China's medicines authority (China State Food & Drug Administration, SDFA) approved the cancer therapy after it achieved promising results in a clinical trial on October 16, 2003. The treatment, called Gendicine, has been launched commercially by SiBiono GeneTech Co. of Shenzhen, Guangdong province. Gendicine was approved for the treatment of head and neck squamous cell carcinoma. The gene therapy product is an adenovirus vector carrying the p53 tumour-suppressor gene. Gendicine is similar to Advexin developed by the Texas-based Introgen Therapeutics. Advexin is still waiting for FDA approval.
The results of the Gendicine clinical trial are published in Human Gene Therapy, says Zhaohui Peng, the SiBiono 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. There were concerns about the approval among researchers elsewhere in the world as to quality of the trials performed and thereby the safety and efficacy of the treatment (Controversial Chinese gene-therapy drug entering unfamiliar territory). The available clinical data and conclusions drawn were obtained from a relatively small number of patients in clinical trials. There have been more patients treated, but the clinical data of these patients are hard to access, partly due to the fact that they were published only in Chinese journals. Furthermore, it seemed that approval had been made on the basis of tumour shrinkage rather than extension of patient lifetime (An update on gene therapy in China). Despite these concerns, patients have flown to China to undergo therapy (see Medical Tourism)
Shanghai Sunway Biotech Co. Ltd. announced in November 2005 that the SFDA has approved Oncorine (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. H101 is essentially a modified version of Onyx-015, initially developed by Onyx Pharmaceuticals. Besides Oncorine, Shanghai Sunway Biotech develops a tumor-targeted recombinant adenovirus injection (H102) and an oncolytic recombinant adenovirus injection (H103) for treatment of cancer. H102 specifically targets primary hepatocellular carcinoma. H103 adenoviruses lyses the tumor cells and expresses Hsp70 that can potently stimulate an antitumor immune response.
See the following reviews regarding the developments of gene therapy in China:
- Current status of gene therapy in Asia
- Gene medicine for cancer treatment: commercially available medicine and accumulated clinical data in China
- Gene Therapy in China - From a Dutch perspective (2010). This study was initiated by The Netherlands Commission on Genetic Modification (COGEM) to retrieve information from Chinese sources, esp. Chinese literature databases, Chinese scientists, scientific meetings in China, on gene therapy developments and risk assessment.
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 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.
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 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.
|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 Oncorine (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.
|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.