MegaPro’ s MPB-1734 Expected to Seek Prostate Cancer NDA via 505(b)(2) Pathway Supported by Bioequivalence Study
Source Eqs
|
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. |
Disclaimer: For information purposes only. Past performance is not indicative of future results.
Recommended Articles
Musk says Tesla could hit $100 Trillion, but needs "enormous work"Elon Musk acknowledged over the weekend that getting Tesla to a $100 trillion company value would demand massive effort and fortune. The statement came after investors suggested this sky-high number could happen if his various businesses merge together. Right now, Tesla sits at $1.5 trillion in market value. Getting to $100 trillion would mean multiplying […]
Elon Musk acknowledged over the weekend that getting Tesla to a $100 trillion company value would demand massive effort and fortune. The statement came after investors suggested this sky-high number could happen if his various businesses merge together. Right now, Tesla sits at $1.5 trillion in market value. Getting to $100 trillion would mean multiplying […]
Lyn Alden says the Federal Reserve is likely entering a gradual phase of money printing rather than aggressive stimulus.
Global interest in crypto is at a year-long low, with Google searches dropping as the market cap falls 43%.
Arthur Hayes, the co-founder of BitMEX, suggested that institutional dealer hedging is exacerbating the recent downward pressure on Bitcoin prices.In a February 7 post on X, Hayes pointed to structure
BitMine, the largest corporate holder of Ethereum, has capitalized on the digital asset’s recent price volatility to expand its treasury holdings.On February 7, blockchain analysis platform Lookonchai
