Table 1
From the following article
Chinese health biotech and the billion-patient market
Sarah E Frew, Stephen M Sammut, Alysha F Shore, Joshua K Ramjist, Sara Al-Bader, Rahim Rezaie, Abdallah S Daar & Peter A Singer
Nature Biotechnology 26, 37 - 53 (2008)
doi:10.1038/nbt0108-37
Table 1. Chinese health biotech firms interviewed and their product/technology portfoliosa
| Company name | Products/technologies on the market | Products in developmentb | Services provided | Domestic/international quality certifications |
|---|---|---|---|---|
aAs of September 2007. | ||||
bAb, antibody; Ag, antigen; CMV, cytomegalovirus; ELISA, enzyme-linked immunosorbent assay; ESC, embryonic stem cell; FSH, follicle-stimulating hormone; GM-CSF, granulocyte-macrophage colony stimulating factor; GMP, good manufacturing practice; GPCR, G-protein coupled receptor; HAV, hepatitis A virus; HBV, hepatitis B virus; HBsAg, HBV surface antigen; HCC, hepatocellular carcinoma; HCMV, human cytomegalovirus; HCV, hepatitis C virus; HDV, hepatitis D virus; HEV, hepatitis E virus; hGH, human grown hormone; HGV, hepatitis G virus; HIV, human immunodeficiency virus; HLA, human leukocyte antigen; HPV, human papilloma virus; HSV, herpes simplex virus; HTLV, human T-lymphocyte virus; IFN | ||||
| Amoytop Biotech | Recombinant human proteins granulocyte macrophage colony stimulating factor (Topleucon, molgramostim), granulocyte colony-stimulating factor (Topneuter, filgrastim) and IL-11 (Topmega, oprelvekin), produced in Escherichia coli. | Recombinant human proteins manufactured using additional expression systems (yeast, Escherichia coli or mammalian cell lines), including IL-2, IFN  -2a, IFN -2b, IFN  , human growth hormone and pegylated versions of Amoytop's products already on the market. | Protein expression, manufacturing process development. | cGMP operation guidelines and quality assurance system. |
| Beijing Wantai Biological Pharmacy Enterprise | ELISA diagnostic kits for HIV 1/2, H5(HA)Ag, H5(HA)Ab, SARS-Ag, SARS-Ab, SARS-IgM, HAV-IgG, full set of HBV markers, HCV, HDV-Ab, HDV-IgM, HDV-Ag, HEV-IgM, HEV-IgG, HEV-Ab(total), HEV-Ag, HGV-IgG, anti-Treponema pallidum recombinant antigen, HTLV 1/2, Syphillis-Toluidine Red Unheated Serum Test (TRUST) and -fetoprotein. Rapid double antigen sandwich ELISA immunodiagnostic tests for H5-HA(Ag), rotavirus Ag, syphillis, HIV 1+2 Ab, total HBV marker (serum) and HBsAg (serum/plasma/whole blood). Recombinant antigens from coronavirus (SARS), HEV, HTLV and HIV. | ELISA diagnostic kits for HBsAg Ab (rapid), gonorrhea (rapid), Chlamydia trachomatis (rapid).
Double Antigen Sandwich ELISA tests for pre-S1, troponin, C-reactive protein, rhabdoviridae (rabies) or HIV (one step plus two step incubation). Rapid tests for SARS antigen and rhabdoviridae. Diagnostic for chromosome abnormality in amniotic cells (cell culture method). Recombinant vaccines against HPV and HEV. | Registration of medical devices in China, market research and market consultation services for international clients doing business in China, clinical evaluations according to SFDA requirements, contract manufacturing and research. | cGMP certification, ISO 13485. |
| Bio-Bridge Science | Distribute class 1 surgical instruments in the United States. | Oral therapeutic HIV-1 vaccine using papilloma pseudovirus, prophylactic HIV-1 vaccine, HPV vaccine and colon cancer vaccine. | No services offered. | cGMP compliant facility. |
| CapitalBio | Research and diagnostic microarrays for analyzing miRNA and mRNA expression and transcription factor profiling arrays for cancer and cardiovascular disease, HLA typing, food-borne pathogen detection, autoimmune disease detection, drug resistance genotyping systems (for TB and Gram-positive bacteria, etc).
