24.05.07 (ȭ) 14:27

Dailypharm

X
ƾ ùз 㰡 Z-Ʈ, ڴ?
Ȱ 2017-09-08 12:15:00
ƾ ùз 㰡 Z-Ʈ, ڴ?
Ȱ 2017-09-08 12:15:00
EMA 㰡 ٸ , 8~12 ȸ



ASCO(̱ӻȸ) Բ о ִ м #ESMO 2017(ȸ) мȸ Ұ ð ٰԴ.

ESMO 帮. Ͽȸ(EACR) Ʒ 8Ϻ 12ϱ(ð) Ǵ ̹ 翡 ڵ Ͽ ϰ ȴ.

ʷϸ 3260ǿ ̸ 1736 ΰ ÷ äõ Ȯε, ⸦ ǰ ϰ ִ. νÿ Ŀ(satellite symposium) ڻ (R&D) ˸ ִ ȸ Ǵ 鿡Ե ҳ ߿ ȸ иϴ.

߱ ̿ùз, 7 ƾ ?=  ̹ ȸ Ÿ ٷ #Z̿ǽ Ʈ ̴.

Ǵ籹 '#ƾ(ƮƮָ)' #̿ùз 㰡û ߴ. 6 ASCO 2017 ׾ ü ̿ùз '(CT-P6)' 'SB3' 3ӻ ó ŭ, ȸ ѹ Ϸ ̴.

̿ùз 80% ϴ ַ¸̴. 7 9000 ø ν ȿڳ븩 ϰ ִ 'ƾ' ù ̿ùз ŸƲ ɳ ۿ .

8 ʷ ƾ ̿ùз(MYL-1401O) 㰡û ߴ ̿ܰ ж ϰ ִٴ 鿡 ȣ ۿ ϴ.

7 ̱ Ǿ Ǿĸ(FiercePharma) " ƾ ̿ùз ƴ ж ̿ 氥(Banglore) 忡 ߰ߵƴ", "ġ 並 㰡ñⰡ ȴ" ߴ.

ٱ ƾ ̿ùз ߿ ø , ȭ ð ʿ Ȳ̴.

߼Ʈ, "ָ 㰡 ڽ"=Ʈ 긶 HER2 缺 Ұ ̴ ȯ 549 3ӻ ٰŷ ๰(ƾ)  ް ִ.

ݷ (Lancet Oncol 2017;18:917-928) , Ź ִ 10ȸ ๰ ˻ ׿͸ ǹϴ (TPCR) 긶 (46.8%) ƾ (50.4%) ̰ . ̻ ߻ 7% 8% ߴ.

ֱ GMP ǻ ߰ߵ ̽ȭ DZ ÷Ʈ(ø ̿ùз) ⸦ ִ Ʈ¿ ǰ Ժ ̷ ϰ ִ. Ʈ 긶 㰡 ڽŰ ǥϴ .

Ʈ ڴ "̹ ESMO 2017 ȸ ASCO ǥƴ 긶 3ӻ ͷ ǥϰ Ŀ Ƿ鿡 ȫϴ ȸ ȹ"̶, " 긶 㰡û ߰ EMA ڷ ģ Ͷ 㰡 ϰ ִ" .

㰡û Z, EMA 㰡ǰ ޳= Z̿ǽ ⼼ ġ ʴ.

޹̶ ̿ùз 'Ӷ(ƴ޸)' 㰡 Z 迡 ȸ ڰ鿪ȯ ġ 3(근̵塤޹̶) ̿ùз ι ȸ簡 ƴ.

9 29ڷ 'SB3' 㰡û 뺸 , ռ 㰡û ģ ̿ܰ ж ȹ п Z̿ǽ ̴.

Z ASCO ǥߴ SB3 ӻ3 ߰ 52 ͸ Ʈ Ȯεȴ. ESMO Ȩ ʷ 9(ð) ǥ ִ ð õư, 11Ͽ յΰ ִ. 8 Ŀ ؼ SB3 ͸ ȹ̴.

ASCO 2017 ȸ ϰ ƴ  ؼҽų ָغ Ʈ. SB3 3ӻ ó ڸ SB3 ȿ ǥ (upper limit) ߰ߴٴ "SB3 ƾ ̿ùз " Ȥ ִ. ׿͸ (TPCR) ƴ, (BPCR) κ ̵ ־.

11 ü (full data) Ȥ ׷, Ǿǰû(EMA) ๰ڹȸ(CHMP)κ ǰ ް ȴٸ Z̿ǽ θ 䳢 ȣ ȸ ȴ.

Z̿ǽ ڴ "̹ ESMO 2017 ȸ 6 ASCO ǥ SB3 ӻ3 Բ 52 ͸ ǥ "̶, "Ŀ ۷ι ׾ ü ̿ùз ϰ ȴ" .

簡 ƾ ̿ùз ù 㰡 ȹ Ǵ ̴.
Ȱ (kjan@dailypharm.com) ٸ
  • μ
  • īī
  • ̽
  • Ʈ
  • 0
ñ
/home/dailypharm/issueData2017/
ǰ
0
͸ǰ | Ǹǰ߾ Ģ
ݱ

Ǹ ͸ , Ǹ ̸ ̵ ˴ϴ. ͸ ʸ ϸ, ͸ մϴ.

ڹ(-ڴϾ-ʱ ) ˵ ϸ ȸ Խ ⡯ ĺ Ʈ ׻ ֻܿ ˴ϴ. ο ø Ϲȸ Խ ĺ ڴϾ ȸ ϴܿ ǽð ˴ϴ.

뺸 ϰ ̵ ̿ Ǵ ֽϴ.

  • ۱ǡΰݱ Ÿ Ǹ ħϴ

    α׷ ϰ , ȳϴ Խù

    Ÿ Ǵ 3 ۱ Ÿ Ǹ ħ Խù

  • ٰ 桤 Ѽϴ Խù

    Ư ̿ ο ν 弳

    Ư 븳 ϴ

    Ȯ ȵ ҹ Ű

    弳 , Ӿ

    Ź, ɿ ˵Ǵ ( û )

    Ư ̳ ü ϴ

    Ư ѼϿ ش ûϴ

    Ư (ֹεϹȣ, ȭ, ּ ) Խϴ

    Ÿ ID Ȥ г ϴ

  • Խ Ư ѵǴ

    ʴ

    翡 ߺ

    κ Ͽ ݺ ϴ 쵵

    Խù,

    Ե Խù

    Խù б

  • û ִ

  • Ÿ

    ʿ伺 ̸

    Ÿ ˵Ǵ 縦

    Ÿ  ڰ ʿϴٰ ǴܵǴ

  • Ȯ

    ۱ڷκ , , ϴ

    Ÿ ʻ ħϰų ϴ

    翡 ̿ (Ÿ ID, йȣ )

  • ̻ Ϻ ׿ ̿ 縦 , Ρ ó ֽϴ.

    õ ̴ ҹ Ǵܵǰų ϸ 񽺿 ٶ ʴٰ ǴܵǴ ġ ϰڽϴ.

    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
ü



ͳݽŹϹȣ: 00048 | 2005.09.09 | 2005.09.09 | : | : ȣ
ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
ȭ : 02-3473-0833 |ѽ : 02-3474-0169 | ûҳ⺸ȣå(å ű)
Contact dailypharm@dailypharm.com for more information
ϸ () ϴ ۱ǹ ˵Ǹ, 縦 ֽϴ.