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 ...

Financial Performance - For the fiscal year ending December 31, 2024, the total revenue of the company was RMB 2,123.9 million, a decrease of 53.08% compared to RMB 4,526.3 million for the fiscal year ending December 31, 2023[4]. - The company recorded a loss of RMB 501.1 million for the fiscal year ending December 31, 2024, compared to a profit of RMB 1,942.4 million for the fiscal year ending December 31, 2023[6]. - The gross profit for the fiscal year ending December 31, 2024, was RMB 1,834.9 million, down 58.23% from RMB 4,393.0 million in the previous year[5]. - The commercial licensing income for the year ending December 31, 2024, was RMB 121.6 million, a significant decrease from RMB 2,922.8 million for the year ending December 31, 2023[65]. - The total employee compensation cost for the year ending December 31, 2024, was RMB 944.7 million, an increase from RMB 847.1 million for the year ending December 31, 2023, attributed to an increase in employee numbers[85]. - The company reported a net loss of RMB 501,093 thousand for the year ending December 31, 2024, compared to a profit of RMB 1,942,351 thousand in the previous year[103]. Research and Development - The company has over 50 innovative projects under research, with 61 self-developed products approved for market and 12 products undergoing Phase III clinical trials[8]. - Research and development expenses for the year ending December 31, 2024, were RMB 1,187.7 million, a 5.29% decrease from RMB 1,254.0 million for the year ending December 31, 2023, as the company strengthened its clinical team and reduced reliance on external clinical service providers[69]. - The company achieved key milestones in its R&D pipeline, with the global launch of the first-in-class bispecific antibody Iwoshib (PD–1/VEGF) approved in May 2024, and multiple new lines receiving IND approval, including AK135 (IL–1RAP biologic) and AK138D1 (HER3 ADC)[70]. - The company is focusing on tumor immunotherapy, with several products in clinical trials, including approved drugs like Ketanil® and Yidafang®[48]. Product Development and Clinical Trials - Cardunili's sNDA for first-line treatment of cervical cancer is in the final review stage at NMPA, with III phase clinical trial results presented at the 2024 IGCS global conference[14]. - Yidafang® (Ivosidenib, PD-1/VEGF) has been deployed in 18 indications with over 27 clinical trials, including 12 III phase trials covering various cancers[18]. - The Phase III clinical trial for the combination therapy of Ivoris in treating pancreatic cancer is underway, demonstrating superior efficacy and safety, establishing its potential as a cornerstone in tumor immunotherapy[25]. - The III phase clinical trial results for Yidafang® were published at the 2024 ASCO conference and included in major treatment guidelines[21]. - The company has successfully developed Tetrabody technology to overcome challenges in the development and production of bispecific antibodies[7]. Market Strategy and Commercialization - The company expects to become a leading global biopharmaceutical enterprise through efficient and innovative research, development, and commercialization platforms[8]. - The commercial system has undergone a comprehensive upgrade, focusing on a "patient-centric" approach to achieve rapid market entry and growth[58]. - The company aims to leverage its foundational drugs Ketanil® and Yidafang® to cover a broader market space through extensive combination therapies[48]. - The company anticipates significant market demand for its products due to excellent clinical data and innovative clinical value[9]. Financial Position and Assets - As of December 31, 2024, the group's current assets amounted to RMB 8,691.6 million, with cash and cash equivalents, time deposits, and financial products totaling RMB 7,343.9 million, an increase of RMB 2,449.4 million from RMB 4,894.4 million as of December 31, 2023[76]. - The group's current liabilities as of December 31, 2024, were RMB 1,686.6 million, including trade payables of RMB 425.2 million and other payables of RMB 715.1 million[77]. - The total assets minus current liabilities amounted to RMB 11,068,335,000 in 2024, up from RMB 7,976,508,000 in 2023, indicating an increase of approximately 38.5%[105]. - The company reported cash and cash equivalents of RMB 6,918,065,000 in 2024, compared to RMB 4,041,986,000 in 2023, reflecting a growth of about 71.2%[105]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes during the reporting period, except for C.2.1[90]. - The audit committee has been established to assist the board in providing independent opinions on financial reporting processes and internal controls[98]. - The company plans to continue reviewing and monitoring its corporate governance practices[92]. - The chairman and CEO roles are currently held by the same individual, which the board believes provides strong and consistent leadership[91].

