歌禮制藥-B(01672.HK)公佈中期業績 研發開支增加43.1% 有五項臨牀試驗申請獲得中國NMPA批准
格隆匯8月26日丨歌禮制藥-B(01672.HK)發佈公吿,截至2021年6月30日止六個月,公司總收入增加14.8%至約人民幣3650萬元。集團的研發開支增加43.1%至約人民幣7400萬元,主要由於NASH、HBV以及腫瘤候選藥物的臨牀開發開支增加。
於報吿期間及直至本公吿日期,集團有五項臨牀試驗申請(ASC40-NASH、ASC42-NASH、ASC40-複發性膠質母細胞瘤(rGBM)、ASC42-HBV、ASC40-痤瘡)獲得中國NMPA批准及一項臨牀申請(ASC41-NASH)獲得美國食品藥品監督管理局(FDA)的批准。在中國或美國,集團已加快(i)ASC40-rGMB進入III期臨牀試驗;(ii)ASC40-NASH進入IIb期臨牀試驗;(iii)ASC42-HBV及ASC40-痤瘡進入II期臨牀試驗的進程。
自2021年起,集團聚焦於NASH、腫瘤(脂質代謝與口服檢查點抑制劑)和病毒性疾病領域。於2021年,集團取得了另一項重大里程碑式進展:同類第一、可皮下注射PD-L1抗體ASC22(恩沃利單抗)聯合核苷(酸)類似物的中國IIb期臨牀試驗完成149名慢性乙型肝炎患者入組並取得良好中期結果。公司預計於2022年上半年獲得此項臨牀試驗的頂線數據。
此外,於2021年八月,集團宣佈啟動ASC42在中國針對慢性乙型肝炎適應症的II期試驗。公司預期於2022年下半年獲得此項II期試驗的頂線數據。於2021年,集團擴展了新的疾病領域:痤瘡。公司預計於2022年獲得ASC40治療中、重度痤瘡患者的II期臨牀試驗的頂線數據。
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