Bora Health receives government approval to build an R&D and operations center in Hsinchu Science Park. The center will be committed to developing NDFs

March 25, 2022

<p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">HSINCHU, Taiwan, Feb. 15, 2022  /PRNewswire/ -- Bora Health Inc., a subsidiary of Bora Pharmaceuticals (6472.TWO) (hereafter referred to as the "Group"), has received approval from Taiwan's Ministry of Science and Technology to build a research and development facility in Taiwan Hsinchu Science Park, a new milestone in Bora's professional service roadmap.</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">With a focus on the development of new dosage forms (NDFs), the company aims to enhance Bora's international competitiveness by creating the first pharmaceutical brand in Taiwan that combines its R&D competence in the domestic market with the Group's manufacturing capabilities in world markets.</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">"Bora Health plans to build an independent R&D and operations center in Hsinchu Science Park by integrating the Group's internal R&D resources," said Bora Health general manager Henry Kuo. "The center will be mainly engaged in the development of highly marketable, high tech NDFs by leveraging the Group's key technologies for oral preparations and the CDMO business unit's manufacturing capabilities in global markets, with an initial focus on technologies for developing NDFs and their application scenarios."</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">To accelerate the development of the R&D technology platform, Bora Health will build the R&D and operations center at the Zhunan site of the Group's other subsidiary Bora Pharmaceutical Laboratories Inc.. Certified by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the Zhunan facility is expected to help facilitate Bora Health's pilot development and mass production of NDFs as the firm plans to invest over NT$80 million (approx. US$2.8 million) in the center over the next three years, most of which will go to the R&D, human resources and clinical trial divisions.</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><strong><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">Focus on key technologies for oral NDFs to treat central nervous system (CNS) diseases</span></strong></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">In line with Bora Pharmaceuticals' commitment to developing treatment solutions for CNS diseases, Bora Health intends to initially focus on developing orally disintegrating tablets (ODTs) for treating CNS disorders in a move to improve medication adherence by patients given the faster pace of population ageing.</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">According to the Market Research Engine Forecast 2021-2026, the global ODTs market is expected to exceed US$26.5 billion by 2025, with the compound annual growth rate estimated at 11.5 per cent from 2021 to 2026. Mostly notably, the Asia Pacific region has been noted as having the greatest growth potential among all regions worldwide, with a growth rate forecast at just over 12 per cent.</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">“Bora Health plans to develop a number of new offerings over the next three years, including multiple NDFs for CNS diseases and ODTs, as well as NDFs for a compound analgesic, alongside a drug for epilepsy and neuropathic pain, both of which were developed through the application of technologies from Bora Pharmaceuticals.”  </span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><strong><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">Accelerate the certification process for and commercial availability of niche products while seeking patents in international markets</span></strong></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">Bora Health is building a technology platform for its NDFs that were developed by using the patent's technologies while improving the drugs' stability through the combination of multiple formulations and production processes. At the same time, the company plans to establish a new development platform for NDFs of ODTs. With the patient-focused dosage form design and the improvement in formulation design, the firm looks to meet the needs of patients by making the experience less stressful for the patient and, by doing so, enhancing patient compliance.</span></p> <p style="margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;"><span lang="EN-US" style="font-size: 10pt; font-family: Arial, sans-serif;">Going forward, Bora Health plans to apply for patents for its to-be-developed NDFs in major markets worldwide where the drugs will be made available. Currently, the firm has already obtained patents in Taiwan and Europe for its drugs that were developed through the patent's technology transfer. Kuo added: “In the medium term, the business' goal is to seek certification for its drugs, expand sales channels while continuously improving dosage form design in addition to successfully developing new offerings by virtue of its niche technology and strong R&D competence in the domestic market before getting approval to launch these new drugs worldwide. The long-term goal is to enhance the visibility of the Taiwanese pharmaceutical brand in international markets and contribute to the Group's operational performance.”</span></p>

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