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Weekly News Recap #Phispers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...
About the Company : Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We...
About the Company : The last few years have seen dramatic growth in outsourcing to India in all areas of technology. The trend has been particularly noticeable in the pharmaceuticals sector. Leading p...
About the Company : KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services...
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
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Details:
Perjeta (pertuzumab) is approved for use in combination with Herceptin and chemotherapy in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Docetaxel
Therapeutic Area: Oncology Brand Name: Perjeta
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2025
Lead Product(s) : Pertuzumab,Trastuzumab,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
APHINITY 10-Year Data Show Perjeta Regimen Cuts Death Risk by 17% in HER2+
Details : Perjeta (pertuzumab) is approved for use in combination with Herceptin and chemotherapy in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer.
Product Name : Perjeta
Product Type : Antibody
Upfront Cash : Inapplicable
May 13, 2025
Details:
Enhertu (trastuzumab deruxtecan) is a HER2-directed antibody and topoisomerase inhibitor, being investigated for high-risk, locally advanced HER2 positive early-stage breast cancer. conjugate
Lead Product(s): Trastuzumab Deruxtecan,Paclitaxel,Trastuzumab
Therapeutic Area: Oncology Brand Name: Enhertu
Study Phase: Phase IIIProduct Type: Antibody-drug Conjugate
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 07, 2025
Lead Product(s) : Trastuzumab Deruxtecan,Paclitaxel,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ENHERTU Plus THP Shows Benefit in High-Risk HER2+ Breast Cancer Trial
Details : Enhertu (trastuzumab deruxtecan) is a HER2-directed antibody and topoisomerase inhibitor, being investigated for high-risk, locally advanced HER2 positive early-stage breast cancer. conjugate
Product Name : Enhertu
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
May 07, 2025
Details:
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists and hyaluronidase, an endoglycosidase, indicated for HER2-positive breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area: Oncology Brand Name: Phesgo
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 30, 2025
Lead Product(s) : Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CHMP Supports EU Label Update for Phesgo for Out-of-Clinic Use
Details : PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists and hyaluronidase, an endoglycosidase, indicated for HER2-positive breast cancer.
Product Name : Phesgo
Product Type : Antibody
Upfront Cash : Inapplicable
April 30, 2025
Details:
Dazublys is a trastuzumab biosimilar (HER2 inhibitor), indicated for the treatment of HER2-positive metastatic and early breast cancers.
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Brand Name: Dazublys
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2025
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CuraTeQ Biologics Receives Positive Opinion for Biosimilar Dazublys from EMA
Details : Dazublys is a trastuzumab biosimilar (HER2 inhibitor), indicated for the treatment of HER2-positive metastatic and early breast cancers.
Product Name : Dazublys
Product Type : Antibody
Upfront Cash : Inapplicable
April 28, 2025
Details:
HLX11 (pertuzumab) is a HER2/neu receptor antagonist indicated in combination with rastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Docetaxel
Therapeutic Area: Oncology Brand Name: HLX11
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2025
Lead Product(s) : Pertuzumab,Trastuzumab,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Validates Henlius and Organon Filing for Perjeta Biosimilar HLX11
Details : HLX11 (pertuzumab) is a HER2/neu receptor antagonist indicated in combination with rastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer.
Product Name : HLX11
Product Type : Antibody
Upfront Cash : Inapplicable
March 28, 2025
Details:
HLX22 is a recombinant humanized Anti-HER2 mAb, being investigated in combination with SoC for HER2-positive advanced gastric/gastroesophageal junction cancer.
Lead Product(s): HLX22,Oxaliplatin,Trastuzumab
Therapeutic Area: Oncology Brand Name: HLX22
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 20, 2025
Lead Product(s) : HLX22,Oxaliplatin,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alligator Bioscience Gets FDA Orphan Drug Status for HLX22 in Gastric Cancer
Details : HLX22 is a recombinant humanized Anti-HER2 mAb, being investigated in combination with SoC for HER2-positive advanced gastric/gastroesophageal junction cancer.
