康宁杰瑞(09966.HK)公布2020年度业绩:药物产品管线取得重大进展 研发开支大增99%
格隆汇3月24日丨康宁杰瑞制药-B(09966.HK)公布截至2020年12月31日止年度业绩,公司其他收入达人民币1.11亿元,同比增长223%,主要由于利息收入及政府补助收入大幅增加。期间研发开支达人民币3.31亿元,同比大幅增长99%,此乃主要由于正在进行的临床试验数目增加;临床研究规模的扩大;公司候选药物的临床试验进展;及研发人员增加令员工成本增加所致。
自2020年4月13日以来,公司在药物产品管线及业务经营方面取得了重大进展。KN046已在澳大利亚及中国进行临床试验并于2020年进入关键性试验阶段。目前,有大约20项涵盖10多类肿瘤(包括NSCLC、胰腺癌、HCC、三阴乳腺癌、食管鳞状细胞癌及胸腺癌)处于多个阶段的临床试验。该等临床试验的结果已初步显示KN046具有良好安全性及可观疗效。
目前,公司高度差异化的内部管线由15种肿瘤单克隆抗体及双特异性抗体,及1种新型冠状病毒多功能抗体组成。在公司的管线产品中,公司有一种已提交生物制品许可申请、三种处于临床后期阶段,且两至三种计划于2021年提交IND。
此外,江苏康宁杰瑞的新生产基地I期生产线(2x2,000L)已于2020年7月6日取得江苏省药品监督管理局颁发的药品生产许可证。该基地设计总产能超过30,000L,计划未来扩张。
公司表示,疫情过后,公司相信,行业会更加专注于创新治疗用生物制剂的研发并加大投资新生物技术。公司相信,在未来十年,中国创新治疗用生物制剂的研发将推动整个制药行业的发展。集团将继续通过公司独有的药物发现及开发能力,努力为全球患者提供世界级的创新治疗用生物制剂。
为实现这一宗旨,公司将致力于推进集团产品管线的临床开发,包括采用最快╱最先上市的方法开发用于治疗各类主要癌症适应症及经选定适应症的KN046。公司亦将在KN026临床开发计划中策略性地着重HER2表达癌症。
同时,凭藉公司强大的自主研发能力,公司将进一步推动10种多特异性免疫肿瘤候选药物的前期临床项目,并将凭藉公司的技术平台,发现、验证及选择靶向及先导候选药物,以丰富公司的早期管线,并将重心放在肿瘤免疫治疗双特异性及多特异性药物上。
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