板块主题窝 --- 生物和化学制药

spy2009

去年买过一次CMED，ER不错，当天股票暴跌，几天之后一路上涨。之后再也不碰此股。
Fan8an 发表于 2009-2-28 18:12

老大说的是2006年上半年？

那时候另一支明星股STP也大跌，感觉上是中国概念股的系统风险。

抄个股，系统风险并不可怕，最怕个股风险，其它都大涨，唯独它自个儿大跌。

spy2009

感谢Mab，maomi 两位老大的专业分享。

小分子药物和大分子药物之争由来以久，小分子药物是老大，大分子药物是老二，
老大让出一些市场给老二。

听过一位老同学讲过，本来做小分子药物的，瞄向大分子药物，而本来做大分子药
物的，瞄向小分子药物。

说到这儿，替这儿大部分化学和药物盲的邻居，问一声，能不能弄出个小分子药物
和大分子药物的杂种？老三？

mab

感谢Mab，maomi 两位老大的专业分享。

小分子药物和大分子药物之争由来以久，小分子药物是老大，大分子药物是老二，
老大让出一些市场给老二。

听过一位老同学讲过，本来做小分子药物的，瞄向大分子药物，而本 ...
spy2009 发表于 2009-3-1 10:27

问得好。现在有公司正在研究所谓的靶向治疗。就是在大分子，如抗体，上加上毒性的小分子或者放射性同位素。后着已经在临床上应用。
Antibody conjugate (ADC) is still in development though it has been tested more than 10 years. A few companies are working on this such as IMGN,SGEN, MDEX, and DNA. DNA has the first drug in phase III trial using Transtuzumab-DM1 to treat her2 positive breast cancer. I personally believe ADC would be revolutionary if is successful.

spy2009

问得好。现在有公司正在研究所谓的靶向治疗。就是在大分子，如抗体，上加上毒性的小分子或者放射性同位素。后着已经在临床上应用。
Antibody conjugate (ADC) is still in development though it has been test ...
mab 发表于 2009-3-1 11:46

哈哈哈，希望将来有个老三的泡沫，让我们大家发一次横财。

spy2009

maomi老大，文章中的combinatorial chemical synthesis，应该是组合化学合成吧？

WX的总裁李哥，在哥仑比亚大学的博士导师，是组合化学合成的大师。WX是国内搞
药物研发外包的龙头股，不知老大对WX评级怎么样？

spy2009

这儿有很多HT邻居，也许不知道generic drug这个词什么意思，偶来科普一吧。

generic drug在国内有个俗名，叫仿制药，指的是专利过期的药，大家都可以生产。
国内药厂，除了中药，中成药和保健品，几乎都是生产仿制药。

研发一个新药，动不动就是几十亿美元，美国大药厂雇了一大批化学博士搞研发，
国内药厂根本没这个财力和那么多优秀的化学博士生。

仿制药，因为大家都能生产，竞争激励，利润薄，国内药厂倒也可以象生产玩具，
鞋子一样，搞一搞。但是近来，竞争实在太激励，仿制药价格一再下降，环保成本
和人力成本上升，日子很艰难。

spy2009

日子再艰难，总还是有人要发财。现在收购国内药厂很便宜，这儿就有两支股是搞这个的：SCR和AOB。

麻烦maomi老大，去打听一下，您的兄长或者其他朋友，对SCR和AOB评价怎么样？

spy2009

Mab，maomi 两位老大,

小分子药物容易仿制，做小分子的仿制药，竞争应该更激烈。

而大分子药物仿制，因为需要更多的财力和知识，竞争相对来说，应该没有那么激烈吧。当然，是相对而言。

所以，是否可以更看好国内的生物技术公司？这儿有一支龙头股SSRX。

谢谢！

maomi

sorry, I was in QJ's class for the whole morning.
SPY2009, I know you are one of the HH in HT, I am a green frog in HT, just happen to work in biopharmaceutical company. so please not to call me lao da.

Generic drug refers to the drug with equivalent efficacy to the new drug that was expired.
The big pharm make huge profit from the new drug before the patent expire.
Once the new drug is on market, generic drug company starts
1) research and development on generic drug,  producing the same small molecule but through different synthesis pathway (MAB, correct me if I am wrong, I am not in this area, but I do have a friend work in generic small molecule-based drug company). Therefore, generic company only need hire organic synthesis chemist to synthesize the small molecule, proving they have same structure.
2) once the synthesize pathway is confirmed, they need find out the way to scale up the process of synthesizing the small molecule at larger scale (production scale), and purification process, etc.
3) The generic drug produced at larger scale will be collected and used to collect limited clinical data.
4) prepare the paperwork for file generic drug for FDA, and file the application on the day of new drug patent expiring.
5) the first company whose generic drug application is approved by FDA will have price advantage than the others who filed later.

