On February 11, Johnson & Johnson announced that talquetamab injection had received marketing approval from the China National Medical Products Administration (NMPA). The approved indication is: monotherapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three prior lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). Talquetamab is a subcutaneously administered "first-in-class" GPRC5D×CD3 bispecific antibody, which has already been approved in the United States and Europe for the treatment of relapsed or refractory multiple myeloma.

Talquetamab, as a bispecific antibody, can bind to the CD3 receptor expressed on the surface of T cells and GPRC5D. GPRC5D is a novel target for multiple myeloma, highly expressed on multiple myeloma cells, non-malignant plasma cells, and some healthy tissues such as skin and tongue epithelial cells. Targeting GPRC5D has been shown to provide deep responses, and unlike many other targets, its expression is restricted to immune cells, offering a new approach to targeting this heterogeneous disease. Previously, talquetamab received Breakthrough Therapy Designation and Orphan Drug Designation from the U.S. FDA, and was subsequently granted accelerated approval.

August 2023, FDAAccelerated ApprovalTalquetamab is used for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least four prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies. In the same month, Johnson & Johnson announced that the European Commission granted conditional approval for talquetamab to treat adult patients with relapsed and refractory multiple myeloma who have previously received at least three treatments, including immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies, and have shown disease progression during their last treatment.

In China, the new drug application for talquetamab was accepted by the Center for Drug Evaluation (CDE) of the NMPA in early 2024 and subsequently included.Priority Review, Indication: Monotherapy for adult patients with relapsed or refractory multiple myeloma who have previously received at least three prior lines of therapy. Previously, this new drug was also included by the CDE.Breakthrough Therapies。

Johnson & Johnson announces the approval of Rybrevant® (Amivantamab Injection) in China for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

On February 11, Johnson & Johnson announced that its innovative therapeutic drug Rykolt® (Amivantamab Injection) has been officially approved by the National Medical Products Administration (NMPA) for use in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by a validated test.This approval marks Johnson & Johnson's official entry into the lung cancer treatment field in China, with the potential to redefine treatment standards and usher in a new era of lung cancer therapy.

The approval of Amivantamab is based on the results of the randomized, open-label, PAPILLON Phase III clinical trial. The study demonstrated that, compared to chemotherapy alone, the combination of Amivantamab and chemotherapy reduced the risk of disease progression or death by 61%. Based on the results of the PAPILLON clinical trial, the National Comprehensive Cancer Network (NCCN) "NCCN Clinical Practice Guidelines" recommend Amivantamab in combination with chemotherapy as the preferred first-line treatment for patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

Kelun Biotech's "Cetuximab" Biosimilar Approved for Marketing

On February 7, the official website of the National Medical Products Administration (NMPA) announced that the biologics license application for Kolon Biotech's biosimilar EGFR monoclonal antibody Cetuximab N01 Injection (A140) had been approved. This has drawn attention in the biopharmaceutical field, marking a significant advancement in Kolon Biotech’s innovative drug development and offering new hope to cancer patients. Cetuximab is a classic anti-cancer drug used to treat RAS wild-type metastatic colorectal cancer and squamous cell carcinoma of the head and neck.

Cetuximab is mainly used to treat metastatic colorectal cancer with wild-type RAS gene and squamous cell carcinoma of the head and neck.In the treatment of metastatic colorectal cancer, its performance is particularly outstanding.For example, in the CRYSTAL study, cetuximab combined with the irinotecan (FOLFIRI) regimen as a first-line treatment demonstrated astonishing results.For patients with wild-type RAS genes, the median progression-free survival (PFS) in the combination group reached 9.9 months, compared to only 8.7 months in the FOLFIRI group;The median overall survival (OS) in the combination group was significantly extended to 24.9 months, compared to 21.0 months in the FOLFIRI group.This means that the use of cetuximab combined with chemotherapy reduces the risk of tumor progression and effectively extends the survival time of patients.

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