机构：天风证券 研究员：杨松/曹文清 事件 公司的PD-L1 小分子抑制剂ABSK043 联合KRAS G12C 抑制剂戈来雷塞片开展联合用药治疗KRAS G12C 突变的NSCLC 的临床研究申请获CDE 批准。此前，公司已经与艾力斯就联合用药达成了合作协 议。 ABSK043 初步临床数据疗效和安全性平衡，联合疗法瞄准近半NSCLC 市场ABSK043 具有FIC 潜力， 全球暂无PD-（L）1 小分子药物上市。ABSK043 是一款口服PD-L1 抑制剂，可与PD-L1 受体特异性结 合并诱导其从细胞表面内吞，有效地抑制PD-1/PD-L1 的相互作用，解除PD-L1 介导的T 细胞活化抑制 作用。ABSK043 在多个临床前模型中展现出与已获批PD-L1 抗体相当的抗肿瘤功效。PD-（L）1 口服 抑制剂研发的一大障碍就是出现周围神经病变的风险更高（如Incyte 的INCB086550），而ABSK043 在 临床试验中展现出良好的安全性和显著的抗肿瘤活性。在共入组77 例患者的实体瘤I 期临床中，87.0% 的患者出现TEAE，其中29.9%为≥3 级，无周围神经病变。 除NSCLC 以外，ABS ...

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company’s PD-L1 small molecule inhibitor ABSK043 has received approval for clinical research to treat KRAS G12C mutated NSCLC in combination with the KRAS G12C inhibitor, adagrasib [1] - ABSK043 shows potential as a first-in-class (FIC) oral PD-L1 inhibitor, with no other oral PD-(L)1 drugs currently available globally [2] - The initial clinical data indicates a balance of efficacy and safety, with 87% of patients experiencing treatment-emergent adverse events (TEAEs) and no peripheral neuropathy observed [2] - ABSK043 is designed specifically for combination therapy, offering advantages such as a short half-life, reduced immunogenicity, and oral administration flexibility [3] - The market potential for ABSK043 is significant, targeting approximately 45%-60% of NSCLC cases, with ongoing clinical trials in various treatment settings [3] Financial Projections - The company is projected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [5] - Expected net profits for the same period are 45 million, 70 million, and 102 million yuan [5] - The target price for the stock is set at 22.88 HKD, with the current price at 19.62 HKD [5] Pipeline Developments - The company has several key assets nearing milestones, including: 1. KRAS-G12D inhibitor ABSK141, expected to receive IND approval in the second half of 2025 [4] 2. Pan-KRAS inhibitor ABSK211, anticipated to enter clinical stages in 2026 [4] 3. CSF-1R inhibitor ABSK021, with an NDA submission planned for the second half of 2025 [4] 4. A bispecific antibody-drug conjugate (BsADC) targeting two pan-cancer targets, expected to achieve preclinical candidate status in early 2026 [4]

该行认为，当前估值仅反映其两款后期候选药物pimicotinib及irpagratinib价值，其具高授权潜力的差异 化创新药则尚未被市场充分认可。 ABSK043可与靶向疗法联合使用，且无重大安全性问题，为患者提 供口服治疗方案。其KRAS系列药物，包括ABSK141和ABSK211，已展示良好口服生物利用度和体内疗 效，并将于下半年至明年进入临床阶段。和誉正开发超越肿瘤学的更多候选药物，其中心血管代谢疾病 药P151已进入IND启动阶段。 该行将和誉目标价由17.5港元上调至25港元，维持"买入"评级。 花旗发表报告指，尽管和誉股价今年累升280%，但在该行覆盖的生物科技股中仍属被低估。 ...