复星医药(02196.HK):天津星魅获Raziel许可在中国独家临床开发和商业化RZL012
格隆汇 9 月 17日丨复星医药(02196.HK)公告,上海复星医药(集团)股份有限公司(以下简称“公司”)参与投资的天津星魅生物科技有限公司(以下简称“天津星魅”)获得Raziel Therapeutics(RT)Ltd.(以下简称“Raziel”)许可在区域内(即中国大陆及港澳台地区,下同)及领域内(即美容领域或美容适应症,下同)独家临床开发和商业化其产品RZL012(以下简称“RZL012”或“产品”)(以下简称“次合作”或“次许可”)。
目前,RZL012已在美国开展临床研究的适应症主要包括美容、治疗两大类。截至公告日,美容适应症中,针对腹部塑形的IIa期临床研究已完成、针对下巴塑形的IIa期临床研究正在进行中;治疗适应症中,针对痛性脂肪综合症、脂肪瘤及脂肪水肿的IIa期临床研究已完成,其中,RZL012针对痛性脂肪综合症已获得美国食品药品管理局(以下简称“美国FDA”)孤儿药认证,并正在开展IIb期临床研究。
RZL012仍需按相关试验方案和美国FDA要求完成后续以及其他临床试验后,方可向美国FDA提交新药上市申请。
根据国内外新药研发经验,新药研发均存在一定风险,例如临床试验可能会因为安全性和/或有效性等问题而终止。针对前述已开展临床研究的适应症及/或领域内其他适应症的临床试验能否全部完成、产品能否获得美国药品监管机构最终上市批准,尚具有不确定性。
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