Workflow
AKESO(09926)
icon
Search documents
康方生物(09926):依沃西1L肺癌获批在即,多癌种3期快速推进
Huafu Securities· 2025-04-02 11:51
Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 119 per share, implying a market capitalization of HKD 106.9 billion [6]. Core Insights - The company has made significant progress with its drug Ivonescimab (依沃西), which is expected to receive approval for first-line lung cancer treatment by H1 2025. The drug has also been included in the 2024 National Medical Insurance Directory [2][17]. - Multiple Phase III clinical trials for Ivonescimab are advancing efficiently, with promising data indicating it may become the preferred first-line treatment for advanced PD-L1 positive NSCLC [3][19]. - The company is also developing other indications for Ivonescimab, including colorectal cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer, with expected peak sales exceeding HKD 55 billion domestically and USD 60 billion globally for lung cancer [23][41]. Summary by Sections Ivonescimab Developments - Ivonescimab has received NMPA approval for treating EGFR-TKI resistant non-squamous NSCLC and is included in the national insurance directory for 2024 [3][17]. - The drug's application for first-line treatment of PD-L1 positive NSCLC has received priority review and is expected to be approved by H1 2025, with mPFS data showing significant improvement over existing treatments [3][19]. - Ongoing Phase III trials for various cancers are showing promising results, with the potential for Ivonescimab to become a leading treatment option in multiple indications [19][22]. Financial Projections - The company forecasts revenues of HKD 33.37 billion, HKD 50.18 billion, and HKD 78.85 billion for the years 2025, 2026, and 2027, respectively, with a projected net profit of HKD 6.12 billion in 2026 and HKD 24.73 billion in 2027 [6][8]. - The report highlights a significant growth trajectory, with a projected increase in earnings per share (EPS) from -0.57 in 2024 to 2.76 in 2027 [8]. Market Potential - The report estimates that the domestic sales peak for Ivonescimab in lung cancer could exceed HKD 55 billion, while global sales could surpass USD 60 billion, driven by its first-line treatment potential [23][41]. - The company is also exploring the treatment of colorectal cancer, with expectations of peak sales exceeding HKD 30 billion, supported by strong clinical trial results [43].
康方生物(09926):构建肿瘤免疫核心竞争力,商业化进程即将加速
Minsheng Securities· 2025-04-02 05:15
Investment Rating - The report maintains a "Recommended" rating for the company, indicating a potential upside of over 15% relative to the benchmark index [4][6]. Core Insights - The company has demonstrated strong growth in product sales, achieving a total revenue of 2.124 billion RMB in 2024, with a year-on-year decline of 53.08%. However, commercial sales revenue increased by 24.88% to 2.002 billion RMB, and gross profit reached 1.835 billion RMB, reflecting a 16.53% increase in commercial sales gross profit [1][4]. - The company is building a core competitive advantage in tumor immunotherapy through its two main bispecific antibodies, Cardunilumab and Ivorisumab, which are undergoing extensive clinical exploration across over 40 indications. Notably, Ivorisumab has shown significant efficacy in treating advanced non-small cell lung cancer [2][4]. - The company is investing efficiently in research and development, with approximately 1.2 billion RMB allocated in 2024. This has resulted in the approval of three new drugs and the advancement of multiple clinical trials, including the first bispecific ADC drug entering clinical trials [3][4]. - The commercialization process is expected to accelerate, with key products entering the national medical insurance directory by the end of 2024, enhancing hospital access and coverage [3][4]. Financial Projections - The company is projected to achieve revenues of 3.82 billion RMB, 6.52 billion RMB, and 8.86 billion RMB from 2025 to 2027, with corresponding net profits of 107 million RMB, 1.064 billion RMB, and 2.083 billion RMB [4][5]. - The expected growth rates for revenue are 79.9% in 2025, 70.6% in 2026, and 35.9% in 2027, while net profit is anticipated to grow by 120.8% in 2025 and 896.9% in 2026 [5][4].
