DUALITYBIO-B (09606) surged more than 8%, reaching a 7.36% increase at the time of writing, trading at HK$329.6 with a turnover of HK$658 million. On November 11, the company announced that DB-1418 received Fast Track designation from the U.S. FDA for the treatment of unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC). The following day, China's National Medical Products Administration (NMPA) approved the clinical trial application for DB-1418, a Class 1 new drug injection intended for advanced/metastatic malignant solid tumors.
Earlier this year in January, DUALITYBIO-B entered a global development collaboration with Avenzo Therapeutics for the bispecific ADC product AVZO-1418/DB-1418. DB-1418/AVZO-1418 is an EGFR/HER3 bispecific ADC developed by DUALITYBIO-B. Under the agreement, DUALITYBIO-B received an upfront payment of $50 million and is eligible for up to $1.15 billion in development, regulatory, and commercial milestone payments. Additionally, the company is entitled to a share of Avenzo's sales revenue in its designated regions.