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๐Ÿ“ˆ ๋ˆ์ด ๋˜๋Š” ๋‰ด์Šค๋ฅผ ์ฐพ์•„๋“œ๋ฆฝ๋‹ˆ๋‹ค.
์˜ค๋ฅผ ์ฃผ์‹์„ ๋ฐœ๊ตดํ•˜๊ณ  ๊ณต์œ ๋“œ๋ฆฝ๋‹ˆ๋‹ค.๐Ÿ”ฅ

์œ ๋ฃŒ ๋ฉค๋ฒ„์‰ฝ ๋ฌธ์˜ ๐Ÿ‘‰ https://t.me/QnA_inquiry

๋ชจ๋“  ์ •๋ณด๋Š” ํˆฌ์ž ๊ถŒ์œ  ๋ชฉ์ ์ด ์•„๋‹ˆ๋ฉฐ
ํ•ด๋‹น ๊ฒŒ์‹œ๋ฌผ์˜ ๋‚ด์šฉ์€ ๋ถ€์ •ํ™•ํ•  ์ˆ˜ ์žˆ์Šต๋‹ˆ๋‹ค.
๋งค๋งค์— ๋”ฐ๋ฅธ ์†์‹ค์€ ๊ฑฐ๋ž˜ ๋‹น์‚ฌ์ž์˜ ์ฑ…์ž„์ž…๋‹ˆ๋‹ค
ํ•ด๋‹น ๊ฒŒ์‹œ๋ฌผ์˜ ๋‚ด์šฉ์€ ์–ด๋–ค ๊ฒฝ์šฐ์—๋„ ๋ฒ•์  ๊ทผ๊ฑฐ๋กœ ์‚ฌ์šฉ๋  ์ˆ˜ ์—†์Šต๋‹ˆ๋‹ค.
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#๋Œ€์™•๊ณ ๋ž˜ ์ •๋ถ€์ฃผ๋„ ํ…Œ๋งˆ

์ถ”์„์ดํ›„๋กœ๋„ ๋ชจ๋ฉ˜ํ…€์ด ์ด์–ด๊ฐ€๋Š” ์ด์Šˆ

์ถ”์„ ์ „ํ›„(FOMC๊ฐ€ ์žˆ์œผ๋‹ˆ๊นŒ) ํ•˜๋ฝ์„ ๊ธฐํšŒ๋กœ ๋ณด๊ณ  ์ ‘๊ทผ
์Œ๋ฐ”๋‹ฅ์ธ๊ฐ€? ์งœ์žฅ๋ฉด ๋จน์—ฌ์ฃผ๋Š”๊ฑด๊ฐ€...?
Forwarded from Pluto Research
๋‚ด์—ฐ๊ธฐ๊ด€์œผ๋กœ ํšŒ๊ท€๋ฅผ ์ค€๋น„ ์ค‘์ธ OEM๋“ค
#CCS

ํฌ์Šค์ฝ”์ธํ„ฐ, ์ธ๋„๋„ค์‹œ์•„ ํ•ด์ƒ ํƒ„์†Œ ํฌ์ง‘ยท์ €์žฅ ์‚ฌ์—… ์ง„์ถœ

https://www.theguru.co.kr/news/article.html?no=77043
๐Ÿ‘4
์˜ค๋ฌผํ’์„  ๊ด€๋ จ์ฃผ๋กœ ๊ณต๊ฐ„ ๋ณด์•ˆ ํ…Œ๋งˆ๋กœ ๋ฌถ์ธ #์นดํ‹ฐ์Šค
ํ˜„๋Œ€์ฐจ ์ตœ์žฅ์ˆ˜ 1์ฐจ ๋ฒค๋” ํ˜„๋Œ€๊ณต์—…, ๋งค๊ฐ ์ถ”์ง„

https://v.daum.net/v/20240909103138597
๐Ÿ‘4
#๋Œ€๋ด‰์—˜์—์Šค ์žฌ๋ฃŒ ์ข‹๋‹ค..

๋Œ€๋ด‰์—˜์—์Šค๊ฐ€ GLP-1 ์œ ์‚ฌ์ฒด ๋น„๋งŒ ์น˜๋ฃŒ์ œ ์ฃผ์„ฑ๋ถ„์ธ '๋ฆฌ๋ผ๊ธ€๋ฃจํƒ€์ด๋“œ'๋ฅผ ์ƒˆ๋กœ์šด ํ•ฉ์„ฑ ๋ฐฉ์‹์œผ๋กœ ๋งŒ๋“œ๋Š”๋ฐ ์„ฑ๊ณตํ–ˆ์œผ๋ฉฐ ์ตœ๊ทผ ์ธ๋„ ์ œ์•ฝ์‚ฌ์™€ ํ•ด๋‹น ๋ฆฌ๋ผ๊ธ€๋ฃจํƒ€์ด๋“œ ์œ„ํƒ๊ฐœ๋ฐœ์ƒ์‚ฐ(CDMO) ๊ณ„์•ฝ์„ ์ถ”์ง„ํ•˜๊ณ  ์žˆ๋‹ค.


