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[{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Reveals 1-year Data for Novel Subcutaneous Formulation of Infliximab in Crohn\u2019s disease and Ulcerative colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Daewoong Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Daewoong Pharmaceutical Unveils Phase 3 Clinical Data of Fexuprazan, A Novel Potassium-competitive Acid Blocker","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Daewoong Pharmaceutical"},{"orgOrder":0,"company":"Daewoong Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Daewoong Pharmaceutical Announces Publication of Novel P-CAB Fexuprazan Phase 1 Bridging Study","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Daewoong Pharmaceutical"},{"orgOrder":0,"company":"Daewoong Pharmaceutical","sponsor":"Shanghai Haini Pharmaceutical","pharmaFlowCategory":"D","amount":"$3,240.0 million","upfrontCash":"$6.0 million","newsHeadline":"Daewoong Pharmaceutical Signs Agreement to Export Fexuprazan, A New Drug for Gastroesophageal Reflux Disease, to China","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Daewoong Pharmaceutical"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion USA Announces Submission of the Biologics License Application (BLA) of Novel Subcutaneous Formulation of CT-P13 to U.S. Food and Drug Administration","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
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Details:
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.
Lead Product(s):
Infliximab
Therapeutic Area: Gastroenterology
Product Name: Remsima
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 22, 2022
Details:
Under this agreement, Shanghai Haini (CEO Tan Pengfei) will clinically develop Fexuprazan and obtain marketing authorization, and then YRPG will be responsible for distributing the drug.
Lead Product(s):
Fexuprazan
Therapeutic Area: Gastroenterology
Product Name: DWP14012
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Shanghai Haini Pharmaceutical
Deal Size: $3,240.0 million
Upfront Cash: $6.0 million
Deal Type: Licensing Agreement
March 18, 2021
Details:
Bridging study results, published in the SCI journal, AP&T, demostrate no racial differences exist in pharmacokinetic and pharmacodynamic properties of fexuprazan.
Lead Product(s):
Fexuprazan
Therapeutic Area: Gastroenterology
Product Name: DWP14012
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 06, 2020
Details:
In a Phase 3 clinical trial in patients with erosive esophagitis, conducted in 25 hospitals in Korea, Fexuprazan showed 99% of mucosal healing rate at week 8 and was well tolerated in the patients.
Lead Product(s):
Fexuprazan
Therapeutic Area: Gastroenterology
Product Name: DWP14012
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 08, 2020
Details:
The results from a randomised controlled trial showed that the subcutaneous formulation of infliximab was comparable to the intravenous formulation of CT-P13 in terms of efficacy and safety.
Lead Product(s):
Infliximab
Therapeutic Area: Gastroenterology
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 14, 2020