《大行報告》匯豐研究降和黃醫藥(00013.HK)目標價至30.4港元 料新藥美國審批受阻已被市場反映
匯豐研究發表報告,指美國食品藥物管理局(FDA)本月初拒絕和黃醫藥(HCM.US)(00013.HK)旗下索凡替尼(surufatinib)新藥上市申請(NDA),要求有進一步的多地區臨牀測試(MRCT)以支持在美國上市;進展遜市場預期。該行因此自預測模型剔除索凡替尼2022至2024年海外收入貢獻,並削減海外銷售峯值估算,因海外上市延遲及全球競爭加劇。和黃醫藥5月以來股價大跌,並大幅跑輸同期恆生香港生科指數表現(後者月內累跌約13%)。
該行料負面消息已反映於股價,現時估值未反映公司後期階段資產。該行將和黃醫藥今年至2024年盈測降2%至19%,倫敦上市股份目標價由450便士降至300便士,評級「買入」。予美股及H股目標價分別降至19.5美元及30.4港元。
索凡替尼是一種新型的口服酪氨酸激(酉每)抑制劑,具有抗血管生成和免疫調節雙重活性。報告稱,FDA未有披露詳情,但估計失敗原因是絕大部分腫瘤症狀,FDA也要求進行MRCT。神經內分泌瘤(NETs)在多個地區及不同種族人口之間都有被發現,中國第三階段測試及小型過橋研究不足以代表美國整體病患人口。即使FDA在兩年前NDA前會議認可和黃醫藥在美國進行小型過橋研究,但形勢已改變,認爲FDA對依賴單一國家數據的海外NDA審查更加嚴格。此外,其美國小型過橋研究或未完全反映美國神經內分泌瘤患者的種族、類別及先前醫療程序分佈。
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