Microarray-related equipment and consumables. Clinical information system software. Good agriculture practice (GAP) information management system. | 1) Microarrays for drug resistance detection of HBV and the detection of respiratory infections; 2) chemiluminescence-based auto-immunoanalyzer; 3) personal microarray setup; 4) liquid handlers; and 5) other instruments, consumables and software. | Genotyping, expression profiling, transcription factor profiling, chromatin immunoprecipitation-chip, custom arrays (microarray spotting), human l eukocyte antigen (HLA) typing service (bone marrow banking and blood banking). | Quality Management (ISO 9001, ISO 13485), National Laboratory Accreditation Certificate, GMP production permits (Pharmaceuticals Producer License, Medical Device Trading License, Medical Device Manufacture License), Product Certificates (CE Certificate, TUV/GS Certificate, FDA Accession Permit, SDA Certificate). |
| FusoGen Pharmaceuticals | Nothing on the market. | HIV fusion inhibitor peptide (sifuvirtide), HBV inhibitor peptides and HCV inhibitor peptides. | No services offered. | None yet gained. |
| GeneScience Pharmaceuticals | Recombinant human proteins Jintropin/Jintropin AQ injection (somatropin), G-CSF injection (Scimax, molgramostim), GM-CSF injection (Granmac), octreotide acetate injection (Jintrotide), triptorelin acetate injection (Jintrirelin, agonist of gonadotropin releasing hormone/luteinizing hormone releasing hormone) and GM-CSF gel (Genfelin). | Recombinant human proteins follicle-stimulating hormone (FSH) for use in treating infertility; suppository form GM-CSF gel for wound healing; thymosin for hepatitis B treatment currently in phase 2 trials in China; and long-acting PEG-growth hormone (somatropin) in phase 3 clinical trials in China. | No services offered. | China cGMP certification, Brazil cGMP certification, Pakistan cGMP certification and Peru cGMP certification. |
| HD Biosciences | Research tools: functional assay cell lines; natural compound library of Chinese herbs; mycoplasma detection kit (MycoScan); wash-free calcium assay kit; peptides & peptide library; and full-length cDNAs in mammalian expression vectors. | Universal G-protein coupled receptor (GPCR) assay system. | Assay development; cell-line generation; high-throughput screening; hit to lead solution; compound profiling; cloning services; peptide synthesis; and gene synthesis. | Information not available. |
| Shanghai Fudan-Yueda Bio-Tech | 1) Recombinant viral antigens (Varicella Zoster, human lymphotropic virus, CMV, HBV, Epstein-Barr, SARS, HSV, Tick-born encephalitis, Rubella, HAV, HEV, HIV and HDV) and Toxoplasma gondii antigens; 2) Antibodies against viruses (HCMV, HBV, HCV, HSV, adenovirus and HIV) and glycogen synthase kinase 3; and 3) hybridization kits and diagnostic kits. | Therapeutic vaccines (antigen-antibody–DNA immunogenic complexes) against HBV, HCV and TB. | Large-scale preparation of nucleic acid and proteins.
Hybridoma and polyclonal antibody development. Restriction fragment length polymorphism (RFLP), RNA interference, and single nucleotide polymorphism (SNP) development. Antiviral drug screening (HBV, HCV, influenza virus and HSV). | Information not available. |
| Shanghai Genomics | 'GuBang' nano-biomaterial for bone void filling, new bone growth and controlled drug release drug delivery. | Small-molecules (F135) against liver fibrosis, idiopathic pulmonary fibrosis and radiation pneumonitis (last now in phase 2). | Antibody production and protein expression.
Tissue slides and immuno-histochemistry; real-time Q-PCR; gene cloning; yeast two-hybrid; RNAi-based interference; animal models; drug target discovery and validation; clinical research. | Information not available. |
| Shanghai Genon Bio-Engineering | Transgenic and cloning (milk goat, cow & boer goat) stock-breeding products.
Technology platform for somatic cell nuclear cloning. Processed brewer's yeast for pets and livestock. Animal-sourced protein (plasma protein powder, hemoglobin powder, dried porcine solubles). | Animal bioreactor human recombinant lactoferrin and injectable lysozyme in pre-clinical testing and Prp knockout goats and cows. | Protein production via animal mammary bioreactors and animal cloning with somatic cell nuclear transfer. | ISO 9002 for quality management system. |
| Shanghai Huaguan Biochip | Immunodiagnostics for HCV, HIV, T. pallidum, HBsAg, chlamydia, Helicobacter pylori (dip-stick and cassette formulation); flow-through tests for T. pallidum, Helicobacter pylori, TB; ELISA kits for HAV, HBsAg, HCV, HDV, HEV, HGV, HIV, Rubella; and self-reading, point-of-care pregnancy tests. | Diagnostics for myocardial infarction and gastroenteritis. | DNA shotgun libraries sequencing, quantitative real-time PCR, cDNA libraries construction, serial analysis of gene expression (SAGE). | Information not available. |
| Shanghai Sunway Biotech | Oncolytic adenovirus, (H101, Oncorine) for treating head and neck squamous cell carcinoma; recombinant human G-CSF (SunGran) for chemotherapy induced neutropenia. | Genetically modified oncolytic adenoviruses (H102, H103). H102 targets only hepatocellular carcinoma overexpressing -fetoprotein and is in preclinical development; H103 (AD-HE) expresses HSP70 to target systemic cancer metastases and is in early clinical development. | Clinical trial management in China. | cGMP certification. |