康方生物:2024年年度业绩点评:构建肿瘤免疫核心竞争力,商业化进程即将加速-20250402
Minsheng Securities· 2025-04-02 03:23
Investment Rating - The report maintains a "Recommended" rating for the company, indicating an expected stock price increase of over 15% relative to the benchmark index [4][6]. Core Insights - The company achieved a total revenue of 2.124 billion RMB in 2024, a decrease of 53.08% year-on-year, while commercial sales revenue grew by 24.88% to 2.002 billion RMB [1][4]. - The company is building a core competitive advantage in tumor immunotherapy through its two main bispecific antibodies, Cardunilumab and Ivorisumab, with over 40 clinical therapy explorations [2][4]. - The company invested approximately 1.2 billion RMB in R&D in 2024, achieving significant milestones including three new drug approvals and multiple ongoing clinical studies [3][4]. Financial Performance - The company reported a gross profit of 1.835 billion RMB in 2024, with a gross margin of 86.39% [5][8]. - The projected revenues for 2025, 2026, and 2027 are 3.820 billion RMB, 6.519 billion RMB, and 8.860 billion RMB, respectively, with corresponding net profits expected to be 107 million RMB, 1.064 billion RMB, and 2.083 billion RMB [4][5]. - The earnings per share (EPS) is projected to improve from -0.57 RMB in 2024 to 2.32 RMB by 2027 [5][8]. Product Development and Commercialization - The company is advancing its commercialization process, with key products expected to be included in the national medical insurance directory by the end of 2024 [3][4]. - The company has initiated multiple clinical studies for its bispecific antibodies, establishing a strong pipeline for future growth [2][3].
康方生物:AK112 to validate its potential as next-generation IO therapy-20250402
Zhao Yin Guo Ji· 2025-04-02 01:23
Investment Rating - The report maintains a "BUY" rating for Akeso, indicating a potential return of over 15% over the next 12 months [15]. Core Insights - Akeso's FY24 results showed strong cost controls despite a revenue shortfall, with total revenue of RMB2.1 billion, including RMB2.0 billion from product sales, representing a 25% YoY increase [8]. - The company is expected to see product sales surge by 60% YoY to RMB3.3 billion in FY25, driven by the inclusion of AK104 and AK112 in the National Reimbursement Drug List (NRDL) [8]. - AK112 is positioned as a next-generation immuno-oncology (IO) therapy, with pivotal clinical data demonstrating a meaningful progression-free survival (PFS) benefit in a Phase 3 trial against Keytruda for first-line PD-L1-positive non-small cell lung cancer (NSCLC) [8]. - The report highlights ongoing clinical trials for AK112 in various cancer types, including triple-negative breast cancer (TNBC) and pancreatic cancer, indicating a broad first-line strategy [8]. - The target price for Akeso has been raised from HK$58.97 to HK$102.61, reflecting increased sales projections for AK112 [8]. Financial Summary - For FY23A, Akeso reported revenue of RMB4,526 million, with a YoY growth of 440.3%, followed by a projected revenue of RMB2,124 million for FY24A, reflecting a decline of 53.1% [2]. - The net profit for FY23A was RMB2,028.3 million, with a projected net loss of RMB501 million for FY24A [2]. - R&D expenses are projected to be RMB1,306 million for FY25E, increasing to RMB1,937 million by FY27E [2]. - The company held a cash balance of RMB7.3 billion at the end of FY24, sufficient to support ongoing R&D and future commercial expansion [8]. Share Performance - Akeso's current market capitalization is HK$77,191.5 million, with a current price of HK$86.00 and a target price indicating a 19.3% upside [3]. - The stock has shown strong performance, with a 1-month absolute return of 17.9% and a 3-month return of 41.7% [5]. Valuation - The DCF valuation estimates the equity value at RMB 85,652 million, translating to a DCF per share of RMB 95.43 or HK$ 102.61 [9]. - The report includes a sensitivity analysis indicating how changes in the weighted average cost of capital (WACC) and terminal growth rate affect the target price [10].
