On March 4, 2024 Circio Holding ASA (OSE: CRNA) reported that the TG01 investigational new drug (IND) application filed by partner IOVaxis Therapeutics of Nantong, China, has been approved by the Chinese National Medical Products Administration (NMPA) (Press release, Circio, MAR 4, 2024, View Source [SID1234640728]). Following this acceptance by the NMPA, IOVaxis has the necessary regulatory approval to initiate TG01 clinical development in China.
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Under the parties´ agreement, IOVaxis has an exclusive option to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to the partnership announcement here and the IND-filing here. Within two weeks of the TG01 IND approval by the NMPA, IOVaxis may elect to exercise its license option and trigger a USD 3m milestone payment to Circio.