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Two new indications for BeiGene PD-1 monoclonal antibody will be approved soon

 Last Update: 2021-08-12
 Source: Internet
 Author: User

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Recently, the official website of the State Food and Drug Administration showed that BeiGene's PD-1 antibody drug Bezeran (Tilelizumab) has been in the "approval" stage for two new indications (acceptance number: CXSS2000032, CXSS2000033).

The two indications to be approved this time are: 1) Combined chemotherapy for the treatment of patients with first-line advanced non-squamous non-small cell lung cancer (NSCLC)

An open, multi-center, randomized phase III clinical trial code-named RATIONALE 304 evaluated the combination of pemetrexed with pemetrexed and platinum-based chemotherapy drugs (carboplatin or cisplatin), compared with pemetrexed and platinum only Class chemotherapeutics, curative effect in the treatment of first-line stage IIIB or IV non-squamous NSCLC patients

As of the data cut-off point of January 23, 2020, the median follow-up time was 9.

A pivotal phase II clinical trial (NCT03419897) evaluated the efficacy of Bezan in the treatment of unresectable HCC patients who had previously received treatment

Attached table: PD1/PD-L1 domestic application for listing and approval

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