Biotech investment基本常识

oldfairy

转之前，先写点我自己的从医药公司得到的"野鸡FA"

1。 从clinical--phase 1 ---phase 2---phase 3
按照10--〉2 to 3这个比例进阶。比如10个phase 1有2个能进入phase 2

2. 如果一个公司进入phase 3，很可能被大公司收购

3。据说医药公司认为以后抗癌类药物会带来巨大利润，投入研发很多

4。癌症类药物的FDA通过相对容易

oldfairy

转 168 PB

pennbrook

Post subject:[size=1.1em] Biotech investment基本常识

授人以鱼, 不如授人以渔. 开个thread, 希望大家补充, 互相帮助, 理解一些东西.

Clinical Trials Process
When a drug candidate has completed formal preclinical studies, a regulatory filing must be made with an appropriate regulatory agency in order to initiate human clinical trials.  In the United States, an Investigational New Drug (IND) application must be filed with the FDA before initiating human clinical trials.  The main purpose of an IND is to provide data to the FDA showing that a new drug candidate demonstrates the required safety profile for initial testing in humans.  The IND is not an application for marketing approval.  


Phase 1 Clinical Trials
Phase 1 clinical trials are the first trials in which a new drug candidate is tested in human subjects.  Phase 1 clinical trials are typically designed to assess the safety, tolerability, and pharmacokinetics of a drug.  Usually Phase 1 clinical trials are conducted in a small group of healthy volunteers, although actual patients with disease may be used in certain circumstances.  In a typical Phase 1 study design, subjects are administered a single dose of the new drug and observed over a period of time.  If the subjects do not exhibit any adverse side effects, and the pharmacokinetic data is in line with predicted safety values, the dose is escalated until intolerable side effects appear or pre-calculated pharmacokinetic safety levels are reached.  At this point, the drug is said to have reached the maximum tolerated dose (MTD).  This classic study design is known as a single-ascending dose study.  Following the single-ascending dose study, multiple-ascending dose studies are conducted to better understand the pharmacokinetics and safety profile of multiple doses of the drug.  In these studies, a group of subjects receives multiple doses of the drug.  At various times, blood samples and other fluids are collected and analyzed to understand how the drug is processed within the body.  The dose is subsequently escalated up to a predetermined level.

Phase 2 Clinical Trials
Once the initial safety profile of the drug has been established in Phase 1 clinical trials, Phase 2 clinical trials are conducted to assess how well the drug works in patients with a particular disease.  Phase 2 clinical trials include a larger group of patients and typically test different dose levels.  Safety assessments are also continued.  Phase 2 clinical trials are usually divided into Phase 2a and Phase 2b trials.  Phase 2a is specifically designed to assess dosing requirements, whereas Phase 2b is specifically designed to study the efficacy of the drug.  Some trials combine Phase 1 and Phase 2, and test both efficacy and tolerability.  Most Phase 2 trials are designed as randomized clinical trials, where some patients receive the drug and others receive placebo.

Phase 3 Clinical Trials
Phase 3 clinical trials are randomized, multi-center trials to definitively assess how effective a drug is to treat a particular disease.  Phase 3 clinical trials are the most expensive trials to design and run because of the large number of patients studied and comparatively long duration, especially in therapies for chronic medical conditions.  Certain Phase 3 trials, often called “registrational” or “pivotal” trials will be submitted to support initial approval of the drug for marketing.  Commonly, other Phase 3 clinical trials will continue while the regulatory submission for marketing authorization is pending at the appropriate regulatory agency.  This allows patients to continue to receive possibly lifesaving drugs until the new drug is marketed.  Phase 3 clinical trials may also continue in order to assess additional types of patients or diseases amenable to treatment with the drug to obtain additional safety data, or to support marketing claims for the drug.  

Marketing Approval
Once a drug has proved satisfactory after Phase 3 clinical trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details and shelf life.  This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities. They will review the regulatory submission and may authorize marketing approval.  In some cases, regulatory authorities may ask for additional clinical data to be obtained in subsequent clinical trials.  Once the regulatory authority has approved the drug, it may be actively marketed in the appropriate territory.  Additional regulatory filings must be made in each country where marketing approval is sought.

oldfairy

发信人: jhsph07 (银杏), 信区: Stock
标 题: Biotech投资／投机心得
发信站: BBS 未名空间站 (Wed Sep 9 16:24:44 2009, 美东)


１） 不赌： 以VVUS为例， 昨天跑进去等今天的结果就是纯赌博， 我们不应该因为今
天VVUS大涨（包括前阵子的HGSI大涨）就鼓励这种行为。

真正的biotech玩家应该是在event前打埋伏， 等到量高价升的时候派发出去， 最多留
一小部分free run 来做赌博之用。

２） 多元化： 既指投资对象的pipeline， 又指投资者自己的portfolio， 不要重仓
压宝在某一两支股票上。

３） 做好估值： 对于FDA批准后药品的市场大小 (sale, peak sale)， 份额， 渗透
率， 合作情况 royalty， 要有一个起码的认识， TA很可能在FDA的决定或者是二，三
期结果出来以后才有用 （我承认我对TA在FDA play上面的作用一直持怀疑态度）。
Biotech也是股票， 股票的估值最后还是要落实在盈利上面。

４） 耐心： 对于看好了的long-term pick， 一旦进入， 不要乱动， 做好三年不动
， 一动就是十倍的准备。

oldfairy

发信人: jhsph07 (银杏), 信区: Stock
标 题: Re: Biotech投资／投机心得
发信站: BBS 未名空间站 (Wed Sep 9 16:39:53 2009, 美东)

大家对于biotech视之为洪水猛兽大概多数是因为不了解， 其实biotech比financial好
做， 至少基本面很清楚。 在clinical trial中做假的也不多见。

阻碍大家投资biotech的主要原因大概就是
１） 增发
２） 追涨被套
３） FDA决定， 二三期实验的不可预测性

解决办法：
１） 这个没办法控制
２） 搞好估值会避免大量避免这中情况的发生
３） 不赌就好

oldfairy

maveric wrote:
Very useful introduction. Couple of questions: 1. If Phase 1 fails, then Phase 2 won't be initiated, and so on, right? 2. After Phase 3 clinical trial, is there any way to assess the possibility of FDA approval? 3. According to you, when do you think a stock will be mostly active? Many thanks,

vix answered:
关键是钱，大笔的钱。 phase II 和 phase III 一上马，消耗时间和人力都是一般小生药很难吃的消，一定要有后台VC加码或靠挂大药厂。而target trial population selection也很关键，因为最后的结果就是个统计上的游戏，很大程度上是要靠擦边球得分的。

stonehorse

Thanks for sharing!