Technology & Product Pipeline

Clinical Development Platform(Pipeline)

Registration number Name of drug Indication Popular trial subject
CTR20230825
NCT05816252
SKB264 for Injection NSCLC Phase 2 clinical study of SKB264 monotherapy or combination therapy for advanced or metastatic NSCLC patients
CTR20231535
NCT05870319
SKB264 for Injection Locally advanced or metastatic NSCLC with EGFR mutations that have failed treatment with EGFR-TKI A phase 3 study on the efficacy of SKB264 monotherapy compared to the combination of pemetrexed and platinum-based therapy in locally advanced or metastatic NSCLC with EGFR mutations that have failed treatment with EGFR-TKI
CTR20201069
NCT04152499
SKB264 for Injection Solid tumor SKB264 Phase 1-2 Trial in patients with locally advanced or metastatic solid tumors
CTR20220878
NCT05347134
SKB264 for Injection Triple-negative breast cancer Phase 3 trial of SKB264 for patients with locally advanced, relapsed or metastatic triple-negative breast cancer who received at least 2L setting
CTR20220980
NCT05351788
SKB264 for Injection locally advanced or metastatic non-small cell lung cancer Phase 2 clinical research of SKB264 combination therapies in patients with advanced or metastatic non-small cell lung cancer
CTR20221755
NCT05445908
SKB264 for Injection HER2-negative Breast Cancer SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
CTR20222948
NCT05631262
SKB264 for Injection Advanced solid tumors Multi-center and open Phase 2 research to evaluate effectiveness and safety of SKB264 monotherapy in selected patient with advanced solid tumors
CTR20223165
NCT05642780
SKB264 for Injection Solid Tumors A basket study to evaluate effectiveness and safety of SKB264 in combination with Pembrolizumab in subjects for solid tumors
CTR20232807
NCT06081959
SKB264 for Injection HR+/HER2-breast cancer A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
CTR20240413
NCT06279364
SKB264 for Injection Triple-negative breast cancer A Randomized, Open-Label, Multicenter Phase III Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
CTR20241364
NCT06448312
SKB264 for Injection PD-L1-positive locally advanced or metastatic non-small cell lung cancer A randomized, open-label, multicenter phase III clinical study of SKB264 combined with pembrolizumab versus pembrolizumab as first-line treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer
CTR20243435
NCT06711900
SKB264 for Injection Advanced or metastatic non-small cell lung cancer A randomized, open-label, multicenter phase III clinical study of SKB264 combined with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1-negative locally advanced or metastatic non-squamous non-small cell lung cancer
CTR20243986
NCT06670196
SKB264 for Injection Non-small cell lung cancer A randomized, open-label, multicenter phase III clinical study of SKB264 combined with osimertinib versus osimertinib as first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations
CTR20231740 A166 for Injection HER2-positive unresectable or metastatic breast cancer A randomized, open-label, controlled trial of A166 for injection versus trastuzumab emtansine for injection (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who were previously treated with trastuzumab and taxanes , Multicenter phase III clinical trial
CTR20181301
NCT05311397
A166 for Injection HER2 expression locally advanced or metastatic solid tumor Phase 1 clinical study on the safety and tolerability of A166 injectable solution
CTR20212950 A166 for Injection HER2-positive Advanced malignant solid tumors Phase 1b clinical trial of A166 for injection for patients with HER2-positive Colorectal Cancer
CTR20213396 A166 for Injection Gastric cancer or GEJ cancer Open and multi-center Phase 1b clinical trial of A166 for injection in patients with HER2-positive locally advanced or metastatic gastric cancer or GEJ cancer
CTR20212088 A166 for Injection Breast cancer Phase 2 clinical research of A166 for injection in end-stage HER2+ BC patients
CTR20242261 A166 For Injection HER2-positive unresectable or metastatic breast cancer An open, multicenter phase II clinical study of A166 for injection in the treatment of HER2 positive unresectable or metastatic breast cancer that previously received overload as the drug conjugate of topoisomerase inhibitor antibody (ADC)
CTR20220285
NCT05367635
SKB315 for Injection Advanced solid tumors with CLDN18.2 expression A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB315 for Injection in Patients with Advanced Solid Tumors Expressing CLDN18.2
CTR20231276
NCT05906537
SKB410 for Injection Advanced solid tumors Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SKB410 injection for the treatment of advanced solid tumors in subjects
CTR20242227
