Our Pipeline

ACEA has a robust pipeline of small and large molecules and cell therapies in development for the treatment of cancer, COVID-19 and autoimmune diseases.

Our lead compound Olgotrelvir is a next generation standalone oral treatment for COVID-19. We have completed Phase III trial treatment of over 1200 patients. Submission of NDA to National Medical Products Administration of China (NMPA) is under the plan and expect to get an approval by the end of 2023. 

Abivertinib as a next generation BTK inhibitor, is evaluated as a drug to treat COVID-19 patients with moderate to severe symptoms for the Phase III trial in Brazil. Additional indications for Abivertinib as BTK inhibitor that are currently in clinical trials include B Cell lymphoma (BCL) and prostate cancer. As a more potent inhibitor of mutant than wild-type EGFR, Abivertinib is in Phase III clinical trial of patients with non-small cell lung cancer (NSCLC) harboring the EGFR T790M mutation. In the USA, FDA granted IND clearance for Phase II study of Abivertinib to treat patients with resistance to Tagrisso (Osimertinib). 

AC0058, a potential treatment for autoimmune diseases, has entered Phase Ib trial for systemic lupus erythematosus (SLE) in the USA. 

STI-6129, an antibody drug-conjugate that targets CD38, has entered Phase Ib development in the US and China for the treatment of AL amyloidosis and multiple myeloma.

AC0939, a novel small molecule inhibitor of FMS-like tyrosine kinase 3 (FLT3), has reached Phase I development in China for the treatment of acute myeloid leukemia (AML). 

Also, we have several compounds in preclinical development across multiple cancer settings. 

ProductTargetIndicationScreeningPre-clinicalPhase IPhase IIPhase IIINDA Country
AbivertinibMutated EGFR NSCLC
 
China/US
AbivertinibBTK B-cell lymphoma
 
China
AbivertinibBTK Prostate Cancer
 
US
AbivertinibBTK Severe COVID-19
 
US/Brazil
OlgotrelvirMpro/Cathepsin Mild/moderate diseases
 
China/US/ AUS/Mexico
AC0058BTK Auto-immune diseases
 
US/China
STI-6129Anti-CD38 ADC MM/AL
 
US/China
AC0939FLT-3 and others AML/HCC
 
China
AC-PROtraditional “undruggable” targets (PROTAC) Various tumors
 
US/China
STI-1492AntiCD38 A2 KOKI DAR-T cells Cancers
 
US
Abivertinib
Target: Mutated EGFR
Indication: NSCLC
Pre-clinicalPhase IPhase IIPhase IIINDA Country
China/US
Abivertinib
Target: BTK
Indication: B-cell lymphoma
Pre-clinicalPhase IPhase IIPhase IIINDA Country
China
Abivertinib
Target: BTK
Indication: Prostate Cancer
Pre-clinicalPhase IPhase IIPhase IIINDA Country
US
Abivertinib
Target: BTK
Indication: Severe COVID-19
Pre-clinicalPhase IPhase IIPhase IIINDA Country
US/Brazil
Olgotrelvir
Target: Mpro/Cathepsin
Indication: Mild/moderate diseases
Pre-clinicalPhase IPhase IIPhase IIINDA Country
China/US/ AUS/Mexico
AC0058
Target: BTK
Indication: Auto-immune diseases
Pre-clinicalPhase IPhase IIPhase IIINDA Country
US/China
STI-6129
Target: Anti-CD38 ADC
Indication: MM/AL
Pre-clinicalPhase IPhase IIPhase IIINDA Country
US/China
AC0939
Target: FLT-3 and others
Indication: AML/HCC
Pre-clinicalPhase IPhase IIPhase IIINDA Country
China
AC-PRO
Target: traditional “undruggable” targets (PROTAC)
Indication: Various tumors
Pre-clinicalPhase IPhase IIPhase IIINDA Country
US/China
STI-1492
Target: AntiCD38 A2 KOKI DAR-T cells
Indication: Cancers
Pre-clinicalPhase IPhase IIPhase IIINDA Country
US