Johnson & Johnson's "Daratumumab" new indication for listing

On April 15, the CDE official website showed that the new indication of Johnson & Johnson's daratumumab injection (subcutaneous injection) was applied for listing in China, and it is speculated that its indication may be multiple myeloma

From: CDE official website

Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody developed by Johnson & Johnson

At present, daratumumab is a core product in Johnson & Johnson's oncology business.

Daratumumab sales over the years

From: Insight Database

The subcutaneous formulation developed by Johnson & Johnson for this blockbuster drug consists of a fixed-dose combination of daratumumab and recombinant human hyaluronidase PH20 (rHuPH20).

▼ Overview of the development of domestic and foreign indications for daratumumab

From: Insight Database

According to the Insight database, daratumumab subcutaneous injection submitted a marketing application to the NMPA in November 2020 and was prioritized as "clinically urgently needed drugs in short supply, innovative drugs and improved new drugs to prevent diseases such as major infectious diseases and rare diseases" review

Daratumumab intravenous injection has many indications under development, and these indications have the potential to become the potential development direction of subsequent subcutaneous injections (see the figure below for details)

Progress of daratumumab indications under development

From: Insight Database

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