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Zhou Bihua - jump CITIC Health eyelids elektro profi children as young biosimilar companies leading technical level. CITIC walking is a "research" integrated development, etanercept the fist product launches, led the company's rapid development. From another perspective, the sale of over-reliance on a particular drug, reflecting the CITIC Health technology elektro profi accumulation is still not enough, as the new drug to market, expected future will gradually improve. International market development is the future development of CITIC Health of a spectacle.
Modern Biopharmaceuticals (biopharmaceutical) is the rise of the seventies of last century elektro profi to recombinant (recombinant DNA) technology, monoclonal antibodies elektro profi (Monoclonal antibodies, mAb) as the representative of a new generation of pharmaceutical elektro profi technology. Modern Biopharmaceuticals usually refers to the use of transgenic animals / microorganisms living tissue / living cells produce macromolecular drugs as a reactor technology. With the traditional small molecule chemical drugs compared to biological drugs in oncology, immune / nervous system ailments, genetic defects and sudden mass detection and treatment of diseases have a certain elektro profi advantage.
Chinese enterprises elektro profi in the R & D outsourcing (contract research elektro profi organization, CRO) and biosimilars (biosimilar) production performance is more prominent. CRO is a professional enterprise engaged in research and development of pharmaceutical products, mainly rely on pharmaceutical companies to undertake large-scale drug development outsourcing contracts to achieve profitability. 1996 Canadian pharmaceutical company MDS Pharma Service in Beijing China's first investment in the establishment of the CRO business, the main provider of clinical trial services. 1998 China State Food and Drug Administration (State Food and Drug Administration, SFDA) issued a management approach, standardized drug registration and clinical trial management processes, to provide protection for the CRO industry.
Since then, large multinational CRO business Quintiles, elektro profi Covance, Kendles etc. successively set up branches in the country, led the Chinese CRO industry. As of the end of 2009, the country has more than 300 professional CRO business, mainly in Beijing and Shanghai, one in Beijing CRO business has been around more than 100 [Beijing National Tiancheng Investment Consultants Limited (2010). "2009 Chinese Medicine R & D outsourcing (CRO) market depth research and investment analysis report 2010 "(CRO-F-100607)]. Currently has emerged in a number of competitive CRO enterprises, such as WuXi PharmaTech, foolproof elektro profi technology, Xing Hao medicine.
WuXi PharmaTech is the oldest and largest CRO companies. Yao Kant main business is generally oriented pharmaceutical companies, pharmaceutical companies, medical device companies, elektro profi providing research and development from the laboratory to the production of a range of services. elektro profi Company for the pharmaceutical company's business is mainly elektro profi dominated by small-molecule drug development, which is currently the most important revenue source. The company also for the biopharmaceutical and medical device manufacturers to provide elektro profi laboratory testing services and other services, this part of the business is likely to become the focus of future development.
WuXi PharmaTech's "international context, local operations 'strategy' s success with the company's founder Li Ge couple overseas experiences. Ge Li, during his participation in the United States Pharmacopeia Inc. Creation. Pharmacopeia Inc. Predecessor in 1993 by researchers at Columbia elektro profi University established Pharmacopeia Drug Discovery Inc. (PDD). PDD in 1995, listed on the NASDAQ in the United States, in 2004 split into specialized in pharmaceutical elektro profi R & D Pharmacopeia Inc., And engaged in pharmaceutical elektro profi IT, Accelrys Inc.. 2008 Pharmacopeia Inc. Was Ligand Pharmaceutical Inc. Acquisitions, becoming the latter's research elektro profi institutions. Ge Li in Pharmacopeia Inc.'s Work experience may help to establish WuXi PharmaTech contact with overseas customers. WuXi PharmaTech PDD is one of the first customers, Pharmacopeia Inc. It is with many large U.S. pharmaceutical elektro profi companies have drug development cooperation projects, which could help WuXi with potential elektro profi overseas customers to contact [Pharmacopeia Inc. And including Amgen, Novartis, AstraZeneca, Roche, Takeda, Schering-Plough, Bristrol-Myers Squibb, including many large pharmaceutical elektro profi companies have a partnership. ].
