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Details:
HQP1351 (olverembatinib) is a third-generation BCR-ABL inhibitor. It is being developed for the treatment of previously treated adult patients with chronic-phase chronic myeloid leukemia (CML-CP).
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2024
Details:
HQP1351 (olverembatinib), a novel, small-molecule, orally administered 3G BCR-ABL1 inhibitor, received breakthrough therapy designation by NMPA for olverembatinib for the treatment of patients with naïve philadelphia chromosome-positive acute lymphoblastic leukemia.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351AG301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2023
Details:
HQP1351 (olverembatinib), a novel, small-molecule, orally administered 3G BCR-ABL1 inhibitor, received breakthrough therapy designation by NMPA for olverembatinib for the treatment of patients with naïve philadelphia chromosome-positive acute lymphoblastic leukemia.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Shenzhen Second People's Hospital
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2023
Details:
HQP1351 (olverembatinib) is a novel, small-molecule, orally administered 3G BCR-ABL1 inhibitor and received Breakthrough Therapy Designation by NMPA for Olverembatinib for the treatment of patients with SDH-deficient gastrointestinal stromal tumor.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ascentage Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2023
Details:
HQP1351 (olverembatinib), a third-generation BCR-ABL inhibitor received Breakthrough Therapy Designation (BTD) for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2023
Details:
HQP1351 (olverembatinib) is a novel, small-molecule, orally administered 3G BCR-ABL1 inhibitor. It was approved in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP).
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2023
Details:
HQP1351 (olverembatinib) demonstrated favorable tolerability and durable efficacy. Olverembatinib was highly active against BCR-ABL1T315I mutants and had encouraging clinical activity against compound mutations for which no treatment option is available as of now.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
HQP1351 (olverembatinib), the first and only drug approved for the treatment of chronic myeloid leukemia who are resistant and/or intolerant of first- and second-generation tyrosine kinase inhibitors (TKIs).
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2022
Details:
HQP1351 (olverembatinib) is a novel third-generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation, for the treatment of patients with CML intolerant/resistant to at least two TKIs).
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tanner Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
In November 2021, HQP1351 (olverembatinib) received its first approval in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) harbouring the T315I mutation.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2022
Details:
Orally active, third-generation BCR-ABL inhibitor HQP1351 (olverembatinib) is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant CML, can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ascentage Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
HQP1351 (olverembatinib) is a novel drug developed by Ascentage Pharma and recently received approval in China for the treatment of adult patients with TKI-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
HQP1351 (olverembatinib) was well tolerated and showed antitumor activity in patients with TKI-resistant SDH-deficient GIST. These promising findings warrant further investigation.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
HQP1351 (olverembatinib) inhibited a panel of the Omicron-NTD-mediated cytokines tested, with a EC50 between 7.7 and 56 nM, demonstrating a wider range of concentrations than that of baricitinib.
Lead Product(s): Olverembatinib
Therapeutic Area: Infections and Infectious Diseases Product Name: HQP1351
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
Promising antitumor activity of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor- (TKI-) resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST).
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Olverembatinib is a novel drug developed by Ascentage Pharma and recently received approval in November 2021 in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2021
Details:
Olverembatinib is a novel third-generation BCR-ABL TKI developed by Ascentage Pharma for the treatment of patients with CML resistant to first- and second-generation TKIs, including those harboring the T315I mutation.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
HQP1351 (Olverembatinib) is a novel third-generation BCR-ABL TKI developed by Ascentage for the treatment of chronic myeloid leukemia resistant to first- & second-generation TKIs, including those with the T315I mutation, which confers resistance against these agents.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2021
Details:
This collaboration includes the joint clinical development and commercialization of HQP1351in China; clinical development of Ascentage Pharma's APG-2575 in combination with HALPRYZA® co-developed by Innovent and Eli Lilly and Innovent's letaplimab monoclonal antibody.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: $245.0 million Upfront Cash: $30.0 million
Deal Type: Collaboration July 14, 2021
Details:
Olverembatinib is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2021
Details:
Ascentage Pharma has submitted the company's first New Drug Application (NDA) for HQP1351 (olverembatinib) in China, which was subsequently granted Priority Review status, marking another step forward in Ascentage Pharma's transition from clinical-stage to commercialization.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
The results that will be released through the oral presentation are from the two pivotal Phase II trials of HQP1351 in patients with TKI-resistant and T315I-mutant CML. Results from those two trials of HQP1351 have shown favorable efficacy and tolerability.
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) 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).
Lead Product(s): Olverembatinib
Therapeutic Area: Oncology Product Name: HQP1351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
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