24.05.08 () 09:59

Dailypharm

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ࡤ̿ Ϲݱ Ű '̱ Լ'
õ̼ 2018-07-02 06:30:40
ࡤ̿ Ϲݱ Ű '̱ Լ'
õ̼ 2018-07-02 06:30:40
'Ÿ' Ʈ 'Ʈø긶' 㰡

GC, 캴ġ ̱ 㰡 ...̿ó 20,

ѹ ļ ӻ Ӽ

̿ Ϲݱ ̽ ž ۷ι (IPO) ȴ. ̿ùз ̱ 㰡 ٸ ְ ѹ̾ǰ ž ǰ ļ ӻ ҽ̴. ̿ó 20 ǽ ε帰.

㼿Ʈ¡Z̿ǽ, ̿ùз ̱ Լ

1 迡 ̿ùз ǰ ̱ Լ ߴ.

Ʈ ̿ùз 2 ̱ 㰡 븮 ִ. Ʈ 'Ʈø( )' '긶(ƾ)' ̱ 1ȣ, 2ȣ ϰ ִ.

Ʈø 긶 ̱ ǰǾ౹(FDA) Ͽ䱸(CRL) 5 30 Ʈø, 6 18 긶 ڷḦ ߴ. ɻ 簳(Resubmission) ܰ迡 . DA CRL ڷ 6 㰡 ɻ縦 Ѵ. Ʈø긶 ȴ.

Ʈø 긶 FDA Ʈ 3 ̿ùз ̱ Ȯ´. ռ Ʈ 2016 '̵' ̿ùз 'ø' FDA 㰡 ִ.

Z̿ǽ ƾ ̿ùз ̱ 2ȣ Ѵ. 12 ̱ 㰡 û ´. Ʈ° ȭ, 2ȣ ̱ ο CRL ̽ ȴ.


޵彺ڡSK̿ ̱ 㰡

ʷ ̱ 㰡 յΰ ִ. 'Ÿ' 5 ̱ FDA cGMP, 6 EMA(Ǿǰû) EU-GMP ȹߴ. ü 㰡 ŭ ǰ θ ̱ . ̿Ǿǰ (ü) ǰ 㰡 ޾ƾѴ.

򰡵 ̴. ۷ι ȸ ÿ κƮƮ(Elysium Investments) ֱ "Ÿ(DWP-450) ̱ Ī 彺 κ "̶ ߴ.

޵彺 ̱ 3 . 2013 9 ׻ 彺 ̳彺 ̱ 3 Ϲݱ ð .

̳彺 ü ޵彺 2 Ͽ 븮̼ ޾ 3(ǰ) ̱ 㰡 ȴ. 彺 70% ϴ ȸ.

GCڴ Ϲݱ⿡ IVIG-SN ̱ Ѵ. GCڴ 2015 11 FDA IVIG-SN ǰ㰡 û Ϸ ڷ ޾Ҵ. ̿ FDAκ ϰ IVIG-SN ȴ.

̹ GCڴ Ϲ ijٿ 2200 ׺ȹ ü Ǽϴ ̱ ä ģ ´.

SK̿ ž 'SKL-N05'(и ָ) ̸ ̱ FDA ȴ. SKL-N05 SK̿ 2011 ӻ 1 Ϸϰ ̱ (Jazz)翡 ž ĺ̴.

SK̿ʰ ӻ 3 ߴ. SK̿ 12 FDA SKL-N05 ž Ǹ νû ߰ 3 FDA θ ϱ 並 ߴ.

ѹ̾ǰ ž ļӻ Ӽ ..'ѷƼ' 㰡 û

ѹ̾ǰ ž ǰ鵵 ȭ ӻ Ȯ ̴.

ѹ̾ǰ ž 'ѷƼ' ȭ ܰ迡 ִ. ѷƼ ȣ߱ġ ȿ ð ø ̿ž̴. Ʈ 2015 ѷƼ ӻ3 'Ÿ' 񿭵 1 ȿ 򰡺 Ȯϰ 4б ̱ ǰǾǰ(FDA) Ǿǰ㰡 û Ǿǰ㰡(pre-BLA) յΰ ִ.

