Investment Rating - The report maintains an "Accumulate" rating for 康方生物 (9926) [2][4][5]. Core Views - 康方生物's core product, 依沃西, is entering a harvest period with accelerated revenue growth, leading to an upward revision of revenue forecasts for 2024-2026 to 29.24 billion, 47.69 billion, and 65.95 billion RMB respectively [5]. - The clinical data for 依沃西 against K药 shows record results, with an ITT population HR of 0.51, indicating significant benefits across all subgroups [5]. - The safety profile of 依沃西 in squamous cell carcinoma is superior, breaking through the safety limitations of traditional anti-VEGF therapies [5]. - Multiple clinical trials are advancing, with new plans for first-line NSCLC clinical studies announced by Summit [5]. Summary by Sections Clinical Data - 依沃西's clinical trial results show a median progression-free survival (mPFS) of 11.14 months compared to 5.82 months for K药, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [5]. - The overall response rate (ORR) for 依沃西 is 50.0% versus 38.5% for K药, and the disease control rate (DCR) is 89.9% compared to 70.5% [5]. - Subgroup analyses show strong positive results for various populations, including HRs of 0.46 for PD-L1 TPS≥50% and 0.48 for squamous carcinoma [5]. Safety Profile - The incidence of grade 3 or higher treatment-related adverse events (TRAE) is comparable between 依沃西 and K药 (22.2% vs 18.7%) [5]. - In squamous cell carcinoma patients, the risk of bleeding is not significantly increased, with a grade 3 or higher adverse event rate of 10.2% for 依沃西 compared to 1.0% for K药 [5]. Financial Projections - Revenue forecasts for 康方生物 have been revised upwards, with expected revenues of 2.924 billion RMB in 2024, 4.769 billion RMB in 2025, and 6.595 billion RMB in 2026, reflecting significant growth [9]. - The company reported a net profit of 2.028 billion RMB in 2023, with projections of -334 million RMB in 2024, followed by a return to profitability in 2025 and 2026 [9].

康方生物（09926.HK） 优于大市 研发及商业化均实现快速发展 依沃西头对头 K 药取得优效，正式进入商业化阶段。康方生物的 PD1/VEGF 双抗依沃西头对头K 药单药一线治疗 PD-L1 阳性的 NSCLC 的 3 期临床在上半 年达到 PFS 主要临床终点，且在各个亚组均显示强阳性结果。依沃西已在肺 癌启动 6 项 3 期临床，并且新启动 3 项 3 期临床，广泛覆盖各大瘤种。2024 年 5 月，依沃西获得中国药监局批准上市，用于二线治疗 EGFRm nsqNSCLC； 上半年依沃西实现收入 1.03 亿元。另外，公司与 SUMMIT 签署了补充协议， 拓展了依沃西的许可市场范围。 卡度尼利拓展大适应症，销售端保持增长。PD1/CTLA4 双抗卡度尼利已经完 成 GC 1L 和 CC 1L 的 3 期临床并提交上市申请，并在肺癌、肝癌等大适应症 中推进 3 期临床。卡度尼利上半年实现收入 7.06 亿元（+16.5%），在上市 的前两年累积销售超 26 亿元。公司的两大核心产品依沃西和卡度尼利均有 望通过年底的谈判进入医保目录。 自免管线进入收获期，早期管线布局丰富。康方生物的 AK101（IL- ...

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 -19% -6% 8% 21% 34% 47% 23-0823-1023-1123-1224-0124-0224-0324-0424-0524-0624-0724-08 相关研究 1.《康方生物（9926.HK）：打造新 一代 I/O 创新药旗舰，强势出海未来 可期》，2024.07.29 | --- | --- | |-----------------------|----------------------| | 股价数据： 2024 | 年 9 月 3 日 | | 收盘价（港元） | 49.05 | | 年内最高/最低（港元） | 60.00/26.45 | | 总市值（亿港元） | 424.70 | 公司点评 2024 年 9 月 4 日 康方生物 (9926.HK) 买入（维持） ——业绩符合预期，产品销售持续高增，重磅临床加速推进 投资要点： ➢ 公司事件：康方生物发布 2024 年中期业绩公告，产品收入为 9.4 亿元，同比+24%(去年同 ...

