Janssen Submits New Indication Application for Daratumumab Subcutaneous Injection in China Targeting Multiple Myeloma

On April 15, the CDE website showed that Johnson & Johnson's daratumumab injection (subcutaneous injection) had a new indication submitted for marketing authorization in China. The indication is speculated to be multiple myeloma. Previously, in October 2021, the drug was just approved for marketing in China for primary light chain amyloidosis.

Source: CDE Official Website

Daratumumab, developed by Johnson & Johnson, is a humanized, anti-CD38 IgG1 monoclonal antibody. In November 2015, daratumumab received FDA approval for priority review and was launched on the market. The approved indications are: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients with multiple myeloma who have received at least one prior therapy; in July 2019, it was conditionally approved for marketing in China for the first time as a single agent to treat adult patients with relapsed or refractory multiple myeloma, under the brand name "Zhaoke".

Currently, Daratumumab has become a core product in Johnson & Johnson's oncology business, evolving from a third- or fourth-line treatment to a second-line treatment, and now to a first-line treatment. Darzalex has achieved a remarkable upgrade, with consistently positive performance expectations, maintaining a growth rate of over 40% for several years. In 2020, the sales of Darzalex reached $4.19 billion; in 2021, its sales continued to grow by 43.8% to $6.023 billion.

Daratumumab Annual Sales

Source: Insight Database

Johnson & Johnson has developed a subcutaneous injectable formulation of this blockbuster drug, which is a fixed-dose combination of daratumumab and recombinant human hyaluronidase PH20 (rHuPH20). According to the Insight database, the subcutaneous injection was first approved by the FDA for marketing in May 2020 under the trade name Darzalex Faspro, and currently has two approved indications. In addition to AL amyloidosis, it is also approved for the treatment of multiple myeloma. In China, the first indication approved in October 2021 was primary light chain amyloidosis, and the indication for multiple myeloma has not yet been approved. It is speculated that the indication for this application is likely to be multiple myeloma.

▼ Overview of the Development of Daratumumab Indications in and Outside of China

Source: Insight Database

According to the Insight database, the subcutaneous injection formulation of Daratumumab submitted an application for marketing authorization to the NMPA in November 2020 and was granted priority review under the category of "innovative and improved new drugs urgently needed clinically for the prevention and treatment of major infectious diseases, rare diseases, and drug shortages." Compared with intravenous injection, subcutaneous injection often offers advantages such as faster administration and higher convenience, reducing the administration time from several hours to 3 to 5 minutes. Therefore, it is also highly favored by doctors and patients.

Moreover, daratumumab intravenous injection is under research for numerous indications, all of which have the potential to become possible development directions for subsequent subcutaneous injections (see the figure below for details).

Progress of Daratumumab Indications in Research

Source: Insight Database

Editor: Add One