Drugs / APG-2575
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | chronic lymphocytic leukemia/small lymphocytic lymphoma | — | “NDA for lisaftoclax monotherapy for the treatment of R/R CLL or small SLL was accepted with Priority Review designation by the CDE of China’s NMPA” ascentage.com ↗ “the NDA for lisaftoclax (APG-2575) monotherapy for the treatment of R/R CLL/SLL was accepted and granted the Priority Review designation” ascentage.com ↗ “In China, a New Drug Application (NDA) for lisaftoclax has already been accepted and granted the Priority Review designation” ascentage.com ↗ “lisaftoclax (APG-2575), has been accepted and granted a Priority Review designation by the China Center for Drug Evaluation.” ascentage.com ↗ “lisaftoclax (APG-2575), has already been accepted and granted the Priority Review designation by the China CDE.” ascentage.com ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03537482 | Aug 2018 → Sep 2024 overdue | hematopoietic and lymphoid cell neoplasm | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT07428486 | Apr 2026 | T lymphoblastic leukemia/lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05701306 | Feb 2023 → Jun 2026 overdue | neuroblastoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05517616 | Sep → Nov 2022 | — | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05495035 | Sep 2022 → Aug 2024 | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), childhood acute lymphoblastic leukemia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 1 | NCT04260217 | May 2021 → Feb 2024 | Waldenstrom macroglobulinemia | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04215809 | Mar 2020 → Oct 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT03913949 | Jun 2019 → Oct 2024 overdue | B-cell chronic lymphocytic leukemia | Ascentage Pharma Group Inc. | Active not recruiting | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07601607 | May 2026 → May 2028 expected | relapsed/refractory diffuse large B-cell lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07398638 | Feb 2026 → Feb 2029 expected | diffuse large B-cell lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07159906 | Sep 2025 → Aug 2027 expected | diffuse large B-cell lymphoma | First Affiliated Hospital of Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06182969 | Aug 2024 → Apr 2026 overdue | systemic lupus erythematosus | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04942067 | Dec 2021 → Sep 2024 | amyloidosis, plasma cell myeloma | Ascentage Pharma Group Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04946864 | Aug 2021 → Aug 2024 | breast cancer | Ascentage Pharma Group Inc. | Suspended | No outcome recorded |
| Phase 1/2 | NCT04964518 | Jul 2021 → Jul 2024 | acute myeloid leukemia | Ascentage Pharma Group Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04674514 | Apr 2021 → Jan 2024 | plasma cell myeloma | Ascentage Pharma Group Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04501120 | Sep 2020 → Sep 2028 expected | acute myeloid leukemia | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04494503 | Aug 2020 → Oct 2024 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07831395 | Sep 2026 → Dec 2030 expected | Richter transformation | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07813390 | Sep 2026 → Sep 2027 expected | acute myeloid leukemia | Guangdong Second Provincial General Hospital | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07684950 | Jun 2026 → Oct 2028 expected | mantle cell lymphoma | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07602322 | May 2026 → May 2028 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07552324 | May 2026 → May 2027 expected | T-cell/histiocyte rich large B cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07459608 | Mar 2026 → Jan 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07255963 | Nov 2025 → Sep 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT07272499 | Sep 2025 → Sep 2028 expected | mantle cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05147467 | Dec 2021 → Dec 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04496349 | Jul 2021 → May 2026 overdue | T-cell prolymphocytic leukemia | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT07597941 | Jul 2026 → Jun 2028 expected | acute promyelocytic leukemia | The Affiliated People's Hospital of Ningbo University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07651163 | Mar 2026 → Dec 2029 expected | acute myeloid leukemia | First Affiliated Hospital of Zhejiang University | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT07651176 | Mar 2026 → Dec 2029 expected | acute myeloid leukemia | First Affiliated Hospital of Zhejiang University | Enrolling by invitation | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07686965 | Aug 2026 → Aug 2030 expected | acute myeloid leukemia | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06641414 | Jan 2025 → Jun 2029 expected | myelodysplastic syndrome | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06389292 | Jun 2024 → May 2028 expected | acute myeloid leukemia | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06319456 | Apr 2024 → Aug 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07795099 | Aug 2026 → Aug 2029 expected | acute lymphoblastic leukemia | LanZhou University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06104566 Comparator | Dec 2023 → Dec 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 51
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Its First Dataset on MDM2-p53 Inhibitor Alrizomadlin (APG-115) in Pediatric Solid Tumors at ASCO 2026 ascentage.com ↗
In combination with investigational selective Bcl-2 inhibitor lisaftoclax, encouraging antitumor activity was observed, with an objective response rate (ORR) of 23.5% among 17 response-evaluable patients, including one complete response in a patient with Ewing sarcoma and three partial responses (PRs). |
| 2025-12-07 | Ascentage Pharma Group Inc. | Results ASH 2025 | Ascentage Pharma Presents Encouraging Data from Phase Ib/II Study of Bcl-2 Inhibitor Lisaftoclax in Venetoclax–Exposed Patients with Myeloid Malignances ascentage.com ↗
These data suggest that this combination regimen has substantial therapeutic potential for the treatment of newly diagnosed or venetoclax–exposed patients. |
| 2025-12-06 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Pivotal China Registrational Study Data for Lisaftoclax in Oral Report at 2025 American Society of Hematology (ASH) Annual Meeting ascentage.com ↗
Lisaftoclax achieved a 62.5% objective response rate (ORR) in heavily pretreated, BTKi-refractory patients, nearly half with complex karyotype |
| 2025-08-17 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA ascentage.com ↗
Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). |
| 2025-07-10 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Its Novel Bcl-2 Inhibitor Lisaftoclax Approved by China NMPA, Ushering in a New Era for the Treatment of CLL/SLL ascentage.com ↗
its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China’s National Medical Products Administration (NMPA) |
| 2025-06-09 | Ascentage Pharma Group Inc. | Results Thirteen Studies of Ascentage Pharma’s Assets Including Olverembatinib and Lisaftoclax Selected for Presentations at 2025 European Hematology Association Annual Congress ascentage.com ↗
Synergistic Effects of Olverembatinib (HQP1351) Combined with Bcl-2 Inhibitor Lisaftoclax (APG-2575) and Bcl-2/Bcl-xL Inhibitor Pelcitoclax (APG-1252) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) |
| 2025-06-02 | Ascentage Pharma Group Inc. | Results Live from ASCO 2025 | Ascentage Pharma Presents Clinical Data on Bcl-2 Inhibitor Lisaftoclax in Venetoclax-Refractory Patients in Oral Report ascentage.com ↗
Findings of this study once again underscored the promising antitumor activity and manageable tolerability of lisaftoclax in myeloid malignancies. |
| 2025-05-22 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Clinical Data of Lisaftoclax, Which Shows Therapeutic Potential in Venetoclax-Refractory Patients, Selected for Oral Report at ASCO 2025 ascentage.com ↗
Data from this global, multicenter study that has enrolled nearly one hundred patients show that lisaftoclax in combination with azacitidine was well tolerated with preliminary efficacy. |