30 Aug 2024 CMB International Global Markets | Equity Research | Company Update Akeso (9926 HK) Eyes on the detailed head-to-head data of AK112 at WCLC in Sep In 1H24, Akeso recorded RMB1.03bn in revenue, including RMB939mn from product sales. Cadonilimab/AK104 (PD-1/CTLA-4) recorded RMB706mn in sales in 1H24, +16% YoY or -6% HoH, accounting for 39% of our previous full-year estimate. We attribute the weaker-than-expected sales performance to the preparation for NRDL inclusion. Recall that Akeso reduced the ...

证券分析师 周新明 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 -29% -14% 0% 14% 29% 43% 57% 康方生物 恒生指数 | --- | --- | --- | --- | |--------------------------------|----------------|--------------|-------| | 2023-09 \n恒 生 指 数 对 比 | 2024-01 \n1M | 2024-05 \n2M | 3M | | 绝对涨幅 (%) | 16.08 | 30.07 | 11.59 | | 相对涨幅 (%) | 12.36 | 28.54 | 12.09 | | 资料来源：德邦研究所，聚源数据 | | | | 相关研究 1.《康方生物(9926.HK)：AK112 获批 +击败 K 药，创新药龙头价值当被重 估》，2024.7.19 2.《康方生物(9926.HK)：管线矩阵丰 富，多个产品将获批，收入有望继续高 增》， ...

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926.HK) with a target price of 63 HKD, indicating a potential upside of 28% from the current price of 49.1 HKD [2][3]. Core Insights - The company's 1H24 performance is largely in line with market expectations, achieving revenue of 1.02 billion RMB, with product revenue of 939 million RMB, reflecting a year-on-year growth of 24% [2][3]. - The report highlights the upcoming WCLC conference, where interim analysis data for the K drug head-to-head study in lung cancer is expected to be announced, serving as a key catalyst for the company's stock [2][3]. - The company has initiated seven new Phase III clinical trials in the first half of 2024, focusing on its core assets, 卡度尼利 and 依沃西, with a projected total R&D expenditure of 1.3 to 1.4 billion RMB for the year [2][3]. Financial Performance Summary - For 1H24, 康方生物 reported a gross margin of 91.3%, with a net loss attributable to shareholders of 239 million RMB, compared to a net profit of 253 million RMB in 1H23 [2][3]. - The company’s cash and cash equivalents stood at 5.69 billion RMB as of the end of the first half of 2024 [2][3]. - Revenue projections for the upcoming years are as follows: 2024E at 2.39 billion RMB, 2025E at 3.45 billion RMB, and 2026E at 5.41 billion RMB, with significant year-on-year growth anticipated [3][4]. Clinical Development and Upcoming Catalysts - The report outlines several key data readouts expected in the second half of 2024, including interim analysis data for 依沃西 in the AK112-303 trial and data for 卡度尼利 in the 1L CC trial [2][3]. - The company is also preparing for potential inclusion in the 2024 medical insurance negotiations, which could significantly boost the sales volume of its drugs [2][3]. Valuation and Financial Estimates - The report adjusts the net loss estimates for 2024E to 540 million RMB, with slight adjustments to future profit estimates for 2025E and 2026E [2][3]. - The valuation is based on a DCF model with a WACC of 9.4% and a perpetual growth rate of 3% [2][3].

业绩简评 2024 年 8 月 28 日，公司发布半年度业绩，1H24 实现营收 10.25 亿元，同比下降 72%（1H23 和 1H24 当期确认的许可费收入分别为 29.15 亿元和 0.80 亿元）；其中，产品销售收入 9.39 亿元，同比 增长 23.96%；1H24 亏损 2.49 亿元。业绩符合预期。 经营分析 商业化强劲：卡度尼利增长，依沃西首月告捷，2 款新品获批在即。 （1）2024 上半年，产品收入 9.39 亿元，同比增长 23.96%。其中， 开坦尼（卡度尼利）收入 7.06 亿元，较 1H23 的 6.06 亿元收入， 同比增长16.50%。1H24公司收到/确认许可费收入0.85/0.80亿元， 主要来自 Summit 支付的依沃西拓展许可市场范围的授权许可首付 款（2）报告期内，①依沃西，于 2024 年 5 月 24 日首次获批上市， 用于治疗 EGFR-TKI（表皮生长因子受体-酪氨酸激酶抑制剂）治疗 进展后的 EGFR 突变的局部晚期或转移性非麟非小细胞肺癌患者； 获批一周内，即实现首批发货，一个月左右实现收入 1.03 亿元。 ②派安普利单抗，于 2024 年 4 月 ...

