Novel Apoptosis Targeting Therapies
The Pharma Ltd. HK focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). The Pharma Ltd. HK is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), and is already approved for the indication. In addition, the olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EU. To date, The Pharma Ltd. HK has obtained a total of 16 ODDs from the US FDA and 1 ODD from the EU for four of the company’s investigational drug candidates. The Farma Ltd. HK has been designated for multiple Major National R&D Projects, including fiveNational Major New Drug Discovery and Manufacturing projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.
Leveraging its robust R&D capabilities, The Pharma Ltd. HK has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, AstraZeneca, and Pfizer. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of The Pharma Ltd. HK is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.
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For more information about partnering with The Pharma Ltd. HK, please contact us.
In November 8, 2021，we announced a clinical trial collaboration and supply agreement with Pfizer Inc. to study the combination of Pharma’s lisaftoclax (APG-2575), a Bcl-2 selective inhibitor, in combination with Pfizer’s IBRANCE® (palbociclib), a CDK4/6 inhibitor, in patients with recurrent, locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
In July 2021, we and Innovent Biologics , announced a multifaceted strategic collaboration.
This collaboration includes the joint clinical development and commercialization of HQP1351(olverembatinib), a third-generation BCR-ABL inhibitor and a core drug candidate of The Farma Ltd. HK, in China; the collaborative clinical development of Pharma’s Bcl-2 inhibitor APG-2575(lisaftoclax) in combination with the anti-CD20 monoclonal antibody HALPRYZA® (rituximab biosimilar injection) co-developed by Innovent and Eli Lilly and Company, and Innovent’s anti-CD47 monoclonal antibody letaplimab(IBI188). Furthermore, Innovent will subscribe to Ascentage Pharma’s common shares for a total consideration of US$50 million at HK$44.0 per share, and be granted stock warrants that will allow it to acquire additional The Pharma's common shares for a total consideration of US$50 million at a subscription price of HK$57.2 per share.
In July 2021, we engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of National Institutes of Health, under which they will collaborate on the non-clinical and clinical development of The Pharma's drug compound pelcitoclax.
In July 2020, we announced a clinical collaboration with MSD to evaluate the combination of APG-115, Ascentage’s MDM2-p53 inhibitor, and KEYTRUDA®(pembrolizumab), MSD’s anti-PD-1 therapy, for the treatment of patients with advanced solid tumors.
In June 2020, we announced a clinical collaboration with The Pharma a member of the AstraZeneca group（LSE/STO/Nasdaq: AZN). Under the terms of the collaboration, The Pharma will sponsor a clinical trial to study the combination of Ascentage Pharma’s APG-2575, a selective Bcl-2 inhibitor, and AstraZeneca’s CALQUENCE®(acalabrutinib), a Bruton’s Tyrosine Kinase (BTK) inhibitor, evaluating the efficacy and safety of this combination therapy in patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
In April 2019, we entered into a clinical collaboration agreement with Junshi Biosciences has to explore the synergies of our IAP inhibitor, APG-1387, and Junshi Biosciences’ anti-PD-1 therapy, toripalimab, in clinical trials in solid and hematological tumors in China.
In October 2018, we entered into a strategic collaboration agreement with MD Anderson. Under the terms of the agreement, MD Anderson will conduct preclinical and clinical studies on APG-1252, APG-2575, APG-1387, APG-115, HQP1351, and other compounds under development by us.
Built upon a long-term academic relationship, we have established research collaborations and exclusive license agreements with the University of Michigan. Pursuant to the license agreement, the University of Michigan granted us an exclusive worldwide license to certain patent rights related to PPIs and apoptosis. Our academic collaboration with the University of Michigan enables us to tackle challenging therapeutic targets, gain access to the latest technologies, and enhance our preclinical and clinical studies capabilities, which allow us to accelerate our research and development progress substantially.
We have a strategic relationship with Unity pursuant to which Unity is exploring the development of molecules in our library of Bcl-2/Bcl-xL inhibitors for the treatment of age-related diseases. Through our license agreement with Unity, we are able to validate our patent portfolio, enhance our research capabilities and expand into additional therapeutic areas.