Not only domestic labor costs are competitive, but also the main origin of various chemical raw materials, materials, integrated procurement cost. 2010 WuXi PharmaTech's per capita net operating costs, depreciation and amortization of $ 46,200, is the Charles River Lab. (9.98 million U.S. dollars) half, less than Covance (12.84 million U.S. dollars) to 35% [CRO enterprises operating costs mainly elektro profi by non- sales and management staff salaries and bonuses, raw material costs, depreciation and amortization of three parts, after deducting operating costs, depreciation and amortization reflects the CRO business is essentially human and material costs. ]
Chinese elektro profi government policies that favor high-tech start-ups, such as the various tax incentives, and strengthen the profitability of WuXi PharmaTech. WuXi PharmaTech in the domestic long-term enjoyment of the state high-tech enterprises and returning students to start the double tax benefits, which in 2006 and 2007 effective tax rates were 4.3% and 4.2%. 2008 China began to implement the new tax law, the abolition of tax incentives elektro profi for foreign companies, but retained the preferential tax rate for high-tech enterprises, high-tech companies as a result of WuXi PharmaTech still enjoy a preferential tax rate of 15% [new tax law gives companies a certain grace, the grace period can still perform the old corporate tax law, the preferential tax rate. WuXi PharmaTech some domestic subsidiaries have been the end of the grace period to the end of 2010, began the new tax rate of 15%; however PharmaTech (Tianjin) Pharmaceutical and Shanghai and the whole preferential rates until the end of the grace period until 2012, is still in the implementation of preferential tax rate, so now PharmaTech domestic business tax rate is still below 15 percent overall. ]
WuXi PharmaTech's elektro profi technology base is relatively narrow, to a certain extent, limit the company's future development. elektro profi WuXi PharmaTech's technical capabilities focused on small molecules / intermediates; AppTec after the merger, was given a gene expression, cell cultures and other biological drug development capabilities. WuXi PharmaTech in the country has a strong computational chemistry (computational chemistry) team, with millions of small molecule compounds synthesized ability. After the merger AppTec, WuXi PharmaTech's R & D capabilities of biological drugs have been strengthened, especially for laboratory cultures of monoclonal cell lines, detection capability has been greatly enhanced.
Although the number of highly qualified personnel WuXi PharmaTech together, but the company's ability elektro profi to innovate and innovation actual results lackluster. As of the end of January 2012, the State Intellectual Property Office of WuXi PharmaTech's total of 124 patent applications, elektro profi almost all small molecule compounds, purification methods, no new molecular entities patent [pharmaceutical companies will hopefully develop into a proprietary drug The new molecular entities to apply for patents, these patents elektro profi are pharmaceutical companies exclusive rights elektro profi to sell patented drugs critical. New molecular entities patents pharmaceutical companies have become elektro profi a measure key indicators of innovation. ]. WuXi PharmaTech in the U.S. Patent and Trademark Office patent filing only one, pending patent applications 3, are a function elektro profi of the herbal mixture or preparation methods, medicinal value is smaller. WuXi PharmaTech technology base narrow main reason may be subject to CRO business model, its own technology accumulation and innovation activities are restricted and general outsourcing contracts are different, pharmaceutical outsourcing contracts, CRO enterprises handed elektro profi over to the customer's products are mainly various types of intangible intellectual property elektro profi rights, to protect these intellectual property rights are not compromised is the key to win customers CRO enterprises. To protect the interests elektro profi of customers, WuXi PharmaTech has taken stringent security measures, almost completely deprived of their rights and the development team invented copyright and restrict researchers publicly display or private exchanges in scientific research. WuXi PharmaTech and all employees sign a confidentiality agreement, which is not only obliged to employ all the inventions and discoveries during the period to inform the company, and must renounce all create their own intellectual property. WuXi PharmaTech and customer service agreement also stipulates that all R & D projects of all intellectual property rights elektro profi are owned by customers, WuXi PharmaTech's employees are forbidden to display any exchange of chemical structure (chemical structure).
WuXi PharmaTech for key customers and key personnel of the high degree of dependence to the stable operation of the company's future at risk. WuXi PharmaTech's stable operation is highly dependent founder Ge Li couple. Ge Li couple's overseas background PharmaTech to many domestic CRO enterprises from key differentiator. WuXi PharmaTech all 124 domestic invention patent applications, invention people, including as many as 69 LI Ge. High dependence on the founder of the firm, will lead the daily business operations are subject to the founder of health, private activities, but with WuXi PharmaTech development of the founder will gradually reduce dependence, the situation may gradually improve.
