Phase II Completion and Phase III Prep
February/June: CS060304 IND approved in China and U.S.
April: CS0159 completed Phase II trial in the U.S. (NASH).
May/August: CS060380 IND approved in China and U.S.; Phase I trial started.
December: Recognized as an Outstanding Enterprise at the 13th China Innovation and Entrepreneurship Competition.
Phase II Trials for CS0159
January: CS0159 received Fast Track designation (NASH) from FDA.
March: Named a "Specialized and Innovative SME" by Shanghai Government.
March: IND approval for NASH in China.
August: Held launch meeting for Phase II trial in China.
December: Listed as one of Shanghai's "Top 50 Most Investable Startups 2023".
Phase I Trials for CS0159
January: NMPA approved IND for CS0159 (PSC).
September: Phase I dosing completed in the U.S.
October: NMPA approved IND for CS0159 (PBC).
December: FDA approved IND for CS0159 (NASH).
December: First patient dosed (FPI) in China.
First IND Approval
September: CS0159 received FDA Orphan Drug Designation (ODD) for PSC.
October: FDA approved IND for CS0159 (PSC).
December: First patient dosed (FPI) in the U.S.
First IND and Series A Financing
July: Started IND-enabling studies for CS0159.
August: Adjusted equity structure and set up ESOP.
Relocation
April: Zhoupu Site started operations.
May: Animal facility approved.
Start-up
March: Kangqiao East Road Site started operations.
Established
December: Cascade was founded.