List of Contract Manufacturing Companies in South Korea - 10

BMI KOREA: A DYNAMICALLY-GROWING BIOPHARMACEUTICAL COMPANY, ALWAYS CHALLENGING FOR HEALTHY LIFE OF HUMAN-BEING. BMI is a pharmaceutical and biotechnology company based in South Korea that focuses on development and commercialization of new medicines (incl. biologics) and medical devices. BMI started to operate in 2005, and for more than a decade it has been growing with successful development of new medicines and biologics based on its own novel technologies and know-hows. BMI has specialized in sterile formulation and has developed many products such as HA, PN, PDRN and Botulinum Toxin etc. One of main BMI’s assets is “Hyaluronidase”. BMI has led the market over the last 10 years with two formulations: (A liquid sterile-brand: “Hirax® and a lyophilized sterile power vial- brand: “BM Hylunidase ®”). With these experiences and expertise, BMI has recently developed new generation of it, “Recombinant Hyaluronidase” which is well-known to be used for changing monoclonal antibody’s formulation from IV to SC. On top of that, BMI provides integrated CDMO services to help other pharmaceuticals and biotech companies develop and commercialize medicines. With the most advanced cGMP facilities and R&D center in JEJU and OSONG, BMI can deliver the highly qualified DS, DP and ensure partners’ success to IND, NDA and BLA. Full of speed and customer tailored flexibility are the main strengths. For more information, please visit our website below: www.bmikr.co.kr

CHA Bio Group is continuing its challenge to become the best in various initial achievements in the bio and healthcare fields. We are developing and producing advanced biopharmaceuticals, including cell and gene therapy products and vaccines, based on our global R&D capabilities, such as our unique ‘CHA Bio ecosystem': Academic, Research, Medical Network, and Bio-Industry Business, the world's largest cell library, and our independently developed vaccine adjuvant platform. We will leap forward as a true global bio company centered on the third-generation CGT CDMO and global healthcare business.

GC Biopharma (formerly known as Green Cross Corporation, KRX: 006280) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein product manufacturers in the world and has been dedicated to quality healthcare solutions for more than half a century.

Biologics, Small Molecules

Inventage Lab has the technology to mass-produce micro/nano drug delivery systems using microfluidics technology. Sustained-release injectables using polymeric microspheres have been commercialized, and lipid nano delivery systems such as liposome and LNP are now being manufactured.

Headquartered in Seoul, South Korea, LOTTE BIOLOGICS was founded in 2022 with a mission to deliver therapies that contribute to a healthier world. At the Syracuse Bio Campus in New York, LOTTE BIOLOGICS provides high-quality GMP manufacturing services for drug substances. The facility offers a total production capacity of 40,000L, supported by eight 5,000L stainless steel bioreactors. Additionally, the campus includes extensive analytical QC testing laboratories and warehouse facilities that have received approval from over 62 regulatory agencies worldwide. LOTTE BIOLOGICS is also advancing into a new area of expertise with Antibody-Drug Conjugates (ADCs) conjugation services, expected to be fully operational by early 2025. With over $80 million invested in ADC modalities, including both drug substance and conjugation capabilities on-site, we offer a seamless, end-to-end service from drug substance manufacturing to conjugation. Looking ahead to 2030, LOTTE BIOLOGICS is constructing three advanced bio plants in Songdo, South Korea. With construction of the first plant already underway and expected to be operational by 2026, each facility will feature eight 15,000L stainless steel bioreactors for large-scale commercial production, along with multiple 2,000L single-use bioreactors to meet clinical production needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity. Through our commitment to delivering innovative medicines to patients worldwide, LOTTE BIOLOGICS aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.

Prestige Biologics Co., Ltd is a biopharmaceutical CMO, CDMO, CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in your drug discovery from early stage to product registration and commercialization. Based on our fully established antibody drug & vaccine manufacturing capabilities, we now offer our upgraded CDMO service, CDEMO in which we provide customized engineering solutions for your manufacturing process in a customized manufacturing suite speed-built with our proprietary technology, ALITA Smart BioFactory™.

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.

"ST Pharm provides reliable and timely custom manufacturing services for API following stringent quality system and close communication with the clients." Founded in 1983, ST Pharm (formerly known as Samchully Pharmaceutical) has been offering excellent custom manufacturing services of APIs and their intermediates to meet clients' high expectation for their use in pharmaceutical development in compliant to cGMP requirements. Our reliability in service, which is well-proven through decades of business relationship with many big pharmas and biotech clients, is the essence of our strength along with our expertise in process development and scale-up optimization. Historically, ST Pharm has been focusing our expertise on nucleoside based active pharmaceuticals in various antiviral drug applications; we became the world largest supplier of Thymidine in the late 1990s and Zidovudine in the mid 2000s and protected nucleosides in the early 2000s. ST Pharm has continuously been expanding its service offering, including synthesis of therapeutic oligonucleotides. In June 2010, ST Pharm became a subsidiary of Dong-A Pharmaceutical, the top pharmaceutical company in Korea. ST Pharm is committed to expanding its business scope into generic APIs and their intermediates with full support and collaboration with parent company Dong-A Pharmaceutical.

Yuhan Corporation is an integrated healthcare company founded in 1926. It has achieved top market value and sales revenue in Korean pharmaceutical industries, and been awarded for the most respected and trusted company in Korea for recent 11 consecutive years. It has two subsidiaries, Yuhan Chemical and Yuhan Medica, and the affiliates including Joint Ventures with Janssen(Belgium), the Clorox Company(USA), and Kimbery-Clark Corporation(USA). The core business of Yuhan can be classified into Primary & Specialty care, Dietary supplement, Household & Animal care, and contract manufacturing of active pharmaceutical ingredients.