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FDA ߱ 鿪׾...ѱ ܰ
2023-11-11 05:50:37
FDA ߱ 鿪׾...ѱ ܰ
2023-11-11 05:50:37

FDA, 彺̿ '丣' Ρ̳Ʈ ̱ 㰡

κ 1/2 ӹHLB, ߱ ׼ 'įָ' μ


[ϸ= ] ߱ 簡 鿪׾ ƽþ ʷ ̱ 㰡 鼭 鿪׾ ȭ ɼ ̸ ߵȴ.

27 ̱ǰǾ౹(FDA) ߱ 彺̿̾𽺰 鿪׾ 丣(и 丮ȸ) ߴ.

װ PD-L1/PD-1 Ÿϴ 鿪׾ ߱ 㰡 ȹ濡 ۷ι 㰡 ̹ ʴ. ̿ װ ȹ濡 ߴ ߱ ٱ , ̳Ʈ  ̱ 㰡 븰ٴ ȹ̴.

߱ 鿪׾ ƿ 㰡 ̳Ʈ 2015 ϶ 10 ޷( 13375) Ը üߴ. Ҽ ȯ ġḦ ƿ 㰡 û FDA ȹ濡 ߴ.

̳Ʈ FDA û ǥġ ƿ+׾ȭп ӻ ߰ Ѵٴ ȹ̴.

߱ 鿪׾ Ƽָ ȭ Ƽ 22 ޷( 29425) Ը üߴ. 9 Ͽ 㰡 ȯ ü ۷ι 㰡 ȹ濡 ̶ ̴.

Ƽ ̼ Ƽָ ȸ(EC)κ ĵ 2 ġ ޾Ҵ. Ƽָ ӻ ϰ ִ.

, ȭ 鿪׾ ӻ

ټ Ȯ ϴٴ ܳ ̿赵 鿪׾ ߿ پ ټ ӻ2 ܰ迡 ӹ ִ. ߱ ӻ3 ۷ι ȭ ִ Ϳ ̰ Ÿ ִ.

鿪׾ ߿ پ Ƽ̿, HLB, ̳뺣̼, ̹ÿ½þ, ̺񿤹̿ ִ.

Ƽ̿ ֱ 鿪׾ ĺ TU2218 ܵ ӻ1a Ϸߴ. TU2218 ̼ȯ ȿ PD-1 Ȱ ϴ ֿ ڷ ˷ TGF- 缼 ֺ ϴ VEGF ÿ Ѵ.

ӻ1a󿡼 TU2218 TGF- ؼ Ǵ ˷ (CTGF) ֿ ̿Ŀ ߳󵵰 ߴ. CTGF ߳󵵴 7 27% ߴ. Ƽ̿ TU2218 ܵ ܿ ̱ ŰƮٿ ӻ ̴.

̳뺣̼ 鿪׾ ĺ GI-101 ŰƮ, (߷縿) ӻ ɼ Ȯ ̴.

ֱ ģ ӻ1/2 GI-101+ŰƮٴ 鿪 2000 ̻ Ÿ. ȸ ȯڱ Ⱓ(PFS) ī ๰ ǹϰ ߴٰ ߴ. ̳뺣̼ ӻ2 Ѵٴ ȹ̴.

̹ÿ½þ 鿪׾ ĺ IMC-002 뷮 ӻ1󿡼 ü Ȯߴ. IMC-002 ϼ CD47 ļ ȣ ϴ ִ.

2022 5~2023 10 12 ȯڿ IMC-002 , 뷮 ๰ Ÿ ʾҴ. ȯ 12 6 (SD) · Ÿ. ȸ ӻ1󿡼 Ȯ ӻ2 뷮 Ѵٴ ħ̴.

ġ HLB ֱ ߱ ׼ 鿪׾ ĺ įָ DZ 鿴. HLB ̱ ȸ ٴ ׼ 鿪׾ įָ ι ۷ι DZ μ üߴ.

HLB ٴ հ įָ ɼ Ȯϰ ִ. ȸ мȸ(ESMO 2023) , +įָ+׾ȭп ǥġ (Ƽ) ü(OS) Ⱓ(PFS) Ÿ. ȸ ̱ 㰡 ٴ ȹ̴.

̺񿤹̿ ༺̼ ȯڸ 鿪׾ ĺ ABL103 ȿ ϱ ӻ1 ߴ.

̹ ӻ ABL103 ܵ ༺ ϰ ӻ2 뷮 ִ볻뷮 ȹ̴. ӻ1 ѱ ̱ ȴ.

ӻ󿡼 ABL103 B7-H4 ̼ȯ濡 4-1BB Ȱȭ ϴ Ÿ. ϼ ϼ ȿ Ȯ ִ.
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ֽż ݴ
  • 2023.11.11 11:01:22 |

    ~~(HLB)

    "ȸ ̱ 㰡 ٴ ȹ̴.">>>>>>HLB ӻ3 FDA NDA 2023 5 ûϿ ٸ ִ.

    0 3 0
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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ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
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