Janssen's Daratumumab Nears Approval in China for New Multiple Myeloma Indication

Recently, the official website of the National Medical Products Administration (NMPA) showed that the new indication marketing application for daratumumab injection (English brand name: Darzalex), submitted by Xian Janssen in China (acceptance numbers: JXSS2000019/JXSS2000020), is currently in the "under review" stage and is expected to receive NMPA approval soon. The indication is for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, in combination with lenalidomide and dexamethasone or with bortezomib and dexamethasone. This will be the second approved indication for this product in China.

Multiple Myeloma (MM) is an incurable hematologic malignancy. In China, its incidence has surpassed that of acute leukemia, ranking it as the second most common hematologic malignancy. Despite significant advances in the treatment of multiple myeloma in recent years, the majority of patients still face the challenges of relapse or drug resistance. Relapsed and refractory multiple myeloma remains a major concern for clinicians and poses a serious threat to patient survival.

Regardless of the disease stage, CD38 is a protein that is highly expressed on multiple myeloma cells in all patients. Daratumumab has a unique dual mechanism: on one hand, it directly binds to CD38 and induces myeloma cell death through multiple mechanisms, achieving rapid remission; on the other hand, it modulates the immune microenvironment by activating immune cells such as CD8+ cytotoxic T cells and CD4+ helper T cells, continuously promoting myeloma cell death.

Daratumumab is the first fully human monoclonal antibody targeting CD38 to be approved globally and in China. As a blockbuster product of Janssen, it received FDA approval in November 2015 and was granted conditional marketing authorization in China in July 2019. It is indicated as monotherapy for adult patients with relapsed and refractory multiple myeloma who have previously received treatments including proteasome inhibitors and immunomodulatory agents and demonstrated disease progression during their last therapy. Financial reports indicate that global sales of daratumumab reached $4.19 billion in 2020, representing a year-over-year increase of 39.8%.

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Furthermore, on November 6 last year, Xian Janssen submitted a marketing application in China for daratumumab subcutaneous injection (Darzalex Faspro). Clinical data showed that compared with the intravenous formulation, the subcutaneous formulation had similar overall response rates and pharmacokinetic profiles, and required only about 3–5 minutes for administration, whereas the intravenous formulation took several hours. In addition, the incidence of systemic administration-related reactions (ARRS) with the subcutaneous formulation was nearly one-third lower than that with intravenous administration (13% vs. 34%).

Henlius’ Daratumumab Biosimilar Clinical Trial Application Received Implicit Approval from the CDE on January 12 This Year, with Plans to Conduct Clinical Studies for the Treatment of Multiple Myeloma (MM).