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宜明昂科-B(01541.HK)年度淨虧損減少至3.8億元,持續快速推進藥物管線的開發
格隆匯 03-25 22:37

格隆匯3月25日丨宜明昂科-B(01541.HK)公佈年度業績,集團的年內虧損由截至2022年12月31日止年度的人民幣402.9百萬元減少至截至2023年12月31日止年度的人民幣379.5百萬元。研發開支由截至2022年12月31日止年度的人民幣277.3百萬元增加5.3%至截至2023年12月31日止年度的人民幣291.9百萬元,主要由於(i)臨牀試驗開支因臨牀候選藥物的進展而增加人民幣24.9百萬元;及(ii)薪金及相關福利費用因2022年集團的臨牀團隊不斷擴大而增加人民幣12.2百萬元,與集團持續推進及擴大藥物管線的研發工作相符合;部分被臨牀前及CMC開支減少人民幣13.7百萬元(由於(i)若干臨牀前藥物資產的IND申請提交準備的檢測開支減少;及(ii)以股份為基礎的付款減少人民幣9.6百萬元(由於截至2023年12月31日止年度已歸屬的受限制股份數目減少))所抵銷。

報吿期間,持續快速推進藥物管線的開發,包括以下里程碑及成就。核心產品進展:

IMM01(SIRPα-Fc融合蛋白)

2023年1月,我們自國家藥監局獲得Ib/IIa期臨牀試驗的IND批件,以評估IMM01與硼替佐米和地塞米松聯用治療多發性骨髓瘤(MM)。

2023年6月,我們已完成IMM01聯合阿扎胞苷作為高危骨髓增生異常綜合徵(MDS)一線治療的II期臨牀試驗的患者招募。截至2023年12月31日,在51例可評估的患者中,總體緩解率(ORR)為64.7%(33/51),完全緩解率(CRR)為29.4%(15/51)。在已治療≥4個月的患者中,ORR達85.3%(29/34),CRR達44.1%(15/34)。在已治療≥6個月的患者中,ORR達89.3%(25/28),CRR達53.6%(15/28),表明隨着治療持續時間延長,療效不斷增強。

2023年3月,我們已完成IMM01聯合阿扎胞苷作為慢性粒-單核細胞白血病(CMML)一線治療的II期臨牀試驗的患者招募。截至2023年12月31日,在22例可評估的患者中,ORR達72.7%(16/22),CRR達27.3%(6/22)。在已治療≥4個月的患者中,ORR達87.5%(14/16),CRR達37.5%(6/16)。在已治療≥6個月的患者中,ORR達84.6%(11/13),CRR達46.2%(6/13),表明隨着治療持續時間延長,療效不斷增強。

2023年1月19日,我們對IMM01與替雷利珠單抗聯用治療PD-1抑制劑治療後復發或病情有所進展的複發性或難治性(R/R)經典霍奇金淋巴瘤(cHL)患者的II期臨牀試驗的首例患者進行給藥並2023年12月完成II期招募。截至2024年3月1日,在33例可評估的患者中,8例達到完全緩解(CR),14例達到部分緩解(PR),ORR為66.7%,CRR為24.2%。該等結果顯示令人鼓舞的抗腫瘤療效,且耐受性及安全性良好。

2023年11月,FDA已授予IMM01聯合阿扎胞苷治療CMML的孤兒藥資格認定。

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