| 2025-04-28 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Results from Five Preclinical Studies at 2025 American Association of Cancer Research (AACR) Annual Meeting, Highlighting Strong Synergistic Effects of Olverembatinib Combined with Lisaftoclax ascentage.com ↗
In particular, the combination of olverembatinib and lisaftoclax, two of our key drug candidates, has demonstrated strong synergistic effects in preclinical models of acute myeloid leukemia and T-cell acute lymphoblastic leukemia. |
| 2025-03-27 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2025 AACR Annual Meeting innoventbio.com ↗
Olverembatinib* (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) |
| 2024-12-10 | Ascentage Pharma Group Inc. | Results Live from ASH 2024 | Oral Report Features Encouraging Data of Ascentage Pharma’s Bcl-2 Inhibitor Lisaftoclax in R/R MM, Including a Median PFS Over 9 Months ascentage.com ↗
The data featured in this Oral Report on lisaftoclax in R/R MM further demonstrated compelling clinical benefit and favorable safety profile of the combination regimen. |
| 2024-12-10 | Ascentage Pharma Group Inc. | Results Live from ASH 2024 | First Dataset of Olverembatinib in Combination with Bcl-2 Inhibitor Lisaftoclax Demonstrates Potential Clinical Benefits as a Chemotherapy-Free Regimen for Children with R/R Ph+ ALL ascentage.com ↗
This study in children and adolescents with R/R Ph+ ALL provides the preliminary evidence revealing the favorable efficacy and safety of olverembatinib in combination with lisaftoclax. |
| 2024-12-10 | Ascentage Pharma Group Inc. | Results Live from ASH 2024 | Ascentage Pharma’s Bcl-2 Inhibitor Lisaftoclax in Combinations Demonstrates Potential Clinical Benefit in Patients with Prior Exposure to Venetoclax ascentage.com ↗ |
| 2024-12-10 | Ascentage Pharma Group Inc. | Results Live from ASH 2024 | Ascentage Pharma Releases Updated Data of Bcl-2 Inhibitor Lisaftoclax in MDS that Demonstrates Potential Clinical Benefits and Favorable Safety ascentage.com ↗
In the results, the combination regimen demonstrated an overall response rate (ORR) of 75% in patients with treatment-naïve (TN) or relapsed/refractory (R/R) MDS, and no patient withdrew from the study due to intolerable toxicities. |
| 2024-11-17 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces a New Drug Application for Its Novel Bcl-2 Inhibitor Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA ascentage.com ↗ |
| 2024-11-06 | Ascentage Pharma Group Inc. | Results ASH 2024 | Results From Three Clinical Studies of Ascentage Pharma’s Bcl-2 Inhibitor Lisaftoclax Selected for Presentations, Including an Oral Report ascentage.com ↗
These findings suggest that lisaftoclax improves the depth of response in patients with R/R MM or AL amyloidosis when combined with Pd or DRd. |
| 2024-06-17 | Ascentage Pharma Group Inc. | Results Live from EHA 2024 | Ascentage Pharma Releases Updated Data of Lisaftoclax in Patients with R/R MM and AL Amyloidosis Highlighting Marked Improvement in ORR ascentage.com ↗
From the primary analysis, it demonstrated that lisaftoclax + pomalidomide in R/R MM could achieve ≥very good partial response (VGPR) rate of 33.3%, and higher VGPR along with increasing lisaftoclax dosage. |
| 2024-06-04 | Ascentage Pharma Group Inc. | Results Live from ASCO 2024 | Ascentage Pharma Releases Updated Data Showing Promising Efficacy and Safety of Lisaftoclax in Patients with WM ascentage.com ↗
The latest results from this clinical study validated the favorable safety and efficacy of lisaftoclax monotherapy and in combinations in WM. |
| 2024-06-03 | Ascentage Pharma Group Inc. | Results Live from ASCO 2024 | Updated Data of Bcl-2 Inhibitor Lisaftoclax Combined with Azacitidine in Patients with AML Demonstrate Promising Efficacy and Manageable Safety ascentage.com ↗ |
| 2023-12-11 | Ascentage Pharma Group Inc. | Results Live from ASH 2023 | Ascentage Pharma Releases the First Dataset of Bcl-2 Inhibitor Lisaftoclax in Patients with R/R MM, Demonstrating Encouraging ORR and VGPR ascentage.com ↗
This is the first data readout of lisaftoclax for the treatment of patients with R/R MM. |
| 2023-12-11 | Ascentage Pharma Group Inc. | Results Live from ASH 2023 | Ascentage Pharma Releases Encouraging Long-Term Data of Bcl-2 Inhibitor Lisaftoclax in R/R CLL, Including an ORR of 73.3% ascentage.com ↗
