On August 31st 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 accepted IND application for Class I new drug GH21. This is the second application of Genhouse in China. Around the same time, HUYABIO, the strategic partner of Genhouse has also announced that FDA has accepted IND application for GH21 in the U.S.
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.
Dr. Keifung Wang, CEO and founder of Genhouse, said: “GH21 is a SHP2 allosteric inhibitor with very high selectivity Both in vitro and in vivo studies have shown that HBI-2376 is effective against multiple SHP2 point mutations and has very good PK and safety profile. Therefore, GH21 is a very promising small molecule drug candidate that Genhouse along with HUYABIO will coordinate the global clinical development to make it available for global cancer patients as soon as possible. ”
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, “This submission represents a first filing of simultaneous INDs, to coordinate the development of our SHP2 inhibitor in both the US and China. We believe the drug’s global testing will accelerate its commercialization as an important new agent. It will add synergy to current immuno-oncology products which to date, have transformed cancer care. The potential here is to transform current immuno-oncology therapy to an even higher level and so improve public health.”
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.
About Huya Biosciences International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com
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