Overview
- Summary
- A specialized bio company in new drug development and in-vitro diagnostics, with core businesses in pharmaceutical quality control, new drug development support, and the research, development, and sales of human and animal in-vitro diagnostic devices. An innovative company actively developing and commercializing various diagnostic kits based on NTMD (Nano-bio Technology Multiplex Diagnostics) and NALF (Nucleic Acid Lateral Flow) platform technologies. A KOSDAQ-listed company pursuing continuous growth in new drug development support and diagnostic sectors, leveraging stable revenue from its pharmaceutical quality control business. A company that has grown through securing professional technical personnel and active R&D investment.A specialized bio company in new drug development and in-vitro diagnostics, with core businesses in pharmaceutical quality control, new drug development support, and the research, development, and sales of human and animal in-vitro diagnostic devices. An innovative company actively developing and commercializing various diagnostic kits based on NTMD (Nano-bio Technology Multiplex Diagnostics) and NALF (Nucleic Acid Lateral Flow) platform technologies. A KOSDAQ-listed company pursuing continuous growth in new drug development support and diagnostic sectors, leveraging stable revenue from its pharmaceutical quality control business. A company that has grown through securing professional technical personnel and active R&D investment.
- Key Products/Technologies
- **In-vitro Diagnostic Kits**: Commercialized Fragile X kits [cite: database, 7]. Commercialized STR kits [cite: database, 7]. Allergy Rapid Kit for upcoming commercialization [cite: database, 7]. Small Pregnancy Rapid Kit for upcoming commercialization [cite: database, 7]. SsmarTest COVID-19 IgG/IgM detection kit, a COVID-19 antibody diagnostic kit, with export approval from the MFDS. COVID-19 antigen diagnostic kits (SsmarTest COVID-19 Ag detection kit) and COVID-19 immunity diagnostic kits (SsmarTest COVID-19 Neutralizing Ab detection kit) currently under research and development.**In-vitro Diagnostic Kits**: Commercialized Fragile X kits [cite: database, 7]. Commercialized STR kits [cite: database, 7]. Allergy Rapid Kit for upcoming commercialization [cite: database, 7]. Small Pregnancy Rapid Kit for upcoming commercialization [cite: database, 7]. SsmarTest COVID-19 IgG/IgM detection kit, a COVID-19 antibody diagnostic kit, with export approval from the MFDS. COVID-19 antigen diagnostic kits (SsmarTest COVID-19 Ag detection kit) and COVID-19 immunity diagnostic kits (SsmarTest COVID-19 Neutralizing Ab detection kit) currently under research and development.
- **Platform Technologies**: NTMD (Nano-bio Technology Multiplex Diagnostics) is a nano-bio fusion multiplex diagnostic technology that measures the quantity of nanomaterials after antigen-antibody reactions by tagging specific nanomaterials to antibodies or antigens [cite: database, 2, 4, 7, 8, 12, 14, 19, 21, 26, 32]. It offers high sensitivity and specificity, with the advantage of simultaneously detecting multiple targets with a single diagnostic kit. Potential for expansion into various fields such as virus diagnosis, cancer diagnosis, and antibiotic residue testing. NALF (Nucleic Acid Lateral Flow) platform technology.**Platform Technologies**: NTMD (Nano-bio Technology Multiplex Diagnostics) is a nano-bio fusion multiplex diagnostic technology that measures the quantity of nanomaterials after antigen-antibody reactions by tagging specific nanomaterials to antibodies or antigens [cite: database, 2, 4, 7, 8, 12, 14, 19, 21, 26, 32]. It offers high sensitivity and specificity, with the advantage of simultaneously detecting multiple targets with a single diagnostic kit. Potential for expansion into various fields such as virus diagnosis, cancer diagnosis, and antibiotic residue testing. NALF (Nucleic Acid Lateral Flow) platform technology.
- **Service Businesses**: Pharmaceutical Quality Control services include finished drug product quality inspection, stability testing, and customized inspections, with service expansion into new biopharmaceutical quality inspection areas such as viral agents, antibody therapeutics, and mRNA vaccines [cite: database, 1, 5, 6, 8, 9, 11, 12, 14, 16, 17, 18, 20, 23, 24, 29, 32]. New Drug Development Support services involve efficacy evaluation of candidate substances, clinical trial sample analysis, toxicity testing, potency/purity/content analysis, and PK (pharmacokinetics) analysis [cite: database, 1, 5, 8, 12, 14, 18, 20, 26, 29, 32]. Plans for expanding research and development in pet medicine and quality control services [cite: database, 12, 20]. Plans for entering the food and cosmetics testing and inspection market.**Service Businesses**: Pharmaceutical Quality Control services include finished drug product quality inspection, stability testing, and customized inspections, with service expansion into new biopharmaceutical quality inspection areas such as viral agents, antibody therapeutics, and mRNA vaccines [cite: database, 1, 5, 6, 8, 9, 11, 12, 14, 16, 17, 18, 20, 23, 24, 29, 32]. New Drug Development Support services involve efficacy evaluation of candidate substances, clinical trial sample analysis, toxicity testing, potency/purity/content analysis, and PK (pharmacokinetics) analysis [cite: database, 1, 5, 8, 12, 14, 18, 20, 26, 29, 32]. Plans for expanding research and development in pet medicine and quality control services [cite: database, 12, 20]. Plans for entering the food and cosmetics testing and inspection market.
- Core Advantages
- Securing continuous growth momentum through professional technical personnel and active R&D investment [cite: database, 5, 32].Securing continuous growth momentum through professional technical personnel and active R&D investment [cite: database, 5, 32].
- Possession of in-vitro diagnostic device development and commercialization capabilities based on proprietary platform technologies such as NTMD and NALF.Possession of in-vitro diagnostic device development and commercialization capabilities based on proprietary platform technologies such as NTMD and NALF.
