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1. 2-propenamide, N-(5-((4-(4-((dimethylamino)methyl)-3-phenyl-1h-pyrazol-1-yl)-2-pyrimidinyl)amino)-4-methoxy-2-(4-morpholinyl)phenyl)-
2. Leclaza
3. N-(5-((4-(4-((dimethylamino)methyl)-3-phenyl-1h-pyrazol-1-yl)-2-pyrimidinyl)amino)-4-methoxy-2-(4-morpholinyl)phenyl)acrylamide
1. 1903008-80-9
2. Yh-25448
3. Gns-1480
4. Yh25448
5. Gns1480
6. Jnj-73841937-aaa
7. Lazertinib [usan]
8. C-18112003-g
9. N-[5-[[4-[4-[(dimethylamino)methyl]-3-phenylpyrazol-1-yl]pyrimidin-2-yl]amino]-4-methoxy-2-morpholin-4-ylphenyl]prop-2-enamide
10. 4a2y23xk11
11. N-(5-((4-(4-((dimethylamino)methyl)-3-phenyl-1h-pyrazol-1-yl)pyrimidin-2-yl)amino)-4-methoxy-2-morpholinophenyl)acrylamide
12. 2-propenamide, N-(5-((4-(4-((dimethylamino)methyl)-3-phenyl-1h-pyrazol-1-yl)-2-pyrimidinyl)amino)-4-methoxy-2-(4-morpholinyl)phenyl)-
13. Leclaza
14. Lazertinib [inn]
15. Lazertinib [inn]
16. Lazertinib (yh25448)
17. Lazertinib [who-dd]
18. Unii-4a2y23xk11
19. Chembl4558324
20. Schembl17670400
21. Gtpl10136
22. Bcp30440
23. Ex-a1912
24. Bdbm50555575
25. S8724
26. Who 10587
27. Akos037515597
28. Ccg-270023
29. Lazertinib (yh25448,gns-1480)
30. Yh-25448;gns-1480
31. Ac-36243
32. Bs-15742
33. Compound 73 [wo2016060443a2]
34. Hy-109061
35. Cs-0032992
36. A16827
37. A903188
38. Yh-25448; Yh 25448; Yh25448; Gns-1480; Gns 1480; Gns1480
39. N-(5-((4-(4-((dimethylamino)methyl)-3-phenyl-1h-pyrazol-1-yl)-2-pyrimidinyl)amino)-4-methoxy-2-(4-morpholinyl)phenyl)acrylamide
40. N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1h-pyrazol-1-yl)pyrimidin-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide
Molecular Weight | 554.6 g/mol |
---|---|
Molecular Formula | C30H34N8O3 |
XLogP3 | 3.4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 10 |
Exact Mass | 554.27538698 g/mol |
Monoisotopic Mass | 554.27538698 g/mol |
Topological Polar Surface Area | 110 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 837 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
Registrant Name : Yuhan Chemical Co., Ltd.
Registration Date : 2021-01-18
Registration Number : 1791-9-ND
Manufacturer Name : Yuhan Chemical Co., Ltd.
Manufacturer Address : 402, 5-ba, Sihwa Industrial Complex, 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (S...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is indicated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Lead Product(s): Amivantamab,Lazertinib,Dexamethasone
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2024
Lead Product(s) : Amivantamab,Lazertinib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
CHMP Recommends RYBREVANT® and LAZCLUZE® for EGFR-Mutated Lung Cancer
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is indicated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 15, 2024
Details:
Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) and dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non-small cell lung cancer.
Lead Product(s): Amivantamab,Lazertinib,Dexamethasone
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2024
Lead Product(s) : Amivantamab,Lazertinib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dexamethasone Reduces Infusion Reactions in EGFR-Mutated NSCLC Patients On RYBREVANT®
Details : Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) and dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non-small cell lung cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 10, 2024
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is indicated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Lead Product(s): Amivantamab,Lazertinib,Dexamethasone
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 20, 2024
Lead Product(s) : Amivantamab,Lazertinib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
J&J's Chemotherapy-Free Treatment for Lung Cancer Gets US Approval
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is indicated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 20, 2024
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2024
Lead Product(s) : Amivantamab,Lazertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amivantamab BLA Submitted to FDA for EGFR-Mutated Non-Small Cell Lung Cancer
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 17, 2024
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of exon 19 deletions or L858R mutated NSCLC.
