Handa's Multi-Target Cancer Drug Receives FDA Tentative Approval, Aiming for Final Approval Within One Quarter

Handa (6620-TW) announced that its 505(b)(2) new drug HND-039 OMCAZIO has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA). The company has initiated the application process for Final Approval (FA), and the FDA review is expected to be completed within one quarter. Upon receipt of FA, the product will be launched in the U.S. market as soon as possible.

According to U.S. regulations, if a product completes FDA review and meets approval criteria before the expiration of relevant patents or market exclusivity periods, the FDA typically issues a TA. Receiving TA indicates that the FDA has completed the technical review of the product's quality, safety, and efficacy. Once the legal restrictions are lifted and the FDA's conversion procedures are completed, FA will be granted.

The current TA was issued because the reference product’s compound patent for HND-039 OMCAZIO has not yet expired, with an expiration date of August 14 in U.S. time. Handa stated that it is continuing preparations for direct product sales and has not ruled out potential collaborations with partners.

Although the multi-target cancer drug received TA, the company's stock price performed weakly on the 31st. It opened at 98.3 yuan, turned negative after an initial rise, and dropped as low as 94 yuan, with trading volume exceeding 3,000 shares.