Recently, the official website of the State Food and Drug Administration showed that Xi’an Janssen’s application for new indications for Darzalex injection (English trade name: Darzalex) submitted in China (acceptance number: JXSS2000019/JXSS2000020) is already in the “approval” stage.
It is expected to receive NMPA approval in the near future.
The indication is the combination of lenalidomide and dexamethasone or the combination of bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least first-line treatment in the past.
This will be This product is the second indication approved in China.
Multiple myeloma (MM) is an incurable hematological malignancy.
Its incidence in my country has exceeded that of acute leukemia, ranking second in hematological malignancies.
Although many progresses have been made in the treatment of multiple myeloma in recent years, most patients still face the problem of relapse or drug resistance.
Relapsed and refractory multiple myeloma bother clinicians and threaten the lives of patients.
Regardless of the stage of the disease, CD38 is a protein that is highly expressed on multiple myeloma cells in all patients.
Daratumumab has a unique dual mechanism.
On the one hand, it can directly bind to CD38 and induce the death of myeloma cells through multiple mechanisms to achieve rapid remission; on the other hand, it can activate immune cells CD8+ toxic T cells and toxic T cells by regulating the immune microenvironment.
CD4+ helper T cells continue to promote the death of myeloma cells.
Daratumumab is the first fully human monoclonal antibody targeting CD38 approved globally and domestically.
This drug is a blockbuster product of Janssen, which was approved by the FDA in November 2015 and July 2019.
It has been approved for marketing conditionally in China.
It is used as a single agent to treat adult patients with relapsed and refractory multiple myeloma.
The patient has previously received treatments including proteasome inhibitors and immunomodulators and the disease progressed during the last treatment.
The financial report shows that the global sales of daratumumab in 2020 will reach 4.
19 billion U.
Medicine Rubik's Cube NextPharmaMedicine Rubik's Cube NextPharma
In addition, Xi'an Janssen submitted a listing application for Darzalex Faspro in China on November 6 last year.
Clinical data shows that compared with intravenous injections, subcutaneous injections have a similar overall response rate and pharmacokinetic characteristics, and only need about 3-5 minutes, while intravenous injections require several hours.
In addition, the incidence of systemic drug-related reactions (ARRS) for subcutaneous injections was reduced by nearly 1/3 compared with intravenous injections (13% vs 34%).
The clinical application of Fuhong Henlius daratumomab biosimilar has been approved by the CDE by default on January 12 this year, and it intends to carry out clinical research on the treatment of multiple myeloma (MM).