Lead Product(s): Amivantamab,Lazertinib,Carboplatin
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2024
Lead Product(s) : Amivantamab,Lazertinib,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
PALOMA-2 Shows Positive Results for Subcutaneous RYBREVANT® in EGFR-Mutated NSCLC
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of exon 19 deletions or L858R mutated NSCLC.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 03, 2024
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2024
Lead Product(s) : Amivantamab,Lazertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Phase 3 PALOMA-3 Shows Five-Fold Reduction in Reactions with Amivantamab Injection
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 31, 2024
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of EGFR-mutated NSCLC after failure of prior therapy.
Lead Product(s): Amivantamab,Lazertinib,Carboplatin
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2024
Lead Product(s) : Amivantamab,Lazertinib,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
RYBREVANT® Plus Lazertinib Shows Longer PFS vs. Osimertinib in High-Risk NSCLC
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib for the treatment of EGFR-mutated NSCLC after failure of prior therapy.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 31, 2024
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody evaluated with lazertinib for first-line treatment of patients with EGFR-mutated non-small cell lung cancer.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2024
Lead Product(s) : Amivantamab,Lazertinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Janssen Submits Type II Extension for RYBREVANT and Lazertinib
Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody evaluated with lazertinib for first-line treatment of patients with EGFR-mutated non-small cell lung cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 08, 2024
Details:
JNJ-73841937 (lazertinib) is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation. It is under phase 3 clinical development in combination with Rybrevant (amivantamab) for the treatment of EGFR-mutated non-small cell lung cancer.
Lead Product(s): Lazertinib,Amivantamab-vmjw
Therapeutic Area: Oncology Brand Name: JNJ-73841937
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Lead Product(s) : Lazertinib,Amivantamab-vmjw
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : JNJ-73841937 (lazertinib) is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation. It is under phase 3 clinical development in combination with Rybrevant (amivantamab) for the treatment of EGFR-mutated non-small cell l...
Brand Name : JNJ-73841937
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 21, 2023
Details:
Rybrevant (amivantamab) is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity. It is being evaluated in combination with lazertinib for the treatment of patients with EGFR-mutated non-small cell lung cancer.
Lead Product(s): Amivantamab,Lazertinib,Carboplatin
Therapeutic Area: Oncology Brand Name: Rybrevant
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Lead Product(s) : Amivantamab,Lazertinib,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Rybrevant (amivantamab) is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity. It is being evaluated in combination with lazertinib for the treatment of patients with EGFR-mutated non-small cell lung cancer.
Brand Name : Rybrevant
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 21, 2023
ABOUT THIS PAGE
A Lazertinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lazertinib, including repackagers and relabelers. The FDA regulates Lazertinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lazertinib 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 Lazertinib supplier is an individual or a company that provides Lazertinib active pharmaceutical ingredient (API) or Lazertinib finished formulations upon request. The Lazertinib suppliers may include Lazertinib API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Lazertinib Drug Master File in Korea (Lazertinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lazertinib. The MFDS reviews the Lazertinib KDMF as part of the drug registration process and uses the information provided in the Lazertinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lazertinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lazertinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lazertinib suppliers with KDMF on PharmaCompass.
Lazertinib 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 Lazertinib 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 Lazertinib GMP manufacturer or Lazertinib GMP API supplier for your needs.
A Lazertinib CoA (Certificate of Analysis) is a formal document that attests to Lazertinib's compliance with Lazertinib specifications and serves as a tool for batch-level quality control.
Lazertinib CoA mostly includes findings from lab analyses of a specific batch. For each Lazertinib 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.
Lazertinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Lazertinib EP), Lazertinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lazertinib USP).
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