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VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
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X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
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UID:evt-jazz-zanidatamab-gea-pdufa-aug2026@catalyst-calendar.local
DTSTAMP:20260720T200617Z
DTSTART:20260825T130000Z
DTEND:20260825T133000Z
SUMMARY:Jazz zanidatamab一线HER2阳性胃食管腺癌sBLA FDA优先审评PDUFA窗口
DESCRIPTION:Jazz Pharmaceuticals的Ziihera zanidatamab联合方案用于一线HER2阳性局部晚期或转移性胃、胃食管结合部或食管腺癌的sBLA获FDA优先审评，PDUFA目标日期为2026年8月25日。\\nImpact score: 67\\nExpected: FDA决定将影响HER2双抗在一线胃癌/GEA治疗中的定位，并对HER2 ADC、双抗和胃癌免疫联合竞争格局产生外溢。\\nAffected: JAZZ(subject\, mixed\, score 82)\; ONC.HK(licensee\, unknown\, score 80)\; ZYM(licensor\, mixed\, score 76)\; ZYME(licensor\, unknown\, score 70)\; RHHBY(peer\, mixed\, score 64)\; BGNE(licensee\, mixed\, score 58)\\nSources: Jazz FDA acceptance and priority review press release: https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0\\nPRNewswire Jazz release mirror: https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-supplemental-biologics-license-application-for-ziihera-zanidatamab-hrii-combinations-in-first-line-her2-locally-advanced-or-metastatic-gea-302753741.html\\nESMO GI 2026 official page: https://www.esmo.org/meeting-calendar/esmo-gastrointestinal-cancers-congress-2026\\nBeOne priority review release: https://ir.beonemedicines.com/news/us-fda-grants-priority-review-to-beone-medicines-tevimbra-in-first-line-her2-gea/2dd4da40-4943-4a0a-ad05-81899dc06d7d\\nBeOne HERIZON-GEA-01 NEJM/ASCO update: https://www.businesswire.com/news/home/20260527389623/en/BeOne-Medicines-Announces-Phase-3-HERIZON-GEA-Data-Published-in-NEJM-and-Presented-at-ASCO-2026\\nJazz FDA acceptance and priority review release: https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0/\\nJazz Q1 2026 results: https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-first-quarter-2026-financial/\\nZymeworks corporate update: https://zymeworks.gcs-web.com/press-releases/\\nFDA prior Ziihera accelerated approval: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanidatamab-hrii-previously-treated-unresectable-or-metastatic-her2\\nZymeworks corporate update: https://www.globenewswire.com/news-release/2026/05/07/3290579/0/en/zymeworks-provides-corporate-update-and-reports-first-quarter-2026-financial-results.html\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-jazz-zanidatamab-gea-pdufa-aug2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,HER2\,胃癌\,双抗\,gastric cancer\,GEA\,bispecific antibody\,zanidatamab\,tislelizumab\,bispecific\,GI oncology\,gastric-cancer
SEQUENCE:0
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DESCRIPTION:Review catalyst preview: Jazz zanidatamab一线HER2阳性胃食管腺癌sBLA FDA优先审评PDUFA窗口
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DESCRIPTION:Complete post-event review: Jazz zanidatamab一线HER2阳性胃食管腺癌sBLA FDA优先审评PDUFA窗口
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