| |
 |
Menu |
 |
|
|
|
|
| |
|
Site Info |
|
|
|
|
|
| |
|
Newsletter |
|
|
|
|
|
| |
|
Ads by Google |
|
|
|
|
|
|
| |
|
Review of Gene Therapy development in China |
|
|
 |
For the first time, a gene therapy-based treatment has been given the go-ahead by regulatory authorities. In 2001, the 500th gene therapy clinical trial was submitted to the FDA/NIH for approval. Whereas in 2003, the first commercial gene therapy medicine (Gendicine  ) was available on the market in China.
China's medicines authority (SDFA) approved the cancer therapy after it achieved promising results in a clinical trial.
The treatment, called Gendicine, has been launched commercially by SiBiono GeneTech Co. of Shenzhen, Guangdong province. The results of the trial are published in Human Gene Therapy, says Zhaohui Peng, the company's founder and head.
Gendicine's approval was announced earlier but has gone largely unnoticed outside China (see also China approves first gene therapy and Controversial Chinese gene-therapy drug entering unfamiliar territory ).
Shanghai Sunway Biotech Co. Ltd. announced in November 2005 that the SFDA has approved H101 , an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late stage refractory nasopharyngeal cancer. This marks the first oncolytic viral therapy approved by any regulatory agency in the world and this is the second commercial gene therapy product.
|
|
|
|
|
|
|
| |
|
Gene Therapy Legislation in China |
|
|
|
In May 1993, the Chinese Ministry of Public Health released “An Outline of Quality Controls for Clinical Studies of Human Somatic and Gene Therapy.” It was further revised in June 1999 and reissued as “Guiding Principles for Human Gene Therapy Clinical Trials”. In realization of the rapid development in gene therapy, the State Food and Drug Administration of China (SFDA) published in March 2003, a document named “Guidance for Human Gene Therapy Research and Its Products”. This guidance document outlined requirements for application of gene therapy clinical study, study protocol format, and requirements for construction of a recombinant DNA and gene delivery system. The document also outlined requirements for the establishment and testing of cell bank and engineered strains, manufacturing process, quality controls, and product efficacy and safety tests.
In 2006, Hongzhang Yin published a paper covering the regulations and procedures for new drug evaluation and approval in China . Dr. Peng of Shenzhen SiBiono GeneTech Co. Ltd. published in May 2008 a paper (The application of gene therapy in China) providing an overview of the regulatory guidance for gene therapy research, product development and commercialization in China. Gendicine is highlighted as an example of the innovation occurring in the field in China.
|
|
|
|
|
|
|
| |
|
Gene Therapy & Biotechnology Companies in China |
|
|
|
|
Amoytop Biotech
Amoytop is a high-tech company devoted to discovering, developing and marketing recombinant proteins such as Granulocyte Macrophage Colony Stimulating Factor (Molgramostim,rHuGM-CSF), Granulocyte Colony stimulating Factor (Filgrastim, rHuG-CSF) and Interleukin 11 (rHuIL-11). |
|
Anhui Anke Biotechnology (Group) Co., Ltd.
AnkeBio group are leading in developing, manufacturing and marketing pharmaceuticals and health-care products. Main products are Recombinant Human Growth Hormone (Ansomone®), Recombinant Human Interferon a2b (Anterferon®), and Diagnostic Kits. |
|
Beijing Pharma and Biotech Center (BPBC)
Consulting agency, which belongs to Beijing Municipal Commission for Science and Technology (BMCST). BPBC is a none-profit organization (NPO) with the aim of strengthening the innovative of pharmaceutical and biotechnology industry. The function of BPBC can be described as the pivot of the industry which is composed of government agencies, research institutions, well-known universities, biomedical enterprises and academic organizations. |
|
Beijing SL Pharmaceutical Co., Ltd.
SL PHARM is a high biotechnology-pharmaceutical company, mainly engages in developing and marketing gene engineering drugs. Main products are G-CSF injection, rhIL-11 and 125Ala IL-2. |
|
Beijing WBL Peking University Biotech Co., Ltd.
Pharmaceutical joint venture invested by the Asiapharm Group Ltd. of Singapore, the renowned Peking University of China and the Beijing Enterprises Holdings Limited of Hong Kong. It mainly engages in research, development, manufacture and market of natural medicine and modern Chinese medicine. One of WPU’s leading product is Xuezhikang (RYI) for the prevention and treatment of cardiovascular and cerebrovascular diseases. |
|
Biotech Pharmaceutical Co., Ltd. (BPL)
BPL, based in Beijing, is an innovation-driven high-tech Sino-Cuban joint venture dedicated to monoclonal antibodies, vaccines and etc. It's products include Nimotuzumab, EGF vaccine and Anti-CD6 Antibody. |
|
Dalian Biteomics, Inc.
