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ѹ, 'Ƽ' ߱ 2 ȯ
Ȱ 2019-08-26 06:10:48
ѹ, 'Ƽ' ߱ 2 ȯ
Ȱ 2019-08-26 06:10:48

[DP]  2 26 Ȯ...ϴ뺴 ڸ ܰ ȯ

Ʈ, ZENITH20 2ӻ ȣƮ1 м ǥ

[ϸ=Ȱ ] ѹ̾ǰ ׾Ͻž 'Ƽ' ô Ÿ´. ߱ Ͻ 2ӻ ̴ ߴ. ȯ 40% ̻ ϴ ߱ ѱ ӻ ȭ ϸ鼭 ȭ ǥ Ѱ .

ѡ 26 ӻ, Ҽ ȯڸ

  ѹ̾ǰ
̱ ǿ(NIH) ϴ ӻƮ ŬĮƮ̾(Clinical Trials) ѹ̾ǰ ֱ Ƽ ű ӻ ϰ ȯ ߴ.

ѹ̾ǰ 5 ġ ִ Ҽ(NSCLC) ȯ 114 Ƽ ȿ ϴ 2ӻ ߴ. EGFR Ǵ HER2 (exon) 20 ο 2 ȣƮ Ǵ ̴. ӻ 2022 4 ȴ.

8 Ʈ ü 26 ӻ ϴ뺴 ڸ ܰ迡 ߴ. 4 ǰǾǰóκ EGFR Ǵ HER2 20 ̸ Ҽ ȯ ٱ 2ӻȹ ι 4 ô Ÿ´.

ϼͿ Zﺴ, 뺴, ƻ꺴, ϴ뺴 5 ǥڼ 40̴. ߱ ӻ ¡Ϻ, ϰ濬ǰк, 1μӺ 21 Ȯƴµ, ڸ . ѹ̾ǰ 20 ̰ Ÿ ༺ Ǵ ̼ Ҽ ȯ 114 40 ӻ 켱 ϰ, 74 ߱ ӻ Ѵٴ ȹ̴.

ռ ѹ̾ǰ 2022 Ƽ ߱ 㰡 ǥ ȭߴ. Ǽâ ѹ̾ǰ JP コɾ۷ ǥ Ƽ ߱ ܵ ӻ ȹ ȭ ̴.

߽Ʈ, ȣƮ1 м 4б ǥ

߱ ȯ 40% ̻ ϴ ū ̴. 迡 Ƽ ߱ ⿡ ߿ ǹ̸ ̹ ӻ и ̸ ִٰ ٶ󺸴 ð 켼ϴ.

ѹ̾ǰ Ʈʻ Ʈ Ƽ ZENITH20 ӻ2 ȣƮ1 м ǥѴٴ .

Ƽ 2015 ѹ̾ǰ Ʈ pan-HER2 ׾. Ʈ ѱ, ߱ Ƽ Ѱ DZ Ѵ. Ʈ ϰ Ҽ 2 ġ ɼ Ȯϰ, 20 ڿ ̰ ȯڷ Ȱ õ ̴.

2017 10 ̱ ij, 20 ̸ Ҽ ȯ Ƽ ׾ȿ ϴ ZENITH20 2ӻ ߴ.

  Ʈ ZENITH20 ȣƮ

2 Ӱ Ǵ ̹ ӻ ZENITH20 ϴ 7 ȣƮ ȣƮ1, 2 Ư ߺȴ.

ZENITH20 ӻ ġ ִ EGFR 20 (ȣƮ1) ġ ִ HER2 20 (ȣƮ2) ġ EGFR 20 (ȣƮ3) ġ HER2 20 (ȣƮ3) 4 ȣƮ ߴ. ֱ ġ ο EGFR Ǵ HER2 (exon) 20 ̸ Ҽ(ȣƮ5) Ÿ׸ ߰ ̰ ߻ EGFR 缺 Ҽ(ȣƮ6) EGFR Ǵ HER2 18-21 Ǵ , 뿵 ̰ Ÿ Ҽ(ȣƮ7) 3 ȣƮ ߰Ǹ鼭 7 ȣƮ þ Ȳ̴.

4б ǥ ȣƮ1 м , EGFR 20 ȯڿ 2 ̻ ġμ Ƽ ɼ . ߱, ѱ ƽþο EGFR ߻󵵰 . ѹ̾ǰ ߱ ӻ ϴ ̴.

  ȸ ǥ ZENITH20 ߰м (ڷ: Ʈ)

20 ̴ EGFR Ҽ 3~7% Ѵٰ ˷. EGFR 20 ̿ ȿ Ÿ ġ ̴. 鿪׾ ٸ ׾ 20% Ϸ Ҵ.

а迡 Ƽ ٸ ๰ ޸ ũⰡ ۰, پ Ư 20 ̿ շ پٴ м ȴ.

Ʈ ȸ(WCLC 2018) ZENITH ӻ2 ȣƮ1 ߰ , ORR 43% ǥϸ鼭 밨 . Ʈ 濵 ȣƮ м Ƽ ̱ǰǾǰ(FDA) 㰡 Ѵٴ ǥ . HER2 20 ȯڸ ǹϴ ȣƮ2 ž ߹ݰ ǥ ϴٴ ̴.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 03)
뱸- ౹ 37
ǰ ְ
̰źĸ(100) 35,000 29,000 6,000 31,083
ѽŻ÷(10) 3,500 2,500 1,000 3,144
޾(100) 24,000 22,000 2,000 22,800
Ʒγΰ(100) 30,000 27,000 3,000 28,586
īɾ(10g) 8,000 5,500 2,500 6,773
Ľõ򿬰(5g) 5,500 4,000 1,500 5,104
Ź(4) 5,000 3,500 1,500 4,350
λ絹÷(100) 37,000 30,000 7,000 33,889
ڶ(20) 6,500 6,500 0 6,500
(10) 6,000 4,500 1,500 5,238
Ժ(10) 4,000 3,300 700 3,699
ڱ׸(20) 5,000 4,000 1,000 4,597
ť(10) 3,500 2,500 1,000 3,073
Ȱť(1) 1,200 1,000 200 1,199
Ǯɾ(3.3ml) 27,000 25,000 2,000 26,143
޵𿬰(10g) 7,000 6,000 1,000 6,463
öŸ(34) 13,000 11,000 2,000 12,009
뽺ī(20g) 22,000 18,000 4,000 20,462
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 7,000 3,000 9,121
ͺ(10) 3,500 2,500 1,000 3,126
ݿ(1ڽ) 3,000 2,800 200 2,984
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,952
߽Ÿ(120) 60,000 55,000 5,000 57,842
Źĸ(10ĸ) 3,000 2,000 1,000 2,992
Ÿ̾(120) 60,000 50,000 10,000 55,000
տ(60ĸ) 30,000 25,000 5,000 27,844
Ÿ̷ER(6) 3,000 2,500 500 2,912
ٿ(30g) 12,000 9,800 2,200 11,515
(120) 25,000 22,000 3,000 24,429
Ʒ(6) 4,000 3,000 1,000 3,498
ǽõĸ(270ĸ) 120,000 105,000 15,000 116,250
B(120) 70,000 60,000 10,000 64,111
׳(10) 3,000 2,500 500 2,810
6̺(10) 3,500 2,100 1,400 3,027
(60) 220,000 200,000 20,000 212,000
Ⱦ 12,000 10,000 2,000 10,967
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