NMPA accepts application for new drug listing of Cinda Bio in research drug Adamu mono-anti-injection biosimilars

today, Cinda Bio
Pharmaceutical(HKSE Code: 1801) announced that the NationalPharmaceutical(NMPA) has
accepted thenew drug(NDA) of thePharmaceutical(Adamu mono-injectable biosimilars) (Research Code: IBI303)this is the second new drug listing application accepted by NMPA, following the submission in April of the sintilimab listing application and inclusion in the priority reviewbiosimilars of IBI303
IBI303 as Adamu monoantigens, are monoclonal antibodies for recombinant human anti-tumor necrosis factor-alpha (Tumor necrosis factor-alpha, TNF-alpha)pharmacological results show that IBI303 has the same amino acid sequence as the original drug Adamu mono-injection, and that in vitro biological activity (binding and moderate activity to the target antigen TNF-alpha) is similar;clinicaltrial(showing that IBI303 can effectively improve the symptoms and signs of patients with strong syllititis, reduce the activity of the disease, improve body movement function, spinal activity, tendon enditis, improve the quality of life of patients, reduce the impact of the disease on work, and Adamu mono-injection has a similar clinical efficacy.) 　　The IBI303 is safe and mostly light and moderate adverse events in the clinical development phase, Cinda Biopharma, based on the "Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial)" issued by NMPA, conducted IBI303 in the health (tolerable clinical research in subjects), PK-to-phase studies and clinical effectiveness comparison studies in patients with strong syllititis to evaluate the clinical similarity of IBI303 and the original adamu injection sin results show that the two main comparison studies have reached the preset equivalent standard