Clinical Product Portfolio

Ascentage Pharma has built a highly differentiated novel clinical pipeline with the expertise in structure-based drug design and innovative drug discovery engine. As for now, Ascentage has 8 drug candidates in clinical development, 28 ongoing clinical trials and 21 INDs filed globally.

Core Product: HQP1351
Key Products: HQP1351, APG-1252, APG-2575, APG-115

 

Candidate Mechanism Lead Indications Preclinical Phase I Phase II/III Market Rights
Apoptosis Targeted Compounds
APG-1252 Bcl-2/Bcl-xL Cancer (SCLC, lymphoma)
Global
APG-2575 Bcl-2 Selective Blood cancer
Global
AT-101(1) Bcl-2/Bcl-xL/Mcl-1 CLL
Global
APG-1387 IAP Dimer Solid tumors
Global
IO combo
Global
Hepatitis B
Global
APG-115 MDM2-p53 Solid tumors
Global
Chemotherapy combo (Salivary Gland Carcinoma)
Global
IO combo
Global
Dry AMD
Global
Next-Generation Kinase Inhibitors
HQP1351 BCR-ABL Mutant Resistant CML *pivotal Phase II clinical trials
Global
KIT GIST
Global
HQP8361(2) c-Met Selective Cancer (c-Met+)
Australia, Japan, Greater China
APG-2449 FAK Cancer
(FAK, ALK, Ros)
Global
Age-Related Diseases
Bcl-2 related The Company has a strategic relationship with Unity related to Unity’s development of senolytic drugs. Joint venture in Greater China
(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.”