Drugs / Olverembatinib
Olverembatinib
also known as
HQP1351 · [14C] HQP1351 · D-824 · D-824 DIMESYLATE · GZD-824 · GZD-824 DIMESYLATE · HQP-1351 DIMESYLATE · Olverembatinib dimesylate · +1 more
Small molecule targets ABL1, BCR, FGFR1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | chronic myeloid leukemia | — | “The New Drug Application (NDA) for olverembatinib for the treatment of patients with chronic phase CML (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation...” ascentage.com ↗ “A New Drug Application (NDA) for olverembatinib has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center...” ascentage.com ↗ “a New Drug Application (NDA) for olverembatinib has been submitted and subsequently granted Priority Review by the Center for Drug Evaluation (CDE) in China.” ascentage.com ↗ “Ascentage Pharma has submitted a new drug application (NDA) for its core drug candidate, olverembatinib (HQP1351), in China” ascentage.com ↗ “has accepted and granted Priority Review status to a New Drug Application (NDA) for the full approval of olverembatinib” ascentage.com ↗ |
Trials 36
News releases announcing trial results or a regulatory action · 63
| Date | Issuer | Release |
|---|---|---|
| 2026-06-14 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Multiple Clinical Updates at EHA2026 Congress ascentage.com ↗
In CML, olverembatinib demonstrated deep and durable responses in patients with chronic-phase CML (CML-CP) without the T315I mutation, in whom the disease was resistant and/or intolerant to first-line TKI therapy, supporting its potential as a second-line treatment option. |
| 2026-05-31 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Updated Clinical Data for Olverembatinib as Second-Line Therapy in CML-CP at ASCO 2026 ascentage.com ↗
Data presented in this rapid oral presentation showed that, at cycle 24, patients with CML-CP treated with olverembatinib achieved a complete cytogenetic response (CCyR) rate of 91.3% and a major molecular response (MMR) rate of 60.9%. |
| 2026-05-31 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Data on Olverembatinib in CML-LBP and Ph+ BCP-ALL at ASCO 2026 ascentage.com ↗
The combination regimen demonstrated encouraging clinical activity in patients with relapsed/refractory Ph+ BCP-ALL or CML-LBP, with strong response rates and minimal residual disease (MRD) clearance. |
| 2026-04-19 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Four Promising Preclinical Studies Demonstrating the Potential of Combination Therapies at American Association for Cancer Research (AACR) 2026 Annual Meeting ascentage.com ↗
In a broad range of preclinical in vitro and in vivo EC models, Olverembatinib was efficacious and synergized with chemotherapy agents to promote antitumor effects. |
| 2026-03-17 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Data From Four Preclinical Studies In Its Innovative Pipeline at American Association of Cancer Research (AACR) Annual Meeting 2026 ascentage.com ↗
Multitarget kinase inhibitor olverembatinib (HQP1351) is efficacious and synergizes with chemotherapy in preclinical models of endometrial carcinoma (EC) |
| 2025-12-08 | Ascentage Pharma Group Inc. | Results ASH 2025 | Updated Data for Ascentage Pharma‘s Olverembatinib in Second-Line CML-CP Showing Encouraging Potential for Early-Line Treatment ascentage.com ↗
The latest data suggest that Olverembatinib has potential as a safe and effective new treatment option for a broader population of patients with CML-CP. |
| 2025-12-08 | Ascentage Pharma Group Inc. | Results ASH 2025 | Ascentage Pharma Presents First Dataset from Phase III POLARIS-1 Study of Olverembatinib in Newly Diagnosed Ph+ ALL Shows a Best MRD-Negativity CR Rate Exceeding 60% ascentage.com ↗
By the end of 3 induction cycles, the best minimal residual disease (MRD) negativity rate and the MRD-negative complete response (CR) rate were 66.0% and 64.2%, respectively |
| 2025-12-04 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Global Registrational Phase III Study of Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA ascentage.com ↗ |
| 2025-11-24 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Publication of Olverembatinib Phase Ib Safety, Efficacy and Novel Mechanism Data in Gastrointestinal Stromal Tumors in Nature’s Signal Transduction and Targeted Therapy ascentage.com ↗
The published results demonstrated promising efficacy and safety of olverembatinib in patients with succinate dehydrogenase (SDH) deficient GIST, a type of rare tumor, and revealed a novel mechanism through which olverembatinib exerts antitumor effects by modulating lipid metabolism. |
