海外药品专利到期 百亿美元市场搅热国内药企

  2010年02月25日   

　　证券时报2月25日讯 未来5年，销售额超过770亿美元药品的专利即将到期。这对于在仿制药市场里成长起来的中国制药企业来说，似乎是英雄找到了用武之地。

　　不过，这张天上掉下的馅饼到底是画在纸上还是摆在桌上、而谁又能将这张馅饼吃到嘴里，却需要投资者仔细甄别。

　　2001年到2010年，是世界制药史上商标名药品专利到期高峰时段，一些大型跨国制药公司陆续有一半以上的药品专利到期，一大批单品种销售额超过10亿美元的药品专利保护期也已届满。而从2011年至2015年，又将有价值770亿美元的药品专利过期、美国新医改将在未来10年内消耗约1万亿美元，这两个数字同时刺激着制药企业敏感的神经。

　　一方面，随着大量受到专利壁垒保护的高价药品专利到期，高利润将刺激仿制药厂商迅速进入这些刚刚解禁的市场；另一方面，美国这个全球{zd0}药品市场启动新医保方案，将刺激价格相对低廉的仿制药的需求，促使制药企业加大对廉价中国原料药的采购，甚至将制剂加工业务外包到中国。这种供需之间的微妙变化似乎为正在苦寻国际突破口的中国药企开启了一扇通往国际市场的大门。

　　在这一背景下，2010年以来已有多家上市公司公布了海外项目或海外合作，其中包括 (28.20,-0.01,-0.04%) (行情 股吧)复方丹参滴丸完成FDAⅡ期临床试验； (26.00,0.00,0.00%)(行情 股吧)与韩国LG生命科学股份公司签署排他性协议，双鹤药业将在中国{dj2}许可供应和经销LG生命的2型糖尿病的专利口服药；(25.03,0.32,1.30%)出资980万美元认购注射剂开发公司赛金控股有限公司发行的B类优先股700万股等等。

　　仿制专利药品早有先例

　　长期以来，中国制药类上市公司主要经营处于低端的大宗原料药，只有少量公司利用技术优势进入到特色原料药及非规范的制剂药市场。而由于原料药一般仅占xx总成本的10%左右，中国的制药类企业在国际分工中实际上处于价值链的{zd1}端。

　　不过，以海正药业、 (26.65,0.07,0.26%)(行情 股吧)为代表的少数特色原料药厂商却在国际商场屡有斩获。以辛伐他汀为例，这是一种临床用于xx高胆固醇血症、冠心病的xx，原研厂家是德国默克公司(Merck)，该药曾创造了年销售额70亿美元的记录。

　　该种药品在欧洲和美国的专利期分别在2003年和2006年到期。2003年，海正药业抓住了辛伐他汀专利到期前的机会，在全球率先仿制成功，实现了他汀类原料药的爆发式增长，使得公司的销售收入当年增加{bfb}以上，利润更是飙升200%以上。

　　在此后的2007年，另一家特色原料药公司华海药业申报的抗艾滋病xx奈韦拉平片的新药申请获得FDA批准，成为全国{dy}家制剂药通过FDA认证的企业。不过，当时由于该药专利所属尚未过期，在专利过期前还不能在美国零售。

　　这两个例子证明，以原料药起家的中国制药企业xx有能力在国际药品专利到期的情况下参与其中，并分得一杯羹。不过，也并不是所有的原料药企业都具备参与国际竞争的实力。

　　根据国内不少券商分析师的看法，从价值链{zd1}端的原料药到{zg}端的专利药，以海正药业、华海药业为代表的公司选择的是从低到高逐次发展的模式，目前它们已经试图从特色原料药逐步向利润更高的制剂代工出口方向升级。

　　而这种类型的公司将可以凭借自身在原料药领域内的传统优势，在仿制药需求大增的情况下获得更多的原料药订单；同时，又能通过与国际大厂的合作，提高争取到为国际大厂代工制剂药的可能性，是最为明确的专利药专利到期大潮中的受益公司。

　　对外合作成捷径

　　不过，如此巨大的馅饼并不能轻易吃到。2001年，美国发生了炭疽菌恐慌事件，直接导致用于xx吸入性炭疽菌xx的环丙沙星市场需求大增。当时包括原研药生产企业德国拜耳在内的一些企业迅速做出反应成为主要供应商，其中来自印度的南新制药先期就获得美国政府100万美元的订单。而我国当时环丙沙星生产企业有几十家，却因没有一家制剂通过FDA认证而未获任何订单。

