SinoBiomed Inc. is pleased to announce that the United States Patent and Trademark office has granted a patent for the malaria vaccine PfCP2.9 to which SinoBiomed has exclusive rights to develop, manufacture and sell through its 82 percent owned subsidiary, Shanghai Wanxing Bio-pharmaceuticals Co. Ltd.
Patent number 7,101,556 B2, dated on September 5th 2006, has been assigned to the Second Military Medical University (SMMU) of Shanghai China for the preparation and dosage of plasmodium fusion antigen invented by Dr. Weiqing Pan. Dr. Pan, an advisor to SinoBiomed and an internationally recognized researcher, heads the Department of Parasitology at SMMU and serves on China's national committee to combat parasitic diseases.
"The granting of this US patent enables SinoBiomed to proceed with the vaccine development with full confidence in its potential for commercial development for the global market," said Company President and CEO Banjun Yang. "The potential benefits to humanity as well as to SinoBiomed shareholders are significant."
The invention provides a fusion protein comprising the Plasmodium merozoite surface protein-1 (MSP1) and the Plasmodium apical membrane antigen 1 (AMA-1), the encoding DNA sequence, the vector containing the sequence, the host cell containing the vector and the genetic engineering method for preparing the fusion protein and the usage for producing anti-malarial vaccine. The patent holder was granted the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States with 20 years protection term from the date on which the earliest application was filed (February 1, 2002).
On Mar 22, 2001, Second Military Medical University and Shanghai Wanxing signed the authorization letter that gives Shanghai Wanxing the exclusive right to exploit such technology, including the right to manufacture and sell the malaria vaccine it develops. SinoBiomed is developing and testing the plasmodium fusion antigen as a blood-stage malaria vaccine with the support of the World Health Organization (WHO) and the Malaria Vaccine Initiative (MVI) of the Program for the Appropriate Technology in Health (PATH). The Bill & Melinda Gates Foundation has committed $258.3 million to the global fight to eradicate malaria.
SinoBiomed's malaria candidate vaccine (PfCP2.9) targets the world's most deadly malaria parasite (Plasmodium falciparum) at its most destructive stage-its rapid replication in human red blood cells. In the now completed Phase I Clinical Trial, PfCP2.9 showed greater immunogenicity and fewer adverse reactions. The State Food and Drug Administration (SFDA), which has a drug approval process similar to that of the US FDA, has approved PfCP2.9 for Phase II Clinical Trial to be conducted in China's Yunnan Province and Southeast Asia.
About SinoBiomed Inc
SinoBiomed Inc. is a leading developer of recombinant protein drugs. SinoBiomed’s combination of advanced technology and expertise enables the Company to produce safe, high-yield, high-efficacy recombinant protein drugs at extremely low cost. SinoBiomed employs a patented low-cost, high-yield production process to enhance bioactivity and guarantee the highest levels of purity.
Strategic alliances in China
SinoBiomed’s research team has developed strong strategic alliances with leading Chinese research hospitals and institutes for collaborative development of patented and patentable techniques and treatments. They include the Second Military Medical University (SMMU), its affiliate hospital, Changhai Hospital, and Fudan University. All three are located in Shanghai.
The Company has also established a nationwide sales and marketing network and international marketing support programs. Further strengthening the Company’s ability to develop biopharmaceuticals for global markets are well-established relationships with internationally recognized health researchers and organizations, including the World Health Organization and the Program for the Appropriate Technology in Health (PATH).
SinoBiomed’s integrated research and development facility in Shanghai includes:
A 20,000-square-meter facility for integrated R&D, manufacturing, quality control, and sales and marketing.
A 3,000-square-meter Good Manufacturing Practice (GMP) plant certified by Chinese State Food and Drug Administration (SFDA)
Founded in 1996 as Shanghai Wanxing Biopharmaceutical Co. Ltd., the Company now has a workforce of 140.
Second Military Medical University (SMMU) of Shanghai China has a GLP center certified by Chinese State Food and Drug Administration (SFDA) in Nov.2006.