港股异动 | 歌礼制药-B(01672)午前涨超4% 核心管线ASC30即将启动III期注册临床

智通财经
Apr 24

智通财经APP获悉,歌礼制药-B(01672)午前涨超4%,截至发稿,涨3.46%,报18.82港元,成交额2199.1万港元。

消息面上,歌礼制药此前宣布启动ASC30_39FDC的临床开发,并计划于今年第三季度向美国FDA递交IND申请。东吴证券指出,ASC30是公司自主开发的GLP-1小分子口服/皮下注射双剂型制剂。口服剂型即将向FDA提交III期临床计划,公司预计将在2026年Q3正式启动。按照目前减重临床的入组节奏及治疗周期,预计该临床有望在2028年读出数据。

值得注意的是,智通财经APP在《歌礼制药-B(01672):股价突破前高在即,场外资金为何选择观望?》中指出,礼来Orforglipron已于今年4月1日获FDA批准上市。ASC30以及同礼来架构的口服小分子面对的商业化压力正随着Orforglipron获批而逐渐增大。虽然ASC30的核心优势在于口服便利性、给药频率与患者耐受性等药物层面,但从商业化角度来看,不论是礼来的商业化销售能力还是Orforglipron的市场先行优势,都是现阶段的歌礼与ASC30短时间难以超越的。

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