HUYABIO Files an Investigational New Drug Application with the FDA for the Novel SHP2 Inhibitor HBI-2376

On August 31, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the filing of an investigational new drug application (IND) with the FDA for HBI-2376 along with Genhouse who has filed an IND with the Chinese Center for Drug Excellence CDE (Press release, HUYA Bioscience, AUG 31, 2021, View Source [SID1234587068]).

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"HBI-2376 (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 a very good PK and safety profile," said Dr. Keifung Wang, CEO of Genhouse. "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 cancer patients as soon as possible."

The companies entered into a licensing agreement granting HUYABIO worldwide rights outside China to HBI-2376 prior to filing the regulatory submissions.

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."

About HBI-2376; SHP2 Inhibitor
HBI-2376 is an oral small molecule inhibitor of SHP2 for multiple tumor types whose cellular growth is dependent on the activity of receptor tyrosine kinases in the mitogen-activated protein kinase or MAPK pathway. Extensive biochemical characterization has shown that HBI-2376 is a highly potent and selective inhibitor of SHP2 phosphatase. Furthermore, preclinical investigations showed significant efficacy for HBI-2376 as a single agent or in combination with other small molecule inhibitors or checkpoint inhibitors in multiple tumor models.