港药领衔反弹,康方生物业绩大增,涨超8%,恒生生物科技ETF(513280)强势涨超4%
Sou Hu Cai Jing· 2025-04-01 02:14
Group 1 - The Hang Seng Biotechnology Index (HSHKBIO) has seen a strong increase of 3.70% as of April 1, 2025, with notable gains from constituent stocks such as Kangfang Biotech (09926) up 8.14%, and others like Hong Kong Medicine (00013) and Rongchang Biotech (09995) also showing significant increases [1] - The Hang Seng Biotechnology ETF (513280) rose by 4.18%, reaching a latest price of 0.9 HKD, with a trading volume of 37.5587 million HKD and a turnover rate of 13.91%, indicating active market participation [1] - The latest scale of the Hang Seng Biotechnology ETF reached 262 million HKD, marking a new high for the year, with the number of shares also hitting a recent high of 305 million [1] Group 2 - Kangfang Biotech reported a sales revenue exceeding 2 billion HKD for 2024, reflecting a year-on-year growth of 25%, driven by strong performance in new drug sales [2] - Domestic innovative drugs are entering a harvest period, with 39 new drugs approved in China in 2024, accounting for nearly 40% of global approvals, and 24% of first-in-class drugs in development being from Chinese companies [2] - The overall performance of leading innovative pharmaceutical companies is improving, with many approaching profitability due to mature R&D and sales systems [2] Group 3 - The 2024 Government Work Report indicates an optimization of drug procurement policies, shifting from a price-only focus to a balance of quality and cost, which is expected to benefit leading pharmaceutical companies [3] - The upcoming 11th batch of drug procurement in 2025 is anticipated to enhance quality assessment and regulatory measures, potentially leading to a consolidation of market share among compliant leading pharmacies [3] - The number of retail pharmacies closing has increased to 13,700 by Q4 2024, suggesting a gradual improvement in the competitive landscape for leading pharmacies [3] Group 4 - The Hang Seng Biotechnology ETF (513280) is noted for having the lowest fee rate in the Hong Kong innovative drug market, with a management fee of only 0.15% per year, significantly lower than similar products [4] - As of December 2024, the ETF's index composition includes 66.4% innovative drugs, 15.4% CXO, and over 9% in pharmaceutical distribution and medical devices, indicating a balanced investment strategy [4]
直击业绩会丨康方生物董事长夏瑜谈“明星”双抗产品:今年预计覆盖2000家医院,目前不适合给出业绩指引
Mei Ri Jing Ji Xin Wen· 2025-03-31 14:24
Core Viewpoint - The company is currently in a critical year for its dual antibody drugs, with significant sales potential expected in the future, but it is not appropriate to provide specific revenue guidance at this time [1][2][3]. Financial Performance - In 2024, the company reported revenues of 2.124 billion yuan, a decrease of 53.08% year-on-year, with a gross profit of 1.835 billion yuan, down 58.23%, and a net loss of 501 million yuan [1]. - The decline in revenue is primarily attributed to a significant drop in commercialization revenue, which was 122 million yuan compared to 2.923 billion yuan in 2023 [1]. Product Development and Market Potential - The company’s two key products, Cadonilimab and Ivorisumab, are expected to generate substantial sales and profit returns over the next decade, with plans to cover 2,000 hospitals this year [2]. - 2025 marks the first year these products will be included in the national medical insurance directory, with specific indications for reimbursement [2]. - The company has achieved an 80% hospital access rate for its core products, indicating strong market acceptance [2][3]. Clinical Research and International Expansion - Ivorisumab has shown promising results in clinical trials, outperforming Merck's Keytruda, which is the best-selling cancer drug globally [4]. - Goldman Sachs predicts that Ivorisumab could reshape the immune checkpoint cancer drug market, with peak sales estimates reaching 53 billion dollars by 2041 [5]. - The company is actively pursuing international development for Ivorisumab, with ongoing clinical trials and collaborations with major pharmaceutical companies like Pfizer [6]. Clinical Efficiency and Future Outlook - The company has seen a consistent increase in clinical research activities since 2018, currently having six products on the market, two awaiting approval, and two in Phase III trials [7]. - The management expresses confidence in the future performance of its products, emphasizing the importance of entering the medical insurance directory for market expansion [3].
