医药健康行业专题研究：AACR国产新药展锋芒，ADC成焦点-240426-华泰证券-12页_617kb

报告摘要

English Summary:

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2024 AACR Showcases Global Standing of China’s Innovative Drugs:
The 2024 American Association for Cancer Research (AACR) Annual Meeting concluded, with China’s pharmaceutical companies demonstrating increased participation and influence on the international stage. Approximately 200 drug varieties from about 110 domestic companies submitted abstract summaries, 43% of which for the first time disclosed the drug molecule. China has established a competitive edge in Adnectin-Drug Conjugate (ADC) antibodies, dual/multi-antibody, KRAS inhibitors, and synthetic lethal therapies.

ADC Drugs Lead the Innovation Wave:
Domestic ADC drugs, such as SKB264 (Colinwu Biotech), JSKN003 (CanHong Jieji), HR-4602 (Hengrui Medicine), and IBI300 (Immunecheck Bio), achieved global-leading levels across target binding, molecular types, clinical development stages, and therapeutic efficacy. Notable progress includes:

SKB264: Phase II data showed an ORR of 43.6% and a median PFS of 7.2 months in EGFR-mutated NSCLC, outperforming Dato-DXd.
JSKN003: A novel HER2-targeting ADC achieved a 100% ORR in HER2-positive BC and 50% in low-expression cases.

Dual/Antibody Innovation Rivals Global Standards:
China has global leadership in dual/multi-antibody targeting immune checkpoint markers. Kaduneratib (first-line therapy for GC/GEJ) showed a median OS of 15 months with chemotherapy. Emerging targets like B7-H3 and CCR8 were highlighted by domestic companies. T-cell engagers (TCEs) also showed promise in preclinical studies (e.g., BR111, CLDN182).

KRAS and Synthetic Lethal Therapies Pick Up Pace:

KRAS inhibitors: Garsorasib (KRASG12C-targeting) achieved an ORR of 49.6% in NSCLC, extended DCR to 88.6%, and median PFS to 7.6 months. Competing with Sotorasib.
Synthetic lethals: Companies like Sinopharm are advancing in USP1 inhibitors, showing synergistic potential with PARP inhibition in HRD tumors.

Recommendations:
Top picks include:

Kolinwu Biotech (Colin Pharmaceutical, 002422) for its ADC SKB264 (Trop2) in GC/GEJ and NSCLC.
CanHong Jieji (2162HK) for JSKN003 and its CMG901 program.

Key Risks:

Clinical trial failures, partnerships termination, and competitive pressures remain.

中文总结：

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中国创新药在2024年AACR展示全球竞争力
2024年美国癌症研究协会（AACR）年会落幕，中国药企在国际舞台上的参与度和影响力持续攀升。约200个药品摘要由国内约110家企业提交，其中43%首次披露药物分子。在ADC抗体、双特异性抗体、KRAS抑制剂及合成致死领域，中国药物展现出全球领先水平。

ADC药物表现卓越
SKB264（科伦博泰公司开发）治疗GC/GEJ及NSCLC的II期临床数据取得显著疗效，ORR达到43.6%，并在II期研究中超越Dato-DXd；康宁杰瑞的JSKN003（HER2双抗ADC）在HER2阳性乳腺癌中的ORR高达100%，标志着下一代ADC药物崭露头角。

双特异性抗体技术全球领先
卡度尼利单抗作为首个联合化疗治疗GC/GEJ的国产PD-1抗体，联合方案实现15个月的OS，并在PD-L1低表达患者中验证疗效。百济神州、康源博创等公司在新型靶点双抗（如B7-H3、CCR8）领域取得积极成果，T细胞接合器（TCE）在实体瘤中显示出高活性。

KRAS与合成致死药物加速推进