Group 1 - The Hang Seng Healthcare Index (HSHCI) has seen a strong increase of 1.80%, with notable gains from companies such as Lepu Biopharma-B (up 16.56%) and Zai Lab (up 10.27%) [1] - The Hang Seng Medical ETF (513060) has risen by 2.11%, marking its third consecutive increase, with a trading volume of 4.69 billion yuan [1][2] - The second Boao Lecheng Stem Cell Conference has opened, marking a new phase of standardized and high-quality development in China's stem cell industry [2] Group 2 - Financial analysts predict that the approval and implementation of more projects in the stem cell sector will lead to advanced treatment methods benefiting the public [2] - The domestic medical innovation industry is expected to experience multiple growth opportunities, particularly for companies with true innovation capabilities in new drug development [2] - The Hang Seng Medical ETF has seen a significant growth in scale, increasing by 34.09 billion yuan over the past year, ranking in the top third among comparable funds [2] Group 3 - Since its inception, the Hang Seng Medical ETF has achieved a maximum monthly return of 28.34% and an average monthly return of 7.00% [3] - The ETF has outperformed its benchmark with an annualized excess return of 2.02% over the past year [3] - The ETF's management fee is 0.50%, and the custody fee is 0.15% [3] Group 4 - The tracking error of the Hang Seng Medical ETF is 0.033%, the highest tracking precision among comparable funds [4] - The latest price-to-earnings ratio (PE-TTM) of the Hang Seng Medical Healthcare Index is 24.97, indicating it is at a historical low compared to the past year [4] - The top ten weighted stocks in the Hang Seng Medical Healthcare Index account for 55.64% of the index, with companies like WuXi Biologics and BeiGene among the leaders [4][6]

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]

Negotiation Process - Approximately 20 companies participated in the morning session of the 2024 national drug price negotiation, focusing primarily on diabetes and cancer drugs [1] - The negotiation process appeared to be particularly challenging, as representatives from Akeso Biopharma and AstraZeneca left the venue significantly later than the previous day's participants [1] - Akeso Biopharma's chairman Xia Yu personally led the negotiation for two bispecific antibody products, departing close to 1 PM [1] - AstraZeneca's DS-8201 (Trastuzumab Deruxtecan) negotiation began in the morning and concluded around 1:30 PM, with AstraZeneca China Vice President Huang Bin and others leaving the venue [1] Company Participation - Akeso Biopharma was represented by its chairman Xia Yu, indicating the company's high level of commitment to the negotiation process [1] - AstraZeneca's negotiation team included senior executives such as China Vice President Huang Bin, reflecting the company's strategic focus on the Chinese market [1]

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926) [4][3] Core Insights - The clinical data for 卡度尼利 in first-line cervical cancer is impressive, with significant benefits observed across the entire population. The company has completed a new round of stock placement to accelerate global development of new drugs [3][4] - The revenue forecasts for 2024-2026 have been revised upwards to 29.40 billion, 47.76 billion, and 67.55 billion RMB respectively, compared to the previous estimates of 29.24 billion, 47.69 billion, and 65.95 billion RMB [4] - The ODAC meeting has further refined the first-line gastric cancer population, enhancing 卡度尼利's competitive advantage [4] Summary by Sections Clinical Data - The results from the Phase III clinical study for 卡度尼利 combined with platinum-based chemotherapy ± bevacizumab for first-line treatment of persistent, recurrent, or metastatic cervical cancer showed a progression-free survival (PFS) of 12.7 months versus 8.1 months for the control group (HR=0.62) and overall survival (OS) results of NR versus 22.8 months (HR=0.64) [4][8] - In the gastric cancer setting, 卡度尼利 demonstrated significant overall survival benefits, particularly in patients with low PD-L1 expression [4][9] Financial Overview - The company successfully raised approximately 19.42 billion HKD through a new stock placement, with over 8.2 billion HKD expected to be allocated for accelerating clinical development of core products globally [4][5] - The current market capitalization of 康方生物 is approximately 58.835 billion HKD, with a share price range over the past year between 31.80 and 74.40 HKD [5][4] Competitive Landscape - The FDA's recent ODAC meeting supported the segmentation of PD-1 drug applications based on PD-L1 expression levels, which positions 卡度尼利 favorably against existing treatments for gastric cancer [4][9] - The report highlights that 卡度尼利's treatment regimen offers significant survival benefits compared to PD-1 monoclonal antibodies, particularly in populations with low PD-L1 expression [4][8]