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Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-245
Address of the Firm : Plot No. 11/1,Marvasodo, Usgao...
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-245
Address of the Firm : Plot No. 11/1,Marvasodo, Usgao...
Registrant Name : Korea Organon Co., Ltd.
Registration Date : 2022-01-05
Registration Number : 20220105-209-J-1194
Manufacturer Name : MSD International GmbH T/A MSD...
Manufacturer Address : Kilsheelan, Clonmel, Co. Tipperary, Ireland
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2005-07-28
Registration Number : No. 906-4-ND
Manufacturer Name : MSD International GmbH (Puerto...
Manufacturer Address : Road #2, Kilometer 56.7, Barceloneta, PR 00617
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2014-06-24
Registration Number : Su3281-14-ND
Manufacturer Name : MSD International GmbH
Manufacturer Address : 50 Tuas West Drive Singapore 638408
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2012-12-28
Registration Number : 20121228-179-I-98-03
Manufacturer Name : Schering-Plough (Avondale) Com...
Manufacturer Address : Rathdrum, County Wicklow
Registrant Name : Korea Organon Co., Ltd.
Registration Date : 2020-04-02
Registration Number : 20200402-179-I-602-04
Manufacturer Name : MSD International GmbH(Singapo...
Manufacturer Address : 50 Tuas West Drive Singapore 638408@Polígono Malpica Calle J No. 3-450016 Zaragoza S...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-04-09
Registration Number : 20160429-180-I-461-02(1)
Manufacturer Name : Saurav Chemicals Limited@[Keto...
Manufacturer Address : Village Bhagwanpura, Barwala Road, Derabassi, District Sahibzada Ajit Shigh Nagar, Pu...
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2019-11-22
Registration Number : Su90-29-ND
Manufacturer Name : MSD International GmbH
Manufacturer Address : Ballydine, Kilsheelan, Co. Tipperary, Ireland
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2016-10-14
Registration Number : Su90-17-ND
Manufacturer Name : MSD International GmbH
Manufacturer Address : Ballydine, Kilsheelan, Co. Tipperary, Ireland
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2020-12-11
Registration Number : 20201211-210-J-798
Manufacturer Name : Cherokee Pharmaceuticals LLC
Manufacturer Address : 100 Avenue C Riverside, PA 17868 USA
Registrant Name : Korea Organon Co., Ltd.
Registration Date : 2003-10-19
Registration Number : 906-2-ND
Manufacturer Name : MSD International GmbH (Singap...
Manufacturer Address : 50 Tuas West Drive Singapore 638408
Details:
Keytruda (pembrolizumab), anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1.
Lead Product(s): Pembrolizumab,Paclitaxel,Bevacizumab
Therapeutic Area: Oncology Brand Name: Keytruda
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 15, 2025
Lead Product(s) : Pembrolizumab,Paclitaxel,Bevacizumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Merck’s KEYNOTE-B96 Hits PFS Goal in PD-L1+ Ovarian Cancer Phase 3 Trial
Details : Keytruda (pembrolizumab), anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1.
Product Name : Keytruda
Product Type : Antibody
Upfront Cash : Inapplicable
May 15, 2025
Details:
Welireg (belzutifan) is first and only HIF-2α inhibitor, being investigated for the treatment of 12 years and older with advanced, unresectable pheochromocytoma and paraganglioma (PPGL).
Lead Product(s): Belzutifan
Therapeutic Area: Oncology Brand Name: Welireg
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 14, 2025
Lead Product(s) : Belzutifan
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Clears Merck’s WELIREG for Adults and Teens with Advanced PPGL
Details : Welireg (belzutifan) is first and only HIF-2α inhibitor, being investigated for the treatment of 12 years and older with advanced, unresectable pheochromocytoma and paraganglioma (PPGL).
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 14, 2025
Details:
Under the licensing agreement, MSD will acquire global rights to Cyprumed's platform for developing oral formulations of its peptide therapies.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Peptide
Recipient: Cyprumed
Deal Size: $493.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 15, 2025
Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Recipient : Cyprumed
Deal Size : $493.0 million
Deal Type : Licensing Agreement
Merck Links up with Cyprumed in $493M Oral Peptide Deal
Details : Under the licensing agreement, MSD will acquire global rights to Cyprumed's platform for developing oral formulations of its peptide therapies.
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Undisclosed
April 15, 2025
Details:
Through this acquisition, Organon enhances and broadens its U.S. biosimilars portfolio, gaining commercial rights in the US for tofidence (tocilizumab), an intravenous biosimilar to actemra.
Lead Product(s): Tocilizumab
Therapeutic Area: Immunology Brand Name: Tofidence
Study Phase: Approved FDFProduct Type: Antibody
Recipient: Biogen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 01, 2025
Lead Product(s) : Tocilizumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Recipient : Biogen
Deal Size : Undisclosed
Deal Type : Acquisition
Organon Acquires Tofidenc, A Commercialized Biosimilar to Actemr in U.S
Details : Through this acquisition, Organon enhances and broadens its U.S. biosimilars portfolio, gaining commercial rights in the US for tofidence (tocilizumab), an intravenous biosimilar to actemra.
Product Name : Tofidence
Product Type : Antibody
Upfront Cash : Undisclosed
April 01, 2025
Details:
Enhertu (trastuzumab deruxtecan) in combination with fluoropyrimidine chemotherapy, pembrolizumab is being studied for unresectable, locally advanced or metastatic HER2 positive gastric or GEJ cancer.
