ACellbion is a biotech company that develops radiopharmaceutical therapeutics and molecular imaging diagnostics.
Alongside new drug development aimed at addressing unmet needs in clinical practice, we operate radiopharmaceutical production infrastructure, a specialty generic pharmaceutical business, and a CDMO business.
ACellbion was founded on July 21, 2010, and was listed on the KOSDAQ market as a technology growth company on October 16, 2024.
ACellbion's main businesses are the following three:
1) Development of new radiopharmaceutical therapeutics and diagnostics
2) Production of injection-focused specialty generic pharmaceuticals
3) A CDMO business supporting the contract development and manufacturing of investigational drugs and other pharmaceuticals
AUnder the corporate philosophy “Where Care Meets Innovation,” Cellbion seeks to develop radiopharmaceuticals that can make a real contribution to patient care.
We aim to become a specialized radiopharmaceutical company that connects diagnosis and treatment, and research and development with production.
ACellbion has built its research and development and production capabilities on a foundation that includes a pharmaceutical research institute, the Pangyo R&D Center, the RI-R&D Lab (a radioisotope research facility), and injection GMP production facilities.
We are also expanding the new drug development ecosystem through collaboration among industry, hospitals, and research institutions.
AA radioisotope is an unstable isotope that emits radiation as it decays into a stable isotope, and each radioisotope has its own unique half-life.
Depending on the type of radiation emitted during decay into a stable isotope—gamma rays, beta rays, or alpha rays—radioisotopes are used in various fields, including the diagnosis and treatment of cancer.
AWhether an isotope is used for diagnosis or therapy is determined by the type of radiation it emits. Diagnostic isotopes emit positrons or gamma rays, which allow the location and distribution of disease to be identified using imaging equipment such as PET or SPECT; representative examples include Ga-68, F-18, Cu-64, and Tc-99m.
Therapeutic isotopes are radioisotopes that emit beta or alpha rays, and are used to treat cancer cells by delivering radiation energy to them; representative examples include Lu-177, I-131, Y-90, and Ac-225 and Pb-212, which have recently been the focus of extensive research.
AA radiopharmaceutical is a drug that combines a radioisotope with a targeting substance that seeks out a specific disease site.
When the targeting substance moves to the desired site, such as cancer cells, the attached radioisotope delivers a diagnostic signal or therapeutic radiation energy.
AConventional anticancer drugs act throughout the body, which can also affect normal cells.
Targeted radiopharmaceuticals are designed to seek out specific proteins that are highly expressed in cancer cells, with the goal of delivering radiation energy to the site that needs treatment.
Actual treatment eligibility and effectiveness may vary depending on the patient's condition, the characteristics of the cancer, and the judgment of the medical team.
ATheranostics is a concept that combines “Therapy” and “Diagnostics.”
It is a patient-tailored approach in which a diagnostic isotope is attached to a targeting substance with the same or similar structure to confirm the location of the cancer and whether the target is expressed, after which the isotope is switched to a therapeutic one for treatment.
AThis is because, prior to treatment, imaging studies can be used to select patients whose target is sufficiently expressed, and after treatment, the distribution of and response to the drug can be assessed.
This enables a precision medicine approach that provides treatment to suitable patients and monitors the treatment process.
AA radiopharmaceutical is designed as a structure combining several components.
The ligand plays the role of seeking out a specific target on cancer cells.
The linker connects the part where the ligand and the radioisotope are joined, and affects the drug's movement and distribution within the body.
The chelator plays the role of holding the metallic radioisotope so that it can bind stably.
ACellbion possesses technology for designing targeting substances and linkers, labeling technology for stably binding radioisotopes, and technology for optimizing the production process of radiopharmaceuticals.
Based on these, we are developing therapeutics and diagnostics for various targets, including PSMA in prostate cancer and FAP in solid tumors.
APSMA (Prostate Specific Membrane Antigen) is a protein that is highly expressed on the surface of prostate cancer cells.
Drugs that recognize PSMA can be used to visualize the location of prostate cancer or to deliver a therapeutic radioisotope to cancer cells.
APSMA is highly expressed in many prostate cancer patients and has the characteristic of moving inside the cell after binding to a drug.
As a result, radiopharmaceuticals that target PSMA are developed in a way that accumulates radioisotopes inside cancer cells to deliver therapeutic energy.
ALu-177 is a therapeutic radioisotope that emits beta rays.
When Lu-177 is attached to a targeting substance that binds to PSMA, the drug reaches PSMA-expressing cancer cells and then emits radiation energy, damaging the DNA of the cancer cells.
AGa-68 is a diagnostic radioisotope used in PET imaging studies.
When administered after binding to a targeting substance, it can be used to visualize the location and distribution of cancer and whether the target protein is expressed.
ACellbion's flagship pipeline is Pocuvotide Satetraxetan (177Lu-DGUL, 177Lu-Pocuvotide), a therapeutic radiopharmaceutical that targets PSMA on prostate cancer cells.
It is a drug designed to use the therapeutic isotope Lu-177 to deliver radiation energy to PSMA-expressing prostate cancer cells.
APocuvotide is being developed for patients with metastatic castration-resistant prostate cancer who do not respond to existing treatments or whose disease has progressed despite treatment.
The specific patient population and treatment eligibility will be determined based on future approvals and the judgment of the medical team.
A68Ga-NGUL is a PET imaging diagnostic agent for prostate cancer that targets PSMA.
It is being developed to confirm whether a patient's cancer cells express PSMA and to visualize the location and distribution of the cancer.
Because the therapeutic and diagnostic agents use the same or similar target structure, a theranostics approach is possible.
