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]

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 87.00, indicating a potential upside of 25.8% from the current price of HKD 69.15 [2][7]. Core Insights - The report highlights the approval of two new indications for the company's products, significantly expanding its commercial portfolio into non-oncology areas. The approval of the drug 开坦尼 for first-line treatment of gastric cancer is expected to greatly increase its potential patient population, with an estimated peak sales forecast adjustment to RMB 5.2 billion. Additionally, the approval of AK102 for primary hypercholesterolemia and mixed dyslipidemia is noted as a strong competitive advantage in the market [1][2]. - Recent clinical data releases from major conferences such as ESMO and EADV have shown promising results for the company's products, particularly for IL-17 古莫奇单抗 in treating moderate to severe plaque psoriasis and for the drug 依沃西 in various solid tumors, which may enhance the clinical application and extend the product lifecycle [1][2]. Financial Summary - Revenue projections for 2024-2026 have been increased by 6-10% due to the recent approvals and positive clinical developments. The new revenue estimates are RMB 2,849 million for 2024, RMB 4,786 million for 2025, and RMB 6,465 million for 2026, reflecting significant growth compared to previous forecasts [4][5]. - The company is expected to report a net profit of RMB 786 million in 2025 and RMB 1,880 million in 2026, indicating a recovery from losses in 2024 [4][5]. - The DCF valuation model suggests a fair value of HKD 87.0 per share, supported by anticipated catalysts such as the outcomes of insurance negotiations and the approval of new indications [2][6].

