PharmaSources/CaicaiApril 23, 2019
Tag: clinical trials , biosimilars , R&D progress
Biosimilars that have entered Phase III clinical trials are listed below:
Related: Hot Battle! Which to be the Next "Hanlikang"?
Target | Representative original drug | Enterprise | Biosimilar name | Indication | R&D progress | |
CD20 | Rituximab (trade name: Rituxan) | Henlius | HLX01 | Rheumatoid arthritis | Phase Ⅲ clinical trial (recruiting) | |
Innovent | IBI301 | Diffuse large B-cell lymphoma | Phase Ⅲ clinical trial (recruiting) | |||
Hisun Pharmaceuticals | Recombinant Human/Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection | Previously untreated CD20-positive diffuse large B-cell lymphoma | Phase Ⅲ clinical trial (recruiting) | |||
Sinocelltech | SCT400 Injection | CD20-positive diffuse large B-cell lymphoma (DLBCL) | Phase Ⅲ clinical trial (recruiting) | |||
EGFR | Cetuximab (trade name: Erbitux), nimotuzumab (trade name: Taixinsheng) | Biotech Pharma | Nimotuzumab Injection | Stage IVB, recurrent, or persistent squamous carcinoma of the cervix / metastatic esophageal squamous carcinoma / locally advanced or metastatic pancreatic cancer | Phase Ⅲ clinical trial (recruiting) | |
Kelun | Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Human-Mouse Chimeric Monoclonal Antibody Injection | First-line therapy of metastatic colorectal cancer | Phase Ⅲ clinical trial (having not recruited) | |||
MabTech | Recombinant Anti-EGFR Human-Mouse Chimeric Monoclonal Antibody Injection | Previously untreated wild-type RAS/BRAF metastatic colorectal cancer | Phase Ⅲ clinical trial (recruiting) | |||
VEGF | Bevacizumab (trade name: Avastin), ranibizumab (trade name: Lucentis) | Henlius | HLX04 | Metastatic colorectal cancer | Phase Ⅲ clinical trial (recruiting) | |
Chiatai Tianqing | TQ-B2302 | Non-squamous non-small cell lung cancer | Phase Ⅲ clinical trial (having not recruited) | |||
Innovent | IBI305 | Advanced or recurrent non-squamous non-small cell lung cancer | Phase Ⅲ clinical trial (recruitment completed) | |||
Qilu Pharmaceutical | QL1101 | Non-small cell lung cancer | Phase Ⅲ clinical trial (recruitment completed) | |||
Mabworks | MIL60 | Advanced or recurrent non-squamous non-small cell lung cancer | Phase Ⅲ clinical trial (recruiting) | |||
Bio-Thera | BAT1706 | Non-squamous non-small cell lung cancer | Phase Ⅲ clinical trial (recruiting) | |||
Boan Biological | LY01008 | Non-small cell lung cancer | Phase Ⅲ clinical trial (recruiting) | |||
Genor Biopharma | GB222 | Non-small cell lung cancer | Phase Ⅲ clinical trial (having not recruited) | |||
Hengrui Medicine | BP102 | Non-squamous non-small cell lung cancer | Phase Ⅲ clinical trial (recruiting) | |||
TOT Biopharm | TAB008 | Advanced or recurrent non-squamous non-small cell lung cancer | Phase Ⅲ clinical trial (recruiting) | |||
TNF | Adalimumab (trade name: Humira) , infliximab (trade name: Remicade), etanercept (trade name: Yisaipu) | Henlius | HLX03 | Moderate to severe plaque psoriasis | Phase Ⅲ clinical trial (recruitment completed) | |
Biomabs | CMAB008 | Patients with moderate to severe active rheumatoid arthritis who have failed to respond to one or more disease-modifying antirheumatic drugs (DMARDs) | Phase Ⅲ clinical trial (recruitment completed) | |||
Innovent | IBI303 | Ankylosing spondylitis | Phase Ⅲ clinical trial (recruitment completed) | |||
Hisun Pharmaceuticals | HS016 | Active ankylosing spondylitis | Applied for production | |||
HS626 | Plaque psoriasis | Phase Ⅲ clinical trial (having not recruited) | ||||
Bio-Thera | BAT1406 | Ankylosing spondylitis | Applied for production | |||
Genor Biopharma | Recombinant Anti-TNF-alpha Antibody for Injection | Rheumatoid arthritis | Phase Ⅲ clinical trial (having not recruited) | |||
Sunshine Guojian | Recombinant Human Tumor Necrosis Factor Receptor Type II-Antibody Fusion Protein for Injection | Ankylosing spondylitis | Applied for production | |||
Qilu Pharmaceutical | Recombinant Human Tumor Necrosis Factor Receptor Type II-Antibody Fusion Protein for Injection | Ankylosing spondylitis / moderate to severe active rheumatoid arthritis | Phase Ⅲ clinical trial (recruiting)/Applied for production | |||
HER2 | Trastuzumab (trade name: Herceptin) | Henlius | HLX02 | Breast cancer | Phase Ⅲ clinical trial (recruitment completed) | |
Hisun Pharmaceuticals | Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection | Breast cancer | Phase Ⅲ clinical trial (having not recruited) | |||
Bio-Thera | BAT8001 | HER2-positive advanced breast cancer | Phase Ⅲ clinical trial (having not recruited) | |||
Genor Biopharma | Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection | HER2-positive advanced breast cancer / HER2-overexpressing recurrent metastatic breast cancer | Phase Ⅲ clinical trial (recruiting)/ Phase Ⅲ clinical trial (having not recruited) | |||
Related: Hot Battle! Which to be the Next "Hanlikang"?
(Organized according to public data, by Apr. 3, 2019)
Reference: [Special Report on Biosimilars] In-depth Analysis of the Process of Biosimilar’s Substitution of Original Drugs in Europe and China
Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.
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