康方生物重磅药物海外临床数据年中有望公布,抢占900亿美元肿瘤药市场
Di Yi Cai Jing· 2025-03-31 09:19
Core Viewpoint - 康方生物's innovative drug, Ivoris monoclonal antibody, is set to release overseas Phase III clinical data mid-year, which could lead to FDA submission and increased international market revenue [1][2] Financial Performance - 康方生物 reported over 2 billion yuan in new drug sales for 2024, marking a 25% year-on-year increase, a record high [2] - Despite the sales growth, the company is projected to incur a loss of 500 million yuan in 2024 as its core drugs, Cardunil and Ivoris, will only be included in the national medical insurance directory by the end of 2024 [2] Drug Development and Market Potential - Ivoris monoclonal antibody has shown significant potential in treating various cancers, including lung cancer, and outperformed Merck's Keytruda in a head-to-head trial [2] - The partnership with Summit Therapeutics for Ivoris has resulted in a $500 million upfront payment, with a total deal value of up to $5 billion [2] - Goldman Sachs predicts that Ivoris could reshape the $90 billion immuno-oncology drug market, with peak sales projected to reach approximately $53 billion by 2041 [2]
康方生物两大核心双抗医保放量在即 商业化进程有望全面提速
Zheng Quan Ri Bao· 2025-03-31 08:39
本报记者李春莲 3月30日晚间,康方生物科技(开曼)有限公司(以下简称"康方生物",9926.HK)发布了2024年业绩 报告。在产品商业化方面,2024年公司新药销售收入达20亿元,其中药品商业化销售收入同比增长 25%。同时,公司两款核心双抗2024年成功纳入国家医保目录,全面进入院内市场,达成了其在国内新 药商业化的重要战略目标,这也为其2025年产品放量奠定基础。 在新药开发方面,报告期内康方生物共获得新增3款新药获批,2个新药2项新适应症获批,5个产品的5 项新适应症在审评审批中。其中,核心双抗卡度尼利和依沃西的临床开发实现了在众多高发瘤种一线大 适应症的广泛布局,全年2个产品共有4项三期临床研究获得了阳性结果,总共有超过20项Ⅲ期临床研究 进行中;此外,双抗ADC、自免双抗、单靶点ADC也逐渐进入全球临床。 从业绩报告来看,康方生物2024年在新药研究、临床开发、商业化等方面的跨越式发展彰显了公司源头 创新带来的持续而强劲的全球发展动能。 商业化进程全面提速 在创新药支付环境持续向具有全球竞争力创新药物倾斜的背景下,康方生物两大核心产品双抗卡度尼利 (PD-1/CTLA-4)和双抗依沃西(PD-1 ...
