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].

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]

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 ...

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 ...

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 分 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。 Akeso, Inc. 康方生物科技（開曼）有限公司 （於開曼群島註冊成立的有限公司） （股份代號：9926） 截 至2024年12月31日 止 年 度 業 績 公 告 康 方 生 物 科 技（開 曼）有 限 公 司 董 事 會 謹 此 公 佈 本 集 團 截 至2024年12月31 日 止 年 度 的 綜 合 業 績。該 等 年 度 業 績 已 經 由 本 公 司 審 核 委 員 會 審 閱 及 本 公 司 核 數 師 安 永 會 計 師 事 務 所 同 意。 於 本 公 告 中，「我 們」指 本 公 司 或 按 文 義 指 本 集 團。 財 務 摘 要 1. 收 入 截 至2024年12月31日 止 年 度，本 集 團 ...

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926 HK) with a target price of 87 HKD, indicating a potential upside of 26.7% from the current price of 68.65 HKD [4][5]. Core Insights - 康方生物 has entered a clinical trial collaboration with Pfizer to explore the potential of combining its PD-1/VEGF dual antibody, 依沃西, with multiple vedotin ADCs from Pfizer for treating various solid tumors. The clinical trials are expected to start in mid-2025, primarily focusing on Phase Ib/II studies [1][3]. - The collaboration is significant as Pfizer has a robust pipeline of vedotin ADCs, which have shown promising preliminary clinical results when combined with PD-1 targeted therapies, suggesting a synergistic anti-tumor effect [2][3]. - 康方生物 is also advancing its clinical trials in multiple indications, including biliary cancer, head and neck squamous cell carcinoma, pancreatic cancer, and triple-negative breast cancer, with several key catalysts expected in 2025 [3]. Summary by Sections - **Clinical Collaboration**: 康方生物's partnership with Pfizer aims to leverage the strengths of both companies in developing innovative cancer therapies, with a focus on the efficacy of 依沃西 in combination with vedotin ADCs [1][3]. - **Pipeline and Milestones**: Key milestones for 康方生物 in 2025 include the readout of the HARMONi trial for EGFR TKI-treated NSCLC, the initiation of the ADC combination trials, and ongoing patient enrollment in important Phase III studies [3]. - **Market Position**: 康方生物 is positioned as a key player in the oncology sector, with a strong emphasis on expanding its clinical development efforts and maintaining a competitive edge in the market [3].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 87.00, indicating a potential upside of 45.9% from the current price of HKD 59.65 [1][6][12]. Core Insights - The company has recently submitted its third non-oncology product for market approval and has initiated multiple Phase III trials for its product, Ivoris, in various indications beyond lung cancer, reaffirming the "Buy" rating [2][6]. - The financial forecasts have been adjusted, reflecting a more cautious short-term sales outlook, but the long-term peak sales estimates for key products have been maintained or increased [6][7]. Financial Overview - Revenue projections for 2024, 2025, and 2026 are revised to RMB 2,411 million, RMB 4,096 million, and RMB 5,861 million respectively, with significant growth expected in the following years [5][14]. - The net profit is expected to improve from a loss of RMB 509 million in 2024 to a profit of RMB 595 million in 2025, and further to RMB 1,707 million in 2026 [5][14]. - The company’s market capitalization is approximately HKD 53.42 billion, with a 52-week high of HKD 77.55 and a low of HKD 31.80 [4][6]. Product Development - The company has successfully submitted its eighth innovative drug application, targeting moderate to severe plaque psoriasis, enhancing its product portfolio in the autoimmune field [6][7]. - The ongoing Phase III studies for Ivoris in various cancers are expected to expand its market opportunities significantly, particularly in indications with limited current treatment options [6][7]. Valuation Model - The DCF valuation model estimates the equity value at approximately RMB 70,990 million, translating to a per-share value of HKD 87.00 [8].

