The China National Medical Products Administration (NMPA), a state regulatory body, has approved a Phase 3 clinical study for SB12, referred to as AMT904 in China, Samsung Bioepis said in a statement on Friday.
SB12 was developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare disease in which the destruction of red blood cells leads to red discoloration of the urine. Soliris has been used to treat the rare disorders atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria. The average cost is estimated at around 500 million won ($431,035) for a one-year supply.
The approved clinical trial in China is part of Samsung Bioepis' ongoing global Phase 3 trial that began in August 2019. AffaMed Therapeutics, a biopharmaceutical company founded by the Chinese healthcare private equity firm CBC Group, has received exclusive rights to commercialize the treatment in China and Singapore.
"The clinical collaboration with AffaMed furthers Samsung Bioepis' goal to innovate access to life-changing medicines for patients in need," Samsung Bioepis' clinical operation team vice president Hong Il-sun was quoted as saying.
"This is AffaMed’s second biosimilar candidate to receive CTA approval within one-year of founding, accelerating its goal of providing innovative medicines to Chinese patients improving accessibility," said AffaMed CEO Nathan Pang.
Samsung Bioepsis, a joint venture between Biogen, a U.S.-based pharmaceutical company, and Samsung BioLogics, a bio company affiliated with South Korea's largest Samsung Group, has been known for Imraldi, an adalimumab biosimilar referencing Humira. Trastuzumab, sold under the brand name Herceptin, is a monoclonal antibody used to treat breast cancer developed by Swiss pharmaceutical giant Roche.
Samsung Bioepis has won U.S. approval to sell Ontruzant, a cancer-treating biosimilar referencing Herceptin. In 2019, the company won U.S. approval to sell its biosimilar referencing Enbrel (etanercept), one of the best-selling pharmaceutical products, that treats chronic diseases, including moderate to severe rheumatoid arthritis.
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