Simcere Pharmaceutical Group Enters Exclusive License and Collaboration Agreement for Innovative Drug Rademikibart

On November 21st, Simcere Pharmaceutical Group announced a significant milestone in its strategic expansion in the field of autoimmune diseases. The company has entered into an exclusive license and collaboration agreement with Hong Kong-based Canvard Biopharmaceuticals (referred to as "Canvard Biopharmaceuticals") for the innovative drug IL-4Rα monoclonal antibody Rademikibart.

Exclusive License and Collaboration Agreement:

Under the agreement, Simcere Pharmaceutical Group will obtain exclusive rights for the development, manufacturing, and commercialization of Rademikibart for all indications in the Greater China region. Canvard Biopharmaceuticals will retain the rights for the product outside the agreed-upon territory and continue to be responsible for ongoing clinical trials. Simcere Pharmaceutical Group will independently oversee future clinical trials and the development of new indications for Rademikibart in the agreed-upon territory.

Expansion of Simcere Pharmaceutical Group's Autoimmune Portfolio:

The exclusive license and collaboration for the innovative drug Rademikibart will further enrich Simcere Pharmaceutical Group's product portfolio in the field of autoimmune diseases and strengthen the commercial synergies in this area. Within the strategic focus on autoimmune diseases, Simcere Pharmaceutical Group has already launched the world's first marketed adalimumab biosimilar, Adexin®, for the treatment of autoimmune diseases. Additionally, their independently developed interleukin-2 mutated Fc fusion protein (SIM0278) entered domestic clinical trials in August this year and received FDA approval for clinical trials in the United States through a development and commercialization partnership with Almirall. Simcere Pharmaceutical Group's JAK1 inhibitor LNK01001, which is being developed in partnership with Lingke Pharmaceuticals, has shown positive results in Phase II clinical trials for rheumatoid arthritis and ankylosing spondylitis, two collaborative indications.

About Rademikibart:

Rademikibart (CBP-201) is a fully human monoclonal antibody that targets IL-4Rα (the common subunit of IL-4 and IL-13 receptors). By binding to IL-4Rα, Rademikibart effectively blocks the functions of IL-4 and IL-13, thus interrupting the Th2-mediated inflammatory pathway. This mechanism of action makes Rademikibart a potentially effective treatment for Th2-related inflammatory diseases such as atopic dermatitis and asthma. Rademikibart is currently undergoing crucial clinical trials for atopic dermatitis in China and other relevant clinical trials, including an international Phase II clinical trial for asthma.

The exclusive license and collaboration agreement for Rademikibart represents a significant step for Simcere Pharmaceutical Group in expanding its autoimmune portfolio. With the addition of Rademikibart, the company strengthens its position in the field of autoimmune diseases and enhances its commercialization synergies. The ongoing clinical trials and future development of Rademikibart in the Greater China region demonstrate Simcere Pharmaceutical Group's commitment to addressing unmet medical needs in Th2-related inflammatory diseases.