Product Name : HLX22
Product Type : Antibody
Upfront Cash : Inapplicable
March 20, 2025
Details:
HLX22 is a recombinant humanized Anti-HER2 mAb, being investigated in combination with SoC for HER2-positive advanced gastric/gastroesophageal junction cancer.
Lead Product(s): HLX22,Oxaliplatin,Trastuzumab
Therapeutic Area: Oncology Brand Name: HLX22
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 19, 2025
Lead Product(s) : HLX22,Oxaliplatin,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Henlius Wins Orphan Drug Status for Anti-HER2 HLX22 in Gastric Cancer
Details : HLX22 is a recombinant humanized Anti-HER2 mAb, being investigated in combination with SoC for HER2-positive advanced gastric/gastroesophageal junction cancer.
Product Name : HLX22
Product Type : Antibody
Upfront Cash : Inapplicable
March 19, 2025
Details:
ALX148 (evorpacept) is a next generation CD47 blocker, which is being investigated in combination with trastuzumab in patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.
Lead Product(s): Evorpacept,Ramucirumab,Trastuzumab
Therapeutic Area: Oncology Brand Name: ALX148
Study Phase: Phase II/ Phase IIIProduct Type: Protein
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 23, 2025
Lead Product(s) : Evorpacept,Ramucirumab,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ALX Presents Updated Data from ASPEN-06 Phase 2 Trial in HER2-Positive Gastric Cancer
Details : ALX148 (evorpacept) is a next generation CD47 blocker, which is being investigated in combination with trastuzumab in patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.
Product Name : ALX148
Product Type : Protein
Upfront Cash : Inapplicable
January 23, 2025
Details:
HLX22 is a recombinant humanized Anti-HER2 mAb, being investigated in combination with SoC for HER2-positive advanced gastric/gastroesophageal junction cancer.
Lead Product(s): HLX22,Oxaliplatin,Trastuzumab
Therapeutic Area: Oncology Brand Name: HLX22
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Alligator Bioscience
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024
Lead Product(s) : HLX22,Oxaliplatin,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Alligator Bioscience
Deal Size : Inapplicable
Deal Type : Inapplicable
Alligator Doses First Patient in Shanghai Henlius Biotech Phase 3 Clinical Trial
Details : HLX22 is a recombinant humanized Anti-HER2 mAb, being investigated in combination with SoC for HER2-positive advanced gastric/gastroesophageal junction cancer.
Product Name : HLX22
Product Type : Antibody
Upfront Cash : Inapplicable
December 04, 2024
Details:
BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors.
Lead Product(s): BBO-10203,Trastuzumab
Therapeutic Area: Oncology Brand Name: BBO-10203
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 30, 2024
Lead Product(s) : BBO-10203,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BridgeBio Doses First Patient with BBO-10203 in Phase 1 BREAKER-101 Trial
Details : BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors.
Product Name : BBO-10203
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 30, 2024
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : KANJINTI
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 150MG/VIAL
Packaging :
Approval Date :
Application Number : 2518244
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HERZUMA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 150MG/VIAL
Packaging :
Approval Date :
Application Number : 2506211
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HERZUMA
Dosage Form : KIT
Dosage Strength : 440MG/VIAL
Packaging :
Approval Date :
Application Number : 2480794
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PERJETA-HERCEPTIN
Dosage Form : SOLUTION
Dosage Strength : 440MG/VIAL
Packaging : 14ML & 20ML
Approval Date :
Application Number : 2405024
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HERCEPTIN SC
Dosage Form : SOLUTION
Dosage Strength : 600MG/5ML
Packaging :
Approval Date :
Application Number : 2480697
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PHESGO
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging :
Approval Date :
Application Number : 2512912
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PHESGO
Dosage Form : SOLUTION
Dosage Strength : 60MG/ML
Packaging :
Approval Date :
Application Number : 2512920
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRAZIMERA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 440MG/VIAL
Packaging :
Approval Date :
Application Number : 2483467
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRAZIMERA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 150MG/VIAL
Packaging :
Approval Date :
Application Number : 2483475
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ONTRUZANT
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 150MG/VIAL
Packaging :
Approval Date :
Application Number : 2524317
Regulatory Info : Prescription
Registration Country : Canada
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