Goodwill B (02256): Clinical trial application for the new drug ABSK211, an oral small molecule Pan-Kras inhibitor, was approved by NMPA

Zhitong Finance App News, Heyu-B (02256) announced that China's National Drug Administration (NMPA) has approved ABSK211's new drug clinical trial (IND) application. ABSK211 is an oral, high-potency, small-molecule Pan-KRAS inhibitor. It has broad-spectrum activity against various KRAS gene changes and is used to treat advanced solid tumor patients with KRAS gene changes. Previously, ABSK211 received IND approval from the US Food and Drug Administration (FDA) on July 8. The receipt of IND approval in both China and the US is a key milestone in ABSK211's global clinical development plan.

Heyu Pharmaceutical will launch an open phase I clinical study in the near future to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of ABSK211 in advanced solid tumor patients with KRAS genetic changes.

KRAS is one of the most common carcinogenic genes in human cancer. It changes frequently in various solid tumors, including about 90% of pancreatic cancer, 35% of colorectal cancer, and 25% of lung cancer. Due to its complex and diverse subtypes of changes, KRAS has long been regarded as one of the most challenging targets in the field of cancer treatment. Although Pan-kras inhibitors have entered clinical development, there is still an urgent need to further improve their anti-tumor efficacy.

Preclinical studies have shown that absk211, as a novel oral Pan-KRAS inhibitor, showed broad-spectrum and efficient inhibitory activity against various KRAS gene changes such as KRAS G12D, G12C, G12S, G12V, G13D, and KRAS wild-type amplification. In vitro studies have shown that ABSK211 can significantly inhibit the proliferation of various KRAS mutant tumor cell lines in the sub-nanomolar to nanomole concentration range, and has little activity on KRAS wild-type cell lines with normal copy numbers. In-vivo studies have further shown that ABSK211 can induce deep and long-lasting tumor regression in various KRAS modification tumor models, and has strong target binding ability.

Furthermore, ABSK211 has shown good potential for combination therapy in various tumor models. Research results show that when combined with PRMT5 inhibitors, cetuximab, immunotherapy and chemotherapy regimens, it can further enhance tumor growth inhibition effects and prolong the duration of efficacy compared to monotherapy, supporting future exploration of combined treatment strategies.