Product Development and Innovation - Akeso, Inc. has over 50 innovative projects in development, with 10 products in commercialization or Phase III clinical trials, including 4 approved products and 2 under NMPA review[2]. - The company has developed a Tetrabody technology to address three CMC challenges in developing and producing bispecific antibodies, including low expression levels and stability issues[2]. - Akeso aims to become a leading global biopharmaceutical company through efficient and innovative R&D, focusing on first-in-class and best-in-class bispecific antibodies[2]. - The company is advancing the Phase III clinical trial of Cardunili, focusing on its efficacy in various cancers, with over 20 clinical trials ongoing across 16 indications[14]. - The company is actively pursuing partnerships and collaborations to enhance its research and development capabilities[26]. - The company is focusing on tumor immunotherapy, with products in clinical trials including approved therapies and several bispecific antibodies targeting various indications[24]. - The company aims to address unmet medical needs in oncology through its diverse product pipeline[25]. - The company is advancing its product candidates into Phase Ib/III trials, indicating a strong commitment to clinical development[25]. - The company has submitted IND applications for three candidates: AK137 (CD73/LAG-3) for advanced malignancies, AK138D1 (HER3 ADC) for advanced malignancies, and AK135 (IL-1RAP) for chemotherapy-induced peripheral neuropathy[23]. Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 1,024.7 million, a decrease from RMB 3,676.9 million for the same period in 2023[8]. - Product revenue for the six months ended June 30, 2024, was RMB 939.4 million, up 23.96% from RMB 757.9 million in the same period last year[11]. - Gross profit for the six months ended June 30, 2024, was RMB 943.2 million, compared to RMB 3,599.7 million for the same period in 2023[9]. - The company recorded a loss of RMB 249.3 million for the six months ended June 30, 2024, compared to a profit of RMB 2,489.5 million for the same period in 2023[10]. - The significant decline in licensing revenue was primarily due to the change in the revenue structure, with licensing income dropping to RMB 85.3 million from RMB 2,919.0 million year-on-year[8]. - The company reported a total comprehensive loss of RMB 250,049 thousand for the six months ended June 30, 2024, compared to a total comprehensive income of RMB 2,498,155 thousand in the same period of 2023[161]. - The company reported a loss attributable to equity holders of RMB (238,590,000) for the six months ended June 30, 2024, compared to a profit of RMB 2,525,045,000 in the same period in 2023[189]. Product Sales and Revenue Sources - Sales of the product Kanti® (Cardunili, PD-1/CTLA-4) generated approximately RMB 705.7 million, an increase of 16.50% from RMB 605.8 million in the previous year[12]. - The main revenue source was from the product 开坦尼® (卡度尼利·PD-1/CTLA-4), which generated RMB 705.7 million, up 16.50% from RMB 605.8 million in the previous year[36]. - Other products contributed RMB 233.7 million, representing a significant increase of 53.66% from RMB 152.1 million[36]. - Revenue from mainland China was RMB 938,131,000, up 24% from RMB 756,189,000 in the previous year[180]. - Revenue from the United States significantly dropped to RMB 85,117,000 from RMB 2,920,093,000, indicating a decline of approximately 97%[180]. Clinical Trials and Regulatory Approvals - The new indication for Cardunili in combination with chemotherapy for advanced gastric cancer received acceptance from NMPA in January 2024[13]. - Cardunili's III phase clinical trial results for cervical cancer were positively reported in July 2024, achieving the primary endpoint in interim analysis[13]. - The product revenue for Yidafang (Yivofisi) reached approximately RMB 103 million during the reporting period, following its approval for use in treating EGFR-mutant NSCLC[15]. - The Phase III trial of Yivofisi against Pabrolizumab in NSCLC achieved positive results, marking it as the first and only monotherapy to do so, with a successful sNDA submission to CDE[16]. - The company has initiated multiple Phase III trials for Yivofisi, including combinations with chemotherapy for various cancers, demonstrating its potential as a cornerstone in tumor immunotherapy[16]. - Anika (Pianpuli) received NMPA approval for treating recurrent/metastatic nasopharyngeal carcinoma, with an sNDA for its combination therapy currently under review[18]. - The Phase III trial of Prolaxi (AK109) in combination with Cardunili for advanced G/GEJ cancer has commenced, with initial patient enrollment reported[19]. Employee and Operational Growth - The total number of employees as of June 30, 2024, is 2,815, an increase from 2,520 as of June 30, 2023, reflecting a growth of approximately 11.7%[30]. - The workforce in the clinical department has increased to 661 employees, up from 642 in the previous year, indicating a growth of approximately 2.9%[31]. - The production, quality assurance, and quality control workforce has grown to 686 employees, an increase of 19.3% from 575 in the previous year[31]. - The company has a total production capacity of 54,000 liters as of June 30, 2024, with plans for continuous expansion to meet future clinical and commercialization needs[32]. Cash Flow and Financial Position - Cash and cash equivalents as of June 30, 2024, amounted to RMB 2,487,349 thousand, up from RMB 1,542,313 thousand as of December 31, 2023, reflecting an increase of 61.1%[162]. - The company reported a net increase in cash and cash equivalents of RMB 926,402,000 for the six months ended June 30, 2024, down from RMB 2,084,516,000 in 2023, a decrease of approximately 56%[169]. - The net cash flow from operating activities for the six months ended June 30, 2024, was (RMB 346,503,000), a significant decrease from RMB 2,871,241,000 in the same period of 2023, indicating a decline of approximately 112%[169]. - The company recognized licensing income of RMB 85,318,000 in the first half of 2024, a significant drop from RMB 2,918,988,000 in the same period of 2023, indicating a decrease of approximately 97%[175]. Corporate Governance and Compliance - The company has confirmed compliance with the standard code of conduct for securities trading by all directors during the reporting period[55]. - The company has adopted and complied with all applicable code provisions of the corporate governance code, except for the separation of the roles of Chairman and CEO[54]. - The company plans to review and monitor its corporate governance practices continuously to maintain high standards[54]. - There were changes in the board of directors, with Dr. Xia Yu resigning as an executive director and Dr. Zhang Peng appointed as an executive director[64]. Shareholder Information and Stock Options - The total number of issued shares as of June 30, 2024, is 865,857,176 shares[68]. - Major shareholders owning 5% or more of the issued shares include Cantrust (Far East) Limited with 47,664,282 shares (5.50%) and YAO Yulin with 43,453,668 shares (5.02%) as of June 30, 2024[71]. - The company has established a stock option plan that allows participants to exercise their options under specific conditions, including performance targets[135]. - The stock option plan allows for a maximum exercise period of 10 years from the grant date[135]. - The company will ensure compliance with listing rules and regulations regarding the stock option plan[134].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 81.89 [5]. Core Insights - The company’s drug, Ivosidenib, has shown unprecedented results in the HARMONi-2 study, nearly doubling the median progression-free survival (mPFS) compared to Keytruda, achieving 11.14 months versus 5.82 months [1][9]. - Ivosidenib's single-agent "de-chemotherapy" regimen is expected to become the first-line treatment for lung cancer patients with positive PD-L1 expression, with a New Drug Application (NDA) accepted in August [2]. - The overseas value of Ivosidenib is anticipated to be re-evaluated, with peak sales in the U.S. projected to exceed USD 4.5 billion [3][26]. Summary by Sections HARMONi-2 Study Results - The HARMONi-2 study demonstrated that Ivosidenib significantly outperformed Keytruda in mPFS, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [1][11]. - The study included a diverse patient population, with 42.2% having high PD-L1 expression, and showed consistent results with previous studies, enhancing the credibility of the findings [10][11]. Single-Agent Efficacy - Ivosidenib achieved an mPFS of 11.1 months, outperforming Keytruda combined with chemotherapy in two Phase III studies, indicating its potential as a first-line treatment option [2][13]. - The safety profile of Ivosidenib is favorable, with a discontinuation rate of only 1.5% due to adverse events [16]. Clinical Development and Market Potential - The company is accelerating clinical development for Ivosidenib, with plans for further studies in various cancers, including colorectal and triple-negative breast cancer [3][26]. - Financial projections estimate revenues of CNY 26.5 billion, CNY 40.6 billion, and CNY 64.2 billion for 2024, 2025, and 2026, respectively, with a net profit forecasted to turn positive by 2025 [4][27].