NCT06428331
SKB518 for injection Advanced solid tumors Phase I clinical study on the safety, tolerability, pharmacokinetics, and anti-tumor activity of SKB518 for injection in patients with advanced solid tumors
CTR20244431
NCT06726369
SKB535 for injection Advanced solid tumors Phase I clinical trial of SKB535 for injection in advanced solid tumors
CTR20244432
NCT06725381
SKB571 for injection Solid tumors Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SKB571 injection for the treatment of advanced solid tumors in subjects
CTR20244608
NCT06736327
SKB500 for injection Advanced solid tumors Phase I clinical study on the safety, tolerability, pharmacokinetics, and anti-tumor activity of SKB500 injection in the treatment of advanced solid tumor subjects
CTR20250240
NCT06826040
SKB445 for injection Advanced solid tumors SKB445 for Injection in Solid Tumors
CTR20220691
NCT05294172
KL-A167 for Injection Recurrent or metastatic nasopharyngeal carcinoma Phase 3 clinical research of injectable KL-A167 in patients withrecurrent or metastatic nasopharyngeal carcinoma
CTR20190152
NCT03848286
KL-A167 for Injection Relapsed or refractory nasopharyngeal cancer Phase 2 clinical research of Injectable KL-A167 in patients with relapsed or metastatic nasopharyngeal cancer
CTR20181198 KL-A167 for Injection Advanced solid tumors Phase 1a research of injectable KL-A167 for advanced solid tumors
CTR20202451
NCT04835142
Recombinant Chimeric Anti-EGFR Monoclonala Antibody For Injection RAS wild-type metastatic colorectal cancer Phase 3 clinical research to compare effectiveness and safety of each of A140 and Erbitux® in combination with mFOLFOX6 as a first-line treatment option in patients with RAS wild-type metastatic colorectal cancer
CTR20240403 KL590586 Capsules Advanced solid tumors harboring RET fusions or mutations Study on drug interaction of KL590586 for capsules
CTR20232608 KL590586 Capsules Advanced solid tumors harboring RET fusions or mutations To evaluate the randomized, open-label, two-cycle, double-cross food effects of KL590586 capsules in healthy subjects in a phase I clinical trial
CTR20211547
NCT05265091
KL590586 for Capsule Advanced solid tumors with RET gene fusions or mutations Assess safety, tolerability and pharmacokinetic of KL590586 capsule in advanced solid tumors patients with RET gene fusions or mutations
CTR20232730 KL590586 Capsules Advanced solid tumors harboring RET fusions or mutations Study on material balance and biotransformation of KL590586 capsules
CTR20220985
NCT05387928
KL340399 for Injection Advanced solid tumors Phase 1 Clinical Study to Evaluate the Safety, Tolerability,Pharmacokinetics and Preliminary Efficacy of KL340399 Injection in Patients With Advanced Solid Tumors
CTR20221772
NCT05549804
KL340399 for Injection Advanced solid tumors Phase 1 clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KL340399 Intratumoral in Patients With Advanced Solid Tumors
CTR20202664 KL130008 for Capsule Rheumatoid arthritis Research to evaluate efficacy and safety of KL130008 capsule for mild or moderate activity rheumatoid arthritis patients
CTR20221881
NCT05496426
KL130008 for Capsule Severe alopecia areata Clinical research to evaluate safety and effectiveness of KL130008 capsule
CTR20230853 KL130008 Capsule (new prescription drug) Healthy subjects Randomized, open, two-period, two-sequence, and double-crossover Phase 1 clinical research to evaluate bioequivalence and food effects of KL130008 capsule in healthy subjects
CTR20181763 KL130008 for capsule Rheumatoid Arthritis Phase 1 research of safety and tolerability of KL130008 capsule in healthy subjects
CTR20191446 KL130008 for capsule Rheumatoid Arthritis Phase 1 clinical research of tolerability and PK/PD of KL130008 capsule in patients with rheumatoid arthritis
CTR20211299 KL130008 for Capsule Rheumatoid Arthritis Research to evaluate efficacy and safety of KL130008 capsule in mild or moderate activity rheumatoid arthritis patients
CTR20222274 KL280006 for Injection Uremic pruritus Research to evaluate effectiveness and safety of Injectable KL280006 in patients on hemodialysis with moderate-to-severe uremic pruritus
CTR20221961
NCT05790694
HBM9378(SKB378)for Injection Asthma Phase 1 clinical research in Chinese healthy subjects of randomized, double-blind, placebo-controlled, single-dose and dose expansion to evaluate safety and pharmacokinetic of HBM9378(SKB378) following subcutaneous injection for dosing
CTR20211808 SKB336 for Injection Prevention and treatment of thromboembolic disorders Phase 1a clinical research of safety, tolerability and pharmacokinetic of injectable SKB336 in healthy patients
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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