Joincare subsidiary's psoriasis drug application accepted by NMPA
Joincare Pharmaceutical Group Industry announced that its controlling subsidiary, Zhuhai Livzon Mabpharm Inc., has received acceptance from China's National Medical Products Administration (NMPA) for the marketing authorization application of "Rekonkitta Monoclonal Antibody Injection." This novel treatment, an IL-17A/F dual-target inhibitor, is intended for adult patients with moderate to severe plaque psoriasis who are suitable for systemic treatment or phototherapy.
The drug, a 160mg (1.6mL)/vial injection, is categorized as a Class 1 therapeutic biological product. Clinical trial results indicated superior efficacy compared to secukinumab, demonstrating faster onset, excellent short-term efficacy, long-term durability, and less frequent dosing. The cumulative research and development investment for Rekonkitta Monoclonal Antibody Injection totals approximately RMB 204.03 million.
As of the announcement date, no other IL-17A/F dual-target products for psoriasis have been approved in China. The domestic market for IL-17A and IL-17RA single-target drugs reached an estimated RMB 2.833 billion in 2024. The approval process for Rekonkitta will now move to the NMPA's Center for Drug Evaluation for review and approval, with the timeline and outcome subject to uncertainty.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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