AThis is a development program that administers Pocuvotide together with the immuno-oncology drug pembrolizumab to evaluate safety and therapeutic potential.
Because the two drugs have different mechanisms of action, the purpose is to confirm the feasibility of combination use through clinical trials, and actual efficacy and safety will be evaluated based on the clinical trial results.
AMSA is a molecular imaging diagnostic platform that utilizes targets associated with inflammatory cells.
Cellbion is developing a diagnostic agent for atherosclerosis and cerebro-cardiovascular inflammation using 68Ga-NOTA-MSA, as well as a sentinel lymph node imaging diagnostic agent based on 99mTc-MSA.
AFAP (Fibroblast Activation Protein) is a target that appears in the tumor microenvironment of various solid cancers.
Cellbion is researching a solid cancer imaging diagnostic agent that targets FAP, as well as therapeutic radiopharmaceutical candidates using Lu-177 or Ac-225.
A225Ac-Pocuvotide is a next-generation prostate cancer therapeutic candidate that applies Ac-225, which emits alpha rays, to the PSMA-targeting structure of Pocuvotide.
It is currently a pipeline at the research and development stage, and its safety and efficacy must be verified through future preclinical and clinical trials.
AClinical trial and approval procedures may change depending on regulatory agency review, the progress of clinical trials, and research results.
The latest development stage can be checked on the pipeline page of the Cellbion website, the Financial Supervisory Service's electronic disclosure system, DART, and disclosures on the Korea Exchange's KIND system.
AA new drug candidate goes through a research stage and preclinical trials, after which safety and efficacy in humans are evaluated through Phase 1, Phase 2, and Phase 3 clinical trials.
It must then pass a regulatory agency's marketing authorization review before it can be sold as a drug.
The development plan and timeline may change depending on the results of each stage.
APhase 1 trials mainly confirm the drug's safety, appropriate dosage, and pharmacokinetic characteristics in the body.
Phase 2 trials explore treatment efficacy and safety in patients with a specific disease.
Phase 3 trials confirm efficacy and safety in a larger number of patients by comparing the drug with existing treatments and other standards.
ANo. Approval of a clinical trial plan means that the regulatory agency has reviewed the plan so that the relevant clinical trial can proceed; it is different from marketing authorization for a drug.
After obtaining the necessary data through clinical trials, a separate marketing authorization review must be undergone.
AThis is a system to support the development of drugs for diseases for which treatments are lacking or the number of patients is limited.
A development-stage orphan drug designation means that the drug may receive benefits in development support and the review process.
AGIFT (Global Innovative products on Fast Track) is a rapid-review support system operated by South Korea's Ministry of Food and Drug Safety for globally innovative products.
It is a system that supports review from the development stage so that innovative drugs for life-threatening diseases and similar conditions can be developed quickly.
A GIFT designation likewise does not mean final marketing authorization, and the product must still undergo review of its safety, efficacy, and quality.
AThis is a system that allows a drug to be authorized subject to certain conditions, in order to provide it more quickly to patients with serious diseases or a lack of alternative treatments.
Whether conditional authorization is granted, and what conditions are imposed, is determined based on the regulatory agency's review of the submitted clinical and quality data, among other materials.
AClinical trials involve multiple interconnected processes, including patient recruitment, the schedules of trial institutions, drug production and supply, regulatory agency review, and safety assessment.
Depending on these factors, the expected schedule may be adjusted, and any material changes will be announced through official disclosures or official channels in accordance with relevant laws and regulations.
AGMP (Good Manufacturing Practice) refers to standards for pharmaceutical manufacturing and quality control.
It is a set of standards applied to facilities, manufacturing processes, testing, and record management to ensure that drugs are consistently produced and managed to a defined level of quality.
AA CDMO (Contract Development and Manufacturing Organization) is a business in which a specialized company undertakes the development and production of drugs on behalf of a client.
Based on its GMP injection vial production facilities and drug manufacturing experience, Cellbion supports the production of investigational drugs and other pharmaceuticals.
ANo. In addition to developing new radiopharmaceuticals, Cellbion also operates an injection-focused specialty generic pharmaceutical business and a CDMO business.
Through these, we are building up both research and development capabilities and drug production capabilities.
ARadioisotopes have a half-life characteristic, meaning their radioactivity decreases over time.
As a result, radiopharmaceuticals must be produced, quality-tested, shipped, and supplied to medical institutions within a set time frame.
Stable production facilities and a reliable supply chain are important competitive factors in the radiopharmaceutical business.
ACellbion is pursuing joint research and clinical development collaborations with universities, hospitals, government-funded research institutes, and pharmaceutical/biotech companies in Korea and abroad.
Through these collaborations, we are discovering new targets and drug candidates and expanding opportunities for research, development, and commercialization.
AThe company's key business activities and progress on clinical trials and approvals can be checked through the following official channels:
1) Cellbion website
2) Financial Supervisory Service's electronic disclosure system, DART
3) Korea Exchange's corporate disclosure channel, KIND
Please refer to official disclosures and materials distributed by the company as the basis for key information.
AClinical trial and approval timelines are affected by regulatory agency review, the progress of clinical trials, and data submission schedules, among other factors.
As a result, it is difficult for the company to provide a definitive announcement of review outcomes or completion timing in advance.
Any confirmed material matters will be disclosed in accordance with relevant laws and regulations or announced through the company website.
AThe future plans and schedules presented in IR materials are based on the business plans and projections as of the time the materials were prepared.
Actual results and schedules may vary depending on clinical trials, regulatory review, market conditions, and business circumstances.
