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Why is China Focused on Drug Innovation?

Why is China Focused on Drug Innovation?

Most of the drugs available in the Chinese market or are manufactured out of China. Now Chinese pharmaceutical companies have increased focus on innovative drug R&D. The Chinese government is even very supportive of the idea and have invested $2.7 billion from 2008 t0 2010 and would further invest $5 billion over a period of next five years.

The information on the result of innovative drug R&D in China is very meager primarily because of it being in its early stage. Hence, for the purpose of this study, the authors have analyzed information provided by the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA (CDE) about all novel pharmaceuticals including new drug application (NDA) and investigational new drug applications (INDs), both these have been approved in China between 2003 & 2010.

In this article, the novel pharmaceuticals refers only to chemical drugs in class 1.1 and 1.2 and biological drugs in class 1 which were previously defined by SFDA drugs approved for marketing anywhere in the world. The analysis of this study focuses more on new chemical entities (NCEs) US Food and Drug Administration (FDA), traditional Chinese drugs and even novel drugs have been discussed very narrowly in this article.
The authors stated the reason for discussing only innovative drugs is that all drugs approved as class 1 by SFDA are innovative drugs and are from Chinese pharmaceutical companies.

In- Depth Analysis of Innovative Drug R&D

As revealed by the website of the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA, IND (investigational new drug application); NDA, (new drug application), the number of Approved NDAs and INDs for Innovative drugs from Chinese Market Companies have been limited.

During the period 2005-2010, 25 drugs were granted IND. According to figure above, around 4 drugs per year were given approval for marketing.
Novel Investigation Drugs in China

From the numbers collected by the end of 2010 from websites of the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA, the Chinese State Intellectual Property Office, the US Patent and Trademark Office, the European Patent Office and company press releases, we see that the number of novel investigation drugs in China were mostly therapetic.

According to the study, about 187 therapeutics are under clinical trials, out of which 110 are in phase I while 41 are in the final phase of the test and remaining ones being in phase II. Figure 2 (b) shows that most common therapeutic area is oncology (32%) followed by infectious diseases and cardiovascular diseases with 17% and 10% respectively.

The researchers have also analyzed parent protection, as we all know that patent protection is very important especially after the evolution of patenting laws in China. Pharmaceutical patenting is broadly categorized into major areas compound patent and secondary patent. The graph clearly shows that out of the 187 therapeutic drugs 70 have compound patent in China while 23 have compound patent protection in US and around 16 of them have it in Europe.

Future of Innovative Drug R&D in China

The interest of Chinese government and multinational pharmaceutical companies are providing a competitive and growing environment for innovative R&D in China. There are improvements that are also taking place in the system, which are discussed below.

  • Adoption of INDs: The Chinese regulatory system has gone a massive transformation in order to adapt to INDs. Several laws were introduced and rules and regulations were also put in place, all this was done to improve transparency and efficiency.
  • Patent Protection: The second factor that paved the way for innovative R&D is patent protection, in 1992 patent law were changed in order to provide greater protection to companies and to promote innovative R&D in China. An example was the judgment given for Viagra in favor of Pfizer rejecting 12 Chinese drug companies claim. In order to improve investment, Chi Next, China’s ‘NASDAQ were introduced in 2009 with special focus on innovative enterprises. China also introduced a health- care reform plan in 2009 that will increase demand for innovative drugs in year to come.

Innovative Drug R&D in China is still in the early stages but the effort by the government and the progress by the local and multinational companies surely make us to believe and foresee success of this in China.

Note: The preceding is a summary of an article found though our research, and is provided here with editorial comment for members only. Please see the full article at the following link for full original content:

The New Asia Innovation Team