CMAB007

CMAB007 has completed phase III clinical trials for allergic asthma. Based on new regulations and technical guidelines introduced by the NMPA on new biological drugs, we have also completed a head-to-head phase I comparative study against currently marketed omalizumab products to confirm the similar pharmacokinetic profile and immunogenicity of CMAB007. It is expected that CMAB007 will expand its indications to chronic idiopathic urticarial, seasonal allergic rhinitis and food allergies in the future.The new drug application (NDA) of CMAB007 (omalizumab) has been accepted, Currently, we expect that CMAB007 may be approved by the NMPA for marketing in the fourth quarter of 2022.

CMAB009

CMAB009 is under phase III clinical trials for colorectal cancer. The outbreak of COVID-19 and the recent rebound of the pandemic had certain impacts on our research and development in 2021. We expect to file the new drug marketing application with the NMPA in the third quarter of 2022 upon completion of clinical observation and data analysis of all cases. We are also preparing for clinical trials of other indications of CMAB009. Currently, we expect that CMAB009 may be approved by the NMPA for marketing in the third quarter of 2023.

CMAB807

CMAB807 is currently under phase III clinical trials for osteoporosis and we expect that CMAB807 will be approved by NMPA for marketing in the first quarter of 2024 for the indication of osteoporosis.

We have also developed a dosage form of CMAB807 for the treatment of tumor bone metastasis and conducted pre-clinical research, i.e. CMAB807X (denosumab). We expect that phase III clinical trials for tumor bone metastasis will be launched in the first quarter of 2023. It is currently expected that CMAB807X will be approved by NMPA for marketing in the first quarter of 2027 for the indication of tumor bone metastasis.

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. As of June 30, 2021, we have commenced the phase I clinical trial. We expect that CMAB819 may be approved by the NMPA for marketing in the fourth quarter of 2027. CMAB819 is indicated for the treatment of metastatic non-small cell lung cancer, hepatocellular carcinoma and head and neck squamous cell carcinomas (HNSCC).