We have three core products, CMAB008 (infliximab) has been approved for marketing, the new drug application (NDA) of CMAB007 (omalizumab) has been accepted, and CMAB009 (cetuximab) is in phase III clinical trial.

• 类停®－CMAB008（infliximab）

  • CMAB008类停® (infliximab), with trade name of 类停®, is a recombinant anti-TNF-alpha chimeric monoclonal antibody, approved by the National Medical Products Administration of the People's Republic of China (""NMPA"") on July 12, 2021 (Guo Yao Zhun Zi S20210025) for the treatment of rheumatoid arthritis, Crohn's disease in adults and pediatric patients aged 6 years or above, fistula Crohn's disease, ankylosing spondylitis, psoriasis and ulcerative colitis in adults.
  • CMAB008类停® is the first China-made infliximab approved for marketing, which is a monoclonal antibody biosimilar independently developed by the Company and one of the core products of the Company. CMAB008类停® uses the CHO expression system and is a monoclonal antibody targeting TNFα (tumor necrosis factor α) that specifically merges with TNFα and blocks the inflammatory cascade response caused by TNFα. The researches we have completed have shown that, compared to other anti-TNFα drugs on the market, CMAB008类停®(infliximab for injection) has a stronger affinity for TNFα and a stronger glycosylation character, with rapid onset of effect, long-lasting efficacy, long dosing intervals and no hypersensitivity reactions. The results of our completed researches including, clinical trials, non-clinical comparative studies and pharmacological comparisons of CMAB008类停® have also shown that CMAB008 is identical to the original infliximab in terms of efficacy, safety, pharmacological profile and quality.
  • The only other infliximab currently available for sale in the PRC is “Remicade”, an imported drug sold by Xian Janssen. CMAB008类停® is approved for the treatment of six indications at this time which has huge long-term unmet market demand (with more than 10 million patients in the PRC which is still growing). Infliximab has been listed on China's National Medical Insurance Drug List. According to the relevant regulations of China's basic medical insurance program (the ""Medical Insurance""), our company's CMAB008类停® is applicable to the scope of infliximab medical insurance, thus providing patients with a new and more economical option. With high quality innovative drugs as the foundation, Mabpharm will provide innovative antibody drugs to patients in the PRC by offering more economical and affordable drug supply solutions and fully participating in China’s national healthcare system reform initiatives; The Company has also reached agreements with partners who have accumulated abundant overseas market resources over a long period of time and is applying for drug registration and marketing of CMAB008 in dozens of countries and regions, including Brazil.
• The mechanism of action of CMAB008

• CMAB007 (omalizumab)

  • CMAB007 (omalizumab), a recombinant humanized anti-IgE monoclonal antibody, is our new drug candidate for treatment of asthma patients who remain inadequately controlled despite med/high dose of ICS plus LABA. We believe that, once approved by the NMPA for marketing, CMAB007 will be the first mAb asthma therapy developed by a local Chinese company marketed in China. CMAB007 combines with free IgE to form an anti-IgE complex that inhibits the high affinity IgE receptor and thereby prevents the allergic response. The safety and efficacy of CMAB007 have been confirmed by the results of four clinical trials of a total of 824 subjects who have been administered CMAB007, which were the largest clinical trials of mAb treating asthma in China. Based on our clinical trial results, CMAB007 can improve asthma patients’ conditions with lower-dose inhaled corticosteroids and reduce the incidence of acute asthma attacks.
• The mechanism of action of CMAB007

• CMAB009 (cetuximab)

