MegaPro’ s MPB-1734 Expected to Seek Prostate Cancer NDA via 505(b)(2) Pathway Supported by Bioequivalence Study
Source EQS
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Taipei, June 30, 2025 —MegaPro Biomedical Co., Ltd. (hereafter referred to as “MegaPro”, TPEx: 6827) announced that it has received a written response from the U.S. FDA regarding its novel anti-cancer formulation, MPB-1734, following a Type C meeting. The formulation is based onMegePro’s proprietary nano-micelle platform and does not contian Tween-80. Based on current nonclinical (animal) and partial human clinical data, FDA considered MPB-1734 for the treatment of prostate cancer may be eligible to use a bioequivalence (BE) study served as a scientific bridge, allowing MPB-1734 to seek regulatory approval through the 505(b)(2) NDA pathway. Dr. Yuan-Hung Hsu, President of MegaPro, explained that the company’s nano-micelle technology is designed to improve the solubility of poorly water-soluble hydrophobic drugs. Traditionally, these drugs use Tween-80 as a solubilizer. However, scientific studies has indicated that Tween-80 is associated with hypersensitivity reactions. For instance, the label of the marketed drug Jevtana® includes a black box warning highlighting the risk of severe allergic reactions due to its Tween-80 content,. MPB-1734, is a Tween-80 free formulation, offering improved drug stability and solubility while reducing excipient-associated risks. Based on the preclinical and early clinical pharmacokinetic data showing similarity to the reference drug, the US FDA has indicated that MPB-1734 may be eligible for the 505(b)(2) NDA pathway through a bioequivalence study. MPB-1734 is a novel formulation taegeting the current market of Jevtana®. According to Verified Market Reports, the global market size of Jevtana is USD $350 million in 2024 and projected to reach $750 million by 2033, with a compound annual growth rate (CAGR) of 9.2%,. Key drivers include increasing awareness of prostate cancer, an aging global population, earlier diagnosis, longer survival, and the need for advanced treatment. As a Tween-80 free formulation, MPB-1734 is well positioned as c competitive alternative in a growing market segment. Dr. Jassy Wang, CEO of MegaPro, added that recent market cases—such as Cinvanti (a Tween-80 free antiemetic) and BEIZRAY (Tween-80 free paclitaxel) demonstrated that new formulation without Tween-80 not only obtained regulatory approvals via bioequivalence studies but also rapidly gained market share or achieved successful out-licensing after launch. This validates MegaPro's commercial potential of its nano-micelle platform. The company aims to apply this technology to re-formulate hydrophobic drugs, thus to accelerate regulatory timeline and reach new milestone in business growth.
30/06/2025 Dissemination of a Financial Press Release, transmitted by EQS News. |
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