Ascentage Pharma has developed a robust pipeline of 8 clinical-stage small molecule drug candidates, currently being evaluated in more than 30 Phase I or II clinical trials in the United StatesAustralia, and China.

 

Candidate Mechanism Lead Indications Preclinical Phase I Phase II Countries
HQP1351 BCR-ABL Mutant Resistant CML *pivotal Phase II
China
KIT GIST
China
APG-2575 Bcl-2 Selective CLL/SLL
China, U.S. & Australia
WM
U.S. & Australia
AML
China
APG-1252 Bcl-2/Bcl-xL SCLC/NSCLC  
China, U.S. & Australia
NSCLC (Combo)
China
APG-115 MDM2-p53 Solid Tumors (IO Combo)  
China & U.S.
AML
China & U.S.
APG-1387 IAP Dimer Solid Tumors (IO Combo)
China & U.S.
Hepatitis B
China
AT-101(1) Bcl-2/Bcl-xL/Mcl-1 CLL
China & U.S.
APG-2449 FAK/ALK/ROS1 NSCLC
China
HQP8361(2) c-Met Selective Cancer (c-Met+)
China
Bcl-2 Related Strategic relationship with Unity to develop senolytic drugs. U.S.
(1) AT-101 was in-licensed from the University of Michigan in 2015. While we continue the clinical development of AT-101 by leveraging the historical clinical data from more than 700 patients from the clinical trial of AT-101, we no longer attribute strategic importance to the clinical progression of such trial and we do not plan to increase the number of clinical sites for such trial in the near future. Instead, as set out in “Business — Our Strategies”, our strategic focus is to prioritize our research and development resources on our other drug candidates, including our Key Products, and such decision is primarily driven by (i) the fact that we have developed new generations of drug candidates targeting the Bcl-2/Bcl-xL pathway in our pipeline, namely APG-1252 and APG-2575; (ii) the risk of not achieving a breakthrough in the clinical development of AT-101 before the patent rights for AT-101 expire in 2025; and (iii) then-CFDA’s requirement to manufacture AT-101 in China in order to apply for an IND in China when we obtained the global rights to AT-101 from the University of Michigan. However, as we cannot predict whether there may be encouraging clinical data in the clinical trial of AT-101 which may cause the Directors to decide that it would be in the interests of the Group to re-prioritise the research and development resources of the Group on the clinical development of AT-101, we have not discontinued the clinical development of AT-101, but at the same time, for reasons set out above, we do not at present consider AT-101 to be a Core Product under Chapter 18A of the Listing Rules.
(2) HQP8361, developed by our wholly owned subsidiary Healthquest Pharma, also known as MK-8033, was in-licensed from MSD. See “Business — Collaboration and License Agreements — Our License Agreement with MSD.”