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The Genesis of Gendicine: The Story Behind the First Gene Therapy

Patients do not stay on the drug for the rest of their lives. A patient receives one injection per week for four to eight weeks consecutively as a treatment cycle. A standard dose is 1x1012 viral particles (VP).


GENDICINE AVAILABILITY
BPI: Are you receiving requests for Gendicine from outside of China?

Peng: Yes. Requests are coming from the US, Germany, Denmark, Thailand, the Philippines, Greece, Canada, the UK, Singapore, Russia, Rumania, and Turkey. Patients must come to China to be treated. So far, about 400 patients have been treated.

BPI: How much do you plan to produce in 2004?

Peng: In 2004, 200,000 to 500,000 doses. Gendicine is expected to bring relief to millions of cancer patients over the coming years. We also expect it to accelerate the commercialization of other gene therapy products and to create a significant social and economic impact.

BPI: Is Gendicine currently available?

Peng: Yes. It will be formally launched in late March 2004. Right now, it is just for HNSCC.


MANUFACTURING AND SCALE-UP
BPI: Your manufacturing facility was built in 2000. How is Gendicine produced and how was the process developed?

Peng: Our facility passed GMP approval by SFDA on February 13, 2004. We produced research quantities in roller bottles and parallel-plate reactor systems. However, roller bottles were found unsuitable for production of gene
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