　　这种尴尬一直延续到华海药业的上述突破。虽然经历了技术和管理上的改进，但中国制药业全面落后的现状并没有改变。根据统计，目前国内大大小小通过GMP认证的药厂超过4000家，产品质量良莠不齐。事实上，距离华海药业代表中国{dy}次获得FDA制剂认证已过去了两年有余，第二家认证单位却迟迟不能出现。如何才能通过FDA的认证，现在仍是不少中国药企最伤脑筋的问题。

　　在面临着制剂药认证等问题阻碍的情况下，国内制药企业通过与国外伙伴合作的方式加快了进入欧美的步伐。江苏地区一位从事xx研发的业内人士告诉记者：“许多原料药企业在对外销售原料药的过程中与国外药企存在合作关系。很多这样的企业正在利用国外合作伙伴的优势加快推进制剂药的认证过程。”

　　公开资料显示，上述两家在特色原料xx面颇有建树的上市公司都在积极进行国际合作。其中，华海药业正在与默克、诺华、阿斯利康、GSK、施贵宝等国际原研药巨头洽谈从原料药到制剂的全面合作；而海正药业的合作伙伴则包括礼来、菲玛、雅塞利和先灵葆雅等公司。

　　上海一位长期跟踪药品市场的分析人士告诉记者：“海正和华海之所以选择这条道路，是因为它们都通过特色原料药行业与国外大厂结成上下游的合作关系，在管理经验和生产程序上都学到了很多东西。另外，它们也利用与国外大厂的合作为未来进入利润更高的制剂药代工市场和仿制药市场打下基础。应该说，这是一条捷径。”

　　研发型药企也有机会

　　当投资者都把目光聚焦于从特色原料药领域成长起来的领军企业的同时，不应该忘记中国的制药企业还存在另一种模式，即自主研发与国内市场首仿相结合模式，采取这一发展模式的企业也同样能够分享国际专利药专利到期带来的利益。

　　目前，国内自主研发模式的领军型企业应该算是 (49.11,-0.69,-1.39%)(行情 股吧)，该公司于2009年6月申报新药磷酸瑞格列汀FDA临床一期，希望花费3-5年完成临床试验。实际上，这种新药是在默克公司一种专利药基础上进一步开发而来，恒瑞医药凭借自身相对较强的研发实力通过对专利药的仿制和提升，来达到规避专利限制的目的，相对于海正和华海药业纯粹模仿策略可谓是另辟蹊径。

　　事实上，恒瑞医药也在仿制国外专利药品，并在国内销售。例如，恒瑞医药是赛诺菲-安万特研发的多西他赛的国内{dy}家仿制企业，恒瑞医药仿制的多西他赛于2002年9月30日获得上市批文，第二家仿制企业齐鲁制药于2003年12月获得上市批文。截至2005年底，恒瑞医药已占据该药接近50%的市场份额，而齐鲁制药的份额不到20%。

　　由此可见，仅凭借强大的研发能力，恒瑞医药仍能通过对专利药品的二次研发和优先仿制即将过期的专利药品获得相当大的市场利益。

　　恒瑞医药证券事务代表徐国文告诉记者：“我们选择仿制或再研发的药品有两个条件：一是针对慢性病的长期服用药；二是被市场证明疗效显著的新药。以国内首仿药为例，我们准备了许多梯队的产品，外国专利期一过，我们就能在国内上市。这样的产品每年都会有一两个，而后面梯队的临床试验已经排到了2015年。”

　　显然，以研发见长的恒瑞医药也将国际专利药专利到期大潮看做是自己的机遇。虽然专利药专利到期所带来的对原料药需求增加和可能的生产外包并不能给恒瑞医药这类的公司带来太大效益，但这类研发型的企业将可以借此机会在国际市场上推出自己的创新型xx；并在国内市场上推出首先仿制成功的专利药。

Drug patents expiration of 10 billion U.S. dollars of overseas market, the domestic pharmaceutical companies Jiaore

http://www.sina.com.cn 2010 Nian 02 Yue 25 Ri Panorama network - Securities Times


 
Domestic pharmaceutical companies billions of dollars in the market Jiaore


Securities Times, February 25 hearing the next five years, sales of more than 77 billion U.S. dollars of patent medicines is about to expire. This is in the generic drug market grew up in China's pharmaceutical enterprises, seems to be a hero to find useless.

