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CANbridge Pharmaceuticals Doses First Patient in CAN108 Biliary Atresia Study
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that the first patient has been dosed in the Phase II EMBARK study of CAN108 (maralixibat) for biliary atresia (BA). The global, multi-center, randomized, controlled trial aims to enroll 72 patients, including 20 in China, to evaluate the drug’s efficacy…
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CANbridge Pharmaceuticals Scales Back US Operations, Focuses on China for R&D and Commercialization
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CANbridge Pharmaceuticals Inc., (HKG: 1228), a China-based pharmaceutical company specializing in rare diseases, has announced recent developments regarding its operations in the United States, where the company is considering scaling down its presence. The management has decided to terminate a licensing agreement with the University of Massachusetts (UMASS) that was…
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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
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CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
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CANbridge Pharmaceuticals Partners with Peking Union Medical College to Advance Rare Disease Research
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CANbridge Pharmaceuticals Inc. (HKG: 1228), a specialist in rare diseases based in China, has announced a partnership with Peking Union Medical College Hospital to collaborate on an innovative study spanning drug discovery to clinical translation for rare diseases. The partnership aims to establish a rare disease innovation development platform focused…
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CANbridge’s Maralixibat Receives Priority Review for PFIC Treatment in China
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced that a New Drug Application (NDA) for its maralixibat (CAN108) has been accepted for review by the National Medical Products Administration (NMPA) in China, with the added benefit of priority review status. This marks a significant step forward in…
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CANbridge Pharmaceuticals Reports Positive Phase Ib Results for Omoprubart in PNH Treatment
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China-based rare disease firm CANbridge Pharmaceuticals Inc., (HKG: 1228) has published the preliminary results of a Phase Ib clinical study for its pipeline drug candidate omoprubart (CAN106), a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The drug candidate is under development as a potential treatment for paroxysmal…
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CANbridge Pharmaceuticals’ Maralixibat Approved by NMPA for Alagille Syndrome
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China-based rare disease specialist CANbridge Pharmaceuticals Inc., (HKG: 1228) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug maralixibat (CAN108). The drug is approved to treat pruritus due to cholestasis in patients with Alagille Syndrome (ALGS) aged 1 year and above. Understanding Alagille Syndrome…
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CANbridge Pharmaceuticals Completes Enrollment in Phase II GBM Trial for CAN008
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Sino-US biopharma CANbridge Pharmaceuticals (HKG: 1228) has announced the completion of patient enrollment in a Phase II trial for its pipeline candidate CAN008 (asunercept) in combination with temozolomide for the treatment of glioblastoma multiforme (GBM). The multi-center, randomized, placebo-controlled study, which is potentially registrational, has recruited a total of 117…
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CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
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China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase II part of the ongoing CAN103 Phase I/II study. The trial is focused on treatment-naïve patients with Gaucher disease (GD) Types I and III in China. This milestone marks a significant step forward in the…
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CANbridge Secures Global Rights to Second-Generation Gene Therapy for SMA
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China – based biopharma CANbridge Pharmaceuticals Inc. (HKG: 1228) has unveiled a license deal to secure exclusive global rights to a novel, second – generation gene therapy for spinal muscular atrophy (SMA) from UMass Chan Medical School in the United States. The deal includes all development, manufacturing, and commercialization rights…
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CANbridge’s CAN106 Receives Orphan Drug Designation for Myasthenia Gravis
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China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced receiving Orphan Drug Designation (ODD) status for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system, for use in myasthenia gravis (MG). Myasthenia gravis is a rare and chronic autoimmune disease caused…
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CANbridge Pharmaceuticals Doses First Patient in CAN103 Gaucher Disease Trial
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China-based rare disease firm CANbridge Pharmaceuticals announced the dosing of the first patient in a Phase I/II clinical trial for CAN103, its enzyme replacement therapy (ERT) candidate, in treatment-naïve patients with type I and III Gaucher disease. The trial marks progress in CANbridge’s partnership with WuXi Biologics (HKG: 2269) to…
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CANbridge Pharmaceuticals Presents Positive Phase I Data for CAN106 at EHA Congress
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China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) released the latest data from a Phase I single-dose escalation study for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The results were unveiled at the European Hematology Association (EHA) congress in Singapore.…
