30 July 2019 | News
The first self-developed pre-filled fusion protein injection solution in the PRC
3SBio Inc., a leading biopharmaceutical company in the People's Republic of China (PRC) has announced that an application for the production of new drug has been submitted to the National Medical Products Administration for Yisaipu® pre-filled aqueous injection solution (common name: recombinant human type II tumor necrosis factor receptor-antibody fusion protein injection solution), an antibody fusion protein drug product that is self-developed by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio.
Yisaipu® aqueous injection solution is the first self-developed pre-filled fusion protein injection solution in the PRC. It is used for the treatment of three indications: active ankylosing spondylitis, moderate and severe active rheumatoid arthritis as well as moderate and severe plaque psoriasis in adults of 18 years old and above. According to research, the prevalence rates of such three diseases in the PRC are approximately 0.3%1, 0.4%2 and 0.1%3 respectively. At present, patients' compliance with such biologics agent is not yet satisfactory. Poor patients' compliance is also one of the major causes of repeated disease onset.
Yisaipu® pre-filled aqueous injection solution has achieved significant breakthrough in the process of biologics agents in the PRC. Patients are no longer restricted to hospital treatment and can give self-injections at home. It is expected to greatly improve patients' compliance and enhance patients' quality of life.
Yisaipu® was launched as powder for injection in 2006 and has so far benefited more than 300,000 patients. It has received professional recognition from clinicians and trust from a wide range of patients. In 2017, it was included in the National Reimbursement Drug List as a Class B Drug. Yisaipu® pre-filled aqueous injection solution will bring more dosage forms and is expected to benefit more patients.
Dr. Lou Jing, Chairman and Chief Executive Officer of 3SBio, commented, "I am pleased to see that the application for the production of new drug for Yisaipu® pre-filled aqueous injection solution has been successfully submitted and accepted. 3SBio will continue to focus on the biopharmaceutical field and is committed to exploring and developing more therapeutic biologics agents in different dosage forms, so as to meet different medical needs and provide patients with more choices."