Daratumumab Set for Third Indication Approval in China

Source: PharmaCube Info

Recently, the official website of the National Medical Products Administration (NMPA) indicated that the marketing authorization application for a new indication of daratumumab injection by Xian Janssen (Acceptance No.: JXSS2100015/16) has entered the "administrative approval" stage and is expected to be approved by the NMPA in the near future.

Daratumumab is the first fully human monoclonal antibody targeting CD38 to be approved both globally and in China. In July 2019, as the first CD38-targeted fully human monoclonal antibody approved in China, it received conditional approval from the National Medical Products Administration (NMPA) for use as monotherapy in adult patients with relapsed and refractory multiple myeloma who have previously received treatment including a proteasome inhibitor and an immunomodulatory agent and have demonstrated disease progression on or after their last therapy. The product is marketed under the brand name ZHAOKE.

In late April this year, the second indication for daratumumab was approved 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. Internationally, daratumumab's indications have expanded to cover first- through fourth-line treatments for multiple myeloma, establishing it as a clinical cornerstone therapy. As a blockbuster product from Johnson & Johnson, daratumumab reported global sales of $2.998 billion in 2019 and $4.190 billion in 2020, representing a year-on-year increase of 39.8%.

Additionally, on October 11, daratumumab subcutaneous injection received marketing approval from the NMPA under the brand name Zhaokesu. It is indicated for use in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of patients with newly diagnosed primary light chain (AL) amyloidosis. This product represents the world's first and currently the only approved innovative therapeutic solution for patients with systemic light chain amyloidosis.

Ahead of the upcoming medical insurance negotiations, on July 27, the Liaoning Provincial Centralized Procurement Platform for Drugs and Medical Consumables issued a notice regarding the voluntary price reduction of Daratumumab Injection. The price for the 100mg/5ml specification was reduced from 5,460 RMB to 2,358 RMB, and the 400mg/20ml specification from 19,710 RMB to 8,512.4 RMB, representing a price cut of 56.81%.

Last year, daratumumab injection failed the national medical insurance negotiation. With this year's negotiation scheduled for October–November, the recent price cut of over 50% for daratumumab injection is likely intended as preliminary preparation for this year's negotiation.