This announcement is made by JHBP (CY) Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business updates of the Group.
The board of directors of the Company (the “Board”) is pleased to announce that the Company has received investigational new drug (“IND”) approvals from the National Medical Products Administration (“NMPA”) for two cyclin-dependent kinase 4/6 (“CDK4/6”) inhibitor (GB491 (Lerociclib)) Phase 1b bridging studies: (1) GB491 and Letrozole in first line HR+/HER2- advanced breast cancer; and (2) GB491 and Fulvestrant in second line HR+/HER2- advanced breast cancer. At the same time, the Company is pleased to announce that the Ethic Committee approvals were also obtained for the two trials as of March 6, 2021.
ABOUT GB491 (CDK4/6)
GB491 (Lerociclib) is a highly selective oral CDK4/6 inhibitor for breast cancer. The Company in-licensed exclusive rights of GB491 from G1 Therapeutics, Inc. (Nasdaq: GTHX) in certain APAC countries excluding Japan in June 2020. Based on the latest data published at European Society for Medical Oncology (ESMO) 2020 conference, GB491, compared to the currently approved CDK4/6 inhibitor in China, Palbociclib, has demonstrated better safety profile and could be a potentially best-in-class CDK4/6 drug candidate.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities of The Stock Exchange of Hong Kong Limited: The Company cannot guarantee that it will be able to develop, or ultimately market GB491 successfully. Shareholders and potential investors of the Company are advised to exercise due care when dealing in the shares of the Company.
By Order of the Board
JHBP (CY) Holdings Limited
Mr. Yi Qingqing
Hong Kong, March 8, 2021
As at the date of this announcement, the Board comprises Dr. ZHOU Joe Xin Hua and Dr. GUO Feng (Chief Executive Officer) as Executive Directors, Mr. YI Qingqing (Chairman), Mr. CHEN Yu and Dr. LI Ming as Non-executive Directors, and Mr. ZHOU Honghao, Mr. FUNG Edwin and Mr. CHEN Wen as Independent Non-executive Directors.