24.03.29 () 18:56

Dailypharm

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, R&D м...' ' ȭ
õ 2020-01-02 06:10:55
, R&D м...' ' ȭ
õ 2020-01-02 06:10:55
[DP][2020 ̿ R&D ]➀ ž ӻ

ѹ, 索׾Ͻž ļӻ ӵ..., ۷ι ӻ

ڡ, ۷ι ȭ...SK, FDA 㰡 ž



[ϸ=õ ] ص ۷ι ӵȴ. ѹ̾ǰ, Ѿ, ƿƼ ȭ . SK̿, ۷ι Ѿ ǰ ŸѴ.

ѹ̾ǰ, ѷƼ FDA ...۷Ÿ̵ ȭ ӻ

  ѹ̾ǰ
ѹ̾ǰ 2015 ʴ ״. ׾(ΰ), ν(), 鿪ȯġ(), 񸸴索ġ(Ἶ) Ǹ ȯ ۷ι ɼ ȿϴ.

ȣ߱ġ ѷƼ ̱ ǰǾǰ(FDA) 㰡 ȴ. 2012 ƮĸƼ ѷƼ ȣ߱ ġ ȿ ð ø ̿ž̴. Ʈ 2017 ѷƼ FDA 㰡 û ͺ ް 3 BLA ߴ. ۳ 10 㰡û ٽ ߴ.

FDA ž 㰡 û ɻ 60ϰ 並 ɻ θ µ ѷƼ BLA 並 ϰ ɻ ߴ. BLA 1024ϱ. ȣ߱ ġ ̱ 4 Ը ϰ , Ÿ Ⱓ ϰ ִ.

ѷƼ FDA 㰡 ѹ̾ǰ ܿ οƼ Ȯ ִ. Ʈ ̱ǰŷȸ(SEC) ѷƼ FDA 㰡 ѹ̾ǰ 1000޷ Ͻ ϰ, ߸ Ŀ ⿡ ų οƼ ϱ ߴ.

ǿ 索ž ۷Ÿ̵ ȭ ӻ ׵ Ʈ. ۷Ÿ̵ GLP-1 迭 索ġ, ´ ֻ縦 1ȸ 1ȸ ̿ž̴. ѹ̾ǰ 2015 11 ǿ ۷Ÿ̵ ξµ, 4 ִ Ը ű ̴.

Ǵ ۷Ÿ̵ ӻ3 5 ̴. 2 ȯڸ ƴ. ֱ 3ӻ(AMPLITUDE-M) ȯڸ Ϸߴ. 6 ۷Ÿ̵ ٽӻ 򰡿(AMPLITUDE-O) 4076 ϵǸ鼭 Ը ʰߴ.

Ǵ , ȯ, ȯ, Űȯ 4 ڸ ø 索 ȯ ߴ ϸ鼭 ۷Ÿ̵ ϰڴٰ . ٸ Ǵ ۷Ÿ̵ Ϸ Ǹ Ʈʸ ϰڴٴ ǥߴ. ۷Ÿ̵ Ȥ R&D ο Ǹ Ʈ ̶߱ ߻ ̴.

ѹ̾ǰ 2015 Ʈ ׾ Ƽյ ȭ ɼ 뿡 . Ʈ ϰ Ҽ 2 ġ ɼ Ȯϰ, 20 ڿ ̰ ȯڷ Ȱ Ȯϱ õ ̴.

Ʈ 2017 10 ̱ ij, (Exon) 20 ڿ ̰ ߻ Ҽ ȯ Ƽ ׾ȿ ϴ ZENITH20 2ӻ ߰, 7 ZENITH20 ȣƮ 7 Ȯߴ.

Ʈ ZENITH20 ۷ι 2ӻ ù ° ȣƮ ȿ򰡺 Ű ߴٰ . ù ° ȣƮ ġ ִ EGFR (exon) 20 Ҽ(NSCLC) ȯ Ƽ ġȿ ϴ . ǥ Ƽ (ORR) 14.8%(95% CI 8.9%-22.6%) ǵ ǥġ(17%) ġ ϸ ƽ .

ٸ ù ° ȣƮ 2 ǥ ӱⰣ Ϻ ߴٴ ȣƮ2 ȣƮ3 ӻ غϴٴ ´.

