Nam Yu-jun, Vice President of Ipsell, made this statement during an interview with Edaily on the 7th at BIO JAPAN 2026 in Yokohama, Japan. He emphasized that the partners Ipsell is seeking at this event are not limited to companies interested solely in securing Japanese licensing rights. Regardless of the contract type, the company is targeting pharmaceutical firms and medical institutions willing to collaborate on everything from the design of Japanese clinical trials for the osteoarthritis cell therapy “MIUChon” to its manufacturing and quality control.
Ipsel aims to begin clinical trials in Japan for “MIUChon,” an induced pluripotent stem cell (iPSC)-based cell therapy for osteoarthritis, next year. The company is currently conducting a pre-submission analysis to prepare for review by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and is evaluating the most appropriate pathway between clinical trials for marketing authorization and clinical research under regenerative medicine laws.
Vice President Nam said, “When we held the opening ceremony for our Japan branch at BioJapan two years ago, we did not schedule any separate partnering meetings,” adding, “We determined that it was more appropriate to proceed after accumulating clinical data.”
In the meantime, Ipsel has completed a one-year follow-up of three patients treated with MuCon and has begun a randomized, double-blind, placebo-controlled clinical trial involving 30 participants. With initial human data now available, the company plans to specifically seek partners at this year’s BioJapan for its clinical development in Japan, as well as for its cell line and disease model businesses.
Mucon is an allogeneic cell therapy in which iPSCs are differentiated into chondrocytes, formed into three-dimensional cell clusters, and injected once into the knee joint cavity. Unlike existing osteoarthritis treatments focused on pain relief, it aims to confirm the potential for structural recovery of damaged cartilage.
Previously, Ipsell announced that no serious treatment-related adverse events were observed during a one-year follow-up of three patients who received the initial treatment. Sequential magnetic resonance imaging (MRI) also confirmed a reduction in cartilage defects and a recovery in cartilage thickness in the damaged areas.
Vice President Nam explained, “Osteoarthritis is known to be a condition with a high placebo response, making it difficult to demonstrate treatment efficacy based solely on pain scores,” adding, “In the 30-patient study, we intend to statistically validate structural improvements through a placebo-controlled, double-blind design and MRI-based quantitative metrics.”
“It doesn’t work just by transferring rights”… Keeping contract options open while emphasizing ‘manufacturing and quality’The primary partners Ipsell aims to meet at this event are pharmaceutical companies and medical institutions that will jointly design and conduct Mucon’s clinical trials in Japan. Additionally, key targets include cell therapy developers requiring support for clinical-grade iPSCs and manufacturing and quality control (CMC), as well as pharmaceutical companies and contract research organizations (CROs) seeking to evaluate new drug candidates using iPSC-derived organoids and disease models.
Regarding MuCon, the company’s policy is to discuss a wide range of approaches—including joint development and technology transfer—without limiting the form of the agreement, tailored to the partner’s capabilities and development stage. However, the company maintains that any arrangement must be structured so that cell lines, manufacturing processes, and quality control systems are transferred together. This stance stems from the judgment that, since these elements determine the safety and reproducibility of cell therapy products, it is difficult to reliably advance development and commercialization by transferring only the rights to the candidate substance.
Vice President Nam stated, “Cell therapies do not function simply by transferring rights,” adding, “Since the cell line, process, and quality control are the product itself, it is more important to determine who will jointly be responsible for manufacturing and quality—and how—rather than the name of the contract.” He continued, “As long as that foundation is designed together, not only joint development but also technology transfer or option agreements regarding rights in Japan can be viable options.”
At this year’s BioJapan, Ipsell aims to narrow down potential partners to jointly review Japanese clinical trial sites, regulatory pathways, and manufacturing methods, and to advance to the stage of exchanging data under a non-disclosure agreement (NDA).
Discussions regarding the Japanese clinical trial have centered on Kamakura General Hospital. Since 2024, Ipsel has been discussing the possibility of conducting a MuCon clinical trial targeting osteoarthritis patients in Japan with Kamakura General Hospital, which is located near Shonan i-Park, and by the end of last year, the company had decided to proceed with the clinical trial in collaboration with local hospitals.
Currently, while conducting a preliminary analysis to prepare for PMDA review, the company is evaluating whether to proceed with a clinical trial for regulatory approval or to first conduct a clinical study in accordance with regenerative medicine laws. This is because the required data, development pace, and the path to future approval will vary depending on the chosen route.