| 2025-11-03 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Data from Multiple Studies of Olverembatinib, Including the First Dataset from POLARIS-1 Study, at ASH 2025 ascentage.com ↗
As of the data cut-off date, 71.8% (28/39) of patients achieved a CCyR and 43.6% (17/39) MMR. |
| 2025-06-15 | Ascentage Pharma Group Inc. | Results EHA 2025 | Multiple Studies Report Encouraging Data of Olverembatinib in Ph+ ALL ascentage.com ↗
Notably, in multiple studies presented at this year’s EHA Annual Congress, the third-generation tyrosine kinase inhibitor (TKI) olverembatinib showed broad therapeutic potential and demonstrated particular clinical benefit in the treatment of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). |
| 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) |
| 2025-04-28 | 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) |
| 2025-03-05 | Ascentage Pharma Group Inc. | Regulatory Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) ascentage.com ↗
today announced that its drug, olverembatinib, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) |
| 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 | First Dataset of Olverembatinib as Second-Line Therapy in Patients with Non-T315I-Mutant CP-CML Presented in Oral Report ascentage.com ↗ |
| 2024-12-10 | Ascentage Pharma Group Inc. | Results Live from ASH 2024 | 1.5-Year Follow-Up Data from a Global Study of Olverembatinib Reaffirms Potential in Overcoming Resistance/Intolerance to Ponatinib or Asciminib ascentage.com ↗ |
| 2024-11-28 | Ascentage Pharma Group Inc. | Regulatory New Indication of Olverembatinib Included into China 2024 National Reimbursement Drug List ascentage.com ↗
This indication was added to the NRDL through the simple contract renewal process. |
| 2024-11-21 | Ascentage Pharma Group Inc. | Results Olverembatinib Surmounts Ponatinib and Asciminib Resistance and Is Well Tolerated in Patients With CML and Ph+ ALL: New Report in JAMA Oncology ascentage.com ↗ |
| 2024-09-13 | Ascentage Pharma Group Inc. | Results Live from ESMO 2024 | Ascentage Pharma Releases Latest Data Showing Sustained Clinical Efficacy of Olverembatinib in SDH-Deficient GIST during a Mini Oral Presentation ascentage.com ↗
These data of olverembatinib, presented in the Mini Oral at ESMO 2024, showed sustained clinical benefit in patients with SDH-deficient GIST. |
| 2024-07-07 | Ascentage Pharma Group Inc. | Regulatory Olverembatinib Approved for Commercialization in Macau China ascentage.com ↗
This approval marks another major milestone for olverembatinib following initial approvals granted to the drug in the Chinese mainland for the above indications. |
| 2024-06-17 | Ascentage Pharma Group Inc. | Results Live from EHA 2024 | Posters Featuring Results from Three Studies of Olverembatinib, Including Encouraging Data from US Study in CML and Ph+ ALL ascentage.com ↗
In the results, olverembatinib showed excellent durable clinical benefits and favorable long-term tolerability in patients who had been treated with multiple TKIs (including those who were resistant to ponatinib and/or asciminib), regardless of whether they harbored the T315I mutation. |
| 2024-06-10 | Ascentage Pharma Group Inc. | Regulatory Global Registrational Phase III Study of Olverembatinib for the Treatment of Patients with SDH-Deficient GIST Approved by the China CDE ascentage.com ↗
This approval marks a major milestone in Ascentage Pharma’s clinical development in solid tumors. |
| 2024-06-04 | Ascentage Pharma Group Inc. | Results Live from ASCO 2024 | Oral Report Released Latest Data of Olverembatinib in SDH-Deficient GIST, Including a CBR of 92.3% ascentage.com ↗
Among these patients, 6 achieved partial responses (PR), 18 achieved stable diseases (SD) that lasted longer than four treatment cycles, with a clinical benefit rate (CBR) of 92.3% (24/26) and a median progression-free survival (PFS) of 25.7 months. |
| 2024-04-07 | Ascentage Pharma Group Inc. | Results AACR 2024 | Ascentage Pharma Presents Results from Three Studies at 2024 American Association of Cancer Research Annual Meeting ascentage.com ↗
We are pleased to present the preclinical research data of four assets in our pipeline at the AACR 2024. |
| 2024-03-06 | Ascentage Pharma Group Inc. | Results AACR 2024 | Ascentage Pharma to Present Three Preclinical Studies at 2024 American Association of Cancer Research Annual Meeting ascentage.com ↗
Results from this preclinical study show that in SDH-deficient cancer cells, olverembatinib has superior efficacy compared to other approved tyrosine kinase inhibitors. |
| 2024-02-14 | Ascentage Pharma Group Inc. | Regulatory Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA ascentage.com ↗
The US FDA’s clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted. |