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - Ivonescimab (依沃西单抗) demonstrated significant therapeutic benefits in multiple clinical trials, particularly in the HARMONi-2 study where it outperformed pembrolizumab (帕博利珠单抗), showcasing its potential as a global blockbuster [1] - The overseas expansion of Ivonescimab is expected to enhance its revenue peak and company valuation [1] - The company's mature pipeline, including cadonilimab (卡度尼利单抗) and inusirumab (伊努西单抗), is progressing steadily towards commercialization, with new indications and market potential [4] Clinical Results - In the HARMONi-2 study, Ivonescimab showed a significant PFS advantage over pembrolizumab (11.14 vs 5.82 months, HR=0.51) and demonstrated excellent safety with low rates of TRAE-related discontinuation and mortality (1.5% and 0.5%) [2] - Ivonescimab also showed promising efficacy in NSCLC perioperative treatment, head and neck squamous cell carcinoma, colorectal cancer, and TNBC in Phase II trials [2] Overseas Expansion - Ivonescimab's overseas Phase III trials, HARMONi and HARMONi-3, are progressing, with HARMONi-3 expanding its target population to include both squamous and non-squamous NSCLC [3] - The HARMONi-7 study targeting PD-L1 strong-positive NSCLC patients is set to begin in early 2025, further enhancing Ivonescimab's global potential [3] Other Pipelines - Cadonilimab has seen new indications approved and has been included in the national medical insurance, boosting its commercialization potential [4] - Inusirumab, a PCSK9 monoclonal antibody, was approved in September, and other non-oncology drugs are expected to be launched within the next three years [4] Market Differentiation - The report differs from market consensus by expressing strong confidence in the company's overseas potential, citing the robust data from the HARMONi-2 study and the likelihood of replicating domestic success in international markets [5] Financial Forecasts and Valuation - Revenue forecasts for 2024/2025/2026 have been revised downward to 2.312/3.342/5.409 billion RMB (down 13.0/20.8/14.0% from previous estimates) due to national negotiations and the approval pace of non-oncology drugs [6] - The DCF terminal value has been increased from 36 billion to 65.2 billion RMB, leading to a target market cap of 84.5 billion RMB and a target price of 100.45 HKD [6] Industry Insights - The report highlights the potential of IO (immuno-oncology) combined with anti-angiogenesis therapies, noting that while some combinations have shown promise, others have failed due to toxicity and efficacy issues [27][28] - The LEAP series of studies, which explored the combination of pembrolizumab and lenvatinib, showed mixed results, with some studies achieving positive outcomes while others failed to meet OS endpoints [29][30][31]

