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Approval of phase 1 clinical study for anticancer drug, SOL-804

The modified drug for metastatic castration-resistant prostate cancer, expectation of the fast result

Bukwang Pharmaceutical announced the company’s application to conduct phase 1 clinical study for SOL-804 from the Ministry of Food and Drug Safety.

Dyna,a subsidiary company of Bukwang, obtained exclusive global rights for the development and commercialization of SOL-804 from a Danish company, Solural Pharma, in 2016. The patent application is currently approved in various countries, including Korea, USA, Europe, China, India, Eurasia, Australia, and Mexico.

This study will be conducted to compare SOL-804 to Zytiga in the safety, tolerance, and pharmacodynamics characteristics. It will be randomized, crossed, and single dose administered.

The proprietary formulation removes food effects and allows administration of lower dose hence SOL-804 is expected to increase patient compliance and safety profile. Also, fast results are expected by reducing the development period.

The global market size of prostate cancer has been getting bigger and passed over 12 trillion dollars in 2019. It will reach 23 trillion dollars in 2027.

SOL-804 is an improved and proprietary formulated version of the currently available drug for the treatment of metastatic castration-resistant prostate cancer. Dyna is Bukwang’s 100% owned subsidiary which was established to focus on drug delivery and formulation.

Bukwang has been conducting diverse clinical studies through the subsidiary companies. JM-010(Dyskinesia induced Parkinson Disease) through Contera Pahrma, SOL-804 through Dyna therapeutics are included. Also Bukwang has been developing immuno-oncology through the JV(JaguAhr) and CNS drugs such as drugs for Alzheimer’s disease through Protekt and Parkinson’s disease with Oxford-Dundee Univ.

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