions in China's innovative drug sector, with a total disclosed cooperation amount exceeding $48.44 billion, marking a significant increase compared to the previous year [10][11]. Group 4: Challenges and Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [13][14]. - Some companies, like BeiDa TianHeng, reported significant revenue declines due to high R&D investments and previous income recognition from collaborations [13][14]. - Overall, the industry is transitioning from an "investment phase" to a "harvest phase," indicating a recovery in profitability and a moderate expansion phase [14][15].
多家创新药企业绩大涨
21世纪经济报道· 2025-08-31 00:34
Core Viewpoint - The performance of innovative pharmaceutical companies in China for the first half of 2025 is impressive, with significant revenue and profit growth driven by innovative drug sales, indicating a potential recovery in the pharmaceutical industry [1][3][10]. Summary by Sections Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.761 billion yuan, a year-on-year increase of 15.88%, and a net profit of 4.450 billion yuan, up 29.67%. Innovative drug sales accounted for 60.66% of total revenue [3][12]. - Bai Jie Shen Zhou reported total revenue of 17.518 billion yuan, a 46.0% increase, with a net profit of 450 million yuan, marking a turnaround from losses. The sales of its key products, including the BTK inhibitor and PD-1 inhibitor, significantly contributed to this growth [3][7]. - Xin Da Biotech achieved revenue of 5.953 billion yuan, a 50.6% increase, and a net profit of 1.213 billion yuan, compared to a loss in the previous year, driven by strong sales of its PD-1 inhibitor and new weight-loss drug [8]. - Xian Sheng Pharmaceutical reported a revenue increase of 15.1% to 3.585 billion yuan, with innovative drug revenue reaching 2.776 billion yuan, accounting for 77.4% of total revenue [9]. Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies suggests a shift towards innovation-driven strategies, with increasing market demand for innovative products supported by healthcare policies [10][20]. - Business Development (BD) activities are becoming crucial for growth, with significant deals indicating a robust international presence for Chinese innovative drug companies [12][13]. Challenges and Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [18]. - Some companies, like Bai Li Tian Heng and Bei Da Pharmaceutical, reported declines in net profit due to high R&D costs and overdue payments to partners, highlighting the risks associated with innovation investments [18][19]. - Overall, the industry is transitioning from a low point to a recovery phase, with expectations for sustained growth in the innovative drug sector driven by efficiency and cost advantages [20].
翰森制药(03692.HK):创新收入高速增长 BD收入有望贡献常态化增量
Ge Long Hui· 2025-08-30 03:18
Core Viewpoint - Hansoh Pharmaceutical reported strong financial performance for the first half of 2025, with significant growth in revenue and net profit driven by innovative drug sales and licensing income [1][2]. Financial Performance - In the first half of 2025, Hansoh Pharmaceutical recorded revenue of 7.434 billion yuan, a year-on-year increase of 14.3% - The net profit attributable to shareholders was 3.135 billion yuan, reflecting a year-on-year growth of 15.0% - Innovative drug sales and licensing income amounted to 6.145 billion yuan, accounting for 82.7% of total revenue [1]. Expense Analysis - Sales expenses reached 1.818 billion yuan, up 5.6% year-on-year - Research and development expenses were 1.441 billion yuan, increasing by 20.5% year-on-year - Management expenses decreased to 343 million yuan, down 3.1% year-on-year [1]. Business Segmentation - Revenue from different therapeutic areas included: oncology (4.531 billion yuan, 60.9%), infectious diseases (735 million yuan, 9.9%), central nervous system (768 million yuan, 10.4%), and metabolism/others (1.400 billion yuan, 18.8%) - The company focuses on oncology while also developing products in infectious diseases, central nervous system, and metabolism, creating a robust product matrix [1]. Clinical Pipeline - As of the mid-2025 report, the company has over 40 candidate innovative drug pipelines and is conducting more than 70 clinical trials, including 8 candidates entering clinical trials for the first time and 3 major products in phase 3 trials - The company is actively expanding indications for existing major products and advancing preclinical pipelines [2]. Business Development Opportunities - During the reporting period, the company received a confirmed upfront payment of 112 million USD from Merck, contributing to collaboration revenue - A collaboration agreement with Regeneron for HS-20094 was established, with an upfront payment of 80 million USD received, and a potential total transaction value of 1.93 billion USD [2]. Profit Forecast - The company expects net profits attributable to shareholders for 2025-2027 to be 5.021 billion, 5.567 billion, and 6.355 billion yuan, with year-on-year growth rates of 14.9%, 12.9%, and 12.1% respectively - Corresponding price-to-earnings ratios are projected to be 40, 35, and 31 times [3].
