IHS Global Insight Perspective | |
Significance | The world's first H. pylori vaccine has been successfully developed in China. The SFDA has given it regulatory approval with a categorisation of Class I drug. |
Implications | With current treatments for H. pylori infections mainly combined with antibiotics, the successful development is a significant breakthrough and promising in terms of the commercial value once put onto the market. |
Outlook | The approval of this first-in-class vaccine is in line with the Chinese government's encouragement for the domestic industry's innovative R&D. The collaboration of research institutions, biotech companies and wealthy investors is a novel approach for Chinese firms to follow to undertake high-cost innovative drug discovery, development and commercialisation. |
China's Ministry of Science and Technology (MoST) today announced that the State Food and Drug Administration (SFDA) has given its nod to the country's domestically-developed innovative oral recombinant Helicobacter pylori (H. pylori) vaccine, the first in class in the world. According to Xinhua Net, the SFDA has granted the vaccine a Class I drug certificate, which represents the most innovative drug category it approves.
The vaccine was developed by Chong Qing Kang Wei Biotechnology, a joint venture of Chong Qing Yang Chun Biotech, Yue Yang Xing Chang Petro-Chemical as well as Third Military Medical University. The orally-administered vaccine is developed by fusion with an intra-molecular adjuvant, which generates a mucosal immune response by stimulating the Th2 immune response pathway. In clinical studies the vaccine has demonstrated its efficacy with a protection rate of over 72.1% against H. pylori infection. At the moment it still remains uncertain when the vaccine will be commercialised.
Outlook and Implications
H. pylori, a spiral bacterium inhabiting the stomach and duodenum, is associated with epigastric diseases such as gastritic and duodenal ulcers and also closely linked to stomach cancer. Currently the common treatment for H. pylori infection is to combine with antibiotics, therefore the successful development of the H. pylori vaccine is a significant breakthrough in this therapeutic field. As the country with the highest H. pylori infection rate in the world, China has about 0.6 billion people infected by this bacteria and every year about 200,000 people die of stomach cancer. The vaccine will thus have a sizeable commercial potential as the first-in-class to prevent the H. pylori infection in a market with a vast pool of patients.
In addition to the breakthrough in this specific field, this development is also significant in terms of its reflection of the Chinese government's pro-innovation policies in the domestic pharmaceutical industry in a bid to steal the crown as the "nation of generics". China has adopted a series of drug innovation-encouraging measures including the acceleration of the new drug approval process (see China: 13 January 2009: China's SFDA Applies New Ruling to Speed Up Innovative Drug Approval) and the establishment of a 1.67-billion-yuan (US$245-million) National Key New Drug Creation Programme to support new drug development (see China: 28 August 2008: New Drug Development Programme Launched in China). It is also worth noting the development and financing model of this vaccine, which combines the R&D resources of a research institution and biotech firm and investment of a cash-rich investor outside the drug industry. This may be a model the Chinese drug innovation industry will take to make up for the lack of big drug makers to undertake drug R&D individually.