'Pharma-Bio Veterans' with extensive experience as project managers (PMs) at domestic and international pharmaceutical companies are taking on the challenge of independently developing and producing immunotherapy drugs for immune diseases.
Their goal is to expand their business scope beyond importing and supplying medicines, leveraging research and development (R&D) capabilities to develop raw materials, engage in contract development and manufacturing organizations (CDMO/CMO), and secure proprietary pharmaceuticals.
Kang Gyu-seok and Yoon Doo-won, co-CEOs of Schmitt Healthcare Korea (hereinafter Schmitt), announced on the 12th that they plan to expand their bio and chemical pharmaceutical business starting next year, centered around a company-affiliated research institute of approximately 100 pyeong in size located at Chuncheon Gangwon Technopark in Gangwon Province.
CEO Yoon stated, "We will build a production line compliant with Good Manufacturing Practice (GMP) for pharmaceuticals by 2027 and enhance facilities, equipment, and personnel to meet European Union GMP standards by 2028."
He added, "Through this, we plan to expand our proprietary pharmaceutical portfolio and supply customized products to domestic and international clients through CDMO/CMO services."
Founded in 2014, Schmitt is a pharmaceutical company with annual sales in the range of 5 billion won. Its representative product is Esmigen Sublingual Tablet (dissolved under the tongue for ingestion), which has obtained an indication for recurrent infections of the upper and lower respiratory tracts. It is used in cases where infections recur in chronic respiratory diseases such as bronchitis or sinusitis.
In addition, the company has been raising its recognition in the field of immune diseases by sequentially introducing products including △'Immunogen Injection,' a formulation of Psy-mosin alpha 1; △'Megate Suspension,' a treatment for anorexia and cachexia; and △'Pentacell 100mcg Oral Tablet' for selenium supplementation.
Schmitt is a company that started from concerns in the medical field regarding immune diseases. CEO Kang, who worked as an antibiotic PM at a global pharmaceutical company, encountered the severity of antibiotic resistance during communication with infectious disease specialists at university hospitals, which led him to decide on starting a business with CEO Yoon.
CEO Kang explained, "Esmigen Sublingual Tablet is an immunostimulant that standardizes and lyophilizes components (lysates) obtained by breaking down various bacterial cells." He added, "It restores and enhances immune function, reducing the amount of antibiotics used for respiratory diseases and lowering the risk of resistance due to overuse."
Interest in immune diseases has been a driving force behind continuous R&D investment since the early days of its establishment. In particular, after establishing the Company-Affiliated Immune Research Laboratory (SIRCL) in 2019, the company installed high-priced equipment such as FACS (flow cytometers) necessary for immune research, achieving results such as improving manufacturing processes for pharmaceutical bacterial lysates and securing mass production technology.
CEO Kang stated, "We are now receiving requests from other pharmaceutical companies to develop formulations for immune and allergy drugs, and receiving proposals for joint development." He added, "Regarding the development of FDA orphan drug formulations through external commissions, we have currently reached the completion stage."
The development and production of finished pharmaceuticals will proceed as simultaneous internal and external projects.
Internally, the company is developing an anti-cancer cell therapy based on natural killer (NK) cells for which mass production patents have been secured, and immunotherapies utilizing pharmaceutical bacterial lysates. Externally, it plans to continue cooperation in developing drugs based on allergens with Proragen, with whom it signed a memorandum of understanding last January.
Proragen will be responsible for the development of active pharmaceutical ingredients (APIs), while Schmitt will handle formulation development using these APIs and the production of finished pharmaceuticals.
CEO Yoon stated, "Along with expanding our product sales, we laid the foundation for enhancing R&D by signing a joint sales agreement for Esmigen with Daewoong Pharmaceutical last year."
He added, "Our goal is to build capabilities in the Jeonju stage of pharmaceutical development so that overseas markets, including Europe, will say, 'Let's consult with Schmitt when it comes to making new raw materials into drugs.'"
in THEBIO
