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BeiGene-Amgen's Kyprolis Gets Approval In China For Pre-Treated Multiple Myeloma Patients

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  • The China National Medical Products Administration (NMPA) has conditionally approved Kyprolis (carfilzomib) for relapsed or refractory (R/R) multiple myeloma.

  • The approval covers Kyprolis in combination with dexamethasone for adult patients who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.

  • Kyprolis is licensed to BeiGene Ltd (NASDAQ: BGNE) in China under a strategic collaboration with Amgen Inc (NASDAQ: AMGN).

  • The conditional approval was based on results from the Phase 3 trial. Results showed that the overall response rate, the primary endpoint, was 35.8%.

  • The median progression-free survival (PFS) was 5.6 months.

  • Related content: Benzinga's Full FDA Calendar

  • Price Action: AMGN and BGNE shares closed at $244.28 and $320.11, respectively, on Thursday.

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