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China expands teclistamab use to earlier-line relapsed or refractory multiple myeloma

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Johnson & Johnson's teclistamab, a bispecific antibody targeting BCMA and CD3, has won a new indication in China through the priority review pathway, extending its use to adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The drug was the world's first approved BCMA×CD3 bispecific antibody, gaining conditional EU approval in August 2022, and has since been approved in the United States, China and Japan. The October 2026 approval broadens its Chinese label beyond its original indication. The wider adoption of the drug in earlier-line Chinese multiple myeloma treatment remains an open question, pending further clinical and market developments.

Written by a model from the reports · updated 2 hours ago

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Oct 22
  1. mp.weixin.qq.comPick
    Johnson & Johnson's BCMA×CD3 Bispecific Antibody Teclistamab Wins New Indication in China

    On October 22, Johnson & Johnson announced that teclistamab won approval in China through the priority review pathway for a new indication, covering adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Teclistamab is a bispecific antibody targeting both BCMA and CD3. It first received conditional approval in the EU in August 2022 as the world's first approved BCMA×CD3 bispecific antibody, followed by approvals in the United States, China and Japan; this adds a new indication in China.

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CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org