Janssen Announces China Approval of First-Line Indication for DARZALEX® (Daratumumab Injection) in Adults with Newly Diagnosed Multiple Myeloma Ineligible for Autologous Stem Cell Transplant

Shanghai, November 12, 2021 /PR Newswire/ -- Xian Janssen Pharmaceutical Ltd., a pharmaceutical subsidiary of Johnson & Johnson in China, announced today the launch of its innovative targeted drug, Darzalex.^®(Daratumumab Injection, English trade name: DARZALEX)^®Daratumumab Injection has been approved by the National Medical Products Administration (NMPA) for use in combination with lenalidomide and dexamethasone or in combination with bortezomib, melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation.

Darzalex^®Launched in China in 2019 for monotherapy in adult patients with relapsed and refractory multiple myeloma, it was again approved in April this year for use in combination regimens for adult patients with multiple myeloma who have received at least one prior line of therapy. With the recent approval for first-line treatment, Darzalex will now help more patients achieve deep and durable remission at an earlier stage of the disease, offering hope for long-term survival.

Multiple myeloma is an incurable hematologic malignancy, and its incidence rate has risen to the second highest among blood tumors in China.^[1]。Professor Huang Xiaojun, Director of the Hematology Research Institute of Peking University, pointed out: "For patients with multiple myeloma, disease recurrence is inevitable and the treatment becomes more challenging after recurrence. Therefore, receiving effective treatment at the time of initial diagnosis to extend the first remission period as much as possible is crucial. Although there have been many advances in the treatment of the disease in recent years, clinicians are still looking forward to new treatment options that can more effectively control disease progression in the early stages."

DARZALEX^®It is the first domestically approved fully human monoclonal antibody targeting CD38.^[2]，With a unique and innovative therapeutic mechanism, it can specifically bind to CD38, an important immunotherapy target on the surface of myeloma cells, inducing myeloma cell death through multiple mechanisms to achieve deep and lasting remission.^[3-4]。

Professor Wu Depei, Chairman of the Hematology Society of the Chinese Medical Association and Executive Deputy Director of the National Clinical Research Center for Hematologic Diseases, further pointed out: "First-line treatment is an important opportunity for patients with multiple myeloma to achieve lasting remission. For newly diagnosed patients with multiple myeloma who are not suitable for autologous stem cell transplantation, especially elderly frail or patients with renal impairment, Darzalex^®"The approval of the new indication is exciting news, offering patients the possibility of deep and lasting relief while also bringing new hope for survival."

This time, Megakary^®The approval of the new indication is based on data from a Phase III clinical study in the Asia-Pacific region (OCTANS) and two global Phase III clinical studies (ALCYONE and MAIA). The studies showed that, for newly diagnosed multiple myeloma patients who are not suitable for autologous stem cell transplantation, treatment based on Darzalex...^®The combination therapy regimen can significantly reduce the risk of disease progression or death, and extend patients' progression-free survival period.

Dr. Zili Li, Global Vice President of R&D at Janssen Pharmaceuticals and Head of the Asia-Pacific R&D Center^[6]Represents: "Zytiga^®"The approval of the first-line therapy once again validates the clinical significance of the innovative CD38 monoclonal antibody treatment, and fully reflects our relentless efforts to change the course of the disease and advance the optimization of treatment models."

Craig Tendler, M.D., Vice President of Late Clinical Development and Global Medical Affairs at Janssen Research & Development, stated: "We are very pleased to see that, through joint efforts with the industry and government, the highly efficient advancement of Darzalex..."^®The R&D progress can quickly benefit newly diagnosed multiple myeloma patients. We will continue to explore Megakary.^®The application potential of combination regimens is aimed at halting disease progression at the earliest stage to improve the survival outcomes of patients with multiple myeloma as much as possible."

President of Janssen China, Linda Zheng, stated: "As an innovative leader in the field of hematological oncology, Janssen is committed to continuously addressing the unmet treatment needs of patients in China by expanding our product pipeline. Our investment in the multiple myeloma area demonstrates our long-term commitment to patients in China. In the future, we will continue to ensure that our breakthrough achievements benefit more patients through transformative healthcare innovations."

Darzalex^®Is the second innovative solution for multiple myeloma introduced by Janssen in China. Previously, Velcade^®(Bortezomib Injection) was approved in 2005 for the treatment of multiple myeloma and was included in the national medical insurance in 2017.Contents.

^[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 U.S. 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 is employed by Johnson & Johnson (China