| 2023-12-15 | Ascentage Pharma Group Inc. | Results Live from ASH 2023 | Oral Report Featuring Encouraging Data of Olverembatinib Combined with Reduced-Intensity Chemotherapy in Patients with Ph+ ALL Presented at the ASH Annual Meeting ascentage.com ↗ |
| 2023-12-13 | Ascentage Pharma Group Inc. | Results Live from ASH 2023 | Results from Chinese Studies of Olverembatinib Presented in Oral Report at the ASH Annual Meeting for the Sixth Consecutive Year, Including Data Showing Promising Efficacy in Patients with TKI-Resistant and/or Intolerant CML-CP ascentage.com ↗
Moreover, olverembatinib also showed significant inhibitory activity against BCR-ABL1 compound mutations. |
| 2023-12-11 | Ascentage Pharma Group Inc. | Results Live from ASH 2023 | Ascentage Pharma Presents Updated Data from US Study of Olverembatinib, Further Validating Encouraging Efficacy in Patients Resistant to Ponatinib or Asciminib ascentage.com ↗ |
| 2023-11-17 | Ascentage Pharma Group Inc. | Regulatory Olverembatinib Approved for New Indications, Allowing More Patients with CML to Benefit from the Drug ascentage.com ↗
the China National Medical Products Administration (NMPA) has approved olverembatinib (HQP1351) for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs). |
| 2023-11-02 | Ascentage Pharma Group Inc. | Results ASH 2023 | For the Sixth Consecutive Year, Results from Multiple Clinical Studies of Olverembatinib Have Been Selected for Presentations, Including Two Oral Reports, at the 2023 ASH Annual Meeting ascentage.com ↗
These data show that, in patients with CML-CP who were resistant/intolerant to TKIs, olverembatinib demonstrated statistically significant and clinically meaningful improvement in event-free survival (EFS), compared with the best available therapy (BAT), meeting the prima |
| 2023-07-05 | Ascentage Pharma Group Inc. | Regulatory Registrational Pivotal Phase III Study of Olverembatinib for the First-Line Treatment of Patients with Ph+ ALL Approved by the CDE in China ascentage.com ↗
This approval marks a major milestone that could potentially pave the way for olverembatinib to become the first China-approved tyrosine kinase inhibitor (TKI) for the treatment of patients with Ph+ ALL in the first-line setting. |
| 2023-06-05 | Ascentage Pharma Group Inc. | Results Live from ASCO 2023 | Updated Data of Olverembatinib in SDH-Deficient GIST including a CBR of 93.8% Signals a Potential Clinical Breakthrough ascentage.com ↗
Among these results, the updated data of olverembatinib reaffirmed efficacy and safety in patients with TKI-resistant SDH-deficient GIST, with a clinical benefit rate (CBR) of 93.8%. |
| 2023-05-31 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug ascentage.com ↗ |
| 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 ↗
Our results suggest that combining olverembatinib with a checkpoint inhibitor (CPI) confers synergistic antitumor effects in an RCC cancer mouse model by targeting tumor growth, angiogenesis, and immune regulation. |
| 2023-01-18 | Ascentage Pharma Group Inc. | Regulatory Olverembatinib Included into the China 2022 NRDL ascentage.com ↗
Ascentage Pharma and Innovent Biologics today announced that the novel drug olverembatinib has been included into the China 2022 National Reimbursement Drug List（NRDL), for the treatment of T315I-mutant chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase CML (CML-AP). |
| 2022-12-14 | Ascentage Pharma Group Inc. | Results Live from ASH 2022 | Ascentage Pharma Delivers Oral Report on the First Dataset from the US Study of Olverembatinib (HQP1351) with Promising Efficacy Observed in Patients Who Failed Prior Treatment with Ponatinib ascentage.com ↗
These data showed that close to 80% patients with CML had received at least three lines of treatment, and over 50% had failed prior treatment with ponatinib. |
| 2022-12-14 | Ascentage Pharma Group Inc. | Results Live from ASH 2022 | Ascentage Pharma Delivers Oral Presentations on Chinese Studies of Olverembatinib (HQP1351) at the ASH Annual Meeting for the Fifth Year, with Data Further Validating the Drug’s Long-Term Efficacy and Safety ascentage.com ↗
These two Oral Presentations featured Phase II results and 5-year follow-up data of olverembatinib. |
| 2022-11-04 | Ascentage Pharma Group Inc. | Results ASH 2022 | Ascentage Pharma to Present Data of Olverembatinib (HQP1351) in Three Oral Reports, Including the First Dataset from the First US Study, at the ASH Annual Meeting ascentage.com ↗
These interim results suggest that olverembatinib has promising efficacy and is well tolerated in patients with drug-resistant CML and Ph+ ALL, and has shown promising efficacy in patients who were ponatinib or asciminib resistant. |
