Janssen announces that the innovative targeted drug Zhaoke (R) has been approved for first-line indications in China

Shanghai, November 12, 2021 /PRNewswire/ - Xi'an Janssen Pharmaceutical Co.
, Ltd.
, a subsidiary of Johnson & Johnson in China, announced today that its innovative targeted drug Zhaoke® (Daletuzumab injection, English trade name) : DARZALEX®, English generic name: Daratumumab Injection) was approved by the National Medical Products Administration, and combined with lenalidomide and dexamethasone or combined with bortezomib, melphalan and prednisone is not suitable for the treatment of autologous stem cells Adult patients with newly diagnosed multiple myeloma transplanted
.

Zhaoke® was launched in China in 2019 as a single agent for the treatment of adult patients with relapsed and refractory multiple myeloma, and was approved again in April this year for the combined regimen for adults with multiple myeloma who have received at least first-line treatment Patient
.
Now with the approval of the first-line treatment, Zhaoke will help more patients achieve deep and lasting relief at an earlier stage of the disease, and bring the hope of long-term survival for patients

Multiple myeloma is an incurable hematological malignant tumor, and its incidence has jumped to the second place in China's hematological tumors[1]
.
Professor Huang Xiaojun, Director of the Institute of Hematology, Peking University, pointed out: “For patients with multiple myeloma, the recurrence of the disease is inevitable, and the treatment after recurrence is more difficult

Zhaoke® is the first fully human monoclonal antibody approved to target CD38 in China [2].

Professor Wu Depei, chairman of the Hematology Branch of the Chinese Medical Association and executive deputy director of the National Clinical Research Center for Hematological Diseases, further pointed out: "First-line treatment is an important opportunity
for patients with multiple myeloma to obtain lasting remission .
For new diagnoses that are not suitable for autologous stem cell transplantation.

The approval of Zhaoke® for new indications is based on data from an Asia Pacific Phase III clinical study (OCTANS) and two global Phase III clinical studies (ALCYONE and MAIA)

At a median follow-up of 12.
3 months, the results of the OCTANS study showed that daretuzumab combined with bortezomib, melphalan, and prednisone compared to only bortezomib, melphalan and prednisone.
Many patients achieved very good partial remission (VGPR) or better remission (74% vs 43.
2%), prolonged the patient’s median progression-free survival (not reached vs 18.
2 months), and reduced disease by 57% Risk of progression or death (HR[95% CI]: 0.
43 [0.
24, 0.
77]; p-value=0.
0033) [5]
.
At a median follow-up of 40 months, the results of the ALCYONE study showed that daretuzumab combined with bortezomib, melphalan and prednisone compared with bortezomib, melphalan and prednisone alone can be used.

Dr.
Li Zili, Vice President of Global R&D of Janssen Pharmaceuticals and head of Asia Pacific R&D Center[6] said: “The approval of Zhaoke® first-line therapy once again validates the clinical significance of CD38 monoclonal antibody, an innovative treatment plan, and fully reflects our Unremitting efforts to change the course of the disease and advance the optimization of the treatment model
.
"

Dr.
Craig Tendler, Vice President of Clinical Development and Global Medical Affairs of Janssen, said: “We are very pleased to see that through joint efforts with the industry and the government, the highly efficient R&D process of Zhaoke® can quickly benefit newly diagnosed patients with multiple myeloma.

We will continue to explore the application potential of the Zhaoke® combination program, and strive to curb disease progression at the earliest possible stage, so as to improve the survival of patients with multiple myeloma as much as possible
.
"

Ms.
Zheng Lei, President of Yangsen China, said: “As an innovative leader in deep-rooted hematology and tumor science, Yangsen is committed to continuously addressing the urgent needs of Chinese patients for treatment through continuous expansion of the product pipeline

Zhaoke® is the second innovative solution for multiple myeloma introduced by Janssen in China

[1] Zhang Hui, Jiang Hua, Hou Jian.
Correlation analysis of MM and clinical features.
Chinese Journal of Postgraduates of Medicine.
2012,35(12): 47

[2] Janssen Biotech, Inc.
"DARZALEX (daratumumab) Approved by US FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of multiple Myeloma.
" Issued November 2015.

[3] Overdijk, M.
et al.
Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma, MAbs, 2015;7(2):311-321.

[4] de Weers, M.
et al.
Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors.
J Immunol.
2011;186(3):1840- 1848.

[5] DARZALEX® Prescribing Information, September 2019.

[6] Dr.
Li Zili was employed by Johnson & Johnson (China) Investment Co.
, Ltd.
Beijing Branch in China

About Yang Sen

For 36 years, Yang Sen has used innovation to protect China's health and is committed to creating a disease-free future
.
We are a pharmaceutical company under Johnson & Johnson.
We use science to overcome diseases, use wisdom to expand access, let care bring hope, and enable people to enjoy a better tomorrow
.

We care about patients, driven by innovation, and focus on the six major diseases that can bring huge changes to human health: oncology, immunology, infectious diseases and vaccines, neuroscience, cardiovascular and metabolism, and pulmonary hypertension
.
We work with many parties to continuously bring breakthrough medical and health solutions, and use innovation to help healthy China
.

Source: Xi'an Janssen