Beauty supplement and aesthetic medicine supplier DV Biomed Co Ltd (翔宇生醫) on Friday said that its adipose stem cell treatment would be made available to a wider range of patients following government deregulation earlier this month.
The Ministry of Health and Welfare early last month amended the Regulations Governing the Application of Specific Medical Examination Techniques and Medical Devices (特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法), enabling biotechnology companies to further develop stem and immune cell transplant therapies.
DV Biomed, which has spun off its therapy development arm into UnicoCell Biomed Co Ltd (向榮生技), said that its subsidiary would begin to seek approval for its treatment to be used at partner medical centers.
The companies are hoping to start using Elixcyte, an allogeneic adipose stem cell treatment that uses stem cells from a compatible donor.
The Food and Drug Administration has approved Elixcyte has for phase I/IIa and II clinical studies for chronic kidney disease and knee osteoarthritis, DV Biomed said, adding that the treatment is expected to gain marketing approval for knee osteoarthritis in 2020 and chronic kidney disease in 2021.
The company said that it is an early starter in the field, and has secured patents for Elixcyte in Taiwan, the US, China, Japan and Singapore.
UnicoCell is well-positioned to tap into the demand for stem cell culturing and storage that is anticipated following deregulation, DV Biomed said.
As the biotechnology industry accelerates development in cell transplant therapies, UnicoCell would be able to provide services for allogeneic transplants and autologous transplants, which use the patient’s own cells.
DV Biomed reported that sales in the first eight months of the year rose 54.21 percent annually to NT$1.23 billion (US$40.26 million).
Net income in the first half of the year reached NT$105.07 million, up from NT$58.62 million for the same period last year, with earnings per share rising from NT$1.2 to NT$2.14, company data showed.
DV Biomed shares closed at NT$78.68 in Taipei trading on Friday, down 4.6 percent in the year to date.
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