We are a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing both first- and best-in-class therapies to address global unmet medical needs primarily in hematological malignancies. Our lead assets, olverembatinib and lisaftoclax, have global potential to address the major hematological malignancies, including chronic myeloid leukemia, or CML, acute myeloid leukemia, or AML, chronic lymphocytic leukemia, or CLL, acute lymphocytic leukemia, or ALL, myelodysplastic syndrome, or MDS, and multiple myeloma, or MM, which is expected to exceed US$166 billion in aggregate market size by 2035, according to Frost & Sullivan.
For more than two decades, our founders and team have leveraged their deep expertise to develop our proprietary drug discovery platform to pursue particularly challenging targets and significant unmet global medical needs. Our technical expertise in structure-based drug design and our innovative drug discovery engine have allowed us to develop small molecule and degrader therapies targeted at Bcl-2, Bcl-2/Bcl-xL, IAP and MDM2, in addition to building next- generation cell signaling inhibitors (i.e., BCR-ABL1, ALK, FAK inhibitors) and epigenome-modifying agents (i.e., EED inhibitor). We have eleven completed or ongoing U.S. and/or international registrational trials, including two that are FDA-regulated.
Our first lead asset, olverembatinib, is the first and only third generation BCR-ABL1 TKI approved in China for treatment of patients with CML. We are currently conducting several registrational Phase 3 trials to evaluate olverembatinib as a monotherapy for CML (POLARIS-2, regulated by FDA), in combination with chemotherapy for frontline Ph+ ALL (POLARIS-1), and as a monotherapy for SDH-deficient GIST (POLARIS-3). In June 2024, we entered into an Exclusive Option Agreement with Takeda Pharmaceuticals International AG, or Takeda, pursuant to which we granted Takeda an exclusive option to enter into an exclusive license agreement for olverembatinib (HQP1351). If exercised, the Option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of, among others, People’s Republic of China, Hong Kong, Macau and Taiwan.
Our second lead asset, lisaftoclax (APG-2575) is a novel Bcl-2 inhibitor. We plan to pursue approval in China with CDE in 2024, and we expect that lisaftoclax will be the second Bcl-2 inhibitor for which an NDA is filed in the world and the first in China for the CLL/SLL indication. Through four registrational Phase 3 trials, we are currently evaluating lisaftoclax as a monotherapy and/or in combination with existing treatments for patients with CLL/SLL (GLORA (regulated by FDA) and GLORA-2), AML (GLORA-3) and MDS (GLORA-4). We are also evaluating lisaftoclax in ongoing clinical trials for MM and other hematological malignancies. As of June 30, 2024, more than 1,000 patients have been treated with lisaftoclax as a monotherapy or combination therapy in clinical trials conducted in United States, Australia, China, and Europe, among which approximately 400 patients have CLL/SLL. To date, the FDA has granted five ODDs to lisaftoclax, including for the treatment of CLL, AML and MM.
Intellectual property rights are fundamental to our business. Through our robust research and development, we have strategically developed a global intellectual property portfolio with exclusive rights to issued patents or patent applications worldwide with respect to our products and product candidates. As of June 30, 2024, we had 520 issued patents globally, among which 367 issued patents were issued outside of China. We have also established collaborations and other relationships with numerous leading biotechnology and pharmaceutical companies around the world, including an exclusive option agreement with Takeda, a collaboration and license agreement with Innovent, clinical collaboration agreements with AstraZeneca, Merck and Pfizer, and research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan.
To become a fully integrated globally-focused biotechnology company.
Patients First
Innovation-Driven
Science-Based