双抗龙头有望重塑全球IO治疗格局

公司评级增持（首次） 双抗龙头有望重塑全球IO治疗格局 报告日期2025年08月05日 投资要点： ⚫第二代IO市场潜力巨大，公司占据领先优势。2014年前后，全球药企争相涌入PD-(L)1单抗赛道，公司敏锐洞察到单抗疗法的局限性，转而将重心投向双抗领域。第二代IO相较于第一代IO，能够覆盖更多患者群体，同时进一步延长患者生存期，市场潜力将进一步拓宽。凭借AK112和AK104，公司成为全球唯一拥有2个肿瘤免疫双抗的制药公司，在IO治疗2.0时代占据领先优势。 相关研究 ⚫AK112头对头击败K药，多适应症全面铺开。AK112是全球首个进入临床、首个获批的PD-1/VEGF-A双抗，也是全球首个且唯一在III期单药头对头临床研究中证明疗效显著优于K药的药物。（（1）在国内，AK112已获批两项NSCLC适应症，TNBC、胆道癌、胰腺癌、结直肠癌、头颈鳞癌、SCLC的注册临床也已经启动；（2）在海外，合作伙伴SUMMIT已经启动3项NSCLC注册临床，其中HARMONi已披露初步数据，后续有望在美国递交相关适应症的BLA。 分析师：孙媛媛S0190515090001BUN498sunyuanyuan@xyzq.com.cn 分析师：黄翰漾S0190519020002请注意:黄翰漾并非香港证券及期货事务监察委员会的注册持牌人，不可在香港从事受监管的活动。huanghanyang@xyzq.com.cn ⚫AK104在宫颈癌及胃癌中展现出全人群获益优势。AK104是全球首个进入临床、首个获批的PD-1/CTLA4双抗，与PD-1单抗联合CTLA-4单抗的联合疗法相比，毒性显著降低，具有明显的安全性和疗效优势。（1）在国内，AK112已经获批2L/3L、1L宫颈癌以及1L胃癌适应症，肝癌、肺癌领域的注册临床也在推进中；（2）在海外，公司计划2025年启动临床试验。 ⚫肿瘤领域“IO+ADC”2.0迭代战略加速推进。以AK104和AK112为基石，公司积极展开联合用药探索，包括AK117、AK109、AK119、AK127、AK129以及AK130，有望发挥协同效应，进一步改写肿瘤治疗格局。基于在多特异性抗体药物开发领域丰富的成功经验，公司布局创新型双抗ADC药物，为公司更进一步挖掘创新产品组合的全球临床价值。 ⚫盈利预测与估值：我们预测公司2025-2027年收入为34.24 / 51.25 / 79.02亿元人民币，按照2025年8月5日收盘价对应2025-2027年市销率PS分别为39.12倍、26.14倍、16.95倍。首次覆盖，给予“增持”评级。 ⚫风险提示：新药研发失败的风险、临床推进以及获批时间不及预期的风险、价格降幅超预期的风险、市场竞争加剧的风险。 Akeso Biopharma（09926.HK） TheBispecificAntibodyLeaderIsExpectedto Reshape the Global IOTherapy Landscape Report DateAugust5, 2025 Basic Data Investment Highlights: ⚫The second-generation IO market has enormous potential.Around 2014, whenotherscompeted to develop PD-(L)1 inhibitors, the company recognized the limitations ofsingle-target therapies and pivoted its focus to bispecific antibodies.Compared to thefirst generation IO, the second generation IO can cover more patient groups andfurther prolong patient survival, expanding its market potential.With AK112 andAK104, it has become the only pharmaceutical company globally to possess twoIObispecific antibodies, securing a leading position in the IO 2.0 era. Related Report Analyst：Yuanyuan SUNS0190515090001BUN498sunyuanyuan@xyzq.com.cn ⚫AK112outperforms Keytruda inhead-to-headtrial, with multi-indication expansion.AK112 is the world’s first PD-1/VEGF-A bispecific antibody to enter clinical trials andgain approval. It is also the first and only drug to demonstrate statistically superiorefficacy over Keytruda in a Phase III head-to-head study. In China,AK112 has alreadygained approval for two NSCLC indications. Registration trials for TNBC, biliary tractcancer, pancreatic cancer, colorectal cancer, head and neck squamous cell carcinoma(HNSCC), and SCLC have also been initiated.Overseas, SUMMIT has initiated threeclinicaltrials for NSCLC registration,among which HARMONI has disclosedpreliminary data and is expected to submit BLA in the United States. Analyst：Hanyang HUANGS0190519020002Please note:HanyangHUANGis not aregistered licensee of the Securities andFutures Commission of Hong Kong andis not allowed to engage in regulatedactivities in Hong Konghuanghanyang@xyzq.com.cn ⚫AK104 demonstrates benefit across all populations in cervical and gastric cancers.AK104 is the world's first PD-1/CTLA-4 bispecific antibody to enter clinical trials andthe first to be approved. Compared to combination therapy with PD-1 and CTLA-4monoclonal antibodies,it shows significantly reduced toxicity,offering clearadvantages in safety and efficacy. In China, AK104 has gained approvals for 2L/3Lcervical cancer, 1L cervical cancer, and 1L gastric cancer indications. Registrationtrials in livercancer and lung cancer are also advancing. Overseas, the company plansto initiate clinical trials in 2025. ⚫Accelerating the "IO+ADC" 2.0strategy inoncology.Basedon AK104 and AK112, thecompany is actively exploring combination therapiesto amplify synergistic effects andredefinecancer treatment paradigms.Leveraging its expertise in multispecificantibody development, the company is also pioneering bispecific ADC drugs to furtherunlock the global clinical potential of its innovative portfolio. ⚫Earningsforecast andvaluation:We project 2025-2027 revenues of RMB 3.424 /5.125 / 7.902 billion,based on the closing price as of August5, 2025, the price-to-sales ratios (PS) for 2025-2027 are 39.12 times,26.14 times, and 16.95 times,respectively.Initiating coverage withan “Outperform" rating. ⚫Potential risks：Clinical trial failures, delays in approvals, steeper-than-expected pricecuts, and intensifying competition. 目录 一、康方生物领跑中国创新药3.0时代.........................................................5二、肿瘤疗法持续升级，二代IO市场潜力巨大............................................8三、AK112：肺癌挑战K药迎来曙光，多适应症全面铺开..........................11（一）1L野生型晚期NSCLC.....................................................................12（二）治疗后耐药晚期NSCLC...................................................................15（三）其他：TNBC、胆道癌、结直肠癌、头颈鳞癌、胰腺癌...................18四、AK104：全人群获益，填补多个临床空白............................................20（一）1L及2L晚期胃癌.............................................................................21（二）1L晚期宫颈癌................................................................