Investment Rating - The report assigns a **Buy** rating to the company with a target price of **HKD 77.7**, representing a **19% upside** from the current price of HKD 65.2 [5] Core Views - The company's R&D pipeline demonstrates **world-class potential**, particularly with its key products **AK104 (PD-1/CTLA-4)** and **AK112 (PD-1/VEGF)**, which have shown significant clinical progress and market potential [2][3] - The company's revenue in H1 2024 increased by **24% YoY to RMB 940 million**, driven by strong sales of **AK104 (RMB 710 million, +16.5% YoY)** and **AK105 (RMB 130 million)** [2] - Despite a net loss of **RMB 240 million** in H1 2024, the company maintains a strong cash position of **RMB 2.4 billion**, supported by two successful placements in 2024 raising **HKD 1.17 billion** and **HKD 1.92 billion** respectively [2] Product Pipeline Summary AK104 (PD-1/CTLA-4) - Achieved **PFS (12.7 vs 8.1 months, HR 0.62)** and **OS (not reached vs 22.8 months, HR 0.64)** endpoints in **first-line cervical cancer**, with significant efficacy across all populations, including **PD-L1 low/negative expression** (CPS <1, 23% reduction in death risk) [3] - Approved for **first-line gastric cancer** in October 2024, showing **OS benefit (15 vs 10.8 months, HR 0.62)**, addressing the unmet need in **PD-L1 low/negative gastric cancer** (mOS 17.6 months vs 11 months for PD-1) [3] - Multiple **Phase III trials** ongoing for **gastric cancer post-PD-(L)1 progression**, **hepatocellular carcinoma**, and **non-small cell lung cancer (NSCLC)** [3] AK112 (PD-1/VEGF) - Approved in May 2024 for **EGFR-mutated NSCLC post-treatment progression**, with **Summit global Phase III** trial completed and **FDA Fast Track** designation [3] - Achieved **PFS endpoint (11.14 vs 5.82 months, HR 0.51)** in **first-line PD-L1-positive NSCLC** vs **Pembrolizumab**, with **NDA submitted** in July 2024 [3] - Expanded **Summit Phase III** trial to include **non-squamous NSCLC** with a sample size of **1,080 patients**, alongside ongoing trials for **biliary tract cancer**, **pancreatic cancer**, and **head and neck squamous cell carcinoma** [3] Other Key Products - **AK105 (PD-1)**: Under review for **first-line nasopharyngeal carcinoma** and submitted for **first-line hepatocellular carcinoma** [3] - **AK102 (PCSK9)**: Approved in October 2024 [3] - **AK101 (IL-12/IL-23)**: Submitted for **moderate-to-severe plaque psoriasis** in August 2023 [3] - **AK111 (IL-17)**: Completed Phase III enrollment for **psoriasis** and ongoing for **ankylosing spondylitis** [3] - **AK117 (CD47)**: Global first **Phase III** trial for **solid tumors** [3] Financial Summary - Revenue for 2024E is projected at **RMB 2.5 billion**, with a **32.6% YoY growth** expected in 2025E to **RMB 3.3 billion** [4] - Gross margin remains strong at **91.3%** in H1 2024, with **R&D expenses** increasing by **3% to RMB 590 million** [2] - Net loss for 2024E is estimated at **RMB 184 million**, with a turnaround to **RMB 775 million net profit** expected in 2026E [4] Valuation - The target price of **HKD 77.7** is derived using a **DCF model** with a **WACC of 10.0%** and **perpetual growth rate of 3.0%**, incorporating **AK112's overseas potential** (USD 6 billion sales, 60% success probability) [3]

Investment Rating - The report maintains a "Buy" rating for the company Kangfang Biopharma (09926) [6] Core Insights - Kangfang Biopharma is positioned as a leader in bispecific antibody therapies, successfully challenging established treatments and advancing its internationalization efforts [4][23] - The company has achieved significant clinical trial results, particularly with its product AK112, which has shown promising outcomes against existing therapies in lung cancer treatment [4][6] - The financial outlook is positive, with projected revenues increasing significantly over the next few years, leading to expected profitability by 2025 [6][11] Summary by Sections Company Overview - Kangfang Biopharma focuses on developing innovative and affordable antibody drugs, leveraging a unique end-to-end research and development platform [23] - The company has established a strong pipeline of products, with several in late-stage clinical trials and some already approved for market [23][24] Industry Situation - The tumor immunotherapy market is rapidly growing, with bispecific antibodies playing a crucial role in the evolution of cancer treatment [11][23] - The report highlights the limitations of current T-cell targeting immunotherapies and the potential of bispecific antibodies to address these challenges [11] Company Highlights - AK112 has demonstrated breakthrough results in clinical trials, positioning it as a potential new standard for first-line treatment in lung cancer [4][6] - The company’s product AK104 has also shown significant efficacy in treating advanced cervical cancer, filling a gap in the current treatment landscape [5][6] Financial Forecast and Valuation - Projected revenues for 2024, 2025, and 2026 are estimated at 26.78 billion, 43.33 billion, and 69.78 billion yuan respectively, with a return to profitability expected in 2025 [6][11] - A DCF valuation model suggests a reasonable market capitalization of 754.15 billion HKD, corresponding to a target price of 84.15 HKD per share [6]