Results showed an overall response rate (ORR) of 73.3%; a complete remission (CR)/CR with incomplete blood count recovery (CRi) rate of 24.4%; and a positive correlation between CR/CRi rate and dose levels. |
| 2023-11-02 | Ascentage Pharma Group Inc. | Results ASH 2023 | Ascentage Pharma to Present Results from Three Clinical Studies of Bcl-2 Inhibitor Lisaftoclax (APG-2575), Including the First Data in AML and MM ascentage.com ↗
In two other abstracts on lisaftoclax, results were disclosed from clinical studies of the drug as a single agent and in combination regimens in multiple hematologic malignancies, including relapsed/refractory (R/R) multiple myeloma (MM) and acute myeloid leukemia (AML). |
| 2023-10-12 | Ascentage Pharma Group Inc. | Regulatory Global Registrational Phase III Study of Bcl-2 Inhibitor Lisaftoclax in Treatment-Naïve Patients with CLL/SLL Approved by the China CDE ascentage.com ↗
This global multi-center, randomized-controlled, open-label, pivotal Phase III confirmatory trial (APG2575CC301) is designed to evaluate the efficacy and safety of APG-2575 (lisaftoclax) combined with acalabrutinib versus immunochemotherapy in treatment-naïve patients with CLL/SLL. |
| 2023-08-06 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Received Clearance from U.S. FDA to Proceed with Global Registrational Phase III Clinical Trial for Lisaftoclax (APG-2575) in Previously Treated Patients with CLL/SLL ascentage.com ↗ |
| 2023-06-06 | Ascentage Pharma Group Inc. | Results Live from ASCO 2023 | Ascentage Pharma Releases the First Dataset of Lisaftoclax in WM, Revealing Encouraging Therapeutic Potential ascentage.com ↗
Lisaftoclax alone or combined with ibrutinib/rituximab demonstrated favorable safety and promising activity in patients with treatment-naïve or BTKi-refractory WM, with negligible risk of DDI between lisaftoclax and ibrutinib. |
| 2023-04-18 | Ascentage Pharma Group Inc. | Results AACR 2023 | Ascentage Pharma Presents Results from Three Studies Underscoring Exploratory Efforts in Potential New Indications ascentage.com ↗ |
| 2023-03-15 | Ascentage Pharma Group Inc. | Results Ascentage to Present Three Preclinical Studies at AACR 2023 ascentage.com ↗
the Bcl-2 inhibitor lisaftoclax (APG-2575) and the MDM2-p53 inhibitor alrizomadlin (APG-115), have been selected for presentations at the 2023 American Association of Cancer Research Annual Meeting (AACR 2023). |
| 2022-12-14 | Ascentage Pharma Group Inc. | Results Live from ASH 2022 | Ascentage Pharma Presents Latest Data of APG-2575, Including Encouraging Results of the Combination with BTKi in Patients with R/R CLL/SLL ascentage.com ↗
In particular, the combinations showed high objective response rates (ORRs), on the order of 98% (56/57) when combined with acalabrutinib in patient with R/R CLL/SLL. |
| 2022-11-04 | Ascentage Pharma Group Inc. | Results ASH 2022 | Ascentage Pharma to Present Initial Data of Bcl-2 Inhibitor Lisaftoclax (APG-2575) in Combination with BTK Inhibitors for the Treatment of R/R CLL/SLL, Including an ORR of 98%, in an Oral Report at the ASH Annual Meeting ascentage.com ↗
The combination therapies, especially lisaftoclax plus acalabrutinib, showed high response rates. |
| 2022-06-12 | Ascentage Pharma Group Inc. | Results EHA 2022 | Ascentage Pharma Releases Encouraging Results of Bcl-2 Inhibitor Lisaftoclax (APG-2575) in Chinese Patients with Relapsed/Refractory Non-Hodgkin Lymphoma ascentage.com ↗
The data presented at this year’s EHA Congress show that lisaftoclax was well tolerated at doses of up to 800 mg/day, without evidence of tumor lysis syndrome (TLS). |
| 2022-06-07 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Releases Updated Data Demonstrating Lisaftoclax’s (APG-2575) Therapeutic Potential in Patients with R/R CLL/SLL ascentage.com ↗
In this Phase Ib/II study, lisaftoclax as a single agent showed favorable preliminary efficacy and safety, and a daily ramp-up schedule that is patients’ friendly. |
| 2022-05-27 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Presents Updated Results from Multiple Clinical Studies Demonstrating Rapid Progress in Global Clinical Development ascentage.com ↗ |
