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Simcere Pharmaceutical (02096.HK) Withdraws NDA for Ledeqibai Monoclonal Antibody, Expects to Resubmit Within a Month
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Simcere Pharmaceutical (02096.HK) announced that, for strategic optimization of its overall product commercialization strategy, the company has voluntarily withdrawn the New Drug Application (NDA) for ledeqibai monoclonal antibody and expects to resubmit the NDA within this month. The company will maintain close communication with regulatory authorities and strive to obtain approval for launch as soon as possible. In July last year, the Groups innovative drug ledeqibai monoclonal antibody, developed in collaboration with Hong Kong Connect Biopharma, had its NDA accepted by the National Medical Products Administration for the treatment of atopic dermatitis in adults and adolescents. (de/d) This article was automatically translated by AI, the Chinese version should be considered the authoritative version. AASTOCKS.com Limited does not guarantee its accuracy or completeness and accepts no liability for any damages or losses arising from the use of this translation. Auto-translated by AI AASTOCKS Financial News |
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