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基石药业-B(02616.HK):基石药业首次美国研发论坛在纽约成功举办
格隆汇 01-24 18:38

格隆汇1月24日丨基石药业-B(02616.HK)公告,2020年基石药业美国研发论坛于2020年1月21日在美国纽约市成功举办。通过此次论坛,基石药业的管理层分享了公司成立至今在临床进展、商务拓展、商业化策略及进程等方面所取得的各项重要成就,并介绍了公司目前的管线战略布局。会议期间,中美顶尖学者与关键意见领袖共同探讨了中国肿瘤治疗领域变革发展的最新趋势。

2020年,公司预计在中国大陆及台湾递交针对五个适应症的三个新药上市申请,同时亦计画披露七项重要临床试验资料,这些进展基于抗PD-L1单抗CS1001、RET抑制剂pralsetinib和KIT及PDGFRA抑制剂AYVAKIT™(avapritinib)。公司也将继续以满足中国和全球患者需求为目标,专注开发与商业化创新肿瘤免疫药物及精准药物,进一步完成"管线2.0"创新升级,向成熟的创新平台与商业化阶段转型。未来两至三年内,公司计画将提交针对大约十个适应症的四个新药申请。

基石药业董事长、执行董事兼首席执行官江宁军表示:"中国生物制药正处于转型提升的重要阶段,基石药业是其可喜成果的见证者与推动者一。我们以中国高发癌种及患者需求为出发点,以联合疗法为核心,正高效地推进三十余项临床试验,包括十三项注册临床试验和十四项联合疗法试验。目前本公司正处于从临床研发阶段向商业化公司转型的关键点,非常高兴赵萍在此时作为大中华区总经理和商业运营负责人加入本公司。未来两至三年内,她将全面领导商业化能力的建设,推动多款创新产品在大中华区成功上市。本公司也将借助特有的高效早期临床药物研究平台,计画进一步升级管线,助力中国生物创新走得更远。"

有关基石药业的重点消息包括:基石药业15款肿瘤候选药物中,五款已处于关键性临床后期,且注册性临床试验达13项。公司现阶段已完成了早期产品线和联合治疗的战略布局,以临床开发为引擎,正向商业化阶段转型。2020年,公司预期里程碑最多可达13项。其中包括:

TIBSOVO®(ivosidenib)有望在台湾获批新药上市申请,成为公司管线内首款在大中华区商业化上市的产品。该药将用于治疗IDH1突变的复发难治急性髓系白血病。在中国大陆和台湾递交抗PD-L1单抗CS1001、RET抑制剂pralsetinib和KIT及PDGFRA抑制剂AYVAKIT™(avapritinib)共计五个适应症的新药上市申请,并计划披露以上三款药物共计七项重要临床试验资料。未来两至三年内,公司将有望在大中华地区上市四款创新产品,复盖多个适应症。同时,公司将借助特有的高效研发平台,进一步升级创新管线,确保本公司管线的持续竞争力。

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