However, this sky pie in the end is drawing on paper or on the table, but who would be able to eat this pie mouth, it takes investors to carefully screened.

From 2001 to 2010, is the world's pharmaceutical history of the brand name drug patents expire peak periods, some large multinational pharmaceutical companies in succession more than half of drug patents expire, a large number of single-species more than one billion U.S. dollars in sales of drug patent protection period has expired. From 2011 to 2015, it sent 77 billion U.S. dollars worth of drug patents expire, the new U.S. medical reform in the next 10 years to consume about 1 trillion U.S. dollars, these two figures at the same time stimulate the pharmaceutical companies-sensitive nerves.

On the one hand, with a large number of patent-protected high barriers to drug patents expire, high-margin generic drug manufacturers will stimulate the rapid lifting of the ban, which had just entered the market; the other hand, the United States, the world's largest drug market, to launch a new health insurance program that will stimulate the price of the relatively low demand for generic drugs, prompting pharmaceutical companies increase their purchases of cheap Chinese raw material medicine, and even preparation process outsourcing to China. Such subtle changes between supply and demand seem to be a breakthrough in China are being searched the international pharmaceutical companies opened a door to the international market.

In this context, since 2010, there are many listed companies reported overseas projects or overseas cooperation, including the Tasly (28.20, -0.01, -0.04%) (Quote stock bar) CSDP completed FDA Ⅱ Phase clinical trials; Double-Crane Pharmaceutical (26.00,0.00,0.00%) (Quote stock bar) and the South Korean LG Life Sciences AG, signed an exclusive agreement, Double-Crane Pharmaceutical exclusive license in China LG supply and distribution of life in type 2 diabetes Patent oral medication; Hisun Pharmaceutical (25.03,0.32,1.30%) invested 9.8 million U.S. dollars to subscribe injections Development Company Holdings Limited Gold Cup Class B preferred shares issued 700 million shares and so on.

There are precedents for imitation patent medicine

For a long time, China Pharmaceutical companies mainly engaged in low-end bulk raw material medicine, only a few companies use technological advantages into the characteristics of raw material medicine and non-regulated drug market preparation. And because only drugs bulk drugs in general about 10% of the total cost of China's pharmaceutical enterprises in the international division of labor in fact, in most low-end value chain.

However, with the sea is medicine, Huahai (26.65,0.07,0.26%) (Quote stock bar) is represented by a small number of characteristics of bulk drugs manufacturers are frequently in the international market gains. With simvastatin, for example, which is a clinical used to treat high cholesterol, coronary heart disease drugs, the original research manufacturers Merck, Germany (Merck), the drug had annual sales of 7 billion U.S. dollars to create a record.

The kinds of pharmaceutical patents in Europe and the United States respectively in 2003 and 2006 expire. In 2003, the sea was caught simvastatin patent medicine before the expiration of the opportunity, the world's first copying the success of statins achieved the explosive growth of bulk drugs, making the company's sales revenue increased {bfb} over the year, profit more has shot up over 200%.

Over the next in 2007, another feature API's Huahai declared anti-AIDS drug nevirapine tablets new drug application to obtain FDA approval, became the first drug formulations through the FDA certified company. However, at that time because of the drug patent belongs has not yet expired, before the patent expired in the United States can not be retail.

These two examples have shown that the bulk drugs pharmaceutical companies started in China is fully capable of in the international drug patents expire circumstances involved, and take a slice. However, not all of the raw material drug companies are equipped to participate in international competition strength.

Many brokerage analysts in accordance with national views of the most low-end value chain from raw material to the most high-end drug patent medicines, to the sea are medicine, Huahai selected as the representative of the company is from low to high successive development models, which are currently characteristics of bulk drugs have been trying to gradually move toward more lucrative export orientation to upgrade OEM formulations.

Which types of companies will be able to with their own raw materials of traditional medicine in the field of edge in the high demand for generic drugs to get more orders for raw materials medicine; the same time, but also the cooperation with large international companies, to improve fight to the foundry for large international companies, the possibility of drug formulations, is the most clear-cut trend of patent medicine patent expiration in the recipient company.

External co-operation as a shortcut

However, such a huge pie, and can not be easily eat. In 2001, the U.S. anthrax scare occurred in the incident that led directly used in the treatment of inhalation anthrax, the market demand for the treatment of ciprofloxacin. At that time, including original research drug production enterprises, including some of Germany's Bayer Company to respond quickly become a major supplier, in which a new drug from India early on the southern access to the U.S. government orders for one million U.S. dollars. In China, there were dozens of ciprofloxacin production enterprises, but because there is no one agent has not been through the FDA certification for any order.

