康希诺生物—B(06185.HK)中期综合亏损总额扩大35.3%至6967.7万元不派息
格隆汇8月22日丨康希诺生物—B(06185.HK)发布中期业绩,截至2019年6月30日止6个月,公司尚未将任何产品商业化,因此并未录得任何收入;期内亏损及综合亏损总额6967.7万元人民币(下同),同比扩大35.3%;基本及稀释每股亏损0.38元;不派中期股息。
公告表示,公司的疫苗产品线在战略上旨在针对中国庞大且供不应求的市场,可总结为三个类别:(i)全球创新疫苗(如Ad5-EBOV、在研结核病加强疫苗及在研PBPV),以迎合中国尚未满足的医疗需求;(ii)研发潜在的中国首创疫苗,凭藉质量更高的世界级疫苗取代现时的主流疫苗(如在研DTcP疫苗及在研MCV4);及(iii)研发出与中国市场的进口产品竞争的中国潜在最佳疫苗(如在研PCV13i)。
公司正为12个疾病领域研发15种在研疫苗。除了预防脑膜炎球菌感染及埃博拉病毒病的三项临近商业化疫苗产品之外,有六种在研疫苗处于临床试验阶段或临床试验申请阶段。公司亦有六种临床前在研疫苗,包括一种在研联合疫苗。迄今为止,尚未将任何产品商业化,亦无法保证将能够成功研发及商业化在研疫苗。
迄今为止,公司的生产活动主要限于产品注册目的。目前在天津市拥有并营运一个商业规模的生产厂房,总建筑面积约为3.7万平方米。该设施的设计、建设及运营符合国际标准。公司生产厂房的年原液产能达约7000万至8000万剂,高于按销售收入计中国五大国内民营疫苗企业3000万至5000万剂的平均产能。公司相信,目前的产能完全有能力在可预见的未来支持临近商业化的在研疫苗产品的商业化计划以及支持临床试验材料的生产。
公司的生产厂房配备先进的设备和机械,包括发酵、纯化、结合及超滤、自动包装及灌装设施。公司主要生产设备很多都由领先的国际及国内供应商生产。国家药监局已于生产厂房进行生产及GMP视察。现正进行生产厂房及工艺验证。预期于2019年及2020年年底前分别进行在研MCV2及MCV4的许可证批准前检查。
研发开支方面,研发开支由截至2018年6月30日止六个月的4900万元增加17.6%至期内的5760万元,主要由于对研发人员的员工薪酬1430万元的增加。
未来,公司将继续推进近商业化在研产品走向新药申请批准,并通过内部研发及医疗╱临床团队研发临床试验阶段资产。而且将继续通过内部研发与外部合作发现并研发新的在研疫苗。为支持继续增长,公司计划建立并加强商业化基础设施、扩大营销及商业化团队。公司将继续评估可能的全球合作及对极具潜力的资产的收购。
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