Simcere: Discovering vaccine R&D capabilities in China

Sean Du world vaccine congress

Vaccine research: Dr Sean Du, Executive Director, vaccine research, Simcere Pharmaceutical Groups delivered today an interesting presentation at the World Vaccine Congress in Washington about challenges facing China's vaccine fields in the increasing demands for more and better vaccines

Dr. Sean Su discussed the vaccine development market, current challenges, opportunities and strategies for China, and the work and strategy for Simcere. He said that we were experiencing a "renaissance" in the global vaccine market in the past 7 years. Since 2005 there has been growth in both the paediatric and adult vaccine market, and it will likely continue for the next 5 years. The top 5 players account for about 80% of the market. China itself has 17 million new-borns per year and in 2011 had 35 manufacturers producing > 40 vaccines against 29 diseases. In the 1960s, China established 6 local institutes for biologics. China was the first country to introduce H1N1 split vaccine in 2009.

Some of the social and economic benefits of vaccination in China include the eradication of wild type polio in 1993, and also smallpox in the 1960’s. China’s three "85" vaccination campaigns achieved: 85% coverage in every province (1989), every county (1991), and every town (1996). In terms of China’s important pathogens and infectious diseases, EV71 has highest ranking in terms of reported incidence, followed by Hep B, TB, diarrhea, Mumps, Syphilis, and Shigellosis. In 2011, China had 1,619,706 reported incidents and 509 deaths.

Challenges for the vaccine market in China involve regulatory elements, technical upgrades to vaccines, innovations in R&D throughout the field, new standards / GMPs, competition, and less than optimal vaccination coverage in some areas. There is a pricing imbalance between public and private vaccines. Emergency response capabilities in China need to be improved.

Some beneficial aspects of the R&D environment in China include good work ethics, broad support for learning new innovations, higher relative R&D budgets, and less expense in terms of wages. Even so, there are challenges regarding expensive instrumentation, longer waiting periods, need for better software, etc. China tends to take fewer risks in R&D when compared with more developed countries. The R&D strategy of a typical vaccine manufacturer in China leaves discovery activities to academics. An example is the Hepatitis E vaccine which was approved for production, using private and public funding and collaboration between industry and academic labs.

A big opportunity exists with WHO GMP pre-qualification. Also, there has been a recent increase in both exports and imports of vaccines. Multinational corporations (MNCs) have an established presence in China, with cautious growth. GSK, Sanofi, and Novartis have each taken different strategies regarding joining, purchasing, or starting new R&D or production facilities.

Simcere is a publicly traded company and is ranked #21 in net profits out of 5,000 Chinese healthcare companies. It is the 7th most competitive among publicly listed Chinese healthcare companies. Some goals for the company are to effectively use conventional and genetic engineering vaccines, while beginning to expand into the realm of therapeutic vaccines. China’s vaccine industry may not match the top global leaders quite yet, but Dr. Su noted that there is continuous improvement and encouraged that Simcere is a choice partner for MNCs.

Check back here in a couple of days for the full presentation. Excellent presentation Sean!

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