Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company, 康方生物 (9926.HK), presented significant positive results for its PD-1/VEGF bispecific antibody, 依沃西, in a Phase III clinical trial (HARMONi-2) against the drug, 帕博利珠单抗, for treating PD-L1 positive non-small cell lung cancer (NSCLC) [2]. - 依沃西 demonstrated a median progression-free survival (mPFS) of 11.14 months compared to 5.82 months for 帕博利珠单抗, with a hazard ratio (HR) of 0.51 (P<0.0001), indicating a statistically significant improvement [2]. - The objective response rate for 依沃西 was 50.0% versus 38.5% for 帕博利珠单抗, and the disease control rate was 89.9% compared to 70.5% [2]. - The company reported revenues of 7.1 billion yuan for 卡度尼利 and 1 billion yuan for 依沃西 in the first half of 2024, with ongoing clinical progress for various indications [2]. Financial Summary - The projected revenues for 康方生物 from 2024 to 2026 are 25.8 billion yuan, 42.4 billion yuan, and 60.4 billion yuan respectively, indicating a strong growth trajectory [2]. - The company's net profit attributable to the parent company is expected to grow from 1.28 billion yuan in 2025 to 2.8 billion yuan in 2026, reflecting a significant increase [3]. - The earnings per share (EPS) is projected to rise from 1.48 yuan in 2025 to 3.23 yuan in 2026 [3]. - The return on equity (ROE) is expected to improve from 22.86% in 2025 to 33.27% in 2026 [3].

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 ...

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 ...