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Rockville, Maryland, USA and Suzhou, ChinaApril 27, 2026 /PRNewswire/ — Ascentage Pharma (Nasdaq: AAPG; HKEX: 6855), a leading biopharmaceutical company committed to developing innovative drugs in oncology and other fields, today announced that its independently developed Class 1 new drug, Lisuento® (lisaftoclax), the first domestically developed Bcl-2 inhibitor approved in China, has been included in the newly released 2026 Chinese Society of Clinical Oncology (CSCO) guideline series. In the 2026 editions of the CSCO Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies and the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies, lisaftoclax has established its authoritative recommended status in the fields of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), based on its outstanding performance in multiple clinical studies.
I. CLL/SLL: Comprehensive Coverage from Monotherapy to Combination Therapy
In the 2026 edition of the CSCO Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies, lisaftoclax has achieved a stepwise, precision-oriented layout:
- Grade I Recommendation (Monotherapy/Relapsed/Refractory): Based on the significant benefits observed in the APG2575CC201 study in high-risk, BTKi-pretreated patients (ORR of 62.5%), lisaftoclax monotherapy has received a Grade I Recommendation (high level of evidence), establishing it as a standard treatment option for patients with relapsed/refractory CLL/SLL.
- Grade II Recommendation (Combination Regimen/Relapsed/Refractory): Lisaftoclax in combination with rituximab has received a Grade II Recommendation for patients with relapsed/refractory CLL/SLL.
- Grade III Recommendation (Frontier Exploration): For patients with CLL/SLL who are relapsed/refractory after treatment with BTK inhibitors and venetoclax, lisaftoclax combined with acalabrutinib has demonstrated substantial therapeutic potential, with an ORR of 96.9%, and has received a Grade III Recommendation, making it the only Bcl-2 inhibitor regimen included in this category.
II. AML: Core First-Line and Drug-Resistant Alternative Options under Precision Stratification
In the 2026 edition of the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies, lisaftoclax has further solidified its cornerstone position in myeloid neoplasms through updates to its mechanism category:
- Core First-Line Recommendation: For older/unfit patients, the guidelines list “BCL-2 inhibitors (including lisaftoclax)” in combination with hypomethylating agents (AZA/DAC) or low-dose cytarabine (LDAC) as a core first-line regimen recommendation.
- Breakthrough for Drug-Resistant Patients: Specifically for unfit patients with prior HMA exposure, the guidelines have added the “LDAC + Bcl-2 inhibitor” regimen. Leveraging its unique pharmacokinetic advantages, lisaftoclax has become an important alternative option for these treated/drug-resistant patients.
- Salvage Therapy for Refractory/Relapsed Disease: For targeted therapy or targeted therapy combined with chemotherapy in patients with early relapse, the guidelines have added lisaftoclax as an optional Bcl-2 inhibitor drug.
III. MDS: Sustaining the Therapeutic Value of Bcl-2 Inhibitors Combined with HMAs in Higher-Risk MDS
In the 2026 edition of the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies, for patients with newly diagnosed higher-risk MDS, as well as those with relapse, progression, or non-response, a treatment regimen combining HMA with a Bcl-2 inhibitor is recommended. The guidelines also mention that the global registrational Phase III clinical trial (GLORA-4) evaluating the novel Bcl-2 inhibitor lisaftoclax in combination with AZA for newly diagnosed HR-MDS has been approved and is currently ongoing. As China’s first original next-generation Bcl-2 inhibitor, lisaftoclax also holds clinical application value in the treatment of patients with higher-risk MDS.
Lisaftoclax is a novel oral Bcl-2 selective inhibitor independently developed by Ascentage Pharma. By selectively inhibiting the Bcl-2 protein, it restores the normal apoptotic process of cancer cells, thereby achieving the goal of treating tumors. In July 2025, the drug was approved for marketing in China for the treatment of adult patients with CLL/SLL who have received at least one prior systemic therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi). Lisaftoclax is the first domestically developed original Bcl-2 inhibitor approved in China and the second Bcl-2 inhibitor approved globally. It is also the world’s first Bcl-2 inhibitor approved as a monotherapy for patients previously treated with BTK inhibitors, representing significant clinical value.
