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            Details:

            Idefirix® (imlifidase) specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies for the treatment of anti-glomerular basement membrane (anti-GBM) disease.

            Lead Product(s): Imlifidase,Cyclophosphamide

            Therapeutic Area: Immunology Product Name: Idefirix

            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 May 30, 2023

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            Gamifant (emapalumab-lzsg) is a fully human, anti-IFNÎł mAb that binds free and receptor-bound IFNÎł, neutralizing its biological activity. In the US, it is indicated for pediatric and adult primary hemophagocytic lymphohistiocytosis (HLH) patients.

            Lead Product(s): Emapalumab-lzsg

            Therapeutic Area: Immunology Product Name: Gamifant

            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 April 04, 2023

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            Nefecon, is a proprietary, novel oral formulation of budesonide got MAA for IgA Nephropathy. With revised standard assessment timeline Calliditas estimates potential impact of 3 months on previously communicated timelines with expected decision by EMA in Q1 2022.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 September 16, 2021

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            Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN).

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 September 14, 2021

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            Details:

            The NDA submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 April 28, 2021

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            Details:

            Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 March 15, 2021

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            Details:

            The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 January 21, 2021

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            Details:

            The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 08, 2020

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            Details:

            The poster describes the design of the NefIgArd trial, which is exploring the effect of Nefecon in patients with IgA Nephropathy (IgAN) who are at risk of developing End Stage Renal Disease.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 October 19, 2020

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            Details:

            Following IND approval by the NMPA in December of 2019 and subsequent approval by Human Genetic Resources Administration of China (HGRAC), the first patient in China has now been randomized in the Phase 3 NefIgArd trial.

            Lead Product(s): Budesonide

            Therapeutic Area: Immunology Product Name: Nefecon

            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 September 08, 2020

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