Janssen Submits New Drug Application for Daratumumab Subcutaneous Injection in China

On November 6, Janssen’s marketing application for daratumumab injection (subcutaneous) in China was accepted by the Center for Drug Evaluation (CDE).

Daratumumab is a CD38 monoclonal antibody developed by Janssen. Its intravenous injection was approved by the FDA in November 2015 under the brand name Darzalex. It was approved for import into China in July 2019. Currently, Janssen has submitted a marketing application in China for the second indication of daratumumab.

In May 2020, the subcutaneous formulation of daratumumab developed by Janssen was approved by the FDA under the brand name Darzalex Faspro, marking the first subcutaneously administered anti-CD38 monoclonal antibody for the treatment of multiple myeloma.

Clinical data demonstrate that Darzalex Faspro exhibits similar overall response rates and pharmacokinetic profiles compared to intravenous Darzalex, with the former requiring only approximately 3–5 minutes for administration, whereas intravenous Darzalex takes several hours. Furthermore, Darzalex Faspro is associated with a nearly one-third reduction in the incidence of systemic administration-related reactions (ARRs) compared to Darzalex (13% vs. 34%).

Daratumumab is a key product of Janssen. Financial reports show that its global sales reached $2.998 billion in 2019, and $2.937 billion in the first three quarters of 2020 (+37%).