Director of the Harbin Institute of Hematology & Oncology: “In recent years, domestic biopharmaceutical companies have achieved remarkable breakthroughs in innovative drug R&D. Lisaftoclax, as China’s first original Bcl-2 inhibitor, has garnered significant attention. Its clinical efficacy in CLL/SLL has been recognized by the guidelines and validated in clinical practice. Beyond CLL/SLL, lisaftoclax has shown good efficacy in older/unfit patients with acute myeloid leukemia (AML) when combined with hypomethylating agents (such as decitabine and azacitidine) or chemotherapy regimens, as well as in the treatment of higher-risk MDS patients in combination with AZA. As research exploration progresses, the therapeutic value of lisaftoclax in hematologic malignancies continues to be clarified. The updates in the 2026 editions of the CSCO Guidelines for Lymphoid Malignancies and the CSCO Guidelines for Hematological Malignancies have further strengthened the clinical position of Bcl-2 inhibitors in hematologic tumors. We have always adhered to the original aspiration of ‘Everything for innovation, everything for patients.’ Looking ahead, with the expansion and submission of more indications, lisaftoclax is expected to cover a broader patient population, including those with AML and MDS, continuously releasing its clinical value. To truly bring cutting-edge innovation to the public, accessibility should be further improved in the future. We hope lisaftoclax can be included in the national medical insurance system as soon as possible, enabling more patients with urgent treatment needs to benefit from it and improving the overall treatment level and equity for hematologic malignancies. We believe that with continuous exploration and in-depth application of lisaftoclax, more possibilities will be created for the treatment of hematologic tumors.”
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, stated: “The CSCO guidelines are a crucial basis for Chinese clinicians in the diagnosis and treatment of tumors and are among the most academically influential clinical practice guidelines in China. As the first domestically developed original Bcl-2 inhibitor approved in China, the comprehensive inclusion of lisaftoclax in the 2026 CSCO guideline series fully demonstrates its outstanding clinical value across multiple hematologic tumor fields. This not only breaks the long-standing reliance on imported drugs in this field but also reshapes the treatment landscape for hematologic tumors in China, leveraging differentiated advantages such as ‘daily ramp-up dosing schedules’ that are more aligned with Chinese clinical practice, providing patients with more advanced and accessible innovative solutions. We look forward to lisaftoclax, this significant innovative drug, better serving clinical treatment in the field of hematologic tumors under the rigorous guidance of the CSCO guidelines, benefiting a wider range of patients.”
About Ascentage Pharma
Ascentage Pharma (Nasdaq: AAPG; HKEX: 6855) is a comprehensive global biopharmaceutical company dedicated to the research, development, production, and commercialization of innovative drugs to address unmet clinical needs of patients worldwide in the field of oncology. The company has built a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in the apoptosis pathway, such as Bcl-2 and MDM2-p53, next-generation inhibitors targeting kinase mutants arising in cancer therapy, and protein degraders.
The company’s core product, Noltec®, is the first third-generation BCR-ABL inhibitor approved in China. It has been approved for the treatment of adult patients with chronic myeloid leukemia in chronic phase (CML-CP) and accelerated phase (CML-AP) harboring the T315I mutation, as well as adult patients with CML-CP who are resistant and/or intolerant to first- and second-generation TKIs. All approved indications for this drug have been included in China’s National Reimbursement Drug List (NRDL). Currently, Ascentage Pharma is conducting three global registrational Phase III clinical studies for Noltec®: the POLARIS-1 study, authorized by the U.S. FDA and European EMA, evaluating Noltec® in the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL); the POLARIS-2 study, authorized by the U.S. FDA and European EMA, evaluating Noltec® in the treatment of pretreated adult patients with CML-CP; and the POLARIS-3 study evaluating Noltec® in the treatment of SDH-deficient GIST patients.
The company’s other major product, Lisuento®, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisuento® has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one prior systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Currently, Ascentage Pharma is conducting four global registrational Phase III clinical studies for Lisuento®: the GLORA study, authorized by the U.S. FDA and European EMA, evaluating Lisuento® in combination with a BTK inhibitor in CLL/SLL patients who have received prior BTK inhibitor therapy for more than 12 months and have had a suboptimal response; the GLORA-2 study evaluating Lisuento® as a first-line treatment for treatment-naïve CLL/SLL patients; the GLORA-3 study evaluating Lisuento® as a first-line treatment for newly diagnosed older or unfit AML patients; and the GLORA-4 study, authorized by the U.S. FDA and European EMA, evaluating Lisuento® as a first-line treatment for newly diagnosed intermediate/high-risk MDS patients.
Leveraging its strong R&D capabilities, Ascentage Pharma has established a global intellectual property portfolio and has entered into global collaborations with numerous leading biopharmaceutical companies, including Takeda, AstraZeneca, Merck & Co., Pfizer, and Innovent, as well as academic research collaborations with institutions such as the Dana-Farber Cancer Institute, Mayo Clinic, the National Cancer Institute, and the University of Michigan. For more information, please visit https://ascentage.com/
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