长江生命科技(00775.HK):未有黑色素瘤疫苗商业化时间 若研发成功市场价值庞大
长江生命科技(00775.HK)公布,公司旗下专注於肿瘤免疫学生物制药的美国附属Polynoma的黑色素瘤抗原疫苗免疫疗法研究初始数据正面。
公司副总裁及科学总监杜健明在午宴上表示,目前该黑色素瘤疫苗免疫疗法正进行美国食品及药物管理局(FDA)的第三阶段临床试验,中期数据显示参与试验患者有良好耐受性,使用疫苗的第二B/C期黑色素瘤患者的复发风险,较服用安慰剂的患者为低,有望为早期黑色素瘤患者提供新的辅助性疗法选择。
另一副总裁及营运总监余英才则指,公司研究黑色素瘤疫苗已有十年八载,现时正筹备与FDA开会讨论中期结果,及商讨下一步试验结构等计划。目前疫苗的第三阶段临床试验尚未完成,未能确定疫苗价格、面世及商业化时间等,但估计若可通过临床及监管批准等,或需时数年才可推出。
余氏举例现今市场上用於第三或四期黑色素瘤之药物,患者一年洗费约需12万美元,且用於後期患者的药物毒性及副作用大,难以采用於早期患者。公司是次之研发为市场暂时唯一的黑色素瘤免疫辅助疗法疫苗,用於二期患者的副作用亦较少。而全球每年约有35万宗黑色素瘤病例,近6万人因此死亡,黑色素瘤疗法的环球市场估值逾10亿美元,预计未来五年将以倍数增长,相信如研发成功,市场价值及商机庞大。
他又提到,该疫苗为公司目前最成熟的研究之一,除黑色素瘤外,公司现时亦正研究发展其他癌症疫苗,包括聚焦亚洲病例较多的肝癌等。另外,如是次研发未来有更好发展,他称公司或考虑在长实集团(01113.HK)旗下位於新界古洞的用地扩充研发基地。而公司每年用於研发的开支约1.6亿至1.8亿元,平均分布於不同项目,相信公司花费在科研的费用足以支持黑色素瘤疫苗项目未来的开支。 ~
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