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1. Sunvozertinib [inn]
2. L1q2k5jyo8
3. 2370013-12-8
4. Dzd9008
5. 2-propenamide, N-(5-((4-((5-chloro-4-fluoro-2-(1-hydroxy-1-methylethyl)phenyl)amino)-2-pyrimidinyl)amino)-2-((3r)-3-(dimethylamino)-1-pyrrolidinyl)-4-methoxyphenyl)-
6. Unii-l1q2k5jyo8
7. Schembl21232131
8. Gtpl11672
9. Glxc-25829
10. Ex-a6612
11. Example 52 [wo2019149164a1]
12. Hy-132842
13. Cs-0204146
14. N-[5-[[4-[5-chloro-4-fluoro-2-(2-hydroxypropan-2-yl)anilino]pyrimidin-2-yl]amino]-2-[(3r)-3-(dimethylamino)pyrrolidin-1-yl]-4-methoxyphenyl]prop-2-enamide
Molecular Weight | 584.1 g/mol |
---|---|
Molecular Formula | C29H35ClFN7O3 |
XLogP3 | 5 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 10 |
Exact Mass | 583.2473939 g/mol |
Monoisotopic Mass | 583.2473939 g/mol |
Topological Polar Surface Area | 115 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 885 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Details:
DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2024
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dizal Submits NDA to FDA for Sunvozertinib in Treating NSCLC with EGFR
Details : DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 08, 2024
Details:
DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is indicated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Burning Rock Dx
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2024
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Burning Rock Dx
Deal Size : Not Applicable
Deal Type : Not Applicable
NMPA Grants Approval For NGS-Based Companion Diagnostic For Lung Cancer
Details : DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is indicated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 10, 2024
Details:
DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2024
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
WU-KONG1B Study Shows Sunvozertinib Efficacy in EGFR Exon 20 NSCLC
Details : DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 16, 2024
Details:
DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2024
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sunvozertinib Meets Primary Endpoint in NSCLC with EGFR Exon 20 Insertions
Details : DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 02, 2024
Details:
DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2024
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dizal Highlights Sunvozertinib's Efficacy for Lung Cancer with EGFR Exon 20 Mutations
Details : DZD9008 (sunvozertinib) is an oral, potent, irreversible, & selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic NSCLC.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 24, 2024
Details:
DZD9008 (sunvozertinib), an EGFR tyrosine kinase inhibitor, is being studied for Exon20ins-mutated advanced non-small cell lung cancer.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2024
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Grants Breakthrough Designation to Sunvozertinib for NSCLC Treatment
Details : DZD9008 (sunvozertinib), an EGFR tyrosine kinase inhibitor, is being studied for Exon20ins-mutated advanced non-small cell lung cancer.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 07, 2024
Details:
The partnership aims to accelerate the development of DZD9008 (sunvozertinib), an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity, for patients with EGFR Exon20ins mutant NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Dizal Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 06, 2023
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Dizal Pharmaceutical
Deal Size : Undisclosed
Deal Type : Partnership
Details : The partnership aims to accelerate the development of DZD9008 (sunvozertinib), an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity, for patients with EGFR Exon20ins mut...
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 06, 2023
Details:
DZD9008 (sunvozertinib) is an investigational, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon20 insertion (exon20ins) mutations for the treatment of advanced NSCLC.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2023
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DZD9008 (sunvozertinib) is an investigational, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon20 insertion (exon20ins) mutations for the treatment of advanced NSCLC.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 10, 2023
Details:
DZD9008 (sunvozertinib) also demonstrated a favorable safety profile, Of all 277 patients in the safety set, the most common treatment-related adverse events were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DZD9008 (sunvozertinib) also demonstrated a favorable safety profile, Of all 277 patients in the safety set, the most common treatment-related adverse events were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 05, 2022
Details:
Updated findings from the studies, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%. In patients with baseline brain metastasis, the best ORR at 300 mg QD reached 44%.
Lead Product(s): Sunvozertinib
Therapeutic Area: Oncology Brand Name: DZD9008
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2022
Lead Product(s) : Sunvozertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Updated findings from the studies, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%. In patients with baseline brain metastasis, the best ORR at 300 mg QD re...
Brand Name : DZD9008
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 05, 2022
ABOUT THIS PAGE
A Sunvozertinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunvozertinib, including repackagers and relabelers. The FDA regulates Sunvozertinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunvozertinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Sunvozertinib supplier is an individual or a company that provides Sunvozertinib active pharmaceutical ingredient (API) or Sunvozertinib finished formulations upon request. The Sunvozertinib suppliers may include Sunvozertinib API manufacturers, exporters, distributors and traders.
Sunvozertinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Sunvozertinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sunvozertinib GMP manufacturer or Sunvozertinib GMP API supplier for your needs.
A Sunvozertinib CoA (Certificate of Analysis) is a formal document that attests to Sunvozertinib's compliance with Sunvozertinib specifications and serves as a tool for batch-level quality control.
Sunvozertinib CoA mostly includes findings from lab analyses of a specific batch. For each Sunvozertinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Sunvozertinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Sunvozertinib EP), Sunvozertinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sunvozertinib USP).
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