| 2022-04-14 | Ascentage Pharma Group Inc. | Results AACR 2022 | Ascentage Presents Six Preclinical Studies ascentage.com ↗
today announced that it has presented the latest results from six preclinical studies of the company’s five investigational drug candidates: the Bcl-2 inhibitor lisaftoclax (APG-2575) |
| 2022-03-09 | Ascentage Pharma Group Inc. | Results Ascentage to Present Six Preclinical Studies at AACR 2022 ascentage.com ↗
This study finds that dual targeting the BCL-2 and MDM2-p53 apoptotic pathways can overcome this drug resistance, thereby provide compelling rationale to future clinical stu |
| 2021-12-14 | Ascentage Pharma Group Inc. | Results ASH 2021 | Ascentage Pharma Presents Latest Data from Two Studies of Bcl-2-Selective Inhibitor Lisaftoclax (APG-2575), Including a China Study Demonstrating Complete Responses ascentage.com ↗
As of data cutoff on July 27, 2021, 9 of the 25 patients who had received at least one tumor evaluation (of 31 enrolled patients) achieved complete responses (CR) or partial responses (PR). |
| 2021-12-13 | Ascentage Pharma Group Inc. | Regulatory Pivotal Study of Lisaftoclax in R/R CLL/SLL Approved by the CDE ascentage.com ↗
Based on existing safety and efficacy data of lisaftoclax, the CDE has agreed that results from the APG2575CC201 study can be used to support the future New Drug Application for the indication of R/R CLL/SLL. |
| 2021-06-15 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces IND Clearance by the US FDA for Lisaftoclax (APG-2575) as Single Agent or in Combinations for the Treatment of ER+ Breast Cancer and Other Solid Tumors ascentage.com ↗
the Investigational New Drug (IND) application for the company’s novel Bcl-2 inhibitor, lisaftoclax (APG-2575), has been cleared by the US Food and Drug Administration (FDA) |
| 2021-06-08 | Ascentage Pharma Group Inc. | Results Live from ASCO 2021 | Ascentage Pharma Delivers Oral Presentation Featuring Updated Data Demonstrating Promising Efficacy and Safety of Bcl-2 Inhibitor Lisaftoclax (APG-2575) in Patients with Relapsed or Refractory CLL/SLL ascentage.com ↗
Updated data on lisaftoclax have demonstrated favorable preliminary safety and efficacy, including an objective response rate (ORR) of 80% and a favorable tolerability profile, with manageable adverse events (AEs) in patients with R/R CLL/SLL. |
| 2021-05-20 | Ascentage Pharma Group Inc. | Results ASCO 2021 | Ascentage Pharma to Announce Updated Data of Lisaftoclax (APG-2575) Demonstrating an ORR of Around 80% and Therapeutic Potential in Patients with R/R CLL/SLL in Oral Presentation ascentage.com ↗
Results from this global Phase I study demonstrated an ORR of 85.7%, and favorable tolerability and safety profiles in patients with R/R CLL /SLL. |
| 2021-04-12 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Preclinical Data of Its Core Drug Candidates at AACR Annual Meeting 2021, with Results Signifying the Potential of Multiple Combination Therapies in Cancer ascentage.com ↗
BCL-2 inhibitor APG-2575 and homoharringtonine (HHT) synergistically induces apoptosis and inhibits tumor growth in preclinical models of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS) |
| 2021-03-10 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present the Latest Results from Six Preclinical Studies at AACR Annual Meeting 2021 ascentage.com ↗
BCL-2 inhibitor APG-2575 and homoharringtonine (HHT) synergistically induces apoptosis and inhibits tumor growth in preclinical models of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS) |
| 2021-01-28 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces the Fifth Orphan Drug Designation Granted to Bcl-2 Inhibitor APG-2575 by the US FDA, and the Tenth Obtained by the Company ascentage.com ↗
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to the company’s novel Bcl-2 inhibitor, APG-2575, for the treatment of patients with follicular lymphoma (FL). |
| 2021-01-05 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces its 9th Orphan Drug Designation from the US FDA in 2020, Setting a Record for Chinese Biopharmaceutical Companies ascentage.com ↗
