1차 출처 기록
중대신청 접수
Zymeworks: FDA, zanidatamab sBLA 우선심사 수락; PDUFA 2026년 8월 25일
Jazz의 zanidatamab 1차 HER2+ GEA sBLA가 FDA 우선심사로 수락되었으며, PDUFA 목표 조치일은 2026년 8월 25일입니다. 해당 신청은 Breakthrough Therapy Designation도 받았습니다. Zymeworks는 미국 승인 시 2억 5천만 달러, 중국 승인 시 1천 5백만 달러의 마일스톤을 받을 예정입니다.
핵심 사실
출처 발췌
EX-99.1 2 ex991q12026_earningsxrelea.htm EX-99.1 Document Zymeworks Provides Corporate Update and Reports First Quarter 2026 Financial Results • Jazz announced U.S. FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA); PDUFA target action date of August 25, 2026 • China’s NMPA has accepted the sBLA for zanidatamab; the U.S. FDA has granted Breakthrough Therapy Designation to zanidatamab in combination with fluoropyrimidine- and platinum-based chemotherapy (±) TEVIMBRA, for this indication. • Presented new data from our Phase 1 trial of ZW191 at AACR, continuing to support best-in-class potential in ovarian and endometrial cance