医药行业及创新药板块近期投资策略
2025-03-31 05:54
Summary of Key Points from the Conference Call Industry Overview - The conference call primarily discusses the **pharmaceutical industry** and the **innovative drug sector** in China for the year 2025, highlighting various trends, opportunities, and challenges within the sector [2][4][26]. Core Insights and Arguments - **Policy Support for Innovative Drugs**: The Chinese government has approved a comprehensive plan to support innovative drug development, which includes price management, medical insurance payments, and diversified payment systems. This is expected to accelerate drug approval processes and enhance market opportunities for innovative drugs [2][3]. - **High Growth Potential**: The innovative drug sector is anticipated to maintain a high growth trajectory due to favorable policies and ongoing medical insurance negotiations. Companies like BeiGene and Hengrui Medicine are expected to benefit significantly from these developments [2][4]. - **AI in Healthcare**: The rapid development of AI in healthcare is highlighted, with companies that possess high-quality data expected to lead in AI applications for diagnostics and health management [2][5]. - **Medical Device Sector Recovery**: The medical device sector is showing signs of marginal recovery, particularly in the ophthalmology segment, driven by favorable fertility policies and increased demand for refractive surgeries [2][6]. - **Global Competitiveness of Chinese Firms**: Chinese innovative drug companies are increasingly demonstrating global competitiveness, with a significant share of global upfront payments and R&D milestones [2][8]. - **Transformation of Traditional Pharmaceutical Companies**: Traditional pharmaceutical companies are accelerating their transformation, with a focus on differentiated innovative products. Companies like East China Pharmaceutical and China National Pharmaceutical Group are noted for their promising prospects [2][9]. - **CXO Sector Recovery**: The CXO sector is gradually recovering, with leading companies like WuXi AppTec showing strong fundamentals and rapid order growth [2][27]. - **Technological Innovation in Medical Devices**: The medical device sector is characterized by strong technological innovation, with companies like United Imaging Healthcare expected to achieve significant growth in 2025 [2][38]. Notable Companies and Investment Opportunities - **Recommended Companies**: Key companies to watch include BeiGene, Hengrui Medicine, and Innovent Biologics in the innovative drug space, and United Imaging Healthcare in the medical device sector. These companies are recognized for their differentiated competitive advantages and potential for international expansion [2][7][12]. - **BeiGene's Profitability**: BeiGene is projected to achieve profitability in 2025, with its leading product, Zanubrutinib, expected to continue strong sales growth in the U.S. market [10][11]. - **Hengrui Medicine's Internationalization**: Hengrui is making significant strides in international markets, with a robust pipeline and expected high growth rates [12][15]. - **Innovent Biologics' Breakthroughs**: Innovent is noted for its advancements in tumor immunotherapy, with promising data expected from its overseas trials [16][19]. - **East China Pharmaceutical's Growth**: East China Pharmaceutical is positioned for growth with a diverse pipeline and strong market presence [24][25]. Additional Important Insights - **Market Trends**: The overall pharmaceutical market is expected to see a recovery in 2025, with innovative drugs leading the way due to supportive policies and market dynamics [4][26]. - **Investment Sentiment**: There is a positive sentiment towards the pharmaceutical sector, with expectations of continued growth driven by innovation and policy support [2][26]. - **Challenges and Risks**: While the outlook is positive, potential risks include regulatory changes and market competition, which could impact the performance of certain companies [2][3][4]. This summary encapsulates the key points discussed in the conference call, providing a comprehensive overview of the pharmaceutical industry's current landscape and future prospects.
康方生物发布年度业绩 商业销售收入20.44亿元 同比增加25.34%
Zhi Tong Cai Jing· 2025-03-30 11:19
康方生物(09926)发布截至2024年12月31日止年度业绩,收入21.24亿元(人民币,下同);商业销售收入 20.44亿元,同比增加25.34%;毛利18.35亿元。 此外,报告期内公司亦收到来自多个产品合作方的商业授权收入,共计约1.22亿元,主要为来自 SUMMIT支付的首付款。 截至目前,公司现有产能为94000升,保障大规模产能供应,并有持续和稳定的产能扩张计划以满足未 来的临床及商业化需求。集团符合GMP要求的生产设施是根据美国FDA、EMA和NMPA的规章设计和 验证的,可支持从药物发现到工艺开发、GMP合规试点和商业生产的整个药物开发过程,将有效地支 撑公司临床及商业化发展。 公告称,截止目前,公司总计拥有50多个在研创新项目,涵盖肿瘤、自身免疫及代谢性疾病等多个领 域,其中61款自主研发的产品获批上市以及2款产品在NMPA上市审评中,共有12款产品在开展注册性 III期临床试验,12个产品在I/II期临床试验阶段。管线产品中,15个为潜在全球首创(first-in-class)或同类 最佳(best-in-class)双抗╱多抗╱双抗ADC。公司期望通过高效及创新的研发、生产、商业化平台 ...