The application for the marketing approval of the innovative drug in the field of autoimmune diseases jointly developed with Connect Biopharmaceuticals has been accepted

July 10, 2025  Source: drugdu 52

"/Simcere Pharma (02096) announced on the evening of July 8 that the company and Hong Kong Connect BiopharmaceuticalsInnovative drugs developed by pharmaceutical companiesThe New Drug Application (NDA) for Ledeqibaimab has been accepted by the China National Medical Products Administration (NMPA) and is intended for the treatment of atopic dermatitis in adults and adolescents.

Ledeqibaimab is a fully human monoclonal antibody targeting IL-4Rα (a common subunit of IL-4 and IL-13 receptors). By blocking the functions of IL-4 and IL-13, the drug can effectively inhibit the Th2-type inflammatory pathway, thus providing a possible treatment for Th2-related inflammatory diseases such as atopic dermatitis and asthma.

According to reports, Connect Biopharma is a global clinical-stage biopharmaceutical company focused on the development of innovative therapies for inflammatory diseases. In addition to atopic dermatitis, the company is conducting global studies on Ledeqibaimab for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD) to address unmet medical needs in these areas.

Simcere Pharma is a pharmaceutical company with innovation and R&D as its core, and owns the "National Key Laboratory for Neurological and Oncology Drug R&D". The company focuses on the fields of neuroscience, anti-tumor, autoimmunity and anti-infection, and has established strategic partnerships with many innovative companies and scientific research institutions through a model that combines independent R&D with collaborative innovation, and is committed to providing patients with more treatment options.

The company said that the acceptance of the new drug application marks an important progress of Simcere Pharmaceuticals in the field of autoimmune diseases and also brings new treatment hope for patients with atopic dermatitis. The company said it will continue to promote the research and development of innovative drugs and fulfill its corporate mission of "born for patients".

According to the 2024 annual report, the company achieved total operating revenue of 6.887 billion yuan, a year-on-year increase of 1.66%; net profit attributable to shareholders of the parent was 733 million yuan, a year-on-year increase of 2.57%.

https://finance.eastmoney.com/a/202507083451195334.html

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