What makes a drug company “innovative”? This is a term that regularly gets tossed around in the biopharma industry—a high-risk, high reward sector wherein a promising experimental treatment in the early stages may ultimately prove a commercial bust. A medicine that suggests long-term value may not pan out over the course of the clinical trial process or even win Food and Drug Administration (FDA) approval; a larger sample of patients might not respond to the therapy in the same way a smaller, more selective sample size does, for example.

In an uncertainty-laden industry, IDEA Pharma has come up with one set of metrics to gauge which drug makers are succeeding. And the firm’s latest “Pharmaceutical Innovation Index,” (PII) released, suggests that AstraZeneca, Gilead, and Johnson & Johnson were on the upswing in the past year.

Those three companies took the top spots in the new PII report. Of the three, AstraZeneca gained the most by far compared to IDEA’s 2017 rankings. In fact, AZ rose a staggering 14 places on the list this year (Gilead and J&J both rose by one spot, Novartis by 9, while biotech giant AbbVie sank three rungs).

“The biggest shaker this year is AstraZeneca, coming from the middle of the pack in 2017 to take the 2018 PII Crown,” wrote the report authors. “Gilead also continued their PII ascent, becoming the runner-up in 2018, advancing from 2017’s 3rd. Johnson and Johnson, having ceded the top spot last year after a 4 year run on top, was able to regain some of the lost ground in 2018, landing in a joint 3rd spot with a rapidly-improving Novartis.”

That’s a pretty significant shuffling of the deck. So just how did IDEA come to these conclusions? A lot of the firm’s methodology has to do with how much time it takes to advance a therapy all the way through the regulatory process, from experimental molecule to market. Less than 10% of all drug candidates make it from phase one human trials to approval, according to the Biotechnology Innovation Organization (BIO) trade group. One of the biggest innovation bottlenecks is the progression from mid-stage phase two trials to large-scale phase three studies, which clocked in a success rate of just 31% between 2006 and 2015.

AstraZeneca was able to improve its standing in IDEA’s list through promising clinical data for its experimental drug pipeline and a number of new products that recently hit the market. These regulatory successes are mirrored strongly with a myriad of clinical trial success and advancement. “AstraZeneca managed to launch five significant new medicines in 2017, across their primary therapy areas,” which include cancer and lung diseases, write the report authors. “Based on key internal guidance, the company has narrowed their R&D focus to provide deeper results from their prioritized therapeutic areas, most notably oncology.”

These rankings weigh the “freshness” of new products quite heavily, as IDEA notes.

怎样的一家制药公司才算足够“创新”呢？这在生物制药行业是一个老生常谈的话题。毕竟这个行业是高风险高回报的，一种在前期貌似很有前途的疗法搞了好几年，最后投在研发上的钱都打了水漂的例子简直不要太多。一种据称有长期价值的药品可能会毁在临床测试阶段，甚至永远拿不到药监局的批文。还有的药品可能在小范围测试表现不错，但一旦扩大了样本库却突然发现，它对广大患者又没效果了。

对这样一个充满不确定的行业，有一家叫做IDEA Pharma的公司发明了一组指标，可用于衡量哪些制药公司在创新上做得最成功。该公司正式发布了今年的“制药业创新指数”（PII），从指标上看，阿斯利康、吉利德、强生分列制药业创新排行榜的三甲。

在这三甲之中，阿斯利康的创新得分最高，也是创新速度最快的。它在这张榜单上的排名比2017年整整提升了14位（吉利德和强生分别提升了一位，诺华提升了9位，而生物制药巨头雅培则下降了3名）。

该报告的作者们指出：“今年最大的搅局者是阿斯利康，它从2017年PII排名的中游上升到了2018年的榜首。吉利德的PII得分也在继续上升，从2017年的季军变成了2018年的亚军。强生则在连续四年夺冠后让出冠军宝座，最终屈居季军。同时，诺华的进步也非常迅速。”

今年的排名标志着制药业的创新格局正在迅速洗牌。那么IDEA公司是怎样得出以上那些结论的呢？该公司的评价方法主要基于计算每家制药公司花了多少时间推动新药通过监管审批，也就是多久走完从实验室到投放市场的全部流程。据生物技术创新组织（BIO）统计，在从一期临床试验到获得监管审批的过程中，只有不到10%的新药会幸存下来。目前制药公司的最大创新瓶颈往往是在二期临床试验到大规模的三期临床研究之间，很多新药就是因为在这期间无法取得进展而被毙掉。2006年至2015年，在这一阶段能取得成功的新药只有31%而已。

阿斯利康在PII的排名之所以显著上升，是因为它的试验药品的临床数据非常抢眼，且有多款新药最近投放了市场。有这么多新药通过监管审批，且又不少临床试验的成功和进展，都说明这并非偶然。IDEA公司指出：“阿斯利康2017年在各个主要药品领域接连推出５款新药（包括抗癌和肺病药品）。他们根据内部导向缩小了重点研发领域，深耕一些最优先的治疗领域，尤其是在抗癌方面表现突出。”

IDEA公司指出，PII的排名也着重参考了新药品的“新鲜度”。(财富中文网）

译者：朴成奎