Ildong Pharmaceutical is reworking its drug development strategy. After absorbing its research and development (R&D) subsidiary Unovia two years and seven months after its launch, it has also overhauled the group's R&D organization. The plan is to break away from a structure reliant on technology exports and shift to a model that builds in-house clinical capabilities.
At the center of the change is President Park Jae-hong, who was brought in as Deputy Minister of R&D in April. Having worked at Janssen, Takeda Pharmaceutical, and C. H. Boehringer Sohn AG & Co. KG and gained experience in global new drug development, Park said in an interview with ChosunBiz on the floor of "BIO USA" in San Diego, California, on the 25th (local time), "Because new drugs are a business that must be viewed over 10 to 20 years, I cannot promise immediate results," adding, "What I want to change first within three to five years is the R&D organization's mindset."
Park said, "Korean pharmaceutical companies must also look at R&D from a business perspective and move nimbly," adding, "I want to build an organizational culture in which researchers also think together about business development (BD), partnerships, and open innovation."
◇ Shift to biotech-style R&D… "Keep the organization light, expand research prowess"
Park currently oversees R&D for three group companies: Ildong Pharmaceutical, the oncology developer Idience, and the biotech venture Aims Bioscience. He directly manages the entire R&D process, from project planning to budgeting and partnerships.
He stressed that because Korean pharmaceutical companies are effectively the size of biotechs in the global market, rapid decision-making is essential. Accordingly, immediately after taking office, he streamlined overlapping functions with Unovia and reorganized the group's R&D organization to fit its current scale.
Park said, "We focused on using people and resources efficiently," adding, "The current R&D organization is a flat structure made up of four layers from the head to the most junior researcher."
The goal is to slim down the organization while further strengthening research capabilities. He said, "Our subsidiaries have many projects in clinical stages," adding, "I want to keep building our researchers' experience as we develop these pipelines all the way through, and at the same time strengthen Korea's early clinical capabilities."
◇ GLP-1, "oral from the start" strategy… "If needed, complete it with domestic clinical trials"
The most-watched pipeline at this BIO USA was the GLP-1 receptor agonist "ID110521156." As the global anti-obesity drug market expands competition from injectables to orals, Ildong Pharmaceutical is developing an oral small-molecule compound. In a multiple ascending dose (MAD) phase 1 trial, it confirmed up to 13.8% weight loss.
Park said, "Many companies first use injectables and then develop oral drugs for maintenance therapy, but we aimed for 'oral treatment from the start,'" adding, "We also secured data indicating a relatively low rate of gastrointestinal side effects."
He also expressed confidence about the market's recent focus on preserving muscle. He said, "There was hardly any muscle loss in phase 1," adding, "We aim to prove this in phase 2 and target a 2031 launch." The company is also pursuing a strategy to minimize toxicity by introducing a slow release formulation that raises the dose but is designed so that the maximum concentration (CMAX) does not increase.
They are targeting early next year for phase 2 entry. At this BIO USA, based on phase 1 data, they discussed the possibility of technology export and co-development with global pharmaceutical companies.
Park said, "Corporations highly valued that there was virtually no toxicity from a drug-induced liver injury (DILI) perspective," adding, "Because its core scaffold differs from that of the FDA-approved oforglipron ingredient, companies that were wary of toxicity in that class were particularly receptive."
He added, "It is important to proceed quickly with phase 2 and deliver results, so we are keeping multiple options open," noting, "By around fall, the specific outline for partnering should come into view."
However, he said, "This time we saw a more positive response than expected," adding, "If we accumulate more data, the potential for technology export is sufficient, but even if that does not happen, we gained confidence that we can complete development on our own."
◇ Gastric cancer target "benadaparib," seeking ADC platform expansion while consulting with the FDA
The oncology pipeline is also picking up speed. Benadaparib (IDX-1197), a PARP inhibitor under development by subsidiary Idience, could finalize its approval strategy after an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) as early as the end of this year.
They are consulting with the FDA on whether to target all patients for third-line gastric cancer treatment or narrow development to a biomarker-based patient group, and they are also considering orphan drug and fast track designations. Additional overseas deal news beyond existing contracts in Russia and the United Arab Emirates is expected around year-end.
Park is also focusing on the potential to expand benadaparib's Antibody-Drug Conjugate (ADC) platform. He said, "Existing PARP inhibitors do not dissolve well in water, making them difficult to use as ADC payloads (anticancer agents with cytotoxicity), but benadaparib is highly water-soluble and can be used in a variety of ADC designs," adding, "We are envisioning dual-payload ADCs combined with agents such as topoisomerase inhibitors."
To that end, he added that they are reviewing more than 10 Bispecific Antibody candidates and pursuing collaborations with domestic corporations.
◇ "Two-track" strategy in full swing… Reworking the five-year growth roadmap with "MARS II"
Ildong Pharmaceutical is activating a "two-track" strategy starting this year. In the short term, it aims to raise the value of pipelines close to commercialization, such as the P-CAB formulation "fexuprazan," and in the long term, to build research and development (R&D) capabilities based on artificial intelligence (AI). It is discussing ways to build optimization models with Insilico Medicine and others to discover new drugs.
This strategy feeds into the "MARS II" project. The gist is to secure new pipelines with annual sales of at least 20 billion won within the next five years.
While the original MARS project focused on tasks centered on gastrointestinal and metabolic diseases, MARS II will make fexuprazan and ID110521156, which have clinical data, "anchor assets" and fully pursue a fixed-dose combination (FTC) strategy. It is a shift to a platform-style development strategy premised on combinations and expansion.
In addition, the plan is to broaden the scope by discovering new compounds in oncology and inflammation. Park said, "Five years from now, I want to build a clear R&D model that anyone can use to explain, 'This is what Ildong is.'"