Core Viewpoint - The approval of the Phase III clinical study protocol for IMM0306 by the National Medical Products Administration marks a significant advancement in innovative therapies for relapsed/refractory follicular lymphoma [1] Group 1: Company Developments - The company has received approval for the Phase III clinical study of IMM0306 in combination with lenalidomide for treating relapsed/refractory follicular lymphoma [1] - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The company holds global intellectual property and commercialization rights for IMM0306 [1] Group 2: Product Mechanism - IMM0306 works by inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-FcγRIIa and Fc-FcγRIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving treatment outcomes [1]
宜明昂科-B(01541)：药品审评中心批准IMM0306治疗复发╱难治性滤泡性淋巴瘤的III期临床研究方案