| 2022-10-09 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Phase I/II Data of Olverembatinib (HQP1351) Published in the Journal of Hematology & Oncology, Further Validating the Drug’s Best-in-Class Potential ascentage.com ↗
Results from these studies of olverembatinib were published in a paper titled “Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial” 2. |
| 2022-07-21 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Clinical Trial Application for Olverembatinib (HQP1351) Approved in Canada ascentage.com ↗ |
| 2022-07-20 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma and Innovent Announce the China NMPA Accepted and Granted Priority Review Designation to a New Drug Application for Olverembatinib for the Treatment of Drug-Resistant CML ascentage.com ↗ |
| 2022-06-06 | Ascentage Pharma Group Inc. | Results ASCO 2022 | The First Dataset of Olverembatinib (HQP1351) in Patients with GIST Demonstrates Therapeutic Potential with a Clinical Benefit Rate of 83.3% ascentage.com ↗ |
| 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 ↗ |
| 2021-12-14 | Ascentage Pharma Group Inc. | Results ASH 2021 | Ascentage Pharma Releases Long-Term Clinical Data of Olverembatinib (HQP1351) in Oral Presentation Demonstrating Efficacy and Safety ascentage.com ↗
today announced that it has released the updated data from three clinical studies of the company’s novel drug candidate, olverembatinib, at the 63rd American Society of Hematology (ASH) Annual Meeting. |
| 2021-11-30 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma and Innovent Biologics Announce Approval for China’s First Third-Generation BCR-ABL TKI Olverembatinib, Marking a Clinical Breakthrough in the Treatment of Chronic Myeloid Leukemia ascentage.com ↗ |
| 2021-11-22 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Olverembatinib Granted Orphan Designation by the European Commission for the Treatment of Chronic Myeloid Leukemia ascentage.com ↗
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the European Commission (EC) has granted the company’s novel drug candidate, olverembatinib (HQP1351), an Orphan Designation for the treatment of chronic myeloid leukemia (CML). |
| 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 ↗
FMS-like tyrosine kinase 3 (FLT3) inhibition by olverembatinib (HQP1351) downregulates MCL-1 and synergizes with BCL-2 inhibitor APG-2575 in preclinical models of FLT3-mutant acute myeloid leukemia (AML) |
| 2021-03-24 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s First Third-Generation BCR-ABL Inhibitor in China Olverembatinib (HQP1351) Recommended for Breakthrough Therapy Designation 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 Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has recommended the novel candidate drug olverembatinib (HQP1351) of Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma, for a Breakthrough Therapy Designation (BTD) for the treatment of patients with chronic-phase chronic myeloid leukemia (CP CML) resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). |
| 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 ↗
FMS-like tyrosine kinase 3 (FLT3) inhibition by olverembatinib (HQP1351) downregulates MCL-1 and synergizes with BCL-2 inhibitor APG-2575 in preclinical models of FLT3-mutant acute myeloid leukemia (AML) |
| 2020-12-08 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Positive Data from Pivotal Phase II Studies of HQP1351 (Olverembatinib) in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) at 2020 American Society of Hematology (ASH) Annual Meeting 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 reported positive data from two pivotal Phase II clinical trials of HQP1351 (olverembatinib) in an oral presentation at the 62nd ASH Annual Meeting. |
| 2020-10-21 | Ascentage Pharma Group Inc. | Regulatory Priority Review Granted to Ascentage Pharma’s New Drug Application for Olverembatinib (HQP1351), the First Third-Generation BCR-ABL Inhibitor in China ascentage.com ↗
has granted Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of the company, priority review to its New Drug Application (NDA) for Olverembatinib (HQP1351). |
| 2020-06-18 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Submits Its First New Drug Application to National Medical Products Administration, for HQP1351, the First Third-Generation BCR-ABL Inhibitor in China 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 Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma’s, has submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML). |
| 2020-05-15 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Six Abstracts at 2020 AACR Annual Meeting ascentage.com ↗
