In 2005, YISAIPU was listed as the first tumor necrosis factor (TNF-α) inhibitor in the field of rheumatism in China, and was also the first fully human antibody drug listed in China, marking a Chinese company has for the first time penetrated into fully human therapeutic antibody drugs.
The National Medical Products Administration (NMPA) has approved three indications: rheumatoid arthritis (2005), ankylosing spondylitis and psoriasis (2007), and it has been listed in the western medicine part of the National Reimbursement Drug List as a Class B drug.
YISAIPU’s domestic market share has been leading since 2006, and it is also a domestic market leader in macromolecular immune system diseases.
The “recombinant humanized anti-CD25 monoclonal antibody injection” (trade name: “Xenopax”), independently developed by the company, is currently the only humanized anti-CD25 monoclonal antibody drug approved for marketing in China. It has obtained the drug GMP certificate issued by the NMPA in June 2019 and was launched on the market in October 2019.
The product is for prevention of acute rejection after renal transplantation and can be combined with the routine immunosuppression regime to significantly improve the survival rate of transplanted organs and the quality of life of patients.
Cipterbin (Inetetamab for Injection) was formally approved in June 2020 as the first innovative anti-HER2 monoclonal antibody in China with the engineered Fc region, optimized production process and a stronger ADCC effect. Cipterbin obtained the GMP compliance certificate for drug production issued by the Shanghai Municipal Drug Administration in April 2020, and started to be available on the market in July 2020.
Research showed that in combination with chemotherapy drugs, it can significantly reduce the risk of disease progression in patients with HER2-positive metastatic breast cancer, improve the objective response rate, and prolong the progression-free survival of the patients.