We are a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in hematological malignancies. 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 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 the industry report commissioned by us and independently prepared by Frost & Sullivan in connection with this offering, or the F&S Report. We are the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators, according to the F&S Report. We have eleven completed or ongoing U.S. and/or international registrational trials, including two that are FDA-regulated, for our five key clinical-stage assets. Our first lead asset, olverembatinib, is a novel, next-generation tyrosine kinase inhibitor, or TKI. Olverembatinib is the first and only BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase, or CML-CP, with T315I mutations, CML in accelerated phase, or CML-AP, with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. Olverembatinib has demonstrated favorable clinical benefit and tolerability in heavily pretreated patients, particularly ponatinib- or asciminib-failed patients, with 52.2% and 47.8% of ponatinib-resistant patients achieving complete cytogenic response, or CCyR, and major molecular response, or MMR, respectively, and 30.8% and 26.7% of asciminib-resistant patients achieving CCyR and MMR, respectively. In a five-year follow-up of CML-CP patients treated with olverembatinib, 73% had remained on the treatment, response rates continued to increase and the prevalence of treatment-related adverse events, or TRAEs, continued to decrease over such period. Therefore, we believe that olverembatinib, with its real-world patient data in China, where it is approved, has the potential to be a global therapy for CML. The global CML market was around US$12.3 billion in 2023 and is expected to grow to US$14.6 billion by 2035, according to the F&S Report. We are currently conducting a registrational Phase 3 trial, or POLARIS-2, of olverembatinib as a monotherapy for CML that is regulated by the U.S. Food and Drug Administration, or FDA, and subject to the successful completion, we plan to submit a new drug application, or NDA, to the FDA in 2026. We note that clinical data obtained in China may not be accepted by the FDA or other foreign regulators to support ongoing or future clinical trials, that olverembatinib is approved only in China, and that the outcome of our ongoing clinical trials is uncertain. We are also pursuing label expansion of olverembatinib in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive ALL, or frontline Ph+ ALL, in a registrational Phase 3 trial, or POLARIS-1, and conducting another registrational Phase 3 trial, or POLARIS-3, evaluating olverembatinib as a monotherapy for succinate dehydrogenase, or SDH, -deficient gastrointestinal stromal tumor, or GIST. In June 2024, we entered into an exclusive option agreement with Takeda Pharmaceuticals International AG, or Takeda, where we granted Takeda an exclusive option to take an exclusive license (even as to us and our affiliates) to research, develop, import, export, make, have made, manufacture, have manufactured, use, commercialize and otherwise exploit olverembatinib. Under the terms of the option agreement, we received US$100.0 million from Takeda related to intellectual property income and option payment. We are eligible to be paid an option exercise fee and certain milestone payments up to approximately US$1.2 billion in the aggregate as well as royalties in a range equal to 12-19% of net sales. Our second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor that we are developing for the treatment of various hematological malignancies. In November 2024, we announced that our NDA for the treatment of relapsed and/or refractory, or r/r, CLL and small lymphocytic lymphoma, or SLL, was accepted with Priority Review designation by the Center of Drug Evaluation, or CDE, of China’s National Medical Products Administration, or NMPA. According to the F&S Report, this NDA is the second NDA filed in the world for a Bcl-2 inhibitor and the first in China for a Bcl-2 inhibitor for the treatment of patients with CLL/SLL that are resistant or intolerant to Bruton’s tyrosine kinase, or BTK, inhibitors. If approved, we plan to launch in China in 2025 and pursue regulatory approvals in multiple countries. The global CLL/SLL market was around US$9.4 billion in 2023 and is expected to grow to US$38.2 billion by 2035, according to the F&S Report. We are also conducting an FDA-regulated registrational Phase 3 trial, or GLORA, of lisaftoclax in combination with BTK inhibitors for patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with sub-optimal response and pursuing approval of lisaftoclax for frontline CLL/SLL in a registrational Phase 3 trial, or GLORA-2, of lisaftoclax in combination with acalabrutinib. We believe that lisaftoclax, with its short half-life and potential for patient-friendly ramp-up schedule, can serve as a backbone molecule for combination therapies for many hematological malignancies, including and beyond CLL/SLL. Therefore, we are also evaluating lisaftoclax in combination with azacitidine, or AZA, in two registrational Phase 3 trials, GLORA-3 and GLORA-4, for the frontline treatments of elderly or unfit patients with AML or patients with higher risk, or HR, myelodysplastic syndrome, or MDS, respectively. Backed by our strong scientific foundation, knowledge of small molecule discovery and capabilities to conduct clinical trials worldwide, we use state-of-the-art technologies to develop innovative therapeutic agents to treat cancers and address unmet medical needs within this patient population. Our initial focus has been to leverage our expertise in chemistry to synthesize inhibitors targeting proteins and pathways that drive the key hallmarks of cancer. Earlier in our pipeline, we are harnessing our understanding of protein degraders to develop therapies, such as proteolysis targeting chimera molecules, or PROTACs, that target traditionally undruggable proteins that are implicated in oncogenesis. We are empowered by our technical expertise in structure-based drug design and our innovative drug discovery engine, which allows us to address unmet medical need by targeting key apoptotic pathways and validated tyrosine kinases. These core competencies 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). Beyond our two lead assets, we have several other clinical-stage assets in U.S. or international clinical trials. Leveraging our robust internal research and development capabilities, we have built a portfolio of global intellectual property rights. We have also established collaborations and other relationships with leading biotechnology and pharmaceutical companies around the world, including a collaboration and license agreement with Innovent and 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. As of September 30, 2024, we had a portfolio of more than 384 U.S. and foreign patents and more than 173 U.S. and foreign pending patent applications. Our headquarters and principal executive office is located at 68 Xinqing Road, Suzhou Industrial Park, Suzhou, Jiangsu, China. Our registered office in the Cayman Islands is located at the offices of Walkers Corporate Limited, 190 Elgin Avenue, George Town, Grand Cayman KY19008, Cayman Islands. Our agent for service of process in the United States is Ascentage Pharma Group Inc., located at 700 King Farm Blvd, Suite 510, Rockville, Maryland.
