REDNVIA CEO Lee Hoon-mo poses during an interview for The Korea Times at the company's headquarters in Seocho District, Seoul, Sept. 11. Courtesy of REDNVIA

Creating a novel drug has always been a risky endeavor for biopharmaceutical companies. Developers and investors face significant uncertainties throughout the process. It often demands substantial investments in substances that carry a high risk of failure, as well as enduring rigorous and lengthy evaluations by regulatory authorities. Additionally, the subsequent journey of sales and marketing presents its own set of challenges.

REDNVIA CEO Lee Hoon-mo distinguishes his company from other biotechs by avoiding such risks. After filing a preliminary review for its listing on Korea's secondary Kosdaq market last month, Lee expressed confidence that the company will be able to roll out a novel drug for calcific aortic valve disease (CAVD), one of the most common heart valve disorders, which has so far relied on surgical treatment.

"In 2018, Song Jae-kwan, a cardiology professor at Asan Medical Center in Seoul, and I attended a medical conference in the United States to present Song's research on the possibility of the medical treatment of CAVD, and we witnessed the frenzy of attending doctors who have been frustrated because there is no drug for CAVD patients," Lee said during an interview with The Korea Times.

"Song, now our chief medical officer, said it was his dream to develop drug treatments for CAVD, and I have also spent six years pursuing this dream. I want to see how this will end. The significance of developing this drug is that it will be able to offer a meaningful solution to the suffering of patients and doctors who currently have no choice but to wait for the condition to worsen before undergoing a heart valve surgery."

A researcher tests drug ingredients at REDNVIA's lab in Seocho District, Seoul, Sept. 11. Courtesy of REDNVIA

REDNVIA was established in December 2018 as a company focusing on developing CAVD treatments. It is a joint venture with Dong-A Science Technology (Dong-A ST), a unit of Dong-A Socio Group, a Korean drug-producing conglomerate.

The company's foundation is based on Song's 2017 research on Dipeptidyl Peptidase-4 (DPP-4) inhibitors, a class of medications used in antidiabetic drugs, which have also shown promise for safely treating CAVD. Building on this research, REDNVIA is repurposing Dong-A ST's antidiabetic drug, Evogliptin, for its lead pipeline material, RNV-1001.

Evogliptin, marketed under the brand name Suganon, is already prescribed for patients in Korea and Russia. Dong-A ST is registering over 40 billion won ($30 million) in annual sales from Suganon. As a result, RNV-1001 has progressed to phase II/III clinical trials, enrolling 867 patients across 28 hospitals in the U.S. and Canada to secure approval from the U.S. Food and Drug Administration (FDA).

The drug was able to bypass phase I trials, typically focused on testing safety, thanks to the established safety profile of Evogliptin. Phase II/III clinical trials are conducted when a drug has shown sufficient safety and efficacy in human and animal studies. Instead of running phase II trials for a small group of patients, the process moves directly to testing on a larger patient population, aiming to expedite the approval timeline.

"It typically takes around 10 years for heart valves to narrow due to mineralization and this causes serious impairment of blood flow," Lee said. "To prevent this, patients need to take medication for life, similar to how antidiabetic drugs are used."

"This means that drugs for chronic conditions must be extremely safe and free from side effects. Imagine if your daily pill caused skin rashes — you wouldn't be able to take it every day. This leads to the simple conclusion that repurposing an existing drug with proven safety is the best approach for treating chronic diseases that currently lack effective drug therapies."

Dong-A ST's Suganon / Courtesy of Dong-A ST

Lee projected that RNV-1001 could generate as much as 4 trillion won in annual revenues if it receives FDA approval. This estimate is based on the fact that over 21 million patients worldwide suffer from CAVD, with around two-third of them requiring drug therapies. Currently, no competing drugs exist on the market.

REDNVIA's intellectual property (IP), patented in 20 countries, states that the company has exclusive rights to use Evogliptin and 11 other DDP-4 inhibitors available currently for developing CAVD treatments until 2035. Lee noted that the company expects RNV-1001 will begin generating revenue in 2028, and will be able to enjoy a monopolistic status in the market until 2035.

"After 2035, our second and third pipeline substances for CAVD drugs will be able to debut," he said. "Our focus is on CAVD. We want to be the best in developing CAVD treatments."

Dong-A Socio Group's R&D Center in Songdo, Incheon / Korea Times file

No license out

Unlike most other Korean biotech companies seeking to license out their IPs to bigger global biopharmaceuticals, REDNVIA plans to control the marketing and sales of RNV-1001 on its own by using the supply chain of Dong-A Socio Group.

"Most South Korean biotech companies rely on licensing out as their primary business model, but only a few have successfully signed major licensing deals, and even fewer firms have received milestone payments as the deals progress," Lee said. "This is not a sustainable business model."

REDNVIA CEO Lee Hoon-mo / Courtesy of REDNVIA

According to data from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, there were 177 pharmaceutical and biopharmaceutical companies listed on Korea's main KOSPI and secondary Kosdaq market as of the third quarter of last year. However, 120 of them have failed to sign a single license-out deal between 2015 and 2022. Only six companies succeeded in five or more deals, showing that only a small number of companies can sustain their profitability through a license-out business model.

"Among Korean firms, SK Biopharmaceuticals paved the way for direct sales and marketing in the global market with its partial-onset seizures treatment Cenobamate," Lee said. "The difference is that SK Biopharmaceuticals is a listed unit of SK Group, which is one of the biggest conglomerates in Korea, while we are a non-listed company."

When RNV-1001 receives approval from the FDA, ST Pharm, a Dong-A Socio Group unit, will manufacture active pharmaceutical ingredients, and Dong-A ST will finalize it into a packaged drug. For sales and marketing, the company has signed MOUs with global contract sales organizations including IQVIA.

Recognizing REDNVIA's potential, Dong-A ST invested 81 billion won to build a new plant in Songdo, Incheon, which has been in commercial operation since 2023, in order to secure enough capacity for RNV-1001.

"Since we seek to sell the drug under our brand, we have to take very good care of the manufacturing process as well, because producing a few kilograms for lab testing is vastly different from scaling up to tons for commercial production," Lee said. "Given Dong-A ST's decades of experience in manufacturing quality drugs, I can say we have the best-in-case manufacturing capability."

Lee said he expects the company to raise 150 billion won when its initial public offering (IPO) process is completed in March next year. Following the listing, Lee promised to lock up his stakes in the company for an indefinite period of time, to show his commitment to investors.

"REDNVIA was able to secure over 50 billion won in investments as investors have trust in me," Lee said.

"Converting my shares into cash would not be respectful to those investors, nor to future investors buying shares after the IPO. It could also send a negative signal to the market. To demonstrate my commitment to them, I will lock up my shares for an indefinite period, to the extent that calling it 'indefinite' wouldn't be an exaggeration."