[Special Stock] Sunbio, Newpeg FDA Approval Expected... Anticipation Rises for All-Solid-State Electrolyte with Pegylation Application

Sun Bio is showing strong performance. While all-solid-state battery-related stocks are collectively rising in the domestic stock market, interest in Sun Bio's new business appears to be growing.

As of 11:48 AM on the 30th, Sun Bio is trading at 9,230 KRW, up 6.09% from the previous day.

On this day, Hana Securities introduced Sun Bio as a company possessing PEGylation technology that binds PEG derivatives?biocompatible polymers (PEG) combined with reactors?to target substances to extend their half-life in the bloodstream.

Jae-kyung Park, a researcher at Hana Securities, explained, "Sun Bio has a business model that commercializes PEGylation technology applied to various fields such as biosimilars, new biopharmaceuticals, and medical devices." He added, "The representative products are Neupeg, a biosimilar of Neulasta for neutropenia treatment licensed to Intas Pharma, and MucoPEG, a treatment for dry mouth."

Researcher Park also stated, "In April, the board of directors approved the expansion of the business into the development and technology transfer of all-solid-state electrolyte technology for secondary batteries and fuel cells, as well as the production and sales of related materials." He continued, "There is a plan to apply PEGylation technology to electrolyte development," and explained, "In July, two patents related to secondary batteries were acquired, and research contracts were signed with the Industry-Academic Cooperation Foundation of the University of Seoul and the College of Engineering to develop solid electrolytes."

PEGylation technology is a technique that chemically and covalently attaches PEG derivatives?materials derived from PEG, a biocompatible polymer?to the surface of pharmacologically active substances or other target substances.

He analyzed, "Neupeg is undergoing FDA product approval," and added, "Supplementary documents were submitted following the manufacturing facility inspection in March this year, and approval and launch in the U.S. are expected next year." Furthermore, he emphasized, "Neupeq is sold through partner Intas in India, Canada, and the EU, excluding the U.S., and cumulative royalties for the third quarter of this year reached 3.3 billion KRW."

Researcher Park explained, "MucoPEG received FDA approval as a medical device in November 2019," and said, "In March this year, Sun Bio presented interim comparative clinical results between MucoPEG and GSK's Biotene, the market leader, at the AADOCR (American Association for Dental, Oral, and Craniofacial Research)." He added, "The final results are scheduled to be published in the first half of next year," and introduced, "Separate clinical trials will be conducted through Guangzhou Bairui to enter the Chinese market."

He stated, "Sun Bio supplies PEG derivatives to other clients besides the companies to which it has licensed technology," mentioning, "Clients include Reliance Bio." Additionally, he said, "A new factory is being constructed in Namdong Industrial Complex, Incheon, to prepare for increased production due to FDA product approval of Neupeg and marketing of MucoPEG." He also forecasted, "The new factory is planned to be operational by July next year," and "Full-scale operation is expected in the first half of 2025, with GMP-level PEG derivative production capacity increasing twentyfold compared to the current level."