Technology & Product Pipeline

Clinical Development Platform(Pipeline)

      Our pipeline targets the world’s most prevalent or hard-to-treat cancers, such as breast cancer (BC), non-small cell lung cancer (NSCLC), gastrointestinal (GI) cancers (including gastric cancer (GC) and colorectal cancer (CRC)), as well as non-oncology diseases and conditions affecting a large and underserved population.
      As of November 2024, we had established a robust pipeline of 10+ clinical-stage drug candidates, including one in NDA approval-stage and four in pivotal trial- or NDA registration-stage.

Oncology-ADC

Product
Target
Indication
Pre-clinical
Phase Ia
Phase Ib/II
Registrational Pivotal Ph II/III
NDA/BLA Filing
NDA/BLA Approval
Partners
Sacituzumab Tirumotecan, 佳泰萊​® (SKB264/MK-2870/sac-TMT)
    TROP2 Tumors

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Trastuzumb Botidotin,舒泰萊® (A166)
    HER2 Tumors
SKB315
    CLDN18.2 Tumors
SKB410 (MK-3120)
    NECTIN4 Tumors

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SKB518
    NA Tumors
SKB535 (MK-6204)
    NA Tumors

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SKB571
    NA Tumors

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Oncology-Other Modalities

Product
Target
Indication
Pre-clinical
Phase Ia
Phase Ib/II
Registrational Pivotal Ph II/III
NDA/BLA Filing
NDA/BLA Approval
Partners
Tagitanlimab,科泰萊® (A167)
    PD-L1 Tumors

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A140 (達泰萊®)
    EGFR Tumors
A400/EP0031 (KL590586 Capsules)
    RET Tumors

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A296 (KL340399 for Injection)
    STING Tumors

Non-oncology

Product
Target
Indication
Pre-clinical
Phase Ia
Phase Ib/II
Registrational Pivotal Ph II/III
NDA/BLA Filing
NDA/BLA Approval
Partners
A223 (KL130008 Capsules)
    JAK1/2 Rheumatoid arthritis
A277(KL280006 for Injection)
    KOR Uremic pruritus (CKD-aP)
SKB378 (HBM9378)
    TSLP Asthma

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SKB336
    FXI/FXIa Thromboembolic disorders
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1.作用机制:

SKB264是由科伦博泰拥有自主知识产权的靶向TROP2的人员化单克隆抗体、可酶促裂解的LINKER连接着新型拓扑异构酶I抑制剂组合而成的抗体偶联药物(TROP2-ADC),毒素分子具有中等细胞毒性,连接子可以很好地平衡细胞外的稳定性和细胞内的裂解。

2.临床试验:

SKB264目前正在中美开展针对多个肿瘤的II期临床试验,已初步获得令人期待的临床数据,同时也在积极推进联合用药的临床研究,以期早日为更多肿瘤患者带来福音。2022年上半年,SKB264已开展3项联合用药临床研究:

2022年4月11日,SKB264联合或不联合KL-A167(PD-L1单抗)一线治疗不可手术切除的局部晚期、复发或转移性TNBC患者的II期临床实验获批开展。CTR20221755

2022年4月7日,SKB264单药治疗至少经二线治疗失败的晚期或转移性TNBC患者的III期注册临床研究获批开展,成为首个进入注册性临床研究并具有自主知识产权的国产TROP2-ADC。CTR20220878

Clinical trials

Registration number Name of drug Indication Popular trial subject