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院士曝丹参滴丸三期临床失败 业内人士力挺:基本事实没错

2017-09-19 16:18:59   中国经济网

中国网财经记者查阅天士力2016年年度报告,在产销量情况分析表一栏中显示:复方丹参滴丸(盒)销售量达1.3亿。而中康CMH监测数据显示,2015年度冠心病中成药市场内服用药十大品牌中,天士力位居第一位。天士力则公告称“公司主打产品为复方丹参滴丸,系公司独家产品,多年来凭借良好的疗效、创新的剂型和稳定的消费群体在市场占有率和单产品产销规模方面稳居同行业前列。”

多篇质疑文章被删

天士力回应公告截图

对于“为什么要进行增补试验”,中国网财经记者询问天士力相关人士,给出的答复是, “试验目的不是为了重新做Ⅲ期临床试验,而是再验证一下第六周漂亮的临床结果能够再次重现。”

而一位业内人士认为,获得FDA批准做临床试验并不难,但跟批准上市却相差十万八千里。“这就好比参加高考,第一志愿填的北大跟考上北大差的远了。” 这位业内人士分析,天士力“复方丹参滴丸”在美国申请上市,并不一定是打算在美国进行销售,“在美国申请上市无非是为了在天津当地或国内获得一些优惠政策,或者得到科研上的支持;其次把申请上市当做卖点提高药品销售量。”“到处跟人说到美国申请上市,给人的印象是,这家企业的药品很厉害。”

中国网财经记者了解到,早在2009年2月,李连达就曾通过论文公开指出,由天士力生产的复方丹参滴丸不良反应发生率高达3.1%,且天士力公司未做过长期毒性试验。

天士力公告回应称,李连达对天士力核心产品复方丹参滴丸的攻击引发了人们巨大的恐慌,导致天士力股价急骤下跌乃至被迫停牌等一系列连锁反应。彼时,复方丹参滴丸的FDA项目正按计划在美国5个临床中心进行二期临床试验。2014年,天士力将李连达诉至法院,天津市高级人民法院判定天士力胜诉,对复方丹参滴丸存在质疑的李连达被要求停止发表相关评论,向天士力道歉,并赔偿经济损失30万元。李连达则在个人博客上表示“人民的眼睛是雪亮的”。

2015年5月,李连达在博客上发表《奇案两例共欣赏》讽刺此事,有网友留评质疑网站删除李连达有关天士力复方丹参滴丸的文章,如《复方丹参滴丸不良反应争论的关键》、《中药说明书需要进一步改进、规范化(评复方丹参滴丸说明书)》等。

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