On April 2nd 2021, Genhouse Bio, a biotech company focusing on development of next-generation anti-cancer therapeutics, announced today that the Center for Drug Evaluation (CDE) has recently accepted IND application for Class I new drug GH35. This is the first IND submitted by Genhouse in China.
GH35 is an irreversible KRAS G12C inhibitor with high selectivity. In preclinical studies, GH35 has shown significant efficacy against multiple tumor models and good safety profile. Previous research has identified kras mutation in many tumor types at relatively high frequencies. The G12C mutation of KRAS mainly existed in lung cancer, colorectal cancer and pancreatic cancer—KRAS G12C inhibitors have the potential to become an effective therapeutic option for these cancers.
The ras gene is the first oncogene discovered in history, which is also the most commonly mutated gene in cancer—about 30% of tumors have ras mutations. KRAS is the predominant subtype of the RAS family; mutations in kras count for about 85% of all ras mutations. Although KRAS has been heavily studied for 40 years, the development of targeted therapies for KRAS is quite challenging, which granted KRAS the name of “undruggable target”. Until recently, the study of KRAS G12C mutants have made breakthrough progress, which makes it possible to design small molecule therapeutics to target KRAS.
Genhouse Bio is a clinical-stage biotech company focusing on the development of global next-generation anti-cancer therapeutics, headquartered in the Suzhou Industry Park . The senior management team of Genhouse has multiple years of experience in new drug development, clinical research, and corporate management. Genhouse has a clear focus on original innovation and overcoming those “undruggable” targets.
Genhouse has established intergrated in-house drug development platforms. With these platforms, Genhouse has started to build a highly innovative anti-cancer pipeline and out-licensed the ex-China rights of its SHP2 inhibitor GH21 to HUYABIO , an international biotech company. Genhouse will continue to advance more innovative pipeline programs into global development.
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Effective and Last Updated: April 15th 2021