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mp.weixin.qq.com· 丁香园 Insight 数据库·· 4 hours agoPickScore66

Johnson & Johnson's BCMA×CD3 Bispecific Antibody Teclistamab Wins New Indication in China

全球首创!强生双抗新药在中国获批新适应症

In brief

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.

Why it matters

Teclistamab, the first approved BCMA×CD3 bispecific antibody, gains a new China indication via priority review, comparable to its approval pace in the EU, US and Japan.

Source: mp.weixin.qq.com · mp.weixin.qq.com

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