| Shanghai United Cell Biotech | Recombinant human somatropin (Genheal); oral recombinant cholera toxin B subunit/inactivated whole cell V. cholerae (OraVacs; enteric-coated capsule). | Recombinant human parathyroid hormone for the treatment of osteoporosis. | No services offered. | cGMP certification, ISO 9001:2000. |
| Shenzhen Beike Biotechnologies | Umbilical cord, bone marrow and peripheral blood stem cell injections for Alzheimer's, ataxia, autism, amyotrophic lateral sclerosis, brain trauma, cerebral palsy, Guillain-Barre, diabetic foot/arteriosclerosis and spinal cord injury. | Ongoing research on stem cells, the nuclear transfer and reprogramming of cells, and monoclonal antibodies. | Therapeutic stem cell technology (for hospitals). | cGMP standard laboratories. |
| Shenzhen Chipscreen Biosciences | Natural product nutraceutical for fatty liver/alcohol detoxification (MeiGanLe); chemical genomics-based discovery platform for compound early evaluation. | Chiglitazar (CS038), a small-molecule peroxisome proliferator-activated receptors (PPAR) pan agonist to treat type 2 diabetes in phase 2b trial; Chidamide (CS055), a histone deacetylase inhibitor to treat lung cancer and colon cancer in phase I trials; S220/CS230 (kinase inhibitor/ receptor tyrosine kinase inhibitor), CS204 (PPAR pan agonist), Cs207/307 (PPAR agonist) in preclinical research for cancer, metabolic syndrome and cardiovascular disease (dyslipidemia), respectively. | Contract and collaborative research, including chemistry, assay development and multiple-target high-throughput screening, gene expression analysis by microarray, in vivo efficacy testing, pharmacokinetic/pharmacodynamic profiling, preclinical studies and dossier for synthetic and botanical compounds. | Information not available. |
| SiBiono GeneTech | Gendicine (human wild-type p53 tumor suppressor gene and modified serotyped 5 adenoviral vector) gene therapy approved for cancer treatment (head and neck, including nasopharyngeal squamous cell carcinoma). | Developing viral gene delivery system and non-viral gene delivery system, focused on cancer, AIDS and cardiovascular disease. Currently testing Gendicine for marketing approval for other oncological indications. | Small- and pilot-scale preparations, and quality tests, of clinical-grade recombinant adenovirus products. | cGMP certification. |
| SinoCells Biotech | Stem cell lines, including neural, muscle, corneal, and pancreatic. Other cell lines, including chondrocytes, osteoplasts mononuclear cells, fibroblasts, glial cells, and liver, lung and breast cancer cell lines. | Preclinical research on human mesenchymal stem cells, embryonic stem cells and neural stem cells and their use in cell therapy for endocrine diseases, cellular injury, organ damage, degenerative diseases and cancer. | Isolation and cultivation of human stem cells; stem cell assays for drug screening and cell therapies. | cGMP certification. |
| SinoGenoMax | Various molecular biology reagents and kits (>500 polyclonal antibodies); genetic test for aminoglycoside-induced hearing impairment (A1555G mutation in mitochondrial DNA); human fluorescent in situ hybridization (FISH) probe kits for Down's syndrome or retinoblastoma. | Protein biomarkers for lung and pancreatic cancer, cardiovascular disease and schizophrenia. | DNA sequencing, real-time quantitative PCR, microsatellite marker assays, FISH as well as antibody production. | ISO 9001: 2000 quality management system. |
| Sinovac Biotech | Healive (inactivated HAV vaccine), Bilive (combined inactivated HAV and HBV vaccine) and Anflu (trivalent influenza vaccine). | Japanese encephalitis vaccine, SARS vaccine, pandemic influenza vaccine (H5N1). | No services offered. | China cGMP certification. |
| Starvax International | No products on the market. | SV6182, a nucleic acid based immunomodulator for cancer; immunotherapeutics against HBV, HIV and colorectal cancer; SV8000 prophylactic vaccine for SARS coronavirus; proprietary recombinant adenovirus vaccine. | Preclinical contract research organization capabilities: proof-of-concept drug efficacy studies; small and large animal (including non-human primate) model development; animal model maintenance and testing; multiple drug delivery modes (including intramuscular, intravenous, intracerebroventricular, subcutaneous, intra peritoneal and oral); preliminary pharmacokinetics/pharmacodynamic study; molecular biology; biochemistry; immunology; cell biology; histology; and immunohistochemistry. | Standardized documentation, reporting and record tracking but no national or international certification. |
| Tianjin SinoBiotech | No products on the market. | Tumor-killing viruses (KTV-9) for head, neck, lung, liver, stomach and breast cancers have completed preclinical development; long-acting human recombinant IFN- currently under development. | No services offered. | Information not available. |
| WuXi PharmaTech | No products on the market. | No products under development. | Development from therapeutic target discovery to phase 1 human clinical trials. Range of services include discovery chemistry (e.g., lead generation and optimization), assay development and compound screening, drug metabolism and pharmacokinetics, pharmaceutical development (formulation development for new chemical entities), process development (including research and optimization) and manufacturing of advanced intermediates and active pharmaceutical ingredients. | cGMP quality, ISO 9001:2001. |
, interferon-