INDUSTRY GROWTH

Rapid Rise in Development of Protein-Based Therapeutics

Biopharmaceuticals are proteins produced by living organisms that have medical or diagnostic uses. They are generally complex macromolecules derived from recombinant DNA technology, cell fusion, or processes involving genetic manipulation. They include recombinant proteins, genetically engineered vaccines; therapeutic monoclonal antibodies; and nucleic acid-based therapeutics, including gene therapy vectors.

Protein-based therapeutics is the newest class of chemical compounds being developed by the drug industry, with an estimated 900 to 1,200 clinical candidate proteins and/or peptides currently being investigated. Some 140 therapeutic proteins have been approved and 500 are in clinical trials; at least 50 biotherapeutics are expected to come on to the market over the next few years.

Sinobiomed’s researchers use human proteins, or molecules that mimic or block them, to find new ways to treat disease. The process of discovering a new drug involves determining which proteins cause or contribute to problems in the body because they are lacking, malfunctioning or present in too great numbers and then identifying and engineering a protein or related molecule to correct the problem. Recombinant DNA technology is the process of removing DNA from one organism and placing it into a new organism that reproduces to make proteins of potential therapeutic value. This technology is at the foundation of biotechnology and Sinobiomed.

Protein drugs have moved from the fringes to the center of pharmaceutical R&D, according to Jurgen Drews, M.D., Managing Partner of Bear Stearns Health Innoventures Management. Since 1997 the number of approvals for biopharmaceuticals has increased year by year while at the same time approvals for new chemical entities (NCEs) has dropped. By 2003, the comparative U.S. success rates (approval of new products) for new chemical entities ranged between 15% and 17%, while, on average, various recombinant products were twice as likely to gain approval.

SAFETY, LOW-COST AND EFFICACY

Recombinant protein drugs and other bio-products have three main advantages over traditional chemical pharmaceuticals: their safety, low-cost and efficacy. Because recombinant protein drugs and other biopharmaceuticals are made from human components, such as proteins, enzymes and hormones, they have a built in safety factor. Procedures and processes for developing and purifying these recombined proteins are stringently quality controlled and highly effective and result in products with guaranteed purity of 95% or higher. Sinobiomed uses a patented process that is extremely efficient at purifying recombinant proteins at low cost -- and in producing recombinant proteins that are highly efficacious.

CHINESE BIOPHARMACEUTICAL INDUSTRY

China is currently producing eight of the world's top 10 genetically engineered drugs or vaccines, according to Genetic Engineering news. The revenue from biopharmaceutical production in China reached levels of $4.2 billion in 2005, up from $860 million in 2000, and it's growing at 20% to 30% per year. Several factors are driving this rapid expansion, including:

• Substantial cost advantage and talented labour pool.
• China’s admission to the World Trade Organization in 2001.
• The development of a regulatory system like the U.S. Food and Drug Administration called the State Food and Drug Administration (SFDA).
• The return to China of Chinese nationals with expertise and experience in Western biopharmaceutical companies.
• The Chinese government's commitment to expanding protection for Intellectual Property (IP).