HLB Holds Pre-NDA Meeting with Aphelia and US FDA

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 6th that Elevar, its U.S. subsidiary, and the developer Oasmia Pharmaceutical AB held a pre-NDA meeting with the U.S. FDA on the 30th of last month regarding the new ovarian cancer drug approval application for 'Apealea,' for which HL Biopharma has secured global rights.

An HL Biopharma official stated, "Due to COVID-19, this meeting was conducted via phone, and we will thoroughly prepare the NDA based on the discussions held with the FDA."

Apealea is a third-generation improved drug of paclitaxel, developed using Oasmia's proprietary technology platform 'XR17.' It is an anticancer agent officially approved for sale as an ovarian cancer treatment in Europe as of January this year.

Alex Kim, CEO of Elevar, HL Biopharma's U.S. subsidiary, said, "In addition to preparing the NDA for the U.S., we plan to expand sales regions by discussing launches in individual European countries, MENA (Middle East and North Africa), China, and Latin American countries based on the European marketing authorization."

HL Biopharma is currently making strides to grow into a global anticancer drug specialist company under the slogan '2020 Grand Goal, The Beginning.'

Beyond the existing plan to launch five anticancer drugs within five years, HL Biopharma acquired Immunomic Therapeutics in the U.S. this January and is advancing the development of treatments for glioblastoma and a COVID-19 vaccine, as well as acquiring the global rights to Oasmia's Apealea.

Additionally, by acquiring the global rights to rivoceranib from its original developer Advenchen Laboratories, HL Biopharma will begin receiving royalties from China’s Hansoh Pharmaceutical starting at the end of this year, thereby securing cash flow.

This content was produced with the assistance of AI translation services.