High-tech biological company established by overseas Chinese scientists, specializing in integration of current Chinese and overseas social and technological resources. The business of the company covers drug discovery, peptide synthesis, distribution of biological enzyme, and international business consultation and services. |
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
Jiuyuan is a modern joint venture specializing in the research, development, production and marketing of pharmaceuticals based on gene engineering and biochemical technologies. Jiuyuan firstly developed a white blood cell promotion medicine in China-recombinant human G-CSF injection. |
|
Mediking Pharmaceutical Co. Ltd.
Pharmaceutical R&D company located in Beijing conducting sophisticated R&D of chemical intermediates, custom synthesis and Active Pharmaceutical Ingredients (APIs). Company scope is also research of synthesis process development and manufacture on APIs and Intermediates. |
|
NCPC New Drug R&D Co. Ltd.
North China Pharmaceutical Group New Drug Research and Development is located in Shijiazhuang. NCPC R&D primarily targets on the fields of immunosuppressant including Cyclosporine and Sirolimus, new antibiotics, such as Teicoplanin and hydrochloride, and anti-fungi including amphotericin B, natamycin as well as traditional Chinese medicines. |
|
SCIPROGEN Bio-pharmaceutical Co.,Ltd
ShenZhen based biotechnology company focused on development, manufacture and marketing of therapeutic proteins (Erythropoietin, EPO) involving the installation of a state of the art mammalian cell-manufacturing facility. SCIPROGEN also provides of E.coli-derived recombinant human drugs. |
|
Shanghai GenePharma
The company has internationally lead siRNA chemical synthesis complete core technology, including RNA monomer synthesis technology, common and chemically modified siRNA oligo synthesis technology. |
|
Shanghai Genomics, Inc.
Company's mission is to develop novel therapeutic products for diseases prevalent in Asia, especially in the areas of lung fibrosis, liver fibrosis, cancer, and new biomaterials for bone healing. Shanghai Genomics also provides drug registration services and operates as a clinical research organization (CRO). |
|
Shanghai Kehua Bio-engineering Co., Ltd. (KHB)
Company develops, manufactures and markets in vitro diagnostic products in China. KHB offers products covering five primary business segments: Diagnostic Reagents, Diagnostic Laboratory Instruments, Therapeutic Drugs, Evacuated Receptacles and Laboratory Information Systems. |
|
Shanghai Telebio Biomedical Co., Ltd.
Shanghai based biomedical company involved in gene therapy. Main product is the Televector Lentiviral vector easy-high production kit. Information only in Chinese. |
|
Shanghai Yuhua Life Science & Technology Development Co., Ltd.
Yuhua devotes itself to the research, production and service of the biological high technology. The key object is to research and develop anticancer and cardiovascular pharmacon, and strive to develop original products with remarkable economic and social benefits. |
|
Shenzhen Watsin Genetech Co., Ltd.
The first rhEGF, being formally permitted to enter into the market as a medicine with the name ‘GeneTime’, gained its first emergence in Watsin. |
|
SiBiono GeneTech Co., Ltd.
Chinese biotechnology company commercialized the first gene therapy product Gendicine, a recombinant Human Ad-p53, used for cancer treatment. |
|
Starvax Inc.
Biopharmaceutical company, located in Beijing, providing pre-clinical contract research services for in vivo studies. Leveraging the cost-savings and other advantages of drug development in China, the company’s objective is to provide high quality services with much lower cost for global biotech and pharmaceutical companies. |
|
Sunway Biotech Co., Ltd.
This Shanghai based biotechnology company is the main developer of the H100 technology and genetically engineered adenoviruses for cancer treatments. It has successfully developed drugs to treat cancer such as H101, H102, and H103. |
|
Tri-Prime Genetic Engineering Co., Ltd.
Beijing based biotech company first key product, Hapgen (Interferon-alpha1b), was approved by the Chinese Authority in 1989, the first Class A New Drug of biological drugs in China. Hapgen can efficiently repress intracellular virus replication and tumor cells proliferation. |
|
Union Stem Cell & Gene Engineering Co., Ltd.
The Corporation has a Hematopoietic Stem Cell Bank (Tianjin Cord Blood Stem Cell Bank) with a network service system. The Antibody Project Department developed more than 60 anti-human monoclonal antibodies clustered by Human Leukocyte Differentiation Antigen (HLDA) workshop with different specificities. |
|
Vector Gene Technology Company, Ltd.
VGTC is a leader in recombinant adeno-associated virus (rAAV) large-scale manufacturing. Its novel AAV package and purification systems make the producing of AAV to be one of the most cost-effective AAV producing systems. |
|
Wantai Biological Pharmacy Enterprise Co., Ltd.
This Beijing based company is the official supplier of HIV blood screening reagents in China, as well as the Chinese market-leader for infectious diseases diagnostic test. |
|
|
|
|
|
|
|
|
| |
|
Sources and Information |
|
|
|
|
|
| |
|
ISCGT Conference |
|
|
|
|
|
|
