[̵ϸ ] ̿ ǥ (196170) Hybrozyme Ȱ ΰ ˷δϴ (ALT-B4) 10 ۷ι 簡 ۷ι ӻ (CTD) ߴٰ 7 . ΰ ˷δϴ (ALT-B4) ۷ι 忡 2019 2020 ߹ݿ 10 ۷ι 翡 63000 Ը Ϸߴ. TF ۷ · ӻ ߴ. ̹ ӻ IND û 빮(Common Technical Document, CTD) ۼ, 簡 ۼ CTD Ȯߴ.CTD Ǿǰ ȭ ǿȸ(ICH) ȭ Ǿǰ 㰡 Ǿǰ ǰ 㰡 Ű ɻ翡 شǴ Ǿǰ 㰡 ް ؾ Ѵ. ALT-B4 ܹ ̿ ˷ ΰ ˷δϴ ۿ۰ ȿ Ȱ ϸ鼭 ܹ ο ˷γ Ͻ ܹ ֻ縦 ֻ · ٲپ ִ ̴. ڴ ̹ ALT-B4 CDT ϼ ڷγ ִ ȸ TF 10 ۷ι ȸ ̷ ̴ ۷ι ӻ 1 ̸, ۷ι 츮 ֻ ۷ι ǰ ʰ ̸, ۷ι ̿ ȸ ִ ߴٴµ ū ǰ ִ١ . ʿ Intas Pharmaceuticals Ltd ( Intas) ۷ι ̼ üص ̿ùз ǰ ֻ ǰ ø ϰ ,ǰ ȭ ÿ Ը ִ ڸ ۼƮ ξƼ ִ. (aladin@edaily.co.kr) #24ð #̸ #eNews+ ̹ '̵ϸ ' 䢺 ħؼ, ûᴵ콺 'Ÿ' ̵ ̵ϸ - & ϴ . ȣ ڽ ʸӷ ִ
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