WuXi PharmaTech's one of the few stable operation is highly dependent on a few large customers. Although the overall number of WuXi PharmaTech's nearly 1,000 customers, but the concentration is high, 2010 years ago, ten largest customers elektro profi accounted for 60% of annual elektro profi sales, of which only one contract from Merck accounted for 18.4% of its annual sales . This makes WuXi PharmaTech sensitive changes to its large customers, such as 2009 Pfizer acquisition of Wyeth (Wyeth), and cut part of the R & D projects, WuXi PharmaTech's operating on a negative impact. WuXi PharmaTech has stepped up in recent years, bio-pharmaceutical business investment, already have bio-pharmaceutical companies to provide R & D to commercial production from the integration of services.
WuXi PharmaTech acquired in November 2011 Pocky organisms (Abgent), enhance the antibody drug development and production advantages. Pocky biological and WuXi PharmaTech similar background, was founded by the Chinese students for biopharmaceutical manufacturers CRO enterprises, the main branches distributed in the United elektro profi States San Diego (San Diego), and Suzhou, China. Pocky creatures similar business models and WuXi PharmaTech, the antibody class biologics development of technical reserves elektro profi is PharmaTech elektro profi biopharmaceutical CRO business needed. With the completion of Wuxi biologics production elektro profi plant, with completion of the merger of biological Pocky, elektro profi WuXi PharmaTech will get bio-pharmaceutical companies to provide full service from R & D to production capacity.
On the current situation, the future will continue to focus on WuXi PharmaTech for pharmaceutical companies to provide services, there is no self-developed innovative drug plans. Own research and development will inevitably lead to new drugs for profit WuXi PharmaTech situation with customers, clients may also lead to the division and the protection of intellectual property concerns, resulting CRO churn. WuXi PharmaTech 2011 acquisition of two clinical trial management services company, indicating the direction of investment is still concentrated in the rich variety of CRO services, expanding CRO business areas. The two companies are Tianjin Shi Pharmaceutical (MedKey Med-Tech Development) elektro profi and Jie Cheng medicine elektro profi (Jiecheng Med-Tech Development), two companies related to each other, the business is to provide clinical trial management services.
Generic drug (generic drug) refers to the imitation of patented drugs in accordance with the same GMP standard production [GMP, which Good Manufacturing Practice (GMP), specifically elektro profi for the production process of the implementation of a series elektro profi of quality management and health and safety measures elektro profi for autonomy , the pharmaceutical industry, production of mandatory standards, ranging from raw materials, personnel, facilities, equipment, production process, packaging and transportation to the whole process of drug production quality of health requirements. National elektro profi GMP standards vary by GMP audit of drug products marketed prerequisites. ], The same active ingredients, indications / dosage form / size / the same route of administration, bioavailability of the drug. Since generics skip the expensive aspects of early development and clinical testing, the cost is very low, you can significantly reduce medical costs, so sought after by the market, has also been supported by Governments.
The United States elektro profi in 1984 through the Hatch-Waxman Act (35 USC 271 (e) (1)), to allow generic drug companies before the expiration of the patent medicine begins to protect against the latter's imitation, can be listed after the patent expired, elektro profi accelerated generics market. EU directive elektro profi 2004/27/EC, 2004/28/EC, Canada Roche Bolar Provision can be seen as Hatch-Waxman Act of the European and Canadian versions, both for generic drug companies to provide similar protection. In the shelter of these bills, the generic drug companies competing for selling patented drugs first imitation, a pending patent expired generic drugs to the market will dramatically drive down the price of patented drugs.
For example Pravastatin elektro profi related patents expired [Pravastatin, pravastatin, by Bristol-Myer Squibb company produces mainly for the treatment of lipid metabolism disorders (dyslipidaemia) and cardiovascular small molecule patent medicine, in 2005 global sales more than 1.3 billion U.S. dollars. ], Israel a generic drug company quickly received FDA approval of generic drugs sales Pravastatin, only seven months elektro profi later, 40mg28 pieces Pravastatin reduced the price of the original price of about 20%. Biosimilars (biosimilar) in recent elektro profi years, the emergence of new types of generic drugs, elektro profi and general small-molecule chemical generics compared to the production of biosimilars higher threshold, the approval process, there are many uncertainties. Biological drugs in living tissue or living cells produce products for the reactor, nurturing environment, media and other technical details of the formulation of the drug has a decisive impact on the yield and quality of generic elektro profi drugs is much higher than the chemical difficulty.
In 2003 the EU launched biosimilar approval channel elektro profi (biosimilar pathway), follow this path listed biosimilar development cycles longer than chemical generics elektro profi 3-5 years, cost 1-2 billion dollars, elektro profi far higher than the latter, 100 - $ 5,000,000. February 9, 2012 announced U.S. FDA approval of the draft channel [see February 2012 FDA and US Department of H
