6. 竞争优势及策略
Asia Cell & Gene Therapeutics Group Due Diligent Data Room
当前，细胞与基因治疗(CGT)产业正在迅速增长。Celzyva专注CGT新药研发和全球包括美国、欧盟、中国IND/BLA申报。
Currently, the cell and gene therapy (CGT) industry is experiencing rapid growth. Celzyva focus on CGT novel drug R&D and global regulatory submissions, including IND and BLA filings in the United States, the European Union, and China.
细胞与基因治疗(CGT)药物专利限制相对弱。中国CGT药物研发资源丰富且远低于欧美成本。美国和欧盟药监局依ICH接受中国临床前及临床试验数据。
Intellectual property protection barriers for CGT drugs are relatively weak. China has abundant CGT R&D resources at costs significantly lower than those in Europe and the United States. The U.S. FDA and European regulatory authorities, in accordance with ICH guidelines, accept preclinical and clinical trial data generated in China.
Celzyva战略：与上海partner合作研发，覆盖式me too/me better研发欧美(已II期临床成功)产品，形成巨大的技术和市场(欧美+中国)优势。
Celzyva’s strategy is to engage Shanghai-based partners to conduct broad “me-too / me-better” development of products that have already achieved successful Phase II clinical results in Europe and the United States, thereby creating substantial technological and market advantages across Europe, the United States, and China.
