BoYen Therapeutics Inc. was established in June 2010. In its early years BoYen Therapeutics focused on new drug research and discovery, through our own proprietary prodrug technology platform, we perform chemosynthesis modification and create new patentable drug candidates. Our goal is to provide innovative medical options for patients, and create long-term and sustainable value for shareholder and stakeholders value at the same time.
Through more than a decade of research and development, the Company has successfully established a proprietary prodrug technology platform capable of continuously supporting new drug discovery and development, thereby enabling the creation of a diversified portfolio of drug candidates.
In addition, BY-101 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) in January 2019. The FDA’s Orphan Drug Designation is a special regulatory status intended to encourage the pharmaceutical industry to develop therapies for rare diseases. Currently, BY-101 has initiated Phase II clinical trials at three medical centers in Taiwan. Upon obtaining future regulatory approval, BY-101 will be eligible for a seven-year period of market exclusivity. BY-102 and BY-103 are products developed using the company’s prodrug technology platform, intended for the treatment of multiple sclerosis and acute hematologic malignancies, respectively.
The year 2020 is a year of transition for BoYen Therapeutics. The company decided it is time to commercialize its drug candidates and place most of its efforts on clinical development while maintaining a certain level of drug discovery to gradually increase its pipeline. BY-101 will enter Phase 2/3 clinical trials through USFDA 505(b)2 pathway in 2021.
BY-101 is a novel candidate for treating acute myeloid leukemia (AML). A Phase 2b trial has started at three medical centers in Taiwan, enrolling 15 newly diagnosed patients aged 18–75. Future efforts will focus on advancing clinical development and exploring licensing opportunities.
BY-102 is a next-generation oral drug developed using BoYen’s proprietary prodrug platform. Inspired by the marketed tablet Mavenclad® (Merck, Germany), BY-102 addresses low absorption and side effect issues through stable in vivo conversion to the active drug and powder micronization technology, offering improved bioavailability, convenience, and reduced adverse effects.
The company also takes the initiative to explore collaboration with academic/research institutions to assist them in bringing their research work into drug development process, to create greater value and fruitful results for their hard work.
In 2024 , and 2015, the company was approved and designated by the Industrial Development Bureau, Ministry of Economic Affairs as a Biotechnology New Drug Company.
BoYen Therapeutics office is located in Taipei World Trade Center International Trade Building.
