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Chemistry

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Also known as: Sunvozertinib [inn], L1q2k5jyo8, 2370013-12-8, Dzd9008, 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)-, Unii-l1q2k5jyo8
Molecular Formula
C29H35ClFN7O3
Molecular Weight
584.1  g/mol
InChI Key
BTMKEDDEMKKSEF-QGZVFWFLSA-N
FDA UNII
L1Q2K5JYO8

Sunvozertinib
Sunvozertinib is an orally available, irreversible, dual kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) that shows similar activity against certain activating mutations, including exon 20 insertions (exon20ins), with potential antineoplastic activity. Upon oral administration,sunvozertinib binds to and inhibits EGFR and HER2, which may result in the inhibition of tumor growth and angiogenesis, and tumor regression in EGFR/HER2-expressing tumors. EGFR and HER2 are receptor tyrosine kinases that play major roles in tumor cell proliferation and tumor vascularization. In contrast to other agents active against exon20ins mutations, sunvozertinib appears to be more selective against mutated EGFR than wild-type (wt) EGFR. This may lessen wtEGFR-related dose-limiting toxicity and may allow for the administration of the desired therapeutic dose of sunvozertinib.
1 2D Structure

Sunvozertinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C29H35ClFN7O3/c1-7-27(39)34-22-14-23(25(41-6)15-24(22)38-11-9-17(16-38)37(4)5)35-28-32-10-8-26(36-28)33-21-13-19(30)20(31)12-18(21)29(2,3)40/h7-8,10,12-15,17,40H,1,9,11,16H2,2-6H3,(H,34,39)(H2,32,33,35,36)/t17-/m1/s1
2.1.3 InChI Key
BTMKEDDEMKKSEF-QGZVFWFLSA-N
2.1.4 Canonical SMILES
CC(C)(C1=CC(=C(C=C1NC2=NC(=NC=C2)NC3=C(C=C(C(=C3)NC(=O)C=C)N4CCC(C4)N(C)C)OC)Cl)F)O
2.1.5 Isomeric SMILES
CC(C)(C1=CC(=C(C=C1NC2=NC(=NC=C2)NC3=C(C=C(C(=C3)NC(=O)C=C)N4CC[C@H](C4)N(C)C)OC)Cl)F)O
2.2 Other Identifiers
2.2.1 UNII
L1Q2K5JYO8
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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

2.4 Create Date
2019-11-02
3 Chemical and Physical Properties
Molecular Weight 584.1 g/mol
Molecular Formula C29H35ClFN7O3
XLogP35
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count10
Rotatable Bond Count10
Exact Mass583.2473939 g/mol
Monoisotopic Mass583.2473939 g/mol
Topological Polar Surface Area115 Ų
Heavy Atom Count41
Formal Charge0
Complexity885
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

Drugs in Development

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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

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01

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

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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

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02

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

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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

blank

03

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

blank

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

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04

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

blank

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

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05

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

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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

blank

06

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

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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

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07

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

blank

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

blank

08

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

blank

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

blank

09

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

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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

blank

10

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

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

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ABOUT THIS PAGE

Sunvozertinib Manufacturers

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.

Sunvozertinib Suppliers

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 GMP

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.

Sunvozertinib CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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