Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has entered into a co-development and market promotion service agreement with Huadong Medicine Co., Ltd (SHE: 000963) for the development and commercialization of QX005N injection. Under the terms of the agreement, Huadong will participate in the clinical development of QX005N in mainland China, Hong Kong, Taiwan, and Macau, sharing equally the costs associated with the Phase III clinical study and regulatory filing.
Huadong will also have the exclusive option to promote QX005N within the agreed territory. Should Huadong exercise this option, QYuns will delegate the market promotion activities for QX005N to Huadong, which will include the payment of promotion service fees. Furthermore, Huadong will receive priority cooperation rights for the transfer of the product’s marketing authorization holder (MAH) status.
QX005N is a monoclonal antibody (mAb) that targets IL-4Rα and has been granted approval for clinical studies in China for the treatment of moderate to severe atopic dermatitis, adolescent atopic dermatitis, chronic sinusitis with nasal polyps, spontaneous urticaria, asthma, and chronic obstructive pulmonary disease. The drug has also received breakthrough therapy designation (BTD) in China for the treatment of nodular prurigo (NP). Enrollment for two Phase III clinical studies for QX005N in moderate to severe atopic dermatitis and NP is currently ongoing.- Flcube.com