We do have excellent organic synthesis chemists in China, so we don't need worry about reproducing the small molecule based drug in China But it is not the case for biomolecule -based drugs. We call the generic drug for biomolecule as biosimilar.

spy2009

大家怎么看生物研究设备和医疗器械领域？是不是比较稳定保险？
lami 发表于 2009-3-1 05:11

开发医疗器械，没有开发新药那么多财力投入和知识。偶也看好国内的医疗器械股。

MR和CMED是国内医疗器械的龙头股，CMED的市场主要面向国内，而MR的产品很多是出口，和Philip (PHG)是竞争对手。

spy2009

69# maomi

maomi老大，

您的话，是否可以引申出下面一段话？

小分子药物，结构简单和刚性，只要一改动就没有了原有的药性。

而大分子药物，结构复杂，反而比较容易改动，而又能保持原有的药性。这样，国
内的生物技术公司，可以说，因为不是一模一样的生物药了，在专利保护以外了，
通过这样的方式来侵犯美国的生物药厂，瓜分市场？

Thanks,

天真的冷酷

正好你们谈到genetech。。。

我认识两个人：其中一个是这家公司十年前的sr. director同时也是gilead两年前的sr. director, 先生是这家公司以前的controller; 另一个的先生是这家公司的chief scientist...  前面那一位在公司高峰时期把股票全部脱手，说以后回不来这样的价钱；后面那一位根本不建议我买genetech。。。

昨天一下午和全面那位做事的时候，有谈到一件事，他和他先生很重视这个。。。 所以，想问一下：
有一个女孩子，得了血癌，我们都在找人骨髓移植，一直没找到，本来以为他快没命了，结果后来在华盛顿的一家医院，用一种最近的科技，这个女孩子是目前世界上第十位接受这种治疗并成功的人。。。 这个科技和stem cell 非常接近，可是又不是stem cell...  他们也说不上是怎么新技术，想问你们，你们知道这是怎么？哪家公司的？

maomi

I just checked SSRX's website, I am not 100% sure, but at least some of their drugs on market must be biosimilar.

I just cannot believe my eyes that they have biomolecule-based drugs on market, while they are still going through the clinical trials. God bless Chinese!

I doubt its products can go beyond china's domestic market sales. The biggest profit is from Europe, Japan or US market. No matter what, SFDA does not apply the same criteria as FDA in states for drug approval. FDA is very strict on approving drug to the market. One of my current company's new drug was approved in Europe, and Japan, but not in US.

China is lacking people to guide the new drug R&D, production, and paperwork to get FDA approval.

maomi

ZT -
Generic versions of synthetic chemical drugs are now an accepted and important component of the pharmaceutical industry. In the US, the same is not yet true for follow-on biologics (FOBs). Europe has established a regulatory framework to enable the approval of what it designates similar biological medicinal products (biosimilars).1 In the US, however, legislative discussions to create such an approval pathway are still ongoing. Meanwhile, in both regions, patents on innovator products are conspicuously expiring.

We believe that follow-on biologics must become part of the tool kit used to provide effective and affordable solutions to address patient needs. To make this possible, a regulatory pathway must be established to ensure that rigorous scientific standards are applied to develop high-quality follow-on products that are as safe and efficacious as their reference originator products. The road to success for FOB sponsors is not, and should not be, trivial, but nor should it be made impossible for short-sighted or parochial reasons.

To summarize the above info. Biosimilar products have been approved in EMEA (europe), but the approval pathway in FDA has not established. That explains why my company cut a biosimilar project last year, which was developed by our European subdivision.

mab

69# maomi

maomi老大，

您的话，是否可以引申出下面一段话？

小分子药物，结构简单和刚性，只要一改动就没有了原有的药性。

而大分子药物，结构复杂，反而比较容易改动，而又能保持原有的药性。这样， ...
spy2009 发表于 2009-3-1 12:54

My understanding is just the opposite.
Small molecules are easy to copy, you just need chemistry to synthesize it.
Large molecule are difficult to copy. It may lose its activity if it is manufactured by a second party. This is why there is no legislation on biosmilars so far. 08 is pushing the reform now.

maomi

As for WX, I am not sure if it is the company that my friend forwarded a job opening to me last year. The developing story was that Chinese guy (a director from Bayer, USA) quit his job last year, and took a position as VP in a company like WX. Once he got there, the project was cut, because of slow economy both in States and in China. Now he is still in job market.

Overall, biopharmaceutical innovator or generic company (producing new drug) will be eventually hit hard if the economy is not recovering by end of this year. GSK in NC has cut off a whole analytical sector late last year, Pfizer was laying off scientists. I don't view those as good signs.

Your money your decision, just my 2 cents.

maomi

Thank you so much for providing these useful information. I guess you may work at business development department.
As I mentioned in my early post, the key for drug discovery is the right targets ...
mab 发表于 2009-3-1 02:03

My work is almost 100% technical, except a little bit project management. I work in biopharm, and I have some friends in small-molecule based generic drug company. plus, I have a brother in drug sales. Everything adds up to my view. You are very knowledgeable in drug delivery, and modification. My work has been involved in purification, analytical, and formulation, so I know protein very well :D

mab

Health care used to be the defensive sector in bear market, such as in Japan's lost 10 years. Since 08 is in office now, situation may change a lot in the U.S.
I bought some WX a long time ago and I cut my loss at 15 (I bought at more that 20).

spy2009

73# maomi

读过SSRX的一则新闻，2011年SSRX的益比奥Epiao将进入欧洲市场。

spy2009

78# mab

认识的一个朋友，是李革的同学。曾和这个朋友，一起弄过一个化学药物中间体搜索和合成网站，没成功。