Oneness announced that Bonvadis Cream for scar management has been granted class I medical device import license by regulatory authority CIBG in Europe under registration number NL-CA002-2023-75284 and allowed to be marketed in Europe. Oneness implements dual strategies of both medicine products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets.

New drug Fespixon Cream has been approved with medicine licenses for Taiwan and Singapore markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. The subsequent market access plan with medical device submissions in other countries are ongoing.

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