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As more and more industries are affected by the financial turmoil, the relatively stable performance of the Chinese pharmaceutical industry is particularly noticeable. While some peers are grateful that they "choose" the industry, Xu Guoxiong, vice president of the Shanghai Pharmaceuticals Group, prescription drug division and president of Xinyi Pharmaceutical Co., Ltd. believes that for Chinese pharmaceuticals, we should not only see immediate stability, but should always Be alert to the danger.
According to IMSHealth, which tracks global drug data, US drug sales growth will slow to 1%-2%. Many international pharmaceutical companies have therefore targeted new markets including China, Brazil and Russia, and more brand-name prescription drugs. It is very likely that they will become "weapons" to expand the market.
Xu Guoxiong believes that the most realistic way to combat this pressure is to improve the quality of Chinese pharmaceuticals. The 84-year-old Xinyi Pharmaceutical has taken the lead in implementing a new drug quality control system in China. Regulators and experts believe that this is an important measure for the Chinese pharmaceutical industry to catch up with international standards.
The drug quality control system named QbD is a new method proposed by the US Food and Drug Administration (FDA) in 2006. It requires pharmaceutical companies to improve product quality through design. Because, “The quality of pharmaceuticals is determined not by the production process but by the level of detail in the research and development stage.†Wen Bin, head of the Technical Quality Supervision Department at Xinyi Pharmaceuticals, said that in the past, the data records in the early stage of research and development only required 30 pages of paper. After the new quality control method, at least a 90-page data record is needed.
The pursuit of “meticulous†results can be clearly demonstrated in the research and development of the diabetes drug metformin hydrochloride: in 2005, Xinyi decided to declare the classic old drug metformin hydrochloride as a generic drug to the FDA. The drug that has been produced for more than 10 years has already been used in the production process. Very mature. According to the original idea of ​​R&D personnel, the drug can only enter the reporting process by changing its specifications. The problem is precisely in changing specifications. The production shop cannot press raw materials into tablets.
"The failure of successive batches of drugs made us very puzzled until we compared the requirements of QbD." Wen Bin recalls that the new quality control method puts high quality requirements on pharmaceutical raw materials. In the tableting technology of metformin hydrochloride, only Rectangular crystal material may be neatly arranged and finally pressed into tablets. In the past, the shape of the raw material crystals was varied, long, round, and square... Xinyi immediately put forward higher quality requirements on the raw material pharmaceuticals and solved this problem.
Innovation: Speeding up the transformation of new drug achievements
"Drug medicines must consider the quality of the final product from the beginning of R&D, which may become a breakthrough in the cooperation between industry, universities and research institutes in drug R&D." Xu Guoxiong said.
The success rate of scientific and technological achievements in pharmaceuticals has always been very low. The biggest bottleneck is the poor replication of laboratory data in drug production lines.
"Can't copy and reproduce on the assembly line. No matter how good the patent results can only lie in the laboratory and stay in the thesis stage." This year, Xinyi Pharmaceutical Factory has started to major universities, scientific research institutions, and clinical medicine. The research team promotes QbD's ideas and methods. Xinyi Pharmaceuticals believes that if the researcher's work is done more meticulously and is more in line with production, China's new drug research and development is expected to speed up.
Both the FDA and all major pharmaceutical manufacturers in the world agree with this view. Currently, the implementation of the QbD strategy is the focus of development. Although the use of this method has increased the investment in drug development and production, in the long run, pharmaceutical companies will benefit a lot.
The research and development of Rabeprazole sodium, a drug for the digestive tract, has allowed Xinyi Pharmaceutical to obtain a substantial return. Xinyi Pharmaceutical Co., Ltd. obtained the approval for the production of this drug in 2002. However, the sample parameters in the laboratory are totally different from the large-scale production in the production process. Industrialization has met with great resistance.
The introduction of QbD saved the project. Xinyi Pharmaceuticals decided to re-develop R&D, requiring early-stage developers to provide more detailed data, including accurate data for APIs and excipients. However, one year, the resistance that plagued R&D personnel for four years suddenly disappeared. At the end of 2006, the drug was successfully launched. Dozens of batches of products are not only highly stable but also have outstanding treatment effects.
In the next three years, Shanghai Xinyi Pharmaceutical Factory plans to bring 22 new drugs to the market. At the same time, it spends 5% of the total sales amount on R&D each year. It is very important to rely on the innovation of pharmaceutical technology. "Chinese pharmaceutical companies can no longer look at foreign drugs to seize the market, and China's pharmaceutical industry needs a resounding reputation," said Xu Guoxiong.
Regulators also believe that the new quality control system pioneered by Xinyi is likely to lead to new innovations in China's pharmaceutical industry. The ideal result is “win-winâ€: for producers, it can reduce regulatory pressure and reduce production costs; For regulators, regulatory pressure can be reduced without sacrificing quality; for patients, effective drugs can be obtained and quality can be better guaranteed.
Reviews
In this "economic winter", the "cold resistance" of the pharmaceutical industry is enviable. As a necessity for treating illness and salvaging people, drugs have rigid demands that are unmatched by other commodities. The pharmaceutical industry has not only escaped this catastrophe, but it still maintains its growth momentum. However, is this "freezing resistance" and "growth" sustainable?
The Shanghai Xinyi Pharmaceutical Factory, written in this report, seemed particularly calm at this time. They think that if we think about the quality of Chinese pharmaceuticals, we should not be complacent. From 2006 to now, there has been a serious drug quality incident every six months. The credibility of Chinese medicines has been no small harm. It is an unshirkable responsibility of drug companies to improve the quality of drugs and maintain public health. To improve the industry's "frost-resistance", we must not only look at the situation in an "economic winter" and must focus on the long-term. If the reputation is down, the pharmaceutical industry will not be able to enjoy a comfortable life even in the "economic summer". Those who make medicine must have awe. In this way, companies and industries can live "warm springs" every day.
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