- The only company in Korea providing comprehensive quality control services covering pharmaceuticals, quasi-drugs, and animal pharmaceuticals.The only company in Korea providing comprehensive quality control services covering pharmaceuticals, quasi-drugs, and animal pharmaceuticals.
- Securing unique market competitiveness with over 300 approved test items and products, and testing approvals for 31 types of formulations from the Ministry of Food and Drug Safety.Securing unique market competitiveness with over 300 approved test items and products, and testing approvals for 31 types of formulations from the Ministry of Food and Drug Safety.
- Establishment of an extensive client network with global big pharma companies (such as GSK, Bayer, AstraZeneca, Baxter, Takeda) and major domestic and international pharmaceutical companies.Establishment of an extensive client network with global big pharma companies (such as GSK, Bayer, AstraZeneca, Baxter, Takeda) and major domestic and international pharmaceutical companies.
- Proof of technological capability and reliability through a quality control contract for mRNA vaccines with Pfizer and an exclusive quality control contract for Novo Nordisk's obesity treatment 'Wegovy'.Proof of technological capability and reliability through a quality control contract for mRNA vaccines with Pfizer and an exclusive quality control contract for Novo Nordisk's obesity treatment 'Wegovy'.
- The stable cash cow role of the pharmaceutical quality control business, enabling investment in new businesses and securing growth drivers.The stable cash cow role of the pharmaceutical quality control business, enabling investment in new businesses and securing growth drivers.
- Acquisition of numerous domestic and international certifications such as ISO 9001, ISO 13485, GMP certification, venture company certification, Inno-Biz selection, and an 'A' rating in technology evaluation from Korea Technology Finance Corporation.Acquisition of numerous domestic and international certifications such as ISO 9001, ISO 13485, GMP certification, venture company certification, Inno-Biz selection, and an 'A' rating in technology evaluation from Korea Technology Finance Corporation.
- Target Industrie
- Pharmaceutical IndustryPharmaceutical Industry
- Bio IndustryBio Industry
- Medical Device Industry (In-vitro Diagnostics)Medical Device Industry (In-vitro Diagnostics)
- Animal Pharmaceutical Industry [cite: database, 12, 20]Animal Pharmaceutical Industry [cite: database, 12, 20]
- Food and Cosmetics Industry (planned new entry)Food and Cosmetics Industry (planned new entry)
- Major Markets
- Japan, China (NTMD patent acquisition)Japan, China (NTMD patent acquisition)
- Europe (NTMD patent registration, CE certification pursuit)Europe (NTMD patent registration, CE certification pursuit)
- United States (NTMD patent acquisition, FDA product registration pursuit)United States (NTMD patent acquisition, FDA product registration pursuit)
- Australia (allergy diagnostic kit patent registration)Australia (allergy diagnostic kit patent registration)
- Certifications/Patents
- **Certifications**: ISO 9001 acquisition (2007). Venture company certification (2008, Korea Venture Capital Association). Designated as a Pharmaceutical Quality/Inspection Agency by the Ministry of Food and Drug Safety (2008). Designated as a Bioequivalence Test Institution by the Ministry of Food and Drug Safety (2009). Recognized as a Genetic Testing Institution by the Korea Disease Control and Prevention Agency (2009). Certified as a Corporate R&D Center by the Korea Industrial Technology Association (2009). Selected as an Innovative Small and Medium-sized Business (Inno-Biz) by the Ministry of SMEs and Startups (2011). Medical Device Manufacturing License from the Ministry of Food and Drug Safety (2013). ISO 13485 certification (2016). GMP certification. Acquired 'A' rating in technology evaluation from Korea Technology Finance Corporation.**Certifications**: ISO 9001 acquisition (2007). Venture company certification (2008, Korea Venture Capital Association). Designated as a Pharmaceutical Quality/Inspection Agency by the Ministry of Food and Drug Safety (2008). Designated as a Bioequivalence Test Institution by the Ministry of Food and Drug Safety (2009). Recognized as a Genetic Testing Institution by the Korea Disease Control and Prevention Agency (2009). Certified as a Corporate R&D Center by the Korea Industrial Technology Association (2009). Selected as an Innovative Small and Medium-sized Business (Inno-Biz) by the Ministry of SMEs and Startups (2011). Medical Device Manufacturing License from the Ministry of Food and Drug Safety (2013). ISO 13485 certification (2016). GMP certification. Acquired 'A' rating in technology evaluation from Korea Technology Finance Corporation.
- **Patents**: Holds multiple patents related to NTMD (Nano-bio Technology Multiplex Diagnostics) technology. Acquired technology patents for 'Microparticles and kits for biomolecule analysis and method for manufacturing particles for biomolecule analysis' (Europe 2018, China 2019, USA 2019). Allergy diagnostic kit product Canadian patent registration (April 2024), domestic MFDS sales approval, Australian, and Japanese patent registrations. Acquired Japanese patent for 'Method for analyzing multiple biomolecules with multiple metal Nano tags' (January 2020).**Patents**: Holds multiple patents related to NTMD (Nano-bio Technology Multiplex Diagnostics) technology. Acquired technology patents for 'Microparticles and kits for biomolecule analysis and method for manufacturing particles for biomolecule analysis' (Europe 2018, China 2019, USA 2019). Allergy diagnostic kit product Canadian patent registration (April 2024), domestic MFDS sales approval, Australian, and Japanese patent registrations. Acquired Japanese patent for 'Method for analyzing multiple biomolecules with multiple metal Nano tags' (January 2020).
Introduction
Location
7F, 260 Changnyong-daero, Yeongtong-gu, Suwon, Gyeonggi-do, South Korea
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