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Antibody Drug Analogues

Antibody biosimilar combine great minds and profound expertise, together with high-end technologies, we at KMD Bioscience can help advance your biosimilar research process and make it faster. Such products are used for the inhibition of key molecules for tumour survival, immune intrinsic and adaptive activation of tumours, and antibody-coupled cytotoxic biosimilar. Monoclonal antibodies are antibodies secreted by a single clone of B lymphocytes. After more than 30 years of research and development, monoclonal antibody biosimilar have made considerable progress in the treatment of tumors and autoimmune diseases, and have become a rapidly growing and promising area of medical development.


KMD Bioscience can provide five classed of bio-similars: cytotoxic drugs, inhibit cell proliferation, regulate cell activation and interaction, autoimmune system, neutralize antigens. At present, the biological functions of monoclonal antibody biosimilar are mainly reflected in 3 points: key molecules that inhibit tumor survival, tumor immune intrinsic and adaptive activation, and antibody-conjugated cytotoxic biosimilar. The targets of monoclonal antibody biosimilar mainly focus on HERTNF, CD20, PD-1/L1, VEGF and CD3. Among them, the number of monoclonal antibody biosimilar targeting HER2 is the largest, and its mechanism of action is to down-regulate the expression of HER2 and inhibit tumor growth. The number of monoclonal antibody biosimilar targeting TNF-α is the second largest. Its mechanism of action is to neutralize the activity of free TNF-α and transmembrane TNF-α on the surface of immune cells, and block the binding of TNF-α to receptor subunits.

Currently, there are over 20 monoclonal antibodies on the global market, among which the top ten sales are:

--Adalimumab (Humira), a TNF-α fully human monoclonal antibody, developed by BASF Knoll and Cambridge Antibody Technology (CAT);

--Infliximab (Remicade), a chimeric monoclonal antibody on the human/mouse IgG1k isotype chain, developed by Johnson & Johnson, Merck and Tanabe Mitsubishi Pharmaceuticals, is mainly used to treat Crohn's disease and ulcers Colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, etc.

--Rituxan (MabThera), a chimeric human/mouse monoclonal antibody against CD20 produced by Roche.

--Trastuzumab (Herceptin), developed by Genentech.

-Bevacizumab (Avastin), the world's first anti-angiogenic drug that can be widely used in a variety of tumors, developed by Roche's Genentech.

--Nivoluma (Opdivo), a fully humanized IgG4 monoclonal antibody against PD-1, jointly developed by Bristol-Myers Squibb (BMS) and Ono Pharmaceutical.

--Ustekinumab (Stelara), a high-affinity, fully humanized IgG1k monoclonal antibody, directed against the p40 subunit of IL-12/IL-23, developed by Johnson & Johnson.

--Denosumab (Pralia), the first human monoclonal antibody targeting nuclear factor kappa B (RANK) receptor activator ligand, developed by Amgen.

--Pembrolizumab (Keytruda), a humanized monoclonal antibody that binds to the PD-1 receptor, developed by Merck.

--Ranibizumab (Lucentis), the second-generation humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment, and some antibody fragments derived from bevacizumab, produced by Roche's Genentech and Novartis Joint development.

By the first half of 2021, 12 types of Class 1 innovative drugs in China have been approved by the National Medical Products Administration (NMPA). such as:

--Ainuovirine: HIV-1 non-nucleoside reverse transcriptase inhibitor, inhibits the replication of HIV-1 through non-competitive binding of HIV-1 reverse transcriptase, declared by Jiangsu Aidi Pharmaceutical Co., Ltd.

--Tenofovir Amibufenamide is the phosphoramidite prodrug of Tenofovir, which belongs to the nucleoside reverse transcriptase inhibitor and is declared by Jiangsu Hausen Pharmaceutical Group Co., Ltd.


Monoclonal Antibody Biosimilar provided by KMD Bioscience:


KMD focuses on R&D to stay on the cutting edge, it has independently developed a range of monoclonal antibody biosimilar against different targets. All monoclonal antibody biosimilarfrom KMD Bioscience are for scientific research purposes only, no other purposes are permitted. 

The monoclonal antibody biosimilar provided by KMD Bioscience are classified as follows according to different targets: