HQP1351

Overview

HQP1351 is under investigation in clinical trial NCT03883100 (A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation).

Indication

用于治疗任何酪氨酸激酶抑制剂耐药，并采用经充分验证的检测方法诊断为伴有T315I突变的慢性髓细胞白血病慢性期或加速期的成年患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase	2025/02/10	NCT06817720	Phase 2	Not yet recruiting	M.D. Anderson Cancer Center
Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML	2025/01/03	NCT06757855	Phase 1	Recruiting	Institute of Hematology & Blood Diseases Hospital, China
Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL	2024/12/31	NCT06754267	Phase 2	Recruiting	First Affiliated Hospital of Zhejiang University
Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL	2024/10/26	NCT06658925	Phase 2	Not yet recruiting	Institute of Hematology & Blood Diseases Hospital, China
A Study of Olverembatinib in SDH-deficient GIST.	2024/10/15	NCT06640361	Phase 3	Recruiting	Ascentage Pharma Group Inc.
Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL	2024/07/01	NCT06481228	Not Applicable	Not yet recruiting	Institute of Hematology & Blood Diseases Hospital, China
Study of Olverembatinib (HQP1351) in Patients With CP-CML	2024/05/21	NCT06423911	Phase 3	Recruiting	Ascentage Pharma Group Inc.
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia	2024/05/06	NCT06401603	Phase 1	Recruiting	M.D. Anderson Cancer Center
The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP	2024/04/30	NCT06390306	N/A	Recruiting	Peking University People's Hospital
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia	2023/10/13	NCT06082934	Phase 1	Recruiting	Xijing Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Olverembatinib Tablets	广州顺健生物医药科技有限公司	国药准字H20210048	化学药品	片剂	11/24/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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