News | October 31, 2007

Expanding Horizons: Benda Subsidiary Developing Potential AIDS Vaccine

Benda Pharmaceutical, Inc. ("Benda" or the "Company") , a China-based pharmaceutical company producing traditional Chinese and conventional medicines, as well as Gendicine, the world's first commercialized gene therapy medicine for the treatment of cancer, announced recently that its subsidiary SiBiono has made major strides in developing an anti-AIDS gene therapy. This marks SiBiono's and Benda's anticipated entry into the $14B Chinese anti-AIDS drug market.

SiBiono Partners with DNAVEC to Develop Anti-AIDS Gene Therapy.

As the producer of the world's first commercialized gene therapy drug, SiBiono is acknowledged as a biopharmaceutical pioneer. In May 2007, leading Japanese gene therapy research institute DNAVEC sought out and formed a joint venture with SiBiono to develop the SeV-Gag vaccine, an anti-AIDS gene therapy treatment. DNAVEC designed and constructed the SeV-Gag vaccine several years ago and has patented it in both the United States and China. However, DNAVEC lacks the resources and experience to complete clinical trials and produce the drug on a commercial scale. Under the terms of the joint venture agreement, DNAVEC will leverage SiBiono's proven gene therapy manufacturing platform and will transfer the exclusive development and distribution rights of SeV-Gag in China to SiBiono. SiBiono will be responsible for completing the preclinical tests, clinical trials and manufacturing tests of the SeV-Gag vaccine in China. SiBiono will also seek all related Chinese State Food and Drug Administration (SFDA) approval. All scientific findings resulting from the development processes will be co-patented by both SiBiono and DNAVEC. SiBiono expects to obtain the required "New Drug Certificate" from the SFDA between 2012 and 2018.

"We deliberately selected SiBiono as our partner from hundreds of other leading biopharmaceutical firms because of its unparalleled expertise and technological superiority in developing, manufacturing and commercializing gene therapy treatments," stated DNAVEC CEO Dr. Mamoru Hasegawa. "SiBiono's demonstrated clinical success with Gendicine is a feat no one else in the world has yet matched, and we firmly believe that the joint venture with SiBiono provides us the best opportunity to realize our dream and bring the SeV-Gag vaccine to market."

China's $14B Anti-AIDS Drug Market

A 2006 study conducted by the AIDS research center in Tsinghua University, China's leading scientific research institute, revealed that more than one million Chinese patients were infected with human immunodeficiency virus (HIV). Other studies predicted that this number could grow exponentially in the next 10 years and that China, even with increased prevention education, will likely see 10 million HIV-infected patients by the end of 2010. The average annual treatment cost for American HIV patients is $20,000, while the cost for Chinese patients is only approximately $1,400. However, with more government funding allocated to the cause and the increasing wealth of the population, Chinese AIDS treatment costs are expected to rise in the coming years. But even at the current average annual cost of $1,400, the likely 10 million HIV infected patients by 2010 could create a $14B anti-AIDS drug market in China. Imported anti-AIDS drugs are often too expensive for typical Chinese patients, driving a need for innovative, affordable domestic drugs.

SeV-Gag Development

The development of SeV-Gag is led by Mr. Yi Zeng, who has been enlisted as the Chief Scientist for the project. Mr. Zeng is the only Chinese member of the UNAIDS Asia Pacific Leadership Forum on HIV/AIDS and Development. He is also the Chief Scientist of the Institute of Viral Disease Control and Prevention at the Chinese Center of Disease Control.

The SiBiono research team, under the leadership of Mr. Zeng, has made significant progress in the past five months. In the pre-clinical stage, the SeV-Gag vaccine has successfully passed most of the toxicological, pathological and pharmacological tests. The SeV-Gag vaccine has also proven highly effective in treating infected rats and monkeys. SiBiono is now focusing on the side effects, manufacturing and quality control studies. "We are making excellent progress and expect to be ready for clinical trials in the near future," commented Mr. Yiqing Wan, Chairman and CEO of Benda Pharmaceutical.

How the SeV-Gag Vaccine Works

AIDS is caused by HIV. Gag, a gene encoded for an HIV protein, is carried by the vector SeV and injected into a patient's body. This is intended to induce a strong response in the patient's immune system, stimulating the body to produce the antibodies HIV-specific Cytotoxic T Lymphocytes; these antibodies are necessary to kill HIV-infected cells, limit or eliminate the replication of HIV, reduce HIV volume in the blood serum and thus prevent HIV from progressing into AIDS.

AIDS clearly poses a major threat to global health. According to a UNAIDS report, there are 4.3 million new cases of HIV in the world every year. In 2006, a staggering 39.5 million people were living with HIV and 2.9 million people died of AIDS. There is not yet available a commercialized anti-AIDS vaccine which can prevent or cure AIDS. Officials from UNAIDS, the Joint United Nations Programme on HIV/AIDs www.unaids.org, commented, "SeV-Gag is very likely to be among the first group of commercialized AIDS vaccines in the near future." (Source: Chinese Health Express, May 2007).

About Benda Pharmaceutical, Inc.
Benda Pharmaceutical, Inc. www.bendapharma.com, a China-based pharmaceutical company, is a pure play on explosive Chinese pharmaceutical spending and the global search for a cancer cure. Benda produces traditional Chinese and conventional medicines, as well as Gendicine, the world's first commercialized gene therapy medicine for the treatment of cancer.

SOURCE: Benda Pharmaceutical, Inc.