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to the company’s novel Bcl-2 inhibitor, APG-2575, for the treatment of patients with acute myeloid leukemia (AML). |
| 2020-12-10 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Updates on the Clinical Development of APG-2575, including an ORR of 70% in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia ascentage.com ↗ |
| 2020-12-02 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Clearances in China and the US for the Phase IIa Study of APG-115 Single Agent or in Combination with APG-2575 for the Treatment of Relapsed or Refractory T-cell Prolymphocytic Leukemia ascentage.com ↗ |
| 2020-09-07 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia ascentage.com ↗
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL). |
| 2020-07-15 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Waldenström Macroglobulinemia ascentage.com ↗
the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of Waldenström macroglobulinemia (WM). |
| 2020-05-15 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Six Abstracts at 2020 AACR Annual Meeting ascentage.com ↗
We demonstrated that Combining APG-2575 with tamoxifen or palbociclib therapies substantially enhanced antitumor activity and overcomes tamoxifen resistance in the preclinical models of ER+ breast cancer, suggesting a novel strategy for the clinical development of BCL-2 inhibitors in ER+ breast cancers. |
| 2020-04-07 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Study of Bcl-2 Inhibitor APG-2575 for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in China ascentage.com ↗
today announced that it has received approval from the Center for Drug Evaluation of the China National Medical Products Administration for the Phase Ib/II study of APG-2575 |
| 2020-03-09 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Clearances for Three Phase Ib/II Clinical Studies of APG-2575 in China and the U.S., Beginning Simultaneous Clinical Development in Three Hematologic Malignancy Indications ascentage.com ↗ |
| 2019-03-26 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Nine Abstracts To Be Presented at the 2019 American Association for Cancer Research Annual Meeting ascentage.com ↗
BCL-2 Selective Inhibitor APG-2575 Synergizes with BTK Inhibitor in Preclinical Xenograft Models of Follicular Lymphoma and diffuse Large B-cell Lymphoma |
All press releases naming this drug 62 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APG-2575 | “A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small...” NCT06104566 ↗25“Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.” NCT04260217 ↗ “Safety, tolerability, and pharmacokinetics of lisaftoclax (APG-2575)-based therapy in patients with chronic lymphocytic leukemia: Phase 1b/2 study.” PMID 41109219 ↗ Oct 2025 “Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count \>2.0×10⁹/L or ≥24-hour 2-fold WBC elevation.” NCT07597941 ↗ “Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.” NCT04501120 ↗ “lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor” NCT07459608 ↗ “Drug: Lisaftoclax (APG-2575)” NCT07272499 ↗ “Lisaftoclax (APG-2575)” NCT06319456 ↗ “Lisaftoclax (APG-2575)” NCT07813390 ↗ “Lisaftoclax (APG-2575)” NCT07831395 ↗ “Lisaftoclax (APG-2575)” NCT06641414 ↗ |
| Known as | [14C] APG-2575 | “A Single-center, Open-label, Single-dose Phase 1 Clinical Study to Investigate the Absorption, Metabolism and Excretion of APG-2575 in Healthy Subjects After Oral...” NCT05517616 ↗ |
| Known as | Lisaftoclax | “R 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21” NCT07552324 ↗22“Venetoclax (or Lisaftoclax, depending on study drug) is a selective oral BCL-2 inhibitor that restores apoptosis in tumor cells.” NCT07159906 ↗ “GC Type: Glofitamab + BCL-2 inhibitor (e.g., Lisaftoclax/Venetoclax)” NCT07602322 ↗ “APG-2575(Lisaftoclax )” NCT06389292 ↗ |
| Action | Inhibit | “Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.” PMID 41109219 ↗ Oct 2025 |
| Modality | Small molecule | “Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.” PMID 41109219 ↗ Oct 2025 |
| Route | Oral | “APG-2575 will be administered as an oral tablet” NCT03537482 ↗ |
| Target | BCL2 | “Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.” PMID 41109219 ↗ Oct 2025 |