Investment Rating - The report assigns a "Buy" rating to the company 康方生物 (9926 HK) with a target price of HKD 77.00, indicating a potential upside of 38.0% from the current price of HKD 55.80 [2][13]. Core Insights - The report highlights that the clinical data for the drug 依沃西 (Ivonescimab) in head-to-head trials against K drug exceeded market expectations, positioning it as a potential cornerstone in immuno-oncology [1][2]. - The report anticipates that 依沃西 will receive approval for treating 1L PD-L1+ NSCLC in China in the first half of 2025, with a global Phase III trial (HARMONi-7) set to commence soon [2]. Summary by Sections Clinical Data - The Phase III trial data for 依沃西 showed a progression-free survival (PFS) hazard ratio of 0.51, with median PFS of 11.14 months for the 依沃西 group compared to 5.82 months for the K drug group [1]. - The 9-month PFS rates were 56% for 依沃西 versus 40% for the K drug, with significant improvements across various subgroups [1]. Safety Profile - The safety profile of 依沃西 was validated, showing a lower incidence of severe treatment-related adverse events (TRAE) compared to the K drug [1]. - The incidence of grade 3 or higher TRAE was 29.4% for 依沃西 versus 15.6% for the K drug, with a discontinuation rate due to TRAE of only 1.5% [1][7]. Financial Projections - Revenue projections for 康方生物 are set at RMB 2,692 million for 2024, with a significant increase to RMB 4,342 million in 2025 and RMB 5,989 million in 2026 [4][11]. - The net profit is expected to improve from a loss of RMB 302 million in 2024 to a profit of RMB 683 million in 2025 and RMB 1,664 million in 2026 [4][11]. Valuation Model - The discounted cash flow (DCF) model estimates the equity value of 康方生物 at RMB 60,609 million, translating to a per-share value of HKD 77.00 [12][14].

康方生物（09926.HK） 依沃西头对头战胜 K 药，有望成为下一代免疫基石药物 优于大市 | --- | --- | --- | --- | --- | |--------------|--------------------------------|---------------|----------------------------------------------------|---------------------------------------------------------| | 证券分析师： | 公司研究·海外公司快评 \n张佳博 | 021-60375487 | 医药生物·生物制品 \n zhangjiabo@guosen.com.cn | 投资评级：优于大市（维持） \n 执证编码：S0980523050001 | | 证券分析师： | 陈益凌 | 021-60933167 | chenyiling@guosen.com.cn | 执证编码：S0980519010002 | | 证券分析师： | 陈曦炳 | 0755-81982939 | chenxibing@guosen ...

