Daewoong Pharmaceutical obtains approval from Indonesia for phase-1 cl…

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관리자   |   20-11-16 13:24    |   312 Views


Daewoong Pharmaceutical obtains approval from Indonesia for phase-1 clinical trial of stem cell COVID-19 respiratory symptom treatment

- Confirmed increased survival rates and anti-viral effects for acute respiratory distress syndrome in a non-clinical study
- Conducted joint research with the Indonesian Ministry of Health through joint venture Daewoong Infion
- Aims to proceed with phase-2 clinical trial in Korea after completing phase-1 in Indonesia

Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) obtained approval from Indonesia for phase-1 clinical trial of COVID-19 respiratory symptom treatment based on mesenchymal stem cells (DWP710) on July 2. Daewoong is planning to confirm the safety of the drug in phase-1 clinical trial and enter phase-2 within this year.

To identify anti-viral effects, Daewoong’s stem cell treatment (DWP710) was confirmed in an acute respiratory distress syndrome (ARDS) animal model based on lipopolysaccharide (LPS), an inflammation inducer, that it increased survival rates more than 30% compared to the control group and restored lung tissue damaged by inflammation almost to the level of the normal group. In addition, an efficacy study using the animal model infected with COVID-19 confirmed not only anti-inflammatory effects but also anti-viral effects, where the virus count decreases below the limit of detection in infected lung tissue.

Daewoong is conducting clinical trials in Indonesia with its joint venture Daewoong Infion. Daewoong Infion signed an MOU with the Indonesian Ministry of Health in July and is conducting a clinical trial for COVID-19 respiratory symptom treatment based on mesenchymal stem cells (DWP710). Then, based on phase-1 clinical trial results in Indonesia, a phase-2 clinical trial will begin in Korea.

Currently, conditional approval from the Ministry of Health and Welfare can be obtained only with phase-2 trial data under the Republic of Korea’s Advanced Regenerative Bio Act. If approved, the drug can be used as a treatment in hospitals. In the future, if the efficacy of DWP710 is proven in phase-2 clinical trial, it is expected to be used as a treatment more quickly.

CEO Sengho Jeon at Daewoong said, “Daewoong is developing the best products in cellular therapeutics in terms of quality and price. From phase-2 clinical trial, we will include Korea, and we will accelerate the process so that we can develop the product faster as efficacy is expected for dyspnea patients infected with COVID-19.”

Meanwhile, Daewoong introduced cell banking for the first time in Korea, and obtained a technology that mass-produces quality stem cells derived from one donor. In particular, Daewoong’s stem cells are recognized for competitiveness as they can be cryopreserved and turn into a product immediately in the hospital when there is a patient.

Furthermore, Daewoong established the joint venture Daewoong Infion (CEO Changwoo Suh) in Indonesia in 2012, launched the biosimilar Epodion (EPO) in 2017, and has since then maintained the largest market share in Indonesia. This year, the company acquired halal certification for biopharmaceuticals Epodion and Easyef.

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