ִ Ը 索ž ۷Ÿ̵嵵 ȭ ӵ . ۷Ÿ̵ GLP-1 迭 索ġ ϴ ֻ縦 1ȸ 1ȸ ̿ž 2015 ǿ ƴ. Ǵ ۷Ÿ̵ ӻ3迡 ߰ ȯ ȿ Ȯϴ ߰ ӻ3迡 ߴ.

Ǵ ߰ ۷Ÿ̵ ӻ 3 ȹ̴. ۷Ÿ̵ ν ȹ ̸ ۷Ÿ̵ 2 索 ġῡ ϰ ̴ 汸 ġ Ʈ(metformin) ๰ Ʈ縮Ƽ( dulaglutide) ϴ ӻ ̴. 2019 ۷Ÿ̵+Ʈ(MET) ҿ췹(SU) ߰ϴ ӻ赵 ۵ ̴.

2015 Ἶ 񸸴索ž 'JNJ-64565111' ź ȯڸ ο ӻ迡 ϸ ο ܰ踦 ̴. 2015 Ʈ pan-HER2 ׾ Ƽա , Ҽ ȯڸ 6 ӻ ̴.

㱹 ̿ 20, ڽ

Ϲݱ⿡ ̿ó ű ̽ ٸ ִ. 뷫 20 (IPO) ϰ ִ.

ø, ť 7 ڽ (IPO) б⿡  , ַ̿ ڽ Լ Ѵ. ̿ó κ 򰡸 忡 Ѵ.

߰߱ ϳ൵ 忡 Ѵ. 40 ϳ Ϲݱ ڽ Լ ǥ 6 11 ɻû ߴ. ༺ 忡 ϰ ִ.

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    رŸ ϸ ڿ ֽʽÿ. ּҴ dailypharm@dailypharm.comԴϴ.

ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 05)
౹ 71
ǰ ְ
ѽŻ÷(10) 3,500 2,300 1,200 3,028
޾(100) 25,000 22,000 3,000 23,304
Ʒγΰ(100) 30,000 27,000 3,000 29,237
īɾ(10g) 8,000 5,500 2,500 6,472
Ľõ򿬰(5g) 5,500 4,000 1,500 5,035
Ź(4) 5,000 3,500 1,500 4,449
ڶ(20) 7,000 5,800 1,200 6,433
(10) 6,000 4,000 2,000 4,914
Ժ(10) 4,000 3,000 1,000 3,543
ڱ׸(20) 5,000 3,800 1,200 4,622
ť(10) 3,500 2,300 1,200 2,828
Ȱť(1) 1,200 1,000 200 1,140
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,214
޵𿬰(10g) 7,000 5,000 2,000 6,162
öŸ(34) 13,000 10,000 3,000 12,089
뽺ī(20g) 22,000 18,000 4,000 20,358
ġ(1) 1,100 1,000 100 1,000
ӽ÷(21) 10,000 7,500 2,500 8,998
ͺ(10) 3,500 2,300 1,200 3,138
ݿ(1ڽ) 3,000 2,500 500 2,947
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,973
߽Ÿ(120) 70,000 40,000 30,000 54,203
Źĸ(10ĸ) 3,000 2,000 1,000 2,941
Ÿ̾(120) 60,000 40,000 20,000 49,168
տ(60ĸ) 30,000 24,000 6,000 27,235
Ÿ̷ER(6) 2,500 2,500 0 2,500
ٿ(30g) 12,000 9,000 3,000 11,221
(120) 25,000 18,000 7,000 21,716
Ʒ(6) 4,000 3,000 1,000 3,509
ǽõĸ(270ĸ) 120,000 85,000 35,000 106,875
B(120) 70,000 60,000 10,000 62,308
׳(10) 3,000 2,000 1,000 2,684
6̺(10) 3,500 2,000 1,500 2,965
(60) 250,000 200,000 50,000 224,000
Ⱦ 12,000 9,000 3,000 10,494
̰źĸ(60ĸ) 25,500 22,000 3,500 23,942
Ųť(20) 5,500 4,500 1,000 4,823
λ絹÷(100) 37,000 29,000 8,000 31,878
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