MegaPro Biomedical announced on the 5th that its dual technology platforms are gaining momentum. The company plans to submit a Pre-IND application for its MRI contrast agent MPB-1523 by the end of this year, paving the way for a formal 505(b)(1) NDA submission in 2028. At the same time, its reformulated oncology drug MPB-1734 will advance to bioequivalence testing following successful process scale-up, with a 505(b)(2) NDA submission also expected in 2028.

According to CEO Sian-Jhih Wang, MegaPro is already in licensing discussions with two to three pharmaceutical companies in mainland China regarding MPB-1523. For MPB-1734, feedback from the U.S. FDA indicates the possibility of bypassing Phase II/III trials, requiring only bioequivalence bridging studies. This regulatory pathway has also attracted interest from pharmaceutical companies in India and China, with licensing deals expected to be finalized as early as the first half of next year.

MegaPro Biomedical is built around two core technology platforms: nanoparticle and micelle technologies. With two drug candidates now on track for NDA filings in 2028, and licensing opportunities under active negotiation, the company has also mapped out plans to initiate its IPO filing by the end of next year. To support the capital needs of manufacturing scale-up, its board of directors approved in late June a rights issue of no more than 15,000 shares, expected to raise approximately NT$150 million.

General Manager Yuan Hung Hsu emphasized that MegaPro Biomedical has established a dual platform encompassing both 505(b)(1) and 505(b)(2) regulatory pathways. By focusing on innovative imaging diagnostics and reformulated oncology therapeutics, the company aims to address significant unmet medical needs worldwide. After a decade of research and clinical validation, Hsu noted, this year marks a critical turning point as MegaPro enters its harvest phase.

Resource: 巨生醫雙技術平台發威 二產品拚2028年申請藥證