27 October 2023, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announced that ABSK112, a next-generation small molecule EGFR-Exon20ins inhibitor, has obtained clinical trial approval from the National Medical Products Administration (NMPA) of the People’s Republic of China, and the company will soon launch a Phase I clinical trial for the treatment of patients with non-small cells lung cancer (NSCLC) in China.

ABSK112 has received clinical study approval from the U.S. Food and Drug Administration (FDA), and the Phase I studies will be conducted simultaneously in the United States and China.

ABSK112 is a next-generation oral EGFR-Exon20ins inhibitor discovered and developed by Abbisko. In comparison to previously approved and clinically studied 1st generation EGFR-Exon20ins inhibitors, ABSK112 in preclinical studies demonstrated excellent brain penetrating ability, selectivity over wild type EGFR, broader spectrum of Exon20ins mutation coverage, and superior in vivo efficacy in various EGFR-Exon20ins xenograft models. These findings highlight ABSK112's potential in providing an improved therapeutic window and enhanced efficacy in clinical settings, positioning it as a next-generation and potentially best-in-class EGFR-Exon20ins inhibitor.

About NSCLC

Lung cancer is the second most common cancer worldwide, with more than two million new cases in 2020, including 227,875 cases in U.S. and 815,563 cases in China, respectively. It ranks first in terms of mortality, with more than 1.7 million deaths per year, including 138,225 cases in U.S. and 714,699 cases in China1. Non-small cell lung cancer (NSCLC) comprises the vast majority (85%) of all lung cancers. Epidermal growth factor receptor (EGFR) mutations were reported in about 17% and 50% of lung adenocarcinoma in Caucasians and Asians, respectively2.

About ABSK112-101

This is a first-in-human (FIH), multicenter, non-randomized, open-label, Phase I study. The study will start with a dose escalation of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

Reference：

1. International Agency for Research on Cancer (IARC).Cancer Today (iarc.fr). Released December 14, 2022. Accessed May 6, 2023.

2. Fang W, Huang Y, Hong S, et al. EGFR exon 20 insertion mutations and response to osimertinib in non-small-cell lung cancer. BMC Cancer. 2019;19(1):595.