Ildong Pharmaceutical is redrawing its new drug development strategy. After absorbing its research and development (R&D) subsidiary Unovia two years and seven months after its launch, it has overhauled the group's R&D organization. The plan is to shift from a structure reliant on technology exports 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 R&D Deputy Minister in Apr. He has experience in global new drug development at Janssen, Takeda Pharmaceutical, and C. H. Boehringer Sohn AG & Co. KG. In an interview with ChosunBiz on the floor of Bio USA in San Diego, California, on the 25th (local time), Park said, "New drug development is a business that must look 10 to 20 years ahead, so I cannot promise immediate results," adding, "What I want to change first within three to five years is the mindset of the R&D organization."
He said, "Korean pharmaceutical companies must view R&D from a business perspective and move nimbly," and added, "I want to build an organizational culture where researchers think together about business development (BD), partnerships, and open innovation."
◇ Transition to biotech-style R&D… "Keep the organization light, expand research capability"
Park now oversees R&D not only at Ildong Pharmaceutical but also at the anticancer developer Idience and the biotech venture Aims Bioscience, covering three group companies. He directly manages the entire R&D process from project planning to budgeting and partnerships.
He emphasized that because Korean pharmaceutical companies are effectively the size of biotechs in the global market, swift decision-making is essential. Accordingly, immediately after taking office, he eliminated overlapping functions with Unovia and reorganized the group's R&D organization to match its current scale.
Park said, "We focused on using people and resources efficiently," adding, "The current R&D organization has a flat structure with four layers from the head to the most junior researchers."
The goal is to slim down the organization while further strengthening research capacity. He said, "Our subsidiaries have many clinical-stage programs," adding, "By taking these pipelines all the way through development, we will keep building our researchers' experience and also strengthen Korea's early clinical capabilities."
◇ GLP-1, "oral from the start" strategy… "If needed, take clinical trials in Korea all the way"
The most watched pipeline at this Bio USA was the GLP-1 receptor agonist "ID110521156." As the global anti-obesity market expands its competitive stage from injectables to orals, Ildong Pharmaceutical is developing an oral small-molecule drug. In the multiple ascending dose (MAD) phase 1 trial, it showed up to 13.8% weight loss.
Park said, "Many companies first use injectables and then develop oral drugs as maintenance therapy, but we aimed for 'oral treatment from the start,'" adding, "We also secured data showing relatively low gastrointestinal side effects."
He also expressed confidence about the hot topic in the market: muscle preservation. He said, "In phase 1, there was almost no muscle loss," adding, "We aim to prove this in phase 2 and target a 2031 launch." The team is also pursuing a strategy to minimize toxicity by adopting a slow release formulation to raise the dose while designing it so that the maximum concentration (Cmax) does not increase.
They aim to start phase 2 early next year. At this Bio USA, based on the phase 1 data, they discussed the potential for technology exports and co-development with global pharmaceutical companies.
Park said, "Corporations highly valued that there was virtually no toxicity from the perspective of drug-induced liver injury (DILI)," adding, "Because its core scaffold differs from the ofrogliifron ingredient approved by the FDA, companies that were wary of toxicity in that class were particularly receptive."
He added, "It's important to move quickly into phase 2 and produce results, so we are keeping multiple options open," noting, "Around the fall, the concrete contours of partnering should come into view."
However, he said, "This time, we saw a more positive response than expected," adding, "If we accumulate more data, technology exports are fully possible, but even if not, we gained confidence that we can complete development on our own."
◇ Targeting gastric cancer with "benadaparib," seeking to expand the ADC platform in consultation with the FDA
The oncology pipeline is also picking up speed. The PARP inhibitor "benadaparib (IDX-1197)," under development by subsidiary Idience, could hold an end-of-phase-2 meeting with the U.S. Food and Drug Administration (FDA) as early as the end of this year to finalize an approval strategy.
They are consulting with the FDA on whether to target all patients for third-line gastric cancer therapy or narrow development to a biomarker-defined cohort, and are also considering orphan drug and fast-track designations. Additional overseas deals beyond existing contracts in Russia and the United Arab Emirates are expected around the end of the year.
Park is also eyeing the potential to expand benadaparib into an Antibody-Drug Conjugate (ADC) platform. He said, "Existing PARP inhibitors do not dissolve well in water, making them difficult to use as ADC payloads (cytotoxic anticancer agents), but benadaparib is highly water-soluble, so it can be used for various ADC designs," adding, "We are envisioning dual-payload ADCs combined with agents such as topoisomerase inhibitors."
To that end, they are reviewing more than 10 Bispecific Antibody candidates and are also pursuing collaborations with domestic corporations, he added.
◇ "Two-track" strategy in full swing… Rebuilding a five-year growth roadmap with "MARS II"
Ildong Pharmaceutical is deploying a "two-track" strategy starting this year. In the short term, it will boost the value of pipelines close to commercialization, such as the P-CAB formulation "fexuprazan," and in the long term, it will build AI-based new drug development capabilities. It is discussing building optimization models with Insilico Medicine and others to discover new drugs.
This strategy feeds into the "MARS II" project. The goal is to secure new pipelines that will each generate more than 20 billion won in annual sales within five years.
While the original MARS project focused on tasks centered on gastrointestinal and metabolic diseases, MARS II will use fexuprazan and ID110521156, for which it has clinical data, as "anchor assets" to fully pursue a fixed-dose combination (FDC) strategy. This is a shift to a platform-style development strategy premised on combinations and expansion.
In addition, the company plans to broaden its scope by discovering new compounds in oncology and inflammation. Park said, "In five years, I want to build a clear R&D model that anyone can use to explain, 'This is what Ildong is.'"