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Entry of FDA-approved new Chinese blood cancer drug imminent

By Lee, Tak-Sun | translator Alice Kang

21.12.27 15:49:06

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MFDS approval of BeiGene Korea¡¯s ¡®Brukinsa¡¯ imminent



A new blood cancer treatment that was developed by a Chinese pharmaceutical company and approved by the US FDA will be soon introduced to Korea. The drug awaiting entry is BeiGene Korea¡¯s ¡®Brukinsa.¡¯

If approved, Brukinsa will be the second new drug approved by a Chinese pharmaceutical company following Antengene¡¯s ¡®Xpovio tab 20mg.¡¯

According to the industry on the 27th, the Ministry of Food and Drug Safety completed the safety and efficacy review of BeiGene Korea¡¯s ¡®Brukinsa,¡¯ and the countdown for its marketing authorization has started.

Brukinsa is a Bruton's Tyrosine Kinase inhibitor used in patients with B-cell primary central nervous system lymphoma.

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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