US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market.
Rybrevant Approval
Rybrevant, a fully-human EGFR-MET bispecific antibody (BsAb), was approved for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The decision followed positive Phase III PAPILLON trial results, showing the drug reduced disease progression/death risk by 61% versus chemotherapy alone. Rybrevant was first approved in the US in May 2021.
Talvey Approval
Talvey, a CD3/GPRC5D-targeted BsAb, received approval for adult patients with recurrent/refractory multiple myeloma (RRMM) who failed prior therapies including proteasome inhibitors, immunomodulators, and anti-CD38 antibodies. Clinical data showed an overall response rate (ORR) exceeding 70%, with 65% of patients achieving remission after T cell redirection therapy. Talvey earned accelerated US approval in August 2023.
Strategic Outlook
The approvals position J&J to address unmet needs in China’s cancer landscape. Rybrevant and Talvey’s novel mechanisms target hard-to-treat mutations and relapsed cancers, aligning with J&J’s global strategy to advance precision oncology.-Fineline Info & Tech
