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Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ZYMFENTRA\u2122 Shows Long-Term Efficacy for Crohn's Disease and Ulcerative Colitis Treatment","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Receives EU Approval for Omlyclo\u00ae (CT-P39), Omalizumab Biosimilar","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Celltrion
Through the acquisition, Hasten will own the Marketing Authorisation Holder rights of products in 8 countries, which includes Edarbi (azilsartan medoxomil) indicated for the treatment of hypertension.
Omlyclo (omalizumab) is an antibody inhibiting IgE binding. It is approved to treat chronic spontaneous urticaria & moderate to severe persistent asthma.
Zymfentra (infliximab) a TNF alpha inhibitor, is the first and only FDA-approved SC formulation, for adults with moderately to severely active ulcerative colitis and crohn’s disease.
CT-P39 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous urticaria.
Remsima (infliximab) blocks the action of TNF-alpha. It is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis and crohn’s disease.
CT-P47 (tocilizumab-biosimilar) is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. It is being evaluated in phase 3 clinical trials for the treatment of moderate to severe active rheumatoid arthritis.
Zymfentra is the first and only FDA-approved subcutaneous (SC) formulation of infliximab approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease.
Yuflyma (adalimumab-aaty) is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of autoimmune conditions.
Under the agreement, Celltrion will exclusively supply to Rani the adalimumab biosimilar drug substance (CT-P17) required for the development of RT-105, an oral capsule containing a TNF-α inhibitor antibody being developed for the treatment of psoriatic arthritis.
Yuflyma (adalimumab-aaty) is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of autoimmune conditions.