GI Innovation is a fusion protein novel drug discovery firm that has made two license-out deals that are worth a combined $1.99 billion, just three years since its foundation.

This feat for a small biotech comprising 50 employees has pinned GI Innovation as the next big catch in the health care sector after SK Biopharmaceuticals’ record-breaking initial public offering in June, which was 323 times oversubscribed.

GI Innovation’s stock market listing on Kosdaq was previously anticipated to take place before the end of 2020.

However, the company’s CEO Nam Su-youn said in an interview with The Korea Herald that the IPO schedule has been adjusted to 2021 due to COVID-19. The exact timing for the best valuation is being discussed with the underwriters, NH Investment & Securities and Hana Financial Investment, Nam said.

“We anticipate to make our initial public offering in the first half of 2021, although the exact schedule is prone to change according to our clinical trial results,” said Nam.

GI Innovation was founded in July 2017 by immunologist Jang Myoung-ho, who serves as the company’s chief scientific officer.

Nam is responsible for orchestrating the business path of the company as its CEO.

They make a good team -- Jang, as an immunologist, leads the research and Nam, armed with big-league experience, strategically directs the team to generate value-adding data.

Nam, 54, is a doctor by training. She was professor of internal medicine at Yonsei University Medical School before she transitioned to pharmaceuticals and went to Singapore and the US to work three years for Roche and six years for BMS.

“After working abroad in global big pharma, what made me come back to Korea was the realization that the overseas-educated intellectuals must return home to uplift Korea’s industries. In my case that was the biologics industry. Only when Korea thrives as a nation do expatriate Koreans gain a standing in the global playground,” Nam told The Korea Herald.

She came back to Korea in 2010 and worked with Yuhan as the chief scientific officer for seven years.

Out of the many projects she led at Yuhan, one of the biggest would be non-small cell lung cancer treatment candidate Lazertinib (YH25448), which Yuhan licensed out to Janssen for an upfront payment of $50 million that could potentially lead to $1.25 billion in royalties and milestone payments.

Nam envisions replicating that success at GI Innovation.

GI was originally short for gastrointestinal immunology, which is the specialty of the company founder Jang. But as GI Innovation now develops drugs for wider indications, the company name refers to Great Integration and Innovation.

GI Innovation’s strength is in the GI Smart platform technology that can create fusion protein drug candidates at a fast speed. Using the company’s library of 50 “hinges,” or “linkers,” GI Smart identifies the optimal glue to bind proteins together by the backbone for novel fusion protein drugs.

“Our resources at GI Innovation may be limited as a small biotech, yet our structural agility allows us to expedite decision-making which in turn fuels innovative and strategic thinking,” Nam said.

In less than three years since its foundation, GI Innovation has succeeded in two sizable licensing deals. The first with China’s Simcere Pharmaceutical in November 2019 for GI-101, a bispecific immuno-oncology drug, has resulted in an upfront payment of $6 million and up to $790 million in royalties.

Another deal with Yuhan, signed in July this year for allergy treatment candidate GI-301, could reach $1.2 billion.

“Excellence in science technology is a prerequisite for novel drugs development. How well that excellence is translated to commercial competitiveness determines the final success,” Nam said.

“How will this drug candidate create value in the market, is there an unmet medical need -- this is where laboratory scientists sometimes falter.”

Nam, having been a doctor, knows what’s wanted on the front lines.

“For medical students bent on career development, I wish to show them what a physician scientist can achieve in novel drugs research,” said Nam, adding that she has never once regretted the decision to leave hospital and enter laboratories.

“How to position our drug and create a competitive edge in the eyes of the global pharmaceutical companies that have the financial capabilities to license in -- this requires knowing their rules of the game, knowing what clinical data they are looking for. And that‘s what I direct,” Nam said.

Strategically focusing on specifics, trends and dataset has the benefit of cutting down research time. In drug development, time is money.

GI Innovation’s projects are strategic. This involves not only speed, but also differentiation.

“What good is a new drug, if it’s the same as the one before? At GI Innovation, we cease development if there is no differentiation,” Nam said.

“Biosimilars have the advantage of providing biologics drugs at a lowered cost, however, from the industry perspective, they erode innovation and stoke price competition,” Nam said.

“Our GI-301 has reduced side effects. It has more potent, durable suppression of the IgE, meaning it has efficacy for patients who have had no convalescence using existing drugs,” Nam said.

GI-301 is believed to become a strong challenger to Xolair (omalizumab), which has raked in $3.28 billion in global sales in 2019, despite its patent expiring in 2017 in the US and Europe.

“Again, for GI-101, we have dramatically trimmed down on side effects and cranked up the efficacy. In the past, anti-cancer drugs worked on 20 to 30 percent of the patients, meaning 70 to 80 percent received no benefits from taking the expensive treatment. In adjuvant therapy with an immuno-oncology drug such as GI-101, the responder rate can go up and this is how we provide differentiated value,” Nam said.

GI Innovation recently announced that it will jointly carry out clinical trials with Merck to test the efficacy of GI-101 in adjuvant therapy with the latter‘s blockbuster cancer drug Keytruda (pembrolizumab).

Keytruda has been on the market for six years and is one of Merck’s top performers. It is showing a steady growth in sales, notching $7.2 billion in 2018, and is projected to record $14.39 billion in 2020.

If GI-101 proves to complement Keytruda, the two’s growth will be proportionate to each other.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)