This embarrassment has been extended to the above-mentioned Huahai breakthrough. While the experienced technical and management improvements, but the Chinese pharmaceutical industry fully backward status quo has not changed. According to statistics, the current domestic large and small, through GMP-certified pharmaceutical companies over 4000, the product quality mixed. In fact, the distance Huahai represent the first time, FDA certified agents for more than two years have passed, the second authentication unit still could not appear. How to pass FDA certified pharmaceutical companies in China is still a lot of the most vexing problems.

Certification in the face of issues such as drug formulations impede circumstances, the domestic pharmaceutical enterprises with foreign partners a way to enter Europe and the United States to speed up the pace. Jiangsu region an industry engaged in drug research and development told reporters: "A lot of raw material drug companies in foreign sales of the drug during the existence of cooperative relations with foreign pharmaceutical companies. Many of these companies are taking advantage of the advantages of foreign partners and accelerating the drug formulations certification process. "

Public information shows that the two drugs in the characteristics of raw materials made many achievements of the listed companies are actively carry out international cooperation. Among them, Huahai is working with Merck, Novartis, AstraZeneca, GSK, Bristol-Myers Squibb and other international drug giant, original research to discuss drugs from raw materials to the preparation of comprehensive cooperation; and the sea are pharmaceutical partners include Eli Lilly, Fei Ma , Yasai Li, and Schering-Plow, among others.

Shanghai a long-term follow drug market analysts told reporters: "the sea is, and Huahai chose this path, because they are all characteristics of raw materials through the drug industry, and foreign makers to forge co-operation between upstream and downstream, in the management and production experience, procedures have learned a lot. In addition, they also used the co-operation with foreign makers for future agents to enter more lucrative drug markets and the generic drug market foundry basis. It should be said that this is a shortcut. "

R & D-based pharmaceutical companies have the opportunity to

When investors all eyes are focused on the characteristics of bulk drugs from a leader in the field of growing up at the same time, should not forget China's pharmaceutical companies there is an alternative model in which independent research and development and the combination of the domestic market in the first mode of imitation, taking this a business development model is also able to share the international patent expiration benefits of patent medicines.

At present, the domestic self-developed model should be regarded as the leading enterprise Hengrui Medicine (49.11, -0.69, -1.39%) (Quote stock bar), the company reported in June 2009 Ting FDA Drug phosphate repaglinide clinical one, want to spend 3-5 years to complete clinical trials. In fact, this drug is a Merck & Co., on the basis of a patented drug from further development, Hengrui Medicine by virtue of their relatively strong R & D capabilities through the imitation of patent medicines and promotion to achieve the purpose of circumvent patent restrictions, relative to the sea is, and Huahai pure imitation strategy can be said to look for other ways.

In fact, Hengrui generic medicines are patented drugs abroad, and domestic sales. For example, Hengrui medicine is sanofi - aventis R & D docetaxel first imitation of domestic enterprises, Hengrui Medicine imitation of docetaxel in September 30, 2002 to obtain public approval, the second generic Qilu Pharmaceutical Company in December 2003 to obtain public approval. As of the end of 2005, Hengrui medicine has occupied nearly 50% of the drug's market share, while the share of Qilu Pharmaceutical less than 20%.

Thus, by virtue only of a strong R & D capabilities, Hengrui Medicine still patented drugs through secondary research and development and give priority to a patent about to expire generic drugs with considerable interest.

Hengrui Medicine securities on behalf of Xuguo Wen told reporters: "We chose imitation or re-development of drugs there are two conditions: First, long-term use for chronic disease drugs; 2 is a significant market-proven efficacy of new drugs. In order to imitate China's first drug for the cases, we have prepared a number of echelon of products, foreign patent period is over, we can in the domestic market. Such a product will have one or two each year, while the back-tier of clinical trials have been lined up in 2015. "

Clearly, research and development will also be skilled in Hengrui Medicine international patent medicine patent expiration tide as their own opportunity. While the expiration of the patent medicine patent medicine brought about by increased demand for raw materials and the possible outsourcing of production Hengrui Medicine does not give too much benefit of such a company, but such research and development-oriented enterprises will be able to take this opportunity in the international market, launched its own innovative medicines; and in the domestic market, the successful launch of the first patent generic drugs.