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     137  0 Kommentare Connect Biopharma and Simcere Announce Exclusive Licensing and Collaboration Agreement in Greater China

    • Simcere has been granted an exclusive right to develop, manufacture, and commercialize rademikibart for all indications in Greater China
    • Connect Biopharma retains rights to develop and commercialize rademikibart in all other markets and completed the pivotal atopic dermatitis (AD) trial in China
    • Rademikibart is a human monoclonal antibody against IL-4Rα, a common subunit for IL-4R and IL-13 receptors being developed for the treatment of Th2 driven inflammatory diseases

    SAN DIEGO, CA and TAICANG, China, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, announced today that two of its wholly owned subsidiaries, Connect Biopharma Hong Kong Limited and Suzhou Connect Biopharma Co., Ltd., have entered into an exclusive license and collaboration agreement with Simcere Pharmaceutical Co., Ltd., a subsidiary of Simcere Pharmaceutical Group Ltd. (“Simcere”), to develop and commercialize Connect Biopharma’s rademikibart in Greater China.

    “We are delighted to enter this strategic partnership with Simcere for the development and commercialization of rademikibart in Greater China concurrently with reporting our strong long-term efficacy and safety top-line data from the rademikibart China pivotal trial in AD” said Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. “Simcere is a leading pharmaceutical company in China with an extensive partnership track record and proven capabilities in regulatory affairs, manufacturing, clinical operations, and commercialization. We believe they are the ideal partner to advance the rademikibart program in Greater China and to provide patients with a potentially more efficacious treatment and a more convenient dosing regimen.”

    Under the agreement, Connect Biopharma will complete all of rademikibart’s ongoing China clinical trials and related analysis in atopic dermatitis (AD), which is on track for a new drug application submission for AD in China by the end of Q1 2024. Simcere has been granted exclusive rights to develop, manufacture and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while Connect Biopharma retains rights in all other markets. Simcere will be responsible for rademikibart’s new drug application for AD in China and will also conduct and be responsible for the costs of all future clinical studies in all additional disease indications for rademikibart in Greater China.

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    Connect Biopharma and Simcere Announce Exclusive Licensing and Collaboration Agreement in Greater China Simcere has been granted an exclusive right to develop, manufacture, and commercialize rademikibart for all indications in Greater ChinaConnect Biopharma retains rights to develop and commercialize rademikibart in all other markets and completed the …