Handa Pharmaceuticals is set to transfer from the Emerging Stock Market to the Main Board in late December. Chairman Liu Fang-yu announced that following the successful licensing of the leukemia drug Phyrago (generating NT$730 million in milestone payments), the company is focusing on HND-039, a 505(b)(2) oncology drug targeting a $1.7 billion market.

Handa has been profitable in 2023 and 2024. For the first three quarters of 2024, EPS reached $3.76, surpassing the full-year 2023 performance. This momentum is largely driven by Phyrago, which launched in the U.S. in mid-October.

General Manager Chen Chun-liang highlighted Handa’s "dual-engine" strategy: high-barrier generics and 505(b)(2) novel formulations. The latter now accounts for over 60% of revenue. For Phyrago, Handa holds a competitive edge—its formulation allows co-administration with proton pump inhibitors (PPIs), a clinical advantage that could secure a 31.8% market share in a crowded field.

Regarding HND-039, the FDA has commenced substantive review with a PDUFA goal date of July 29, 2025. As the originator’s patents have not yet expired, Handa aims for "First-to-File" status, potentially capturing the $1.7 billion market ahead of other generics. Strategic partner SciPharm (a Uni-President affiliate) remains Handa’s largest external shareholder, combining their API expertise with Handa’s oral formulation capabilities.

Resource: 漢達12月下旬興櫃轉上櫃 明年抗癌新劑型新藥HND-039拚7月美國取證