华福证券 康方生物（09926.HK） 依沃西头对头 K 药成功，一线肺癌 NDA 获受理 投资要点： 卡度尼利稳定增长，依沃西肺癌 TKI 耐药获批贡献业绩增量 24H1 实现收入 10.2 亿元（-72.13%），其中产品销售收入 9.39 亿元 （+23.96%）。分产品看：卡度尼利实现收入 7.06 亿（+16.5%），依沃西 发货收入 1.03 亿元，其他产品收入 1.31 亿元。24H1 产品销售毛利为 8.58 亿元，产品毛利率高达 91.3%。销售费用 5.16 亿元（同比+16.6%），研发 费用 5.94 亿元（同比+3.4%），净亏损 2.49 亿。公司研发高效，4 个新适 应症 NDA 已递交并审评、5 款产品新启动 7 个三期临床(包括 3 个新产品）。 卡度尼利在 1L 胃癌和 1L 宫颈癌全人群获益，将填补临床空白 1）1L 胃癌：NDA 于今年 1 月获 NMPA 受理，是目前唯一在 PD-1 低表达 人群做出 OS 获益的 IO 产品。2）1L 宫颈癌：NDA 于 4 月获 NMPA 受理， III 期研究已达到 PFS 和 OS 双主要终点，是目前唯一在全人群获益的 3 期 ...

Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 1,024.7 million, a significant decrease from RMB 3,676.9 million for the same period in 2023[1]. - Gross profit for the six months ended June 30, 2024, was RMB 943.2 million, down from RMB 3,599.7 million in the same period last year[2]. - 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 in the previous year[3]. - Other income and net gains for the six months ended June 30, 2024, were RMB 211.8 million, down from RMB 380.1 million in the same period in 2023[42]. - The company reported a loss before tax of RMB 249,348 thousand for the six months ended June 30, 2024, compared to a profit of RMB 2,489,544 thousand in the same period of 2023[72]. - The basic loss per share for the current period was RMB (0.28), compared to earnings of RMB 3.01 per share in the previous year[74]. - The company did not declare or pay any dividends for the six months ended June 30, 2024, consistent with the previous year[97]. Revenue Sources - Product revenue increased by 23.96% to RMB 939.4 million compared to RMB 757.9 million in the previous year[1]. - Sales of the product Akeso® (Cadonilimab) reached approximately RMB 705.7 million, a 16.50% increase from RMB 605.8 million in the same period last year[7]. - The main revenue source was from Kadtunili® (Cardunili, PD-1/CTLA-4), generating RMB 705.7 million, up 16.50% from RMB 605.8 million in the previous year[39]. - Revenue from licensed fees for the six months ended June 30, 2024, was RMB 85,318,000, a substantial drop from RMB 2,918,988,000 in the same period of 2023[86]. - Revenue from customers in mainland China for the six months ended June 30, 2024, was RMB 938,131,000, up from RMB 756,189,000 in 2023, reflecting an increase of approximately 24.0%[89]. Research and Development - The company has over 50 innovative projects in development, with 10 products in commercialization or Phase III clinical trials[5]. - The company is actively pursuing clinical development for Ivosidenib in various indications, including a Phase III trial for biliary cancer and another for pancreatic cancer[16]. - The company is advancing multiple clinical trials, including AK111 (IL-17) for psoriasis and ankylosing spondylitis, and AK120 (IL-4Rα) for moderate to severe atopic dermatitis[21]. - The company is focusing on expanding its ADC platform, with IND applications submitted for AK138D1 (HER3 ADC) for late-stage malignancies[37]. - The company is committed to advancing its clinical development and exploration of various therapeutic areas, ensuring efficient progress across its pipeline[22]. Clinical Trials and Approvals - The sNDA for Cadonilimab as a first-line treatment for gastric cancer was accepted by NMPA in January 2024, with positive Phase III trial results presented at the AACR annual meeting[8]. - Cardinili has entered the third phase of clinical trials for its combination therapy with chemotherapy for advanced gastric and gastroesophageal junction cancer, with the first patient enrolled[11]. - The company received approval for the new drug Yida Fang® (Ivosidenib) for treating locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, marking its second core dual antibody entering commercialization[12][13]. - The company has initiated a Phase III clinical trial for the combination therapy of AK117 (CD47) and other agents in head and neck squamous cell carcinoma[20]. - The company is currently enrolling patients for a study involving AK117 combined with chemotherapy for first-line gastric cancer[26]. Market Expansion and Strategy - The company expects to become a global leader in biopharmaceuticals through innovative R&D and commercialization platforms[5]. - The company is preparing for commercialization of its products by developing comprehensive business plans considering patient affordability, market accessibility, and competitive landscape[20]. - The company is actively pursuing market expansion and new product development strategies, focusing on immunotherapy and metabolic disease treatments[29]. - The company aims to enhance its market presence globally, leveraging innovative therapies to benefit patients worldwide[38]. - The company is expanding its commercialization team to enhance hospital and commercial insurance access, aiming to explore more clinical opportunities with its core bispecific products[38]. Financial Position - As of June 30, 2024, the group's current assets totaled RMB 6,746.5 million, with cash and cash equivalents, time deposits, and financial products amounting to RMB 5,693.6 million, an increase of RMB 799.2 million from RMB 4,894.4 million as of December 31, 2023[49]. - The group has pledged assets and land use rights totaling RMB 1,301.2 million to secure its loans and bank credit facilities as of June 30, 2024[51]. - The group's capital commitments as of June 30, 2024, were RMB 778.5 million, up from RMB 770.0 million as of December 31, 2023, primarily for the construction of world-class production facilities[57]. - The company's total assets minus current liabilities reached RMB 9,049,598 thousand, compared to RMB 7,976,508 thousand in 2023, indicating an increase of approximately 13.46%[75]. - The company’s total current liabilities rose to RMB 1,409,717 thousand, up from RMB 1,204,582 thousand, reflecting an increase of about 17.03%[75]. Employee and Operational Metrics - As of June 30, 2024, the total number of employees is 2,815, with 642 in clinical roles and 575 in production and quality control[30]. - The total employee compensation cost was RMB 539.2 million, an increase from RMB 408.0 million as of June 30, 2023, primarily due to an increase in employee numbers[59]. - The company operates a total production capacity of 54,000 liters, with plans for continuous expansion to meet future clinical and commercialization needs[31]. - The Zhongshan Cuixing Kangfang Bay Technology Park has a planned production capacity exceeding 100,000 liters, equipped with advanced biopharmaceutical facilities[31]. - The company has established production facilities compliant with GMP requirements, supporting the entire drug development process from discovery to commercial production[31].

依沃西第二项适应症 NDA 受理，看好重磅潜力 2024 年 07 月 31 日 ➢ 事件：7 月 29 日，康方生物宣布，公司独立自主研发的全球首创 PD-1/VEGF 双抗依沃西单抗单药一线治疗 PD-L1 表达阳性（PD-L1 TPS≥1%）的局部晚期 或转移性 NSCLC 的新药上市申请已经获得中国国家药品监督管理局受理。 ➢ 单药头对头优于 K 药，一线 NSCLC 适应症潜力巨大。此次依沃西新适应症 上市申请是基于 HARMONi-2（AK112-303）研究。HARMONi-2 是一项评估 依沃西单药对比帕博利珠（K 药）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 NSCLC 的注册性 III 期随机、双盲临床试验，共入组 398 例受试者，其中 PD-L1 TPS 1-49%的受试者占比为 57.8%，PD-L1 TPS≥ 50%的受试者占比为 42.2%，与真实世界患者表达水平分布一致。2024 年 5 月 31 日公司宣布 HARMONi-2 研究的期中分析已经取得了强阳性结果：在意向治 疗人群中，依沃西单抗单药相较于帕博利珠单抗单药显著延长了患者无 ...