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信達生物(01801.HK)抽高逾16% 瑞銀引述信達生物料今年達收支平衡及重申為行業首選
阿思達克 06-04 10:51
信達生物(01801.HK)今早(4日)高開近6.1%後節節上升,盤中高見76.95元一度彈高18.3%,最新報76.1元抽高近17%,成交額26.9億元。信達生物去年虧損收窄至9,463萬人民幣。瑞銀周一(2日)發表報告引述信達生物料今年達收支平衡,公司優先考慮與跨國公司合作開發「PD-1/IL-2a」的全球市場,該行重申其為行業首選,維持「買入」評級及為行業首選。此外摩根大通發表近日報告指,信達生物旗下PD-1/IL-2alpha-bias雙特異性抗體融合蛋白產品IBI363及和重組人源抗CLDN18.2偶聯物(ADC)IBI343最新研究數據都令人鼓舞,認為兩款藥物擁有較大潛力。 瑞銀發表報告表示,信達生物管理層近日參與了該舉行亞洲投資者會議,公司維持2027年產品銷售額200億人民幣的指引(生物仿製藥佔比低於10%),並預計2025年實現盈虧平衡。該行注意到投資者主要關注腫瘤領域的IBI363(PD-1/IL-2a)和ADC,以及非腫瘤領域的GLP-1資產。該行指即將推出的關鍵產品的批准時間表未變,例如馬杜單抗(GLP-1/GCG)預計於2025年上半年獲批,皮卡尼單抗(IL-23)預計於2025年底/2026年上半年獲批。 腫瘤領域:PD-1/IL-2a將在中國啟動兩項三期試驗;信達對IBI363在2025年ASCO會議上的數據表示樂觀,並提到口頭報告中將有更多更新細節。管理層強調IBI363在「冷腫瘤」(如黑色素瘤和結直腸癌,CRC)中的潛力,這些腫瘤對傳統免疫療法(I/O)無反應,適用於I/O失敗的腫瘤及PD-L1<1%的患者。公司已於2025年首季啟動IBI363在I/O初治黑色素瘤的首個關鍵試驗(與Keytruda頭對頭比較),並計劃2025年啟動兩項三期試驗,分別針對I/O失敗的鱗狀非小細胞肺癌(sqNSCLC)和三線結直腸癌。IBI363在首線非小細胞肺癌(NSCLC)和首線結直腸癌的二期試驗正在進行,公司發展策略是從後線治療推進到前線治療。公司還優先考慮與跨國公司合作開發IBI363的全球市場。 關於ADC,信達強調:(1)IBI343(CLDN18.2 ADC)三線胃癌的首個三期全球多中心試驗(MRCT)正在中國和日本招募患者;(2)DLL3 ADC(已授權給Roch)一期試驗在中國、美國和澳洲進展順利;(3)全球首創的CEACAM5雙載荷ADC已招募首名患者。 非腫瘤領域方面,CVM銷售進展順利;公司預計馬杜單抗(GLP-1/GCG)用於肥胖治療將於2025年上半年獲批,定價將介於塞美格魯(月太)和替澤帕(月太)之間。 瑞銀料信達生物2025年扭虧為盈,料錄純利5.54億人民幣,對比2024年虧損近9,500萬人民幣,料2026年及2027年錄純利各17.23億及36.19億元人民幣,料信達生物2025年至2026年每股盈利(攤薄)為0.34元及1.05元人民幣。
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