HUYABIO Files an Investigational New Drug Application with the FDA for the Novel SHP2 Inhibitor HBI-2376
HUYABIO Files an Investigational New Drug Application with the FDA for the Novel SHP2 Inhibitor HBI-2376
SAN DIEGO, Aug. 31, 2021 /PRNewswire/ -- HUYABIO International (HUYABIO™), the leader in accelerating global development of China's pharmaceutical innovations, announced today 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.
聖地牙哥, 二零二一年八月三十一日 /三通社/-胡雅比歐國際（胡雅比奧國際）™），加快全球發展的領導者 中國 製藥創新，今天宣布與 FDA 的 HBI-2376 一起提交了一項研究性新藥申請（IND）以及曾向中國藥品卓越中心 CDE 提交 IND 的 Genhouse。
"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."
「HBI-2376（GH21）是一個 SHP2 具有非常高的選擇性的同種異體抑製劑。體外和體內研究表明，HBI-2376 對多重功能都有效 SHP2 點突變，並具有非常好的 PK 和安全性，」Genhouse 首席執行官王基豐博士說。「因此，GH21 是一個非常有前途的小分子候選藥物，Genhouse 將與 HUYABIO 一起協調全球臨床發展，盡快為癌症患者提供該藥物。」
The companies entered into a licensing agreement granting HUYABIO worldwide rights outside China to HBI-2376 prior to filing the regulatory submissions.
這些公司簽訂了許可協議，授予 HUYABIO 全球權利以外 中國 在提交監管意見書之前，對 HBI-2376 進行。
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."
博士 米雷耶·吉林斯, 首席執行官 & 胡亞比奧執行主席, 說,「這次提交代表同時 IND 的第一份申請, 協調我們的發展 SHP2 抑製劑在美國和 中國。我們相信該藥物的全球測試將加速其作為重要的新代理商的商業化。它將為目前的免疫腫瘤產品增加協同作用，迄今為止，這些產品已經改變了癌症護理。這裡的潛力是將目前的免疫腫瘤治療轉變為更高的水平，從而改善公共衛生。」
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.
關於 HBI-2376； SHP2 抑制劑
HBI-2376 是 SHP2 的口服小分子抑製劑，用於多種腫瘤類型，其細胞生長取決於絲裂原活化蛋白激酶或 MAPK 途徑中受體酪氨酸激酶的活性。廣泛的生化表徵表明，HBI-2376 是 SHP2 磷酸酶的高效和選擇性抑製劑。此外，臨床前研究顯示，HBI-2376 作為單一劑劑或與多個腫瘤模型中的其他小分子抑製劑或檢查點抑製劑結合使用顯著療效。
About HUYABIO 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 the global 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.
關於胡雅比國際
HUYABIO 是加速全球發展新型生物製藥產品機會的領導者，源自於 中國 在全球市場中實現更快、更具成本效益和更低風險的藥物開發。通過與生物製藥，學術和商業組織的廣泛合作，它建立了最大的 中國-來源化合物組合，涵蓋所有治療領域。在美國設有辦事處， 日本, 大韓民國, 加拿大, 愛爾蘭 以及跨越八個策略地點 中國，公司已成為加速產品開發並在全球範圍內最大化價值的首選合作夥伴。欲了解更多信息，請訪問網站。
About Genhouse
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 integrated 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.
關於源屋
Genhouse Bio 是一家臨床階段的生物技術公司，專注於開發全球下一代抗癌治療藥物，總部位於蘇州工業園區。Genhouse 的高級管理團隊在新藥開發、臨床研究和企業管理方面擁有多年經驗。Genhouse 明確專注於原創創新，並克服了那些「不可壓力」的目標。Genhouse 建立了集成的內部藥物開發平台。通過這些平台，Genhouse 已經開始建立一個高度創新的抗癌管道，並超出了前任授權中國 其權利 SHP2 抑制劑 GH21 胡雅比奧, 一家國際生物技術公司.Genhouse 將繼續推進更多創新的管道計劃進入全球發展。
Contact Details:
聯絡資料:
Bob Goodenow, PhD
President
+1.858.342.2430
[email protected]
鲍勃·古德登, 博士
總統
+1.858.342.2430
[電子郵件保護]
Yiota Merianos
Corporate Communications
+1.858.353.1217
[email protected]
塔·梅里亚诺斯
企業溝通
+1.858.353.1217
[電子郵件保護]
SOURCE HUYABIO International
來源胡雅比歐國際
Related Links
相關連結
http://WWW.HUYABIO.COM
http://WWW.HUYABIO.COM
譯文內容由第三人軟體翻譯。