  • CMAB009 (cetuximab), a recombinant anti-EGFR chimeric monoclonal antibody, is our new drug candidate based on cetuximab for first-line treatment of metastatic colorectal cancer (“mCRC”) in combination with FOLFIRI. CMAB009 is the first NMPA approved chimeric anti-EGFR antibody for clinical trial developed in China by a local Chinese company. CMAB009 uses the CHO expression system, which is different from the mouse myeloma cell SP2/0 expression system used in marketed cetuximab products. The safety and efficacy of CMAB009 have been confirmed by the results of two completed clinical trials on a total of 530 subjects, which were the largest clinical trials of anti-EGFR mAb developed in China by a local Chinese company. Based on our clinical trial results compared to published clinical trial results for currently marketed cetuximab products, CMAB009 significantly reduces immunogenicity and decreases the incidence of adverse reactions, such as severe hypersensitivity. We believe that CMAB009 is safer than, and as effective as, currently marketed cetuximab drugs for the treatment of mCRC.
• The mechanism of action of CMAB009

We also have a pipeline of eight other drug candidates that includes our versions of denosumab, nivolumab, etc, all of which have the potential to become key products for the treatment of cancers or autoimmune diseases in the future.

CMAB807 (denosumab)

CMAB807 (denosumab) is a human IgG3 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand), which is a transmembrane or soluble protein essential for the formation, function and survival ofteoclasts, the cells responsible for bone resorption. CMAB807 prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bones.

CMAB819 (nivolumab)

CMAB819 (nivolumab) is our biosimilar drug candidate currently undergoing phase I clinical trial. CMAB819 was approved by the NMPA for clinical trial in September 2017. CMAB819 is indicated for the treatment of metastatic non-small cell lung cancer, hepatocellular carcinoma and head and neck squamous cell carcinomas (HNSCC).

CMAB810 (pertuzumab)

CMAB810 (pertuzumab) is our pre-clinical trial biosimilar drug candidate. The related screening processes, establishment of a cell bank and a lab-scale process for CMAB810 have been completed. CMAB810 is indicated for the treatment of breast cancer.

CMAB816 (kanumumab)

CMAB816 (kanumumab) is our pre-clinical trial biosimilar drug candidate. The related screening processes and the establishment of a cell bank have been completed. CMAB816 is indicated for the treatment of periodic fever syndrome and systemic juvenile idiopathic arthritis. Further, according to the latest research results, canakinumab can potentially reduce the incidence of lung cancer and lung cancer-related mortality rates.

CMAB017

CMAB017 is an innovative candidate in preclinical research stage and an innovative strong antibody drug. At present, the screening of high expression engineering cells and the establishment of engineering cell banks have been completed. The research on the production process and formulation selection has been concluded. Results of the completed experimental study on tissue distribution of tumor-bearing mice show that CMAB017 concentrates locally in tumor 24-72 hours after administration. Regarding CMAB017, the design of blocking peptide is expected to significantly reduce adverse skin reactions, gastrointestinal mucosa, etc. The selection of IgG1 constant region can enhance the effect mediated by Fc fragment of antibody and thus improve the curative effect. Based on the advantages of safety and curative effect, the cost of case medication is far lower than CMAB009, and it is expected that more new strong antibody drugs will be developed by leveraging the research and development platform of CMAB017. CMAB017 is indicated for the treatment of KRAS wild-type colorectal cancer.

CMAB015 (secukinumab)

CMAB015 (secukinumab) is a biosimilar candidate for secukinumab, which is under preclinical study. CMAB015 targets interleukin 17A (IL-17A) for treating plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

CMAB018 (mepolizumab)

CMAB018 (mepolizumab) is a biosimilar candidate for mepolizumab, which is under preclinical study. CMAB018 targets interleukin 5 (IL-5) in treating severe asthma and eosinophilic granulomatous polyangiitis.

CMAB022

CMAB022 is a biosimilar drug candidate of stelara® (ustekinumab, usnumab). Ustekinumab is monoclonal antibody targeting interleukin-12 (IL-12) and interleukin-23 (IL-23). It inhibits these two proinflammatory cytokines by binding to the P40 subunit shared by IL-12 and IL-23 and preventing them from binding to the cell surface IL-12 receptor IL-12Rβ1. IL-12 and IL-23 are natural proteins, which play a key role in immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis and Crohn’s disease, indications include: moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy; adults with active psoriatic arthritis (PsA); adults with active ankylosing spondylitis (AS); adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.