HLB "US Eleva, Neopharma Establish JV... Approved by UAE Government"

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 6th that its U.S. subsidiary 'Eleva' has received provisional approval from the Dubai government in the UAE for the establishment of the joint venture (JV) 'Neolevar FZ-LLC,' a partnership with the UAE global pharmaceutical company 'Neopharma.'

After submitting documents related to the establishment of Neolevar in November last year, the corporate approval, which was expected to take about 3 to 4 weeks, was somewhat delayed due to administrative processing delays.

The corporate establishment process in Dubai proceeds in two stages: first, corporate establishment approval, followed by the second stage of corporate operation licensing. This time, Neolevar received approval for corporate establishment from the Dubai government for one year. Within the next year, it will submit additional documents such as facility design, facility inspection, and the Non-Clinical Operating Permit (NOP) related to health, safety, and environment to obtain the corporate operation license. Thereafter, the NOP must be renewed every two years. Accordingly, HL Biopharma plans to proceed with the follow-up procedures in close cooperation with Neopharma to obtain the corporate operation license as soon as possible.

Neopharma is a global pharmaceutical company conducting R&D, CRO, API manufacturing, pharmaceutical sales, and marketing in nine countries worldwide, including the United States, the United Kingdom, Japan, India, and the United Arab Emirates. It is managed by Chairman B.R. Shetty, the founder of NMC Healthcare, the world's fourth-largest hospital chain. A company official stated, "In July last year, Eleva and Neopharma signed a business agreement to target the pharmaceutical markets in the MENA (Middle East & North Africa) and India regions, and in September last year, they signed an agreement to establish a joint venture. This time, they have received approval for corporate establishment."

HL Biopharma completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in October last year based on the global Phase 3 clinical results of rivoceranib and is currently preparing the NDA.

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