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9 Nov 2023, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announced that ABSK051, a novel small molecule CD73 inhibitor, has obtained the clinical trial approval from the National Medical Products Administration (NMPA) of the People’s Republic of China. ABSK051 is about to enter the first-in-human (FIH) phase I clinical trial for the treatment of advanced solid tumors in China.

ABSK051 is a novel small molecule CD73 inhibitor with strong inhibition against CD73 enzymatic activity. In vitro and in vivo pharmacology data have demonstrated superior potency and selectivity of ABSK051 against CD73 with strong anti-tumor effects. In addition, the toxicological profile of ABSK051 has been well characterized in the preclinical safety assessment study, which supports the use of the study drug in human clinical study.

About ABSK051-101

This is the first-in-human (FIH), multicenter, open-label, phase I clinical trial, which includes Monotherapy Dose Escalation Part and Combination Therapy Dose Escalation Part. This study will evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ABSK051 monotherapy in patients with any types of advanced solid tumors and ABSK051 in combination with Tislelizumab in patients with selected tumor types, such as lung cancer, colorectal cancer (CRC), ovarian cancer, and pancreatic ductal adenocarcinoma (PDAC).