In vivo, HQP1351 single agent demonstrated significant antitumor activity evidenced by a markedly reduction of tumor burden and prolonged survival in mice. |
| 2020-05-07 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Core Drug Candidate HQP1351 Granted Fast Track Designation by the US FDA, Marking Another Milestone in Its Development ascentage.com ↗
This is the first FTD obtained by Ascentage Pharma, and it marks another milestone for HQP1351 following its recent Orphan Drug Designation by FDA. |
| 2020-05-04 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma’s Core Drug Candidate HQP1351 Granted Orphan Drug Designation by the US FDA for the Treatment of Patients with Chronic Myeloid Leukemia ascentage.com ↗
today announced that the US Food and Drug Administration (US FDA) has granted HQP1351, the Company’s core drug candidate, an Orphan Drug Designation (ODD) for the treatment of chronic myeloid leukemia (CML). |
| 2019-12-11 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Updated Data of its Novel BCR-ABL Inhibitor, HQP1351, in an Oral Presentation Nominated for “Best of ASH” ascentage.com ↗ |
| 2019-11-14 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Release Updated Data of its Novel, Third-Generation BCR-ABL Inhibitor, HQP1351, in Chinese Chronic Myeloid Leukemia Patients in an Oral Presentation at the 61st American Society of Hematology Annual Meeting ascentage.com ↗
Trial data have demonstrated that HQP1351 was well tolerated with good and durable anti-tumor activity in TKI-resistant CML patients, including those with the T315I mutation. |
| 2019-07-22 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma to Initiate Phase Ib Study of HQP1351 in Tyrosine Kinase Inhibitors -resistant Chronic Myeloid Leukemia Patients in the US ascentage.com ↗
HQP1351 is the sixth molecule to receive clearance of IND from the FDA for Ascentage Pharma. |
| 2018-12-03 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Oral Presentation of Novel, Third-Generation BCR-ABL Inhibitor in Myelogenous Leukemia Patients at the 60th American Society of Hematology Annual Meeting ascentage.com ↗
Ascentage Pharma, a clinical-stage biopharmaceutical company dedicated to the development of novel therapies for the treatment of cancers, hepatitis B and aging-related diseases, today announced data from a Phase 1 clinical study of its novel BCR-ABL inhibitor, HQP1351, in patients with Tyrosine Kinase Inhibitor (TKI)-refractory chronic myelogenous leukemia (CML) at the 60th American Society of Hematology (ASH) Annual Meeting. |
All press releases naming this drug 76 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | olverembatinib | “Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label,...” PMID 35982483 ↗ Aug 202231“Doses are halved/reduced per protocol: Flumatinib 400/200 mg QD, Imatinib 200 mg QD, Nilotinib 300 mg QD, Dasatinib 50 mg QD, or Olverembatinib 20 mg QD, based on pre-entry therapy.” NCT07839988 ↗ “Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia” PMID 35982483 ↗ Aug 2022 |
| Known as | [14C] HQP1351 | “A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C] HQP1351 After a Single Oral 30mg (100µCi) Dose in...” NCT04126707 ↗ |
| Known as | D-824 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582 ↗ |
| Known as | D-824 DIMESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582 ↗ |
| Known as | GZD-824 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582 ↗ |
| Known as | GZD-824 DIMESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582 ↗ |
| Known as | HQP-1351 DIMESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582 ↗ |
| Known as | HQP1351 | “This phase II trial studies how well the combination of based decitabine and olverembatinib（HQP1351)chemotherapy work for the treatment of blast phase or accelerated phase...” NCT05376852 ↗8“Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label,...” PMID 35982483 ↗ Aug 2022 “Study of Olverembatinib (HQP1351) in Patients With CML-CP” NCT06423911 ↗ “Named Patient Program for Olverembatinib (HQP1351)” NCT05594758 ↗ |
| Known as | Olverembatinib dimesylate | “HQP1351( Olverembatinib dimesylate)” NCT05604755 ↗ |
| Known as | OVB | “All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.” NCT07152041 ↗ |
| Action | Inhibit | “Olverembatinib is a new potent BCR-ABL1 TKI” PMID 35982483 ↗ Aug 2022 |
| Modality | Small molecule | “Olverembatinib is a new potent BCR-ABL1 TKI” PMID 35982483 ↗ Aug 2022 |
| Route | Oral | “HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.” NCT03594422 ↗ |
| Target | ABL1 | “Olverembatinib is a new potent BCR-ABL1 TKI with preclinical activity against T315I-mutated CML.” PMID 35982483 ↗ Aug 2022 |