{"id":"Z02","lang":"zh","question":"藥華藥的 BESREMi 是治療什麼疾病？美國已核准哪些適應症？","answer":[{"text":"BESREMi（ropeginterferon alfa-2b-njft）在美國已核准用於成人真性紅血球增多症（PV）與成人原發性血小板增多症（ET）。","fact_ids":["f1","f2"]},{"text":"FDA 2026 年 8 月修訂仿單將其列為 interferon alfa-2b，並把 ET 列為當月新增的適應症。","fact_ids":["f3","f4"]}],"facts":[{"id":"f1","claim":"美國核准適應症：PV","value":"成人真性紅血球增多症","as_of":"2026-08","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf","quote":"adults with polycythemia vera","date_precision":"month"},{"id":"f2","claim":"美國核准適應症：ET","value":"成人原發性血小板增多症","as_of":"2026-08","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf","quote":"adults with essential thrombocythemia","date_precision":"month"},{"id":"f3","claim":"藥物類型","value":"interferon alfa-2b","as_of":"2026-08","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf","quote":"BESREMi is an interferon alfa-2b","date_precision":"month"},{"id":"f4","claim":"仿單適應症變更","value":"ET 適應症於 08/2026 更新","as_of":"2026-08","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf","quote":"Essential Thrombocythemia (1.1) 08/2026","date_precision":"month"}],"undisclosed":{"text":"本卡核對的公開仿單沒有揭露其他適應症未來取得美國核准的確定日期。","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf","as_of":"2026-10-22","quote":"INDICATIONS AND USAGE","scope":"Only the specific primary documents cited in this card were checked; absence is not a claim about all public disclosures."},"verified_at":"2026-10-22","coverage":"answered"}