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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"},{"orgOrder":0,"company":"Onconic Therapeutics","sponsor":"Livzon Pharmaceutical Group","pharmaFlowCategory":"D","amount":"$127.5 million","upfrontCash":"$15.0 million","newsHeadline":"Livzon Acquires Rights to GERD Therapy from Onconic for $127.5 Million","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Onconic Therapeutics"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
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Details:
Zastaprazan is a P-CAB (potassium-competitive acid-blocking) candidate, a class of drugs that is replacing existing PPIs (proton pump inhibitors) for peptic ulcer disease, including GERD. Livzon will have rights to JP 1366 (zastaprazan) in China, Taiwan, Hong Kong and Macau.
Lead Product(s):
Zastaprazan
Therapeutic Area: Gastroenterology
Product Name: JP 1366
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Livzon Pharmaceutical Group
Deal Size: $127.5 million
Upfront Cash: $15.0 million
Deal Type: Acquisition
March 14, 2023
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