https://news.mtn.co.kr/news-detail/2024090907520441573?sn=123
์˜ค๋ฅผ ์ฃผ์‹(GoUp)๐Ÿ“ˆ - ๋‰ด์Šค/์ •๋ณด/์ฃผ์‹/๊ฒฝ์ œ/์ •์น˜/์ฝ”์ธ
#๋Œ€๋ด‰์—˜์—์Šค ์‚ฌ์—…๋ณด๊ณ ์„œ ๋ฆฌ๋ผ๊ธ€๋ฃจํ‹ฐ๋“œ ์žฌ๋ฃŒ๋Š” ์žˆ์œผ๋‚˜, ์‹œ์ œํ’ˆ ๋‹จ๊ณ„๋Š” ์•„๋‹ˆ๋ผ๋Š” ๊ฒƒ https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20240516002337
#๋Œ€๋ด‰์—˜์—์Šค ์—ญ์‚ฌ์  ์‹ ๊ณ ๊ฐ€ ๋ŒํŒŒ ๊ฐ€์ฆˆ์•„!

์ง€๋‚œ๋ฒˆ ํšŒ์‚ฌ ๋ถ€์ธ์œผ๋กœ ์ธํ•ด ์ฃผ์ถค๋„ ํ–ˆ์ง€๋งŒ

๋Œ€๋ด‰์—˜์—์Šค๊ฐ€ ํ™”์žฅํ’ˆ ํ…Œ๋งˆ์—์„œ ์ด์ œ๋Š” ํ™•์‹คํ•˜๊ฒŒ ๋น„๋งŒ์•ฝ ํ…Œ๋งˆ์ฃผ๋ผ๋Š” ๊ฒƒ์„ ์ฒ˜์Œ ํ™•์ธํ•œ ์žฌ๋ฃŒ๋กœ ๋ณด์ž„
๐Ÿ‘1
2024.09.09 10:57:34
๊ธฐ์—…๋ช…: ์—์Šคํ‹ฐํŒœ(์‹œ๊ฐ€์ด์•ก: 2์กฐ 157์–ต)
๋ณด๊ณ ์„œ๋ช…: ํˆฌ์žํŒ๋‹จ๊ด€๋ จ์ฃผ์š”๊ฒฝ์˜์‚ฌํ•ญ(์ž„์ƒ์‹œํ—˜๊ฒฐ๊ณผ) (ํƒ„ํ‚ค๋ผ์ œ ํ•ญ์•”์ œ STP1002์˜ ์ œ1์ƒ ์ž„์ƒ์‹œํ—˜ ๊ฒฐ๊ณผ)

* ์ž„์ƒ๋ช…์นญ : ์ง„ํ–‰์„ฑ ๊ณ ํ˜•์•” ํ™˜์ž๋ฅผ ๋Œ€์ƒ์œผ๋กœ STP1002์˜ ์ตœ์ดˆ ์ธ๊ฐ„ ๋Œ€์ƒ ๋‹จ๊ณ„์  ์šฉ๋Ÿ‰ ์ฆ๋Ÿ‰ ์—ฐ๊ตฌ
[First-In-Human Dose-Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors]
* ๋Œ€์ƒ์งˆํ™˜ : ์ง„ํ–‰์„ฑ ๊ณ ํ˜•์•”(๋Œ€์žฅ์•”, ๋น„์†Œ์„ธํฌํ์•”, ์œ„์•”, ์‹ ์žฅ์•”, ๊ฐ„์•”)
* ์ž„์ƒ๋‹จ๊ณ„ : ์ž„์ƒ 1์ƒ

* ์Šน์ธ๊ธฐ๊ด€ : ๋ฏธ๊ตญ FDA
* ์ž„์ƒ๊ตญ๊ฐ€ : ๋ฏธ๊ตญ

* ์‹œํ—˜๋ชฉ์  : 1์ฐจ ๋ชฉ์ :
- ์ง„ํ–‰์„ฑ ๊ณ ํ˜•์•” ํ™˜์ž์—์„œ ์ตœ๋Œ€ ๋‚ด์•ฝ์šฉ๋Ÿ‰(MTD)์„ ์ •์˜ํ•˜๊ณ  ์ž„์ƒ2์ƒ ๊ถŒ์žฅ์šฉ๋Ÿ‰(RP2D)์„ ๊ฒฐ์ •ํ•˜์—ฌ STP1002์˜ ์•ˆ์ „์„ฑ ๋ฐ ๋‚ด์•ฝ์„ฑ์„ ํ‰๊ฐ€ํ•จ

