(Health Korea News / Lee Si-woo) The 20-year relationship between Daewoong and Indonesia has reached a major leap forward. Daewoong Biologics Indonesia (DBI), Daewoong’s local subsidiary, announced on the 13th that its stem cell plant in the Cikarang Javabeka Industrial Complex has received GMP certification from the Indonesian Ministry of Food and Drugs (Minister Taruna Ikrar) and has begun full-scale operations. Park Sung-soo, CEO of Daewoong Pharmaceutical, who visited the site for the official opening of the DBI stem cell plant, emphasized, “With this GMP certification, Daewoong has taken the first step toward a large-scale research and development project with the Indonesian pharmaceutical and bio industries.”
Since Daewoong first established a relationship with the Indonesian people through the establishment of a branch in Jakarta in 2005, it has been consistently and intensively carrying out projects for the development of the pharmaceutical and biotechnology industry and talent development as an ‘innovation partner’ in Indonesia under the vision of ‘mutual growth’ of CVO Jaeseung Yoon.
◆A great achievement that will contribute to the health of Indonesian people in the ‘aging era’
The proportion of Indonesia’s population aged 65 and over exceeded 7% last year. The country has entered a full-fledged ‘aging society’. Due to the aging population, degenerative diseases related to aging, such as arthritis, cancer, and brain diseases, are increasing, and the pharmaceutical industry is predicting that the national demand for stem cell treatments will increase significantly.
In this situation, Daewoong’s DBI, which aims to be a healthcare partner for the Indonesian people, has established a foundation to supply high-quality stem cells that can be used to treat intractable diseases that are difficult to treat with chemical drugs to 14 hospitals designated by the Indonesian Food and Drug Administration.
DBI received a stem cell processing facility permit from the Indonesian Ministry of Health in January of this year. After nine months, it obtained GMP, allowing it to supply ‘high-quality stem cells’ to Indonesia in earnest. A Daewoong official said, “As the first Korean company to obtain GMP for stem cell processing among local companies, we will pursue research and development and commercialization of bio-regenerative medicine as well as treatments for incurable diseases.”
Daewoong has the capacity to produce high-quality stem cells. It has already obtained all three major requirements for developing and producing advanced biopharmaceuticals in Korea: ▲advanced biopharmaceutical manufacturing ▲human cell management ▲cell processing facility license. Based on this, it plans to introduce various stem cells such as umbilical cord-derived stem cells and adipose-derived stem cells, and expand the pipeline to exosomes and immune cells to provide innovative treatment options to Indonesian patients.
◆Daewoong and Indonesia’s ‘joint growth’ since 2005
Daewoong’s relationship with the Indonesian pharmaceutical and biotechnology industry and the Indonesian people dates back to 20 years ago in 2005. At that time, Daewoong established a branch in Jakarta and pledged to “grow together with Indonesia.”
Daewoong’s efforts to grow Indonesia’s pharmaceutical and biotechnology industry began in earnest in 2012 with the establishment of Daewoong Infion, a joint venture. That year, it built Indonesia’s first biopharmaceutical plant, and in 2017, it received approval for Indonesia’s first biosimilar, ‘Epodion’, and began production. Epodion is an anemia treatment for chronic renal failure patients undergoing dialysis and cancer patients. It was recognized for providing economical and high-quality medicines by producing and selling it locally, thereby strengthening Indonesia’s biopharmaceutical competitiveness. As a result, Daewoong received the Indonesian Minister of Health Award in 2017 and was selected as the best biopharmaceutical company by the Ministry of Food and Drug Safety in the same year.
Daewoong is now planning to introduce its 34th domestic new drug, Pexuclu, for gastroesophageal reflux disease, and its 36th domestic new drug, Enblo, for diabetes, to Indonesia, and to develop new medicines in various fields such as circulatory, endocrine, digestive, and infectious diseases by applying differentiated formulation technologies such as sustained-release, complex, and reduced-release. In addition, it has established a strategy to conduct local clinical trials targeting Indonesians to verify the safety and efficacy of the drugs, and to develop 50 types of medicines with proven efficacy and quality to contribute to the health of the Indonesian people.
◆Indonesian Minister of Health, Minister of Food and Drug Safety, etc. attended the event on the 12th
On the 12th, Daewoong held an event to celebrate the GMP certification of the DBI stem cell factory located in the Indonesian Cikarang Javabeka Industrial Complex. Around 150 people including Indonesia’s Food and Drug Administration Director Taruna Ikrar and Health Minister Dante Saksono Harbuwono visited the site, along with South Korea’s Food and Drug Safety Bureau Director Kim Sang-bong, South Korean Embassy of the Republic of Korea in Indonesia Minister Park Soo-deok, Korea Pharmaceutical and Bio-Pharma Manufacturers Association Vice Chairman Lee Jae-gook, and Daewoong Pharmaceutical CEO Park Sung-soo attended the event.
“Today, we have established a foundation that will play a pivotal role in the stem cell therapy development and production ecosystem,” said Taruna Iklar, Indonesia’s Food and Drug Administration director. “Our scientists, together with Daewoong’s experts, will advance Indonesia’s cutting-edge medical technology.”
Park Sung-soo, CEO of Daewoong Pharmaceutical, said, “As an innovation partner, Daewoong seeks to grow together with Indonesia’s pharmaceutical and biotechnology industry,” and “We will do our best to improve the quality of life of Indonesian people by introducing cutting-edge stem cell technologies to Indonesia.”
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