创新药企迎来“收获季”
Core Viewpoint - The performance of innovative pharmaceutical companies in China has shown significant growth in the first half of 2025, with many companies reporting impressive revenue and profit increases driven by innovative drug sales [1][4][7]. Group 1: Company Performance - Heng Rui Pharmaceutical achieved a revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, and a net profit of 4.45 billion yuan, up 29.67%, with innovative drug sales accounting for 60.66% of total revenue [1][8]. - BeiGene reported total revenue of 17.52 billion yuan, a 46.0% increase year-on-year, with a net profit of 450 million yuan, marking a turnaround from losses [1][4]. - Innovent Biologics achieved revenue of 5.95 billion yuan, a 50.6% increase, and a net profit of 1.21 billion yuan, compared to a loss of 160 million yuan in the previous year [5]. - Xiansheng Pharmaceutical reported a revenue increase of 15.1% to 3.58 billion yuan, with innovative drug revenue reaching 2.78 billion yuan, accounting for 77.4% of total revenue [6]. Group 2: Market Trends - The rising proportion of innovative drug revenue among multiple pharmaceutical companies indicates a successful shift towards innovation-driven strategies, with increasing market demand for innovative products [7][12]. - The Chinese innovative drug market is expanding, supported by improved public health awareness and favorable healthcare policies [7][12]. - Business development (BD) activities have become a crucial growth engine for innovative pharmaceutical companies, with significant increases in BD transactions in the first half of 2025 [9][10]. Group 3: Challenges and Future Outlook - Despite the positive trends, companies face challenges such as intense market competition, high project uncertainty, and increasing accounts receivable [12][13]. - The overall industry is transitioning from a low point, with profitability beginning to recover, indicating a shift from an "investment phase" to a "harvest phase" [12][14]. - Analysts predict that the innovative drug sector will continue to thrive, driven by high efficiency and low-cost development advantages, particularly in popular technology areas [12][14].
翰森制药(03692):创新药收入驱动业绩增长,核心管线研发持续推进
Huachuang Securities· 2025-08-29 15:29
Investment Rating - The report maintains a "Recommended" investment rating for Hansoh Pharmaceutical (03692.HK) [1] Core Views - The company's revenue for the first half of 2025 reached 7.434 billion yuan, representing a year-on-year increase of 14.3%. Sales from innovative drugs and cooperative products amounted to approximately 6.145 billion yuan, up 22.1%, accounting for about 82.7% of total revenue [1] - Net profit for the same period was 3.135 billion yuan, reflecting a growth of 15.0%. Research and development expenses were approximately 1.441 billion yuan, an increase of 20.4%, constituting 19.4% of total revenue [1] - The report highlights the continuous advancement of the core pipeline and the robust growth driven by innovative drug revenues, with a focus on internationalization strategies [7] Financial Summary - Total revenue projections for 2025-2027 are estimated at 141.63 billion yuan, 155.41 billion yuan, and 179.87 billion yuan, with year-on-year growth rates of 15.5%, 9.7%, and 15.7% respectively [7] - The net profit for the same period is projected to be 51.88 billion yuan, 54.47 billion yuan, and 59.96 billion yuan, with growth rates of 18.7%, 5.0%, and 10.1% respectively [7] - The earnings per share (EPS) is expected to increase from 0.74 yuan in 2024 to 0.99 yuan in 2027 [9] Market Performance - The report indicates that the innovative drug revenue continues to rise, significantly contributing to the company's performance. The revenue breakdown includes 4.531 billion yuan from oncology, 735 million yuan from anti-infection, 768 million yuan from central nervous system, and 1.4 billion yuan from metabolic and other diseases [7] - The company has made significant progress in expanding its core products' indications, including new approvals for Amivantamab and the acceptance of applications for the indications of Inalizumab [7] Pipeline Development - The company is conducting over 70 clinical trials across more than 40 candidate innovative drugs, with 8 new candidates entering clinical trials during the reporting period [7] - Key registration phase III clinical trials include treatments for bone and soft tissue sarcoma, ovarian cancer, and moderate to severe plaque psoriasis [7]