GC녹십자, 미국 미럼과 희귀간질환 신약 상용화 계약 체결'BA' 적응증에 대해서는 현재 글로벌 임상 2상을 진행 중
*아래는 위 기사를 구글 번역기로 번역한 영문 기사의 [전문]이다. [Below is the [full text] of an English article translated from the above article with Google Translate.
GC Green Cross signs a commercialization contract with Miram of the United States for a new drug for rare liver disease
For the 'BA' indication, a global phase 2 clinical trial is currently in progress.
[Introduction to the case/ Reporter Park Yeon-pa] = GC Green Cross (CEO Eun-Cheol Huh) and Mirum Pharmaceuticals (CEO Chris Peetz) of the United States have an exclusive for the development and commercialization of 'Maralixibat', a new drug for pediatric rare liver disease It was announced on the 27th that a license agreement was signed.
Mirum is currently undergoing US and European approval procedures and clinical trials for 'Maralixibat' indications for △ Allazil syndrome (ALGS) [1] △ Progressive familial intrahepatic cholestasis (PFIC) [2] △ Biliary atresia (BA) [3] is in progress In particular, there is currently no approved treatment other than liver transplantation for 'ALGS' and 'BA' indications worldwide.
Maralixibat received the designation of ‘Breakthrough Therapy’ for pruritus in ‘ALGS’ patients aged 1 year and older from the US FDA in 2019 and applied for product approval in January of this year. The product approval process is in progress in Europe for the indication 'PFIC type2'. For the 'BA' indication, a global phase 2 clinical trial is currently underway.
Through this contract, GC Green Cross has secured the right to develop and commercialize Maralixibat exclusively in Korea. The company explained that it expects to receive sequential domestic approval for three indications, starting with ‘ALGS’ next year.
Chris Peetz, CEO of Mirum, said, “I am delighted to share a vision for providing innovative treatments with GC Green Cross. I hope it will,” he said.
Heo Eun-cheol, CEO of GC Green Cross, said, “This cooperation will be another important milestone for overcoming rare diseases in children.
[1] Alagille syndrome, a rare genetic disorder characterized by decreased hepatic biliary tract and biliary stasis [2] Progressive familial intrahepatic cholestasis, cholestasis caused by a genetic defect in a protein involved in bile excretion from hepatocytes [3] Biliary atresia, a condition in which some or all of the biliary ducts connected to the outside of the liver are destroyed or abnormal in their formation
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