Lead Product(s): Trastuzumab Deruxtecan,Cisplatin,Pembrolizumab
Therapeutic Area: Oncology Brand Name: Enhertu
Study Phase: Phase IIIProduct Type: Antibody-drug Conjugate
Recipient: Daiichi Sankyo
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2025
Lead Product(s) : Trastuzumab Deruxtecan,Cisplatin,Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Daiichi Sankyo
Deal Size : Inapplicable
Deal Type : Inapplicable
Enhertu Initiated in Patients with Previously Untreated HER2 Positive Gastric Cancer
Details : Enhertu (trastuzumab deruxtecan) in combination with fluoropyrimidine chemotherapy, pembrolizumab is being studied for unresectable, locally advanced or metastatic HER2 positive gastric or GEJ cancer.
Product Name : Enhertu
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
March 31, 2025
Details:
Capvaxive (21-valent Pneumococcal Conjugate Vaccine) is a prophylactic vaccine candidate which is approved for the treatment of pneumococcal pneumonia in adults.
Lead Product(s): 21-valent Pneumococcal Conjugate Vaccine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Capvaxive
Study Phase: Approved FDFProduct Type: Vaccine
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2025
Lead Product(s) : 21-valent Pneumococcal Conjugate Vaccine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EU Approves Merck's Capvaxive for Invasive Pneumococcal Disease Prevention
Details : Capvaxive (21-valent Pneumococcal Conjugate Vaccine) is a prophylactic vaccine candidate which is approved for the treatment of pneumococcal pneumonia in adults.
Product Name : Capvaxive
Product Type : Vaccine
Upfront Cash : Inapplicable
March 27, 2025
Details:
MK-8591A is a combination of islatravir and Doravirine which are being investigated as non-nucleoside reverse transcriptase translocation inhibitor of HIV-1.
Lead Product(s): Islatravir,Doravirine
Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-8591A
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 12, 2025
Lead Product(s) : Islatravir,Doravirine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Merck’s DOR/ISL Two-Drug Regimen Shows 48-Week HIV-1 Viral Suppression in Trials
Details : MK-8591A is a combination of islatravir and Doravirine which are being investigated as non-nucleoside reverse transcriptase translocation inhibitor of HIV-1.
Product Name : MK-8591A
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 12, 2025
Details:
Keytruda (pembrolizumab) is a PD-1 inhibitor antibody, being evaluated for the treatment of Stage III-IVA resectable LA-HNSCC.
Lead Product(s): Pembrolizumab,Cisplatin
Therapeutic Area: Oncology Brand Name: Keytruda
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2025
Lead Product(s) : Pembrolizumab,Cisplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Priority Review for Merck’s KEYTRUDA Combo
Details : Keytruda (pembrolizumab) is a PD-1 inhibitor antibody, being evaluated for the treatment of Stage III-IVA resectable LA-HNSCC.
Product Name : Keytruda
Product Type : Antibody
Upfront Cash : Inapplicable
February 25, 2025
Details:
Welireg (belzutifan), an oral HIF-2α inhibitor, being evaluated for the treatment of adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Lead Product(s): Belzutifan
Therapeutic Area: Rare Diseases and Disorders Brand Name: Welireg
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 18, 2025
Lead Product(s) : Belzutifan
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications
Details : Welireg (belzutifan), an oral HIF-2α inhibitor, being evaluated for the treatment of adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Product Name : Welireg
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 18, 2025
Details:
MK-2140 (zilovertamab vedotin) is an investigational ADC that targets ROR1 receptor. It is being evaluated for the treatment of previously untreated patients with diffuse large b-cell lymphoma.
Lead Product(s): Zilovertamab Vedotin,Cyclophosphamide,Rituximab
Therapeutic Area: Oncology Brand Name: MK-2140
Study Phase: Phase IIProduct Type: Antibody-drug Conjugate
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 06, 2025
Lead Product(s) : Zilovertamab Vedotin,Cyclophosphamide,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Merck Starts Phase 3 waveLINE-010 Study of Zilovertamab Vedotin in DLBCL
Details : MK-2140 (zilovertamab vedotin) is an investigational ADC that targets ROR1 receptor. It is being evaluated for the treatment of previously untreated patients with diffuse large b-cell lymphoma.
Product Name : MK-2140
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
February 06, 2025
Regulatory Info :
Registration Country : Switzerland
15-valent pneumococcal polysaccharide CRM conjugat...
Dosage Form : Inj Susp
Dosage Strength :
Packaging :
Brand Name : Vaxneuvance
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
15-valent pneumococcal polysaccharide CRM conjugat...
Dosage Form : Inj Susp
Dosage Strength :
Packaging :
Brand Name : Vaxneuvance
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Film-Coated Tablets
Dosage Strength : 300mg
Packaging :
Brand Name : Campral
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtablet
Dosage Strength : 300mg
Packaging :
Brand Name : Campral
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/2800
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/2800
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/5600
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/5600
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Dosage Form : Alendronic Acid 70Mg 4 Units' ...
Dosage Strength : 4 CPR 70 mg
Packaging :
Brand Name : Famax
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Alendronic Acid 10Mg 14 Joined...
Dosage Strength : 14 CPR 10 mg
Packaging :
Brand Name : Famax
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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