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  • 505 (b)(2) is a less expensive and faster new drug development pathway that are particularly attractive to a manufacturer with rich experience in developing drug products. The 505(b)(2) NDA can provide a shorter and less-costly drug development program and bring a profitable drug to market more rapidly.                           Project Catagory Discovery Pre-IND IND Clinical Phase Oncology                         Solid tumor HLK-1001 505(b)(2)         Solid tumor HLK-1002 505(b)(2)       Autoimmune Disease                     HLK-6002 505(b)(2) Additional Pipeline                     HLK-0002 505(j)   HLK-010 505(j)       HLK-0003   505(j)