[ T able_StockInfo] 2024 年 09 月 09 日 证券研究报告•公司动态跟踪报告 当前价：48.20 港元 康方生物（9926.HK）医疗保健 目标价：——港元 HARMONi-2 发表，对比 K 药取得显著阳性结果 [Table_Summary 事件：2024 年] 9 月 8 日，康方生物（9926.HK）在 2024 世界肺癌大会上发布 了公司自主研发的全球首创 PD-1/VEGF 双特异性抗体新药依沃西单药对比帕 博利珠单抗单药一线治疗 PD-L1表达阳性（PD-L1 TPS≥1%）的局部晚期或转 移性非小细胞肺癌（NSCLC）的注册性 III 期临床研究(HARMONi-2/AK112-303） 的重磅研究数据。依沃西 HARMONi-2 研究是全球首个对比帕博利珠单抗取得 显著阳性结果的随机、双盲、对照 III 期临床研究。 依沃西对比帕博利珠单抗取得显著阳性结果，整体安全性优异。依沃西一线治 疗 PD-L1 阳性 NSCLC，相比帕博利珠单抗显著延长了患者的中位无进展生存 期（mPFS），具有统计学和临床双重显著性。在 ITT 人群中，依沃西组和帕博 利珠单抗组的 mPF ...

浦银国际研究 浦银国际 公司研究 康方生物 （9926.HK） 公司研究 | 医药行业 康方生物（9926.HK）：依沃西与 K 药头对头数据好于预期 康方生物于 WCLC 大会公布的 HARMONi-2 数据显示出显著 PFS 获益及 优秀的安全性，好于此前市场预期。我们认为显著的 PFS 获益有望转化 成 OS 获益，值得期待。维持"买入"评级，上调目标价至 65 港元。 依沃西和 K 药头对头期中分析数据发表，PFS 获益及安全性好于预 期：昨晚（9 月 8 日）公司已于 WCLC 大会公布 HARMONi-2 期中分析 数据，符合之前公告的 PFS 获益显著，更为惊喜的是 PFS 数据（mPFS 为 11.14 个月，HR 为 0.51）优于此前市场预期，各个亚组 PFS 获益显 著，安全性数据无论在鳞癌还是非鳞癌均优秀，因此推动公司股价今 日上涨约 16%。 依沃西实现 11.14 个月 mPFS（vs. 帕博利珠单药：5.82 个月），HR 为 0.51，临床获益显著：在 HARMONi-2/AK112-303 (CTR20222137) 试验 中(n=398)，依沃西单药(n=198)与帕博利珠 ...

证券研究报告 医药生物 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 市场表现： | --- | --- | --- | --- | |-------------|-------------------------------------|-------------|-------------------| | | | | | | | 康方生物 | | 恒生指数 | | 47% | | | | | 34% | | | | | 21% | | | | | -19% -6% 8% | | | | | 23-08 | 23-10 23-11 23-12 24-01 24-02 24-03 | 24-05 24-06 | 24-04 24-07 24-08 | 2024 年 9 月 9 日 康方生物 (9926.HK) 买入（维持） —— AK112-303 数据超预期，铸造新一代 I/O 基石药物 投资要点： ➢ 公司事件：2024 年 9 月 8 日，康方生物以 Oral 形式在 2024 WCLC 重磅发布全球首创 PD-1/VEGF 双特异性抗体新药依沃 ...

股 票 研 究 证 券 研 究 报 告 国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 依沃西 vs K 药临床数据创纪录，肺癌领域新突破 康方生物(9926) [Table_Industry] 医药 [Table_Invest] 评级： 增持 ——康方生物公司跟踪点评 股票研究 /[Table_Date] 2024.09.09 | --- | --- | --- | --- | --- | --- | --- | |----------|-----------------------------------|----------------------------|-------|------------------------------|-------|-------| | | | | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 甘坛焕 ( 分析师 ) | | 姜铸轩 ( 分析师 | | | | | 0755-23976735 | 021-38675855 | | 021-3867487 ...