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  • Chinese immunotherapy tislelizumab to soon arrive in KOR
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Nov 15, 2023 05:39am
Marketing authorization for the drug imminent in Korea
MFDS completes the safety and efficacy review¡¦ may soon approve the drug
BeiGene receives approval for 12 indications including NSCLC in China
A PD-1 cancer immunotherapy developed in China is soon expected to receive marketing approval in Korea.

According to industry sources on the 14th, the Ministry of Food and Drug Safety has completed the drug safety and efficacy review for BeiGene Korea¡¯s ¡®Tevimbra 100mg (tislelizumab).¡¯ If no issues were found during the safety and efficacy review, the authorities can immediately grant marketing authorization for the drug.

If approved, the Chinese immunotherapy drug will be competing with MSD¡¯s ¡®Keytruda (pembrolizumab),¡¯ and BMS¡¯s ¡®Opdivo (nivolumab).¡¯

BeiGene Korea has been conducting Phase II and III trials in Korea since 2020. The company completed a Phase III clinical trial on patients with loc
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