Yuan Hung Hsu, General Manager of MegaPro Biomedical, announced at an investor conference on the 13th that the company’s novel formulation drug MPB-1734, developed for prostate cancer treatment and free of Tween-80, has received FDA agreement to proceed with a bioequivalence (BE) study as the scientific bridge for its 505(b)(2) New Drug Application (NDA) submission.
Hsu explained that the company’s polymeric micelle nanotechnology platform is designed to improve the solubility of poorly water-soluble hydrophobic drugs. Traditionally, Tween-80 is commonly used as a solubilizer for such drugs; however, scientific literature and clinical data have indicated that Tween-80 may be linked to allergic reactions. For example, Jevtana—an FDA-approved prostate cancer drug containing Tween-80—includes a warning in its prescribing information regarding the risk of serious hypersensitivity reactions. MPB-1734, formulated without Tween-80, is expected to enhance drug stability and solubility while minimizing the potential risks associated with traditional excipients.
According to animal studies and preliminary human clinical trial data, MPB-1734 exhibits pharmacokinetic profiles in blood that are comparable to those of the marketed reference drug. Upon consultation with the FDA, the company has been granted approval to pursue a bioequivalence-based 505(b)(2) regulatory pathway for NDA submission.
MPB-1734 is an improved version of the marketed drug Jevtana, which, according to market data from Verified Market Reports, is expected to see its combined market for new formulations and generics grow from USD 350 million in 2024 to USD 750 million by 2033, reflecting a compound annual growth rate (CAGR) of 9.2%. Key drivers of this growth include increasing awareness of prostate cancer, an aging global population, earlier detection and longer survival, as well as the development of better formulations. As a Tween-80-free alternative with reduced side effects, MPB-1734 is well-positioned to gain market share rapidly once launched.
CEO Hsien-Chih Wang further noted that similar Tween-80–free formulations—such as Cinvanti, an antiemetic, and BEIZRAY, a European paclitaxel-based cancer therapy—have also obtained regulatory approval via bioequivalence trials and rapidly gained market share or achieved licensing success post-launch. This trend demonstrates that MegaPro’s nanomicelle platform has successfully established a viable commercial model. The company plans to leverage this platform to reformulate hydrophobic drugs and accelerate regulatory timelines for new product development.
Resource: 巨生醫MPB-1734獲FDA透過BE試驗 支持攝護腺癌505b2藥證申請
