CDE Approved IND application of Genhouse for its SHP2 inhibitor GH21


On November 11th 2021, Genhouse Bio, a biotech company focusing on development of next-generation small molecule anti-cancer therapeutics, announced today that the Center for Drug Evaluation (CDE) has recently approved IND application for Class I new drug GH21. The U.S. IND application for GH21, submitted by Genhouse’s strategic partner HUYABIO, has also been approved by FDA in October. GH21 has now received IND approval in both China and the U.S.


The leading PI of phase I clinical study of GH21 in China, Dr. Lin Shen, Vice President of Peking University Cancer Hospital said, “we anticipate to see positive safety and efficacy result of GH21 in the clinical study. We will continue to explore the value of targeted therapies and combination therapies in cancer treatment to benefit more patients.”


“SHP2 is not only downstream of multiple RTK signaling pathways, but also participate in tumor immune escape, ” said Dr. Kuifeng Wang, founder and CEO of Genhouse, “we believe SHP2 has very high clinical potential. In preclinical study, we tested GH21 in multiple CDX and PDX models and accumulated a wealth of knowledge about biomarker, which will provide much help in clinical development. The IND approval of GH21 in China is another critical milestone in its development.”


About SHP2

SHP2, also known as Tyrosine-protein phosphatase non-receptor type 11 (PTPN11), is the first oncogenic tyrosine-protein phosphatase discovered in history. Recently, SHP2 has drawn broad attention. On one hand, it is at the downstream of most RTK pathways, transducing cell proliferative and survival signals for RAS-MAPK/PI3K-mTOR pathway. On the other hand, SHP2 is also at the downstream of multiple immune checkpoints, such as PD-1 and BTLA, transducing immune escape signal in cancer cells, which gives SHP2 broad combo potential with immune checkpoint inhibitors. Therefore, SHP2 inhibitors are believed to have dual effects in both the RTK pathways and immune oncology.


About GH21

GH21 is a SHP2 allosteric inhibitor developed independently by Genhouse with global IP rights. GH21 has very high selectivity and is effective against multiple SHP2 point mutants. Both in vitro and in vivo studies have shown that GH21 does not affect any other tyrosine-protein phosphatases besides SHP2, thus has very low off-target risk. Moreover, GH21 has very good PK and safety profile, and a broad therapeutic window. Therefore, GH21 is a very promising small molecule drug candidate.


About Genhouse

Genhouse Bio is an innovative biotech company focusing on the development of global next-generation small molecule anti-cancer therapeutics, which has a clear focus on overcoming those “undruggable” target and original innovation. Genhouse is dedicated to establishing a specialized new drug development system, with a SAR research platform based on structural biology, a Drug Screening platform based on target research and a Druggability Evaluation platform including efficacy, metabolic and safety profile evaluation.


By virtue of these platforms, Genhouse has built a highly innovative anti-cancer pipeline and successfully out-licensed the ex-China right of its SHP2 inhibitor GH21 to HuYa Bioscience International, a global biotech company. Genhouse will continue to advance more innovative programs into global development.

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