Ѿ Ƽա ۷ι ӻ ...NASHġ ӻ

  Ѿ
2Ⱓ Ѿ൵ ۷ι ӻ 뿡 . Ѿ 2017 ༺ũȯġ(ι̿ĸ) ׾ Ƽ(Ἶ) ü߰ ؿ NASHġ 2 渮 ΰӿ ߴ.

Ƽ ۷ι ӻ . Ƽ Ǽڼü(EGFR) Ҽ ȯ 1 ġ Ǵ EGFR T790M Ҽ ȯ 2 ġ ǥġ.

Ѿ 2017 11 Ἶ ̿ؿ Ƽ ߴ. Ѿ ȯ ǹ 5000޷ ޾Ҵ. ȭ ϸ ܰ躰(Ͻ) ִ 12500޷ Ȯϴ ̴.

Ἶ 7 6 FDAκ Ƽ ۷ι 1ӻȹ ιް, 11 ߴ. 9 ü ׾ü 'JNJ-61186372' ۷ι 1ӻ ȹ ϸ鼭 Ƽհ JNJ-61186372 ߰ϰ ڸ Ը ÷ȴ. ñ Ϻ Ҽ ȯ Ƽհ JNJ-61186372 ϴ 1ӻ Ӱ ߴ.

Ƽ ӻ3󿡵 ߴ. 12 ǰǾǰóκ Ƽ Ȥ ƼϺ ȿ ϴ ӻ3 ȹ ι޾Ҵٰ . 迡 ϴ ѱ ʷ εƴ.

NASHġ ߴܰ ɼ ȴ. Ѿ 1 渮 ڿü 氣(NASH) ġḦ 2 ๰ǥ ۿϴ žĺ ̼ üߴ. Ը ִ 78500޷. 1500޷, 77700 ޷ , 㰡 ⿡ ܰ躰 Ͻ̴. Ѿ ĺ Ž ܰ迡 Ѱ ̸ ĺ ߱ .

7 ΰӿ NASH ġϱ մܹ ѱ鼭 ȯǹ 4000޷ ޱ ߴ. 4000޷ 1000޷ ӻ ̴. Ͻ Ѿ 87000޷. ӻ ܰ迡 ƴµ, Ϸ ӻ Ǵ ȴ.

Ѿ 2017 7 ̱ ι̿ĸ ༺ũȯġ 'YH14618' ߴܵ Ȳ ƴµ, ӻ簳 ο .

߳, FDA 㰡û ...ƿƼ, ž ߼ӵ

 
̱ ָҸ R&D ຸ. ڴ ̱۷κҸ-(IVIG-SN) 10% FDA 㰡 ûϰڴٴ ǥߴ.

IVIG-SN õ 鿪, 鿪 پ 뵵 Ǵ ׺ȹ ϳ. 󵵿 5% 10% ȴ.

̹ ڴ IVIG-SN 5% ̱ ⿡ 踦 ִ. ڴ 2015⸻ FDA IVIG-SN 5% 㰡 ûߴ. ̸ 2016 FDA 㰡 2016 11 FDAκ ڷ ޾Ҵ. ڴ 2017 9 ٽ ڷᰡ ߰ 鼭 IVIG-SN 5% 㰡 ƴ.

ڴ IVIG-SN 5% ǰ ̱ 忡 ӻ 10% ǰ ȹ̾. 5% ǰ 㰡 强 ū 10% ǰ ̱ 忡 ڴٴ ̴. IVIG-SN 10% ̱ ӻ3 ܰ谡 ̴.

ǰ λ Ͷ ؿܽ ȭ ȴ. 2012 㰡 Ͷ 迡 ° ߵ ı ġ. '2 ڴٴ' Ҹ ı 10~15 1 ߻ϴ ˷ ȯ̴. Ͷ 3б 141 ø ½屸ϰ ִ. Ⱓ 138 .

Ͷ ߱ 㰡 ɼ ´. ڴ ۳ 1 ߱ ĵ긮 Ͷ üߴ. ĵ긮 7 ߱ ǰ Ͷ ǰ㰡 ûߴ. ̸ ݱ ߱ 㰡 ް Ϲݱ ߸Ű .

