新药研发经济学

新药研发经济学                                                                                                                                                                                                                                                                                                                        -        新药研发变“烧钱”为“赚钱”                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 1.0 国际创新药研发成本- 10亿还是70亿？                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 提到新药研发，第一时间想到的是10年10亿美金的投入。然而这只是每个成功的新药的成本，如果算上失败的项目，总成本更高- 有数据显示，近15年研发效率最高的诺华，1000亿美元总投入换来22个新药，平均每个新药的成本近50亿美金；而比较背运的AZ，平均每个新药的成本为100多亿美金。再整体计算前十名药厂的战绩，平均成本则为约70亿美金。研发如此烧钱，大公司们为何又乐此不彼呢？原来新产品的高价位和高利润足以弥补这些成本- 看看立普妥单枪匹马即为辉瑞挣得了1000多亿美元的业绩你就能够理解新药给研发型药企带来的30%左右远远高于仿制药和普通商业利润率的10-15%的利润率足以让大药企们费尽心机充实自己的产品线。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 2.0 为何研发虚拟化成为趋势？                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 残酷的事实摆在眼前，大药企自己做全程研发因为摊子过大，分工过细，流程过于复杂，无人敢承担风险，过高的员工福利，都使得研发极为低效。新药研发的成本剧增，促使他们越发转向联合、外包、并购的虚拟化研发之路。这其实是一个务实的思路，是已经被证明效率远远高于过去自己大包大揽但效率低下的传统的研发模式。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 如果你关注医药投资市场，几乎每天都能看到领域内的投资并购案例，这中间既有研发早期的并购，也有产品做到临床二、三期后产生的并购。视阶段和产品不同，并购金额往往在几千万到几亿美金的前期款，加上几亿到十多亿美金的后期里程金。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 两相比较，就算收购三期临床研究即将取得成功的新药，其花费也不过10几亿或者数十亿美金，比起自己搞研发平均成本70亿一个，瞎子也能看出收购别人的产品比自己研发的效率要高得多。这就是为什么近年新药研发投资并购以及虚拟化研发如此火爆的原因。从Citeline的全球研发数据也能说明这个问题，全球在研的10479个产品中，研发10强产品所占比例持续下降，目前仅占总产品的11%。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 即便是大药厂自身的项目开发，也在经历化整为零的改变。例如GSK已经在逐步将自己研发团队拆成一个个小的单元，各自拿一定预算和产品，各自研发，定期评估进度，如果进展不理想，则立即砍掉。而罗氏、默克、BMS则陆续把自己的一些产品和项目以及经费交给一些biotech和小型药企来开发。譬如在中国前者和华医药的合作，默克和百济神州的合作；BMS和先声的合作。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 在具体执行上，无论是大药厂自己管理的新药还是拆分给biotech的项目或者biotech研发的产品，都是使用CRO来执行，这也是虚拟化。这好比今天发达的汽车工业里由众多配件企业生产零件，仅由自己进行最后的组装是一个道理。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 3.0 新药研发就是烧钱？No!                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 既然一个新药的研发成本高达几十亿美元，还有巨大的失败风险，搞新药研发不是烧钱是什么？虽然成功后有高利润，但是这种高风险高回报的赌博式“高帅富”游戏小公司或科研能力不强的“屌丝”公司玩得起吗？                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 其实，换一个角度来看，既然有饥渴的大药厂们愿意为昂贵的新产品买单，既然虚拟化合作化成为趋势，那么做新药、转让新药就有巨大的市场，终端客户就是那些前几十强的跨国药企们。这些药企每年总共上千亿美元的研发预算便是新药研发的市场。在当前如此频繁的医药投资并购的环境下，资本在新药研发的环节里退出的机会很多，再不是过去那种投资几十亿10几年产品上市后才能看到回报的时代。在IND、一期、二期、三期、NDA的整个过程都充满了资本退出盈利的机会。当然，风险和回报成正比，投入越早退出越晚，则风险越高，然而回报也越高。最近多家公司对Onyx表示出浓厚的兴趣，这家加州的biotech仅有数百人，所有研发活动都外包，自己则掌握核心技术和强大的项目管理以及积极的BD活动，目前拥有多个已被FDA批准的抗肿瘤新药，其中包括大名鼎鼎的索拉菲尼以及新一代的“万珂”，投资者对其估价超过百亿美元，折合平均每人身家5000万美元！最近阿斯利康8亿美元收购了Fibrogen的某肾科产品在中美的市场，该品种处于3期临床。Fibrogen在中国其实只有3名临床研发人员，具体工作都由CRO执行。这些研发活动是烧钱还是赚钱？                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 4.0 新药研发投资回报的中国数字                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 仅仅10几年前，创新药开发还离中国尚远，然而随着新药研发的全球化，中国已经开始越来越多的参与到了新药全球研发的活动并且越来越多获得投资者和大药厂的关注。除了前面提到的一些项目，轰动一时的浙江贝达的埃克替尼获得过礼来的投资，和记黄埔的肿瘤药获得过阿斯利康的投资，最近申奥基的抗肝癌产品刚进2期临床便获得了Celgen的青睐。据说Celgen在中国关注的肿瘤品种还不止这一个…                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 从这些案例中基本上能得出一定的价值估计规律。以中国为例，保守估计从实验室筛选出一个有前景的新化合物大约价值500