Oneness Biotech Co., Ltd. Announces submission of registration application for Bonvadis, the wound care topical cream to the Drug Regulatory Authority of Pakistan (DRAP). New drug name or code: Bonvadis. Purpose: Wound Dressing.

Planned development stages-GNA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Regulatory Agent in Pakistan has notified Oneness that Bonvadis topical cream for wound care has submitted a registration application to the Drug Regulatory Authority of Pakistan (DRAP). Oneness implements dual strategies of both medicine products and medical devices for development and marketing of company's 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, Singapore, Malaysia 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.