ڴ ICV Ͷ Ϻ ⵵ ŸѴ. ڴ Ϻ Ŭ(Clinigen K.K.) ͶICV ξ. Ͷ ICV Ӹ ̽ ๰ ǿ ϴ ο ̴. ڴ 1б⿡ Ͷ ӻ Ϸϰڴٴ ǥ.

  ƿƼ
ƿƼ ž ȴ. ƿƼ 2016 12 ֺ ̿ũ ü MerTK DA-4501 ӻ յΰ ִ.

MerTK MerTK(MerTyrosine Kinase) ܹ Ȱ ν 鿪ý Ȱ ο 鿪׾. ƿƼ ĺ Ž ܰ迴 DA-4501 DZ ѱ鼭 4000޷ ޾Ҵ. ӻ 簡 ϰ, ӻ󰳹, 㰡, Ǹ ܰ ֺ ϴ ̴

ƿƼ 4 ̱ȸ(AACR 2019) DA-4501 ǥߴ. MerTK ȣ ׾ϸ鿪 Ѵٴ ȴ. MerTK TAM е ̼ȯ濡 ׾ Ȱ ִٴ ɼ ߴ.

ƿƼ õǾǰ ȭ ܰ迡 ϰ ִ. ƿƼ 2018 1 ̱ κ ĸƼý 索Ű溴ġ DA-9801 üߴ. ƿƼ DA-9801 ӻ2 ġ ξ. ƿƼ κ ༺Űȯġ DA-9803 絵 üߴ.

DA-9801 ä õǾǰ 索Ű溴ġ ๰̴. DA-9803 Ÿƹз̵ ϰ Ű޹ Ű Ű漼 ȣ ȿ õǾǰ̴.

DA-9801 ̱ 3ӻ ´. κ 索Ű DA-9801 ߰ϸ鼭 Ը Űڴٴ ȹ̴. 3 3ӻ 2023⿡ ž㰡û(NDA) ϴٰ ٺô.

JW߿, ѿù̿ĸ ֱ ü ü žĺ ۷ι ӻ ȭ 뿡 .

߱۷ι ߸ SK̿ʡ, ָ

ֱ ۷ι 뿡 ߸ŵ Ǿǰ ָȴ.

  ǰ
SK̿ FDA 㰡 2 ž ߻ ȴ.

3 SK̿ ž (ָ) FDA 㰡 ȹߴ. ָ SK̿ ü ĺ ߱ ӻ1 ġ 2011 ĸƼ ǰ̴.

ָ ̱ ۷ι ȭ Ǹ μ ӻ3 Ϸ 2017 12 FDA 㰡 ûߴ. 㰡û 1 3 ޾Ҵ. ۳ 7 ̱ 忡 ø ߸ߴµ, 3б⿡ 100޷ ÷ȴ.

۳ 11 FDA 㰡 ġ ž ǸŰ ۵ ̴. ٸƮ ٸƮ SK̿ FDA 㰡 ๰̴. SK̿ 2 ƺ ׶ǻƽ üߴ. Ը ȯǹ 1 ޷ 53000޷.

  ֺ ǰ
'Ÿ' 2 FDAκ ָ̰ 㰡 ް ۷ι ӵ ִ.

Ÿ Ϲ, DZ ϴ 罺 ۳ 5 'ֺ(Ÿ ̱ ǰ)' ̱ Ǹſ ߴ. 罺 ֺ 彺 20~30% ϰ åϰ Ȱ ̴.

ֺ ̱ 忡 ο ̰ ִ. 罺 2б ֺ ̱ ù 230޷ ߻ߴٰ ߴ. 3б 1320޷ ȮǸ鼭 ̱ 3 ö.

罺 9 Ǿǰû(EMA) Ǹ㰡 鼭 ߸Ÿ ߰ 11 Ʈʻ Ŭ󸮿 ޵(Clarion Medical) ij ǸŸ ߴ.

ƿƼ ٴ Ϻ ġ . ƿƼ ٴ 9 ׽ ̿ùз Ϻ Ļ뵿 Ǹ 㰡 ޾Ҵ. ƿƼ 'DA-3880' ٴ '׽(CKD-11101)' Ϻ JCRĸƼ ŰĸƼ 'JR-131' 㰡 ȹߴ.

׽(ٺƾ-) ̱ Ϻ ڱ⸰ 2 ġ. źȯ Ǵ ׾ȭп ġῡ ȴ.
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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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