Vice President Nam stated, “Our goal is to complete the 30-patient study by November of next year,” adding, “If we wait until the results are in to begin preparations for Japan, it could delay the process by several more years, so we are looking for a partner to start clinical trial design and regulatory consultations with right away.”
Ipsell opened its Japanese branch office at the Shonan Health Innovation Park in Kanagawa Prefecture in September 2024. The branch serves as a hub for preparing MuCon’s Japanese clinical trials, handling business development with Japanese pharmaceutical companies, and assessing local regulatory and quality standards. Currently, clinical, regulatory, and business development staff from the Seoul headquarters are operating the office at Shonan i-Park on a rotational basis, and the company plans to expand its local workforce in line with the schedule for entering the Japanese clinical trial market.
Vice President Nam stated, “There is a difference between the standards we read about in documents in Seoul and the standards actually applied by local hospitals and companies,” adding, “A key role of the branch office is to verify Japan’s regulatory and quality requirements directly on the ground.”
The decision to select Japan as the first overseas clinical hub also took into account the fact that it is a market where iPSC-based regenerative medicine has entered the actual commercialization phase. In Japan, in March of this year, Kuolips’ heart failure treatment “Rehart” and Sumitomo Pharma’s Parkinson’s disease treatment “Amchepri” were approved as the first iPSC-derived products.
Vice President Nam said, “Japan’s strength lies in the fact that its regulatory system has been tested in practice,” adding, “Since regulatory agencies, hospitals, and review committees have actual experience evaluating issues unique to iPSCs—such as oncogenicity and genetic stability—there is a high degree of predictability from a developer’s perspective.”
However, the company did not view Japan’s conditional and time-limited approval system merely as a fast-track approval pathway. Since conditional approval requires proving efficacy even after market launch, the company explained that securing data verifying the potential for structural improvements in Korea takes priority over rushing to market based solely on initial data.
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ending to Follow-On Agreements with Ono… Expanding Sales Base in Japan with Cell Hub and POLARIn addition to therapeutic drug development, Ipsell is positioning the “Global iPSC Cell Hub” and “POLAR,” an organoid-based animal alternative testing platform, as other pillars of its Japanese business.
Cell Hub is a platform business that integrates the supply of clinical-grade iPSC cell lines with the establishment of cell banks, quality testing, Good Manufacturing Practice (GMP) manufacturing, process development, and regulatory compliance. Ipsell provides cell lines and manufacturing and quality data accumulated during its own therapeutic development process for use by external developers.
Last July, the company signed cell line distribution agreements totaling 6 billion won, including milestone payments, with Asan Medical Center, Eticstem, and Celloid, and generated revenue this past June by supplying actual cell lines to Celloid and Eticstem.
Vice President Nam stated, “The value of clinical-grade cell lines lies not in the cells themselves, but in the package of quality and manufacturing data accumulated during the process leading up to clinical trials,” adding, “As external partners directly use the cell lines and processes and undergo their own clinical reviews, the regulatory history and reproducibility verification of Ipsell’s cell lines will also be established.”
POLAR launched its commercial services this year. In particular, the contract for iPSC-based organoid efficacy evaluation signed with Ono Pharmaceutical in Japan has led to follow-up contracts following the initial agreement. This represents a step forward from previous discussions that merely mentioned the potential for future collaboration, as it confirms the possibility of repeat business with Japanese pharmaceutical companies.
Vice President Nam said, “The fact that a pharmaceutical company from the country considered the pioneer of iPSCs is repeatedly using a Korean company’s evaluation platform serves as an important basis when initiating discussions with other Japanese companies.” He added, “We are also discussing collaborations in the areas of cell materials, disease models, and clinical processes with Japanese pharmaceutical companies and CROs, and some of these are already in the contract negotiation stage.”
iCell aims to expand Cell Hub and POLAR overseas, starting with Japan, to secure annual platform revenue of approximately 3 billion won by the time of its IPO. For its next-generation pipeline, the company is developing a universal iPSC-based cell therapy with reduced immunogenicity to minimize immune rejection. Research on artificial red blood cells is underway with Daewoong Pharmaceutical, while a cardiac therapy is being developed through a joint research project with Stanford University in the U.S.
Vice President Nam said, “The platform business is not merely a supplementary revenue source while we wait for therapeutic development,” adding, “It serves as the manufacturing and quality foundation needed to bring iPSC therapies to market, as well as a channel for external validation of Ipsell’s cell lines and processes.”
