HanDA Bio-Tech's Multi-Target Cancer Drug Secures Tentative FDA Approval

HanDA Bio-Tech (6620) announced a significant milestone as its multi-target cancer drug, HND-039, received tentative approval from the U.S. Food and Drug Administration (FDA). This development has boosted the company's stock, which opened with a jump to the daily limit.

The tentative approval, granted under U.S. regulations, signifies that the FDA has completed its technical review of the drug's quality, safety, and efficacy. This status is typically issued when a product's relevant patent or market exclusivity period has not yet expired. The patent for the reference drug is set to expire on August 14th.

HanDA Bio-Tech stated that it will expedite the process to obtain final approval (FA) and simultaneously prepare for the drug's market launch. Upon receiving final approval, the company plans to officially market HND-039 in the United States. The original branded drug generated $2.113 billion in U.S. sales last year, and HanDA has the opportunity to be the first generic competitor.

The company's stock reacted positively to the news, trading at NT$96.3 with a significant number of buy orders at the upper limit. This tentative approval marks a crucial step for HanDA Bio-Tech in bringing a potentially life-saving cancer treatment to market as a more affordable generic option.