Merck, KEYTRUDA QLEX 피하주사 FDA 승인 획득

문서에 따르면 Merck는 KEYTRUDA의 모든 고형암 적응증에 대해 KEYTRUDA QLEX 피하주사 제형의 FDA 승인을 받았습니다. 기존 정맥주사용 생물의약품을 피하주사용 제형으로 전환한 것으로, 승인된 적응증은 변경하지 않고 동일 자산의 투여 옵션을 확장한 것입니다.

핵심 사실

제출: 2025년 10월 30일 AM 10:40
이벤트: FDA 승인
방향: 긍정적
기업: MRKMSD
자산: pembrolizumab
출처: SEC 8-K
신뢰도: 출처 확인
N: 1841
p: 0.0003
CI: 0.59-0.87
HR: 0.72
24mo DFS: 81% vs 74%

출처 발췌

EX-99.1 2 tm2529620d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 - 1 - News Release Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2025 Financial Results - Total Worldwide Sales Were $17.3 Billion, an Increase of 4% From Third Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 3% o KEYTRUDA Sales Grew 10% to $8.1 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 8% o WINREVAIR Sales Were $360 Million; Growth of 141% Both Nominally and Excluding the Impact of Foreign Exchange o CAPVAXIVE Sales Were $244 Million o GARDASIL/GARDASIL 9 Sales Declined 24% to $1.7 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 25% o Animal Health Sales Grew 9% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 7% - GAAP EPS Was

SEC 8-K