Shenzhen daily July
A SHENZHEN researcher and his company are about to make a major contribution to China’s fight against cancer.
Dr. Peng Zhaohui and his colleagues at his Shenzhen-based company named SiBiono expect China’s State Food and Drug Administration (SFDA) to grant their lead product, a recombinant Ad-p53 anti-cancer agent trademarked as Gendicine, the drug license around the end of the year.
The product has undergone clinical trials for four years, will be the world’s first anti-cancer gene therapy product, and will help millions of Chinese cancer patients.
Peng, a 1.85-meter tall Shaanxi man, has been devoted himself to gene therapy research since 1990. Since he established the Shenzhen SiBiono GeneTech Co. Ltd. in 1998, SiBiono has accomplished a number of "Firsts" in the gene therapy field in China.
It is the first company purely devoted to gene therapy. It published the first comprehensive book covering gene therapy, and has developed the unique gene therapy product -- Gendicine. It has established a complete set of quality control assays and production process following international regulations and standards, and documented them in China’s "Points to consider for the development of gene therapy products." The document has been officially published by the China SFDA as a technical guidance for gene therapy research, development and commercialization in China.
However, Dr. Peng is low-key about his achievements.
"Many scholars come back from abroad but accomplished nothing during their first several years in China," he pointed out, "and later find themselves in an embarrassing situation because of the extensive coverage of the media at the beginning of their work which set high expectations for them."
He has tried to avoid this.
Perhaps this is why SiBiono, nestled in the Hi-Tech Industrial Park of Shenzhen, has no striking signpost and people may have trouble finding the company.
However, there is a big, striking slogan at the entrance of SiBiono office, which reads "Vision, passion, innovation, action." Dr. Peng said it was his idea to put it as a motto for his work team.
"Vision comes first for a scientist to develop a project and it serves to lead the project to either success or failure," said Dr. Peng. "One needs passion and innovative ideas to fling himself into his project. But this is far from enough. Action should always be there. Otherwise, everything is in vain."
The bare foot doctor
Dr. Peng’s medical career can be traced back to the time when he was in junior middle school.
It was the time of the so-called "Cultural Revolution" in China, and middle school students were encouraged to go to villages for "re-education." Peng became a "bare foot doctor" treating patients in a rural area. He was sent to a hospital in a nearby village where he learned much about medicine.
In 1970 when he was 18, Peng joined a military troop stationed in Qinghai Province as a medical soldier. Two years later, Peng was sent to the First Military Medical University in Guangzhou due to his excellent performance and became a teacher there after graduation.
In 1980, Peng went to study in the Fourth Military Medical University in Xi’an, Shaanxi Province for his postgraduate study, where he still serves as a guest professor. He came back to the First Military Medical University in Guangzhou with his degree, where he was promoted from a lecturer to a professor and in 1994, he was appointed to as the director of the institute of Molecular Biology of Guangzhou.
Peng set his career target on gene therapy early in 1990. "I read many reports and materials about it and thought it would have a promising future and bring revolutionary change to the medical field," Peng said.
At that time, some organizations in Beijing and Shanghai were working on gene therapy with funds granted by the Central Government but were stymied in the laboratory because of a lack of plant and a quality control system. As a result, they could only follow the pace of other countries.
In 1987, Peng went to Japan for biochemistry research and two years later, he earned a PhD granted by both the University of Chiba in Japan and the Fourth Military Medical University in Xi’an. His research experience seven years later at the University of California in the United States and two U.S. biotech companies helped him to solve the technical difficulties in gene therapy that could not be resolved in China.
Establishing, reaching goals
On Christmas Day, 1997, Dr. Peng came to Shenzhen, where he decided to realize his dream of completing gene therapy research, development and commercialization.
With 2.4 million yuan (US$289,156.62) in start-up capitol and a about 30-square-meter office granted by the local government, Peng was soon engaged in the preparation work of a new company with unprecedented passion. Peng persuaded one of his best postgraduates, now vice president of the company, to join him.
In order to provide the SFDA with project establishing documents before the annual review date -- March 20, Peng worked day and night during the following months. Their painstaking efforts were rewarded with the approval from SFDA after they filed a document of some 1000 pages on March 20, 1998.
In May, they passed through SFDA’s appraisal of their new medicine for clinical trial, which is said to be even more complicated than the regulations of Federal Drug Administration (FDA) in the United States.
The first clinical trial for Gendicine was soon performed on 12 patients with mid-to-late stage laryngeal cancer in Beijing Tongren Hospital. Over the past four years, the results have been successful with only a few patients complaining of fever as a side effect and no patient relapse after three years.
By the end of 2000, a plant equipped with validated state-of-the-art facilities for the production of gene therapy products had been built. Dr. Peng spent eight months in designing it. It is said to be the first such plant in Asia with world-class equipments and quality control system.
The achievements of Dr. Peng and SiBiono have received attention from home and abroad.
Last week, Dr. W. French Anderson, the world-known "father of gene therapy," visited SiBiono and agreed to be a consultant for the firm, promising to provide it with technological guidance and collaboration on gene therapy and biomedicine technologies. Dr. Anderson highly praised Dr. Peng’s work and said he was "quite impressed with the quality of his team."
Dr. Peng has high hopes for the future of Chinese science. "I hope the scientific circle in China could interact closely with the government to push the Chinese science sector to the world front," he said
Some day, he may record the entire story of his work. "It takes a long time to develop a new medicine, he said, "and there are too many of those stories left behind."
Definitions:
Gene therapy aims to correct the root cause of disease-abnormal genes, instead of treating the symptoms of disease. Gene therapy has been widely applied to cancer, cardiovascular disease, genetic disease, AIDS etc. Gene therapy is a milestone in the evolution and progress of biotechnology along the path of gene research by mankind.