Handa Pharmaceuticals announced on September 30 that its cancer 505(b)(2) new drug HND-039 was submitted to the U.S. FDA for New Drug Application (NDA) review on September 29, 2025 (U.S. time), targeting the nearly $1.8 billion U.S. market.

The news of HND-039’s FDA submission boosted investor confidence, with Handa’s stock opening higher and rising throughout the day. In early trading, shares surged nearly 13% to NT$140, marking a 21-month high.

Handa has focused on 505(b)(2) new drugs and is among the few profitable emerging pharmaceutical companies. In the first half of this year, the company reported revenue of NT$939 million, operating profit of NT$587 million, and net profit attributable to the parent company of NT$367 million, translating to earnings per share of NT$2.42. At the end of August, Handa resumed its stock listing process by submitting an initial application for OTC listing, with expectations that, if approved, the company could debut as early as the end of this year or the beginning of next year.

According to the announcement, Handa Oncology, Handa’s subsidiary, developed HND-039 as a cancer-targeting 505(b)(2) new drug. The NDA was submitted to the U.S. FDA on September 29, 2025. Based on the original patent holder’s 2024 annual report, the reference drug’s sales in the U.S. reached $1.798 billion.

HND-039 is developed using Handa’s ONCORE platform with a novel salt-based formulation, acting as a multi-target tyrosine kinase inhibitor (TKI). The development aims to improve upon certain limitations of the original drug, which had relatively low bioavailability and required higher doses. Handa’s new salt absorption system enhances bioavailability, reduces required dosage, and is designed for co-administration with food to minimize side effects such as diarrhea and hypertension, thereby improving patient compliance and clinical performance. The drug has potential applications across multiple cancer types, presenting broad market opportunities.

Handa noted that after submitting the NDA, the U.S. FDA will first check the completeness of the submitted documentation. The FDA will then notify Handa Oncology whether the NDA will be accepted for substantive review (Accept to File) or not (Refuse to File). Handa will immediately disclose material information upon receiving such notification.

Resource: 漢達癌症505新藥HND-039，向美叩關送藥證申請