2์ฐจ ๋ชฉ์ :
- ์šฉ๋Ÿ‰ ์ œํ•œ ๋…์„ฑ(DLT), ๋ฏธ๊ตญ ๊ตญ๋ฆฝ์•”์—ฐ๊ตฌ์†Œ ๋ถ€์ž‘์šฉ ๊ณตํ†ต ์šฉ์–ด ๊ธฐ์ค€(NCI-CTCAE) ๋ฒ„์ „ 5.0์— ๋”ฐ๋ฅธ ๋ถ€์ž‘์šฉ(AE)์˜ ๋ฐœ์ƒ, ์œ ํ˜• ๋ฐ ์ค‘์ฆ๋„ ๋“ฑ๊ธ‰, ์น˜๋ฃŒ๋กœ ์ธํ•œ ๋ถ€์ž‘์šฉ(TEAE), ์‹ฌ๊ฐํ•œ ๋ถ€์ž‘์šฉ(SAE), ์‚ฌ๋ง ๋ฐ ์‹คํ—˜์‹ค ๊ฒ€์‚ฌ ์ธก๋ฉด์—์„œ ๋‹ค์–‘ํ•œ ์šฉ๋Ÿ‰์˜ STP1002 ๋‹จ๋… ์š”๋ฒ•์„ ํ‰๊ฐ€ํ•จ.
- ์ง„ํ–‰์„ฑ ๊ณ ํ˜•์•” ํ™˜์ž์—์„œ STP1002์˜ ์•ฝ๋™ํ•™(PK)์„ ์ธก์ •ํ•จ.
- ๊ฐ๊ด€์ ์ธ ๋ฐฉ์‚ฌ์„  ์‚ฌ์ง„ ํ‰๊ฐ€๋ฅผ ํ†ตํ•ด STP1002์˜ ํ•ญ์ข…์–‘ ํ™œ์„ฑ์„ ๊ด€์ฐฐํ•˜๊ณ  ๊ธฐ๋กํ•จ.
* ์ž„์ƒ๋ฐฉ๋ฒ• : ์ง„ํ–‰์„ฑ ๊ณ ํ˜•์•” ํ™˜์ž๋ฅผ ๋Œ€์ƒ์œผ๋กœ STP1002์˜ ์•ˆ์ „์„ฑ, ๋‚ด์•ฝ์„ฑ ๋ฐ ์•ฝ๋™ํ•™(PK)์„ ํ‰๊ฐ€ํ•˜๊ณ  ์ตœ๋Œ€ ๋‚ด์•ฝ์šฉ๋Ÿ‰(MTD)์„ ๊ฒฐ์ •ํ•˜๊ธฐ ์œ„ํ•œ ์˜คํ”ˆ ๋ผ๋ฒจ, ๋‹ค๊ธฐ๊ด€, ์šฉ๋Ÿ‰ ์ฆ๋Ÿ‰ ์—ฐ๊ตฌ

* ์ž„์ƒ๊ฒฐ๊ณผ
์šฉ๋Ÿ‰์ œํ•œ๋…์„ฑ๋ฐ˜์‘์ด ๊ด€์ฐฐ๋˜์ง€ ์•Š์•„ ์ตœ๋Œ€ ๋‚ด์•ฝ์šฉ๋Ÿ‰์ด ์„ค์ •๋˜์ง€ ์•Š์•˜์ง€๋งŒ, SMC(์•ˆ์ •์„ฑ๋ชจ๋‹ˆํ„ฐ๋ง์œ„์›ํšŒ) ํšŒ์˜์—์„œ ๋ชจ๋“  ์ฝ”ํ˜ธํŠธ์— ๋Œ€ํ•œ ํ†ต๊ณ„๋ถ„์„ ๊ฒฐ๊ณผ์™€ ์•ฝ๋™ํ•™ ๋ฐ์ดํ„ฐ๋ฅผ ๋ฐ”ํƒ•์œผ๋กœ SMC ์œ„์›๋“ค์˜ ์˜๊ฒฌ์„ ์ˆ˜๋ ดํ•˜์—ฌ MTD์™€ RP2D๋ฅผ ๊ฒฐ์ •ํ•˜์˜€์Œ.
- ์ตœ๋Œ€ ๋‚ด์•ฝ์šฉ๋Ÿ‰(MTD): 360 mg
- ์ž„์ƒ2์ƒ ๊ถŒ์žฅ์šฉ๋Ÿ‰(RP2D): 360 mg

* ๊ธฐํƒ€ํˆฌ์žํŒ๋‹จ ๊ด€๋ จ์‚ฌํ•ญ

- ์ƒ๊ธฐ์˜ ์‚ฌ์‹ค๋ฐœ์ƒ(ํ™•์ธ)์ผ์€ ๋ฏธ๊ตญ ๋™๋ถ€ ์‹œ๊ฐ 9์›” 6์ผ ์ž„์ƒ CRO๋กœ๋ถ€ํ„ฐ ์ž„์ƒ์‹œํ—˜ ๊ฒฐ๊ณผ๋ณด๊ณ ์„œ (CSR, Clinical Study Report)๋ฅผ ์ „๋‹ฌ๋ฐ›์€ ๋‚ ์ž„.
- ๋ณธ ๊ณต์‹œ ๋‚ด์šฉ์€ ํ–ฅํ›„ ๋‹น์‚ฌ์˜ ๋ณด๋„์ž๋ฃŒ ๋ฐ IR์ž๋ฃŒ๋กœ ์‚ฌ์šฉ๋  ์˜ˆ์ •์ž„.


๊ณต์‹œ๋งํฌ: https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20240909900069
ํšŒ์‚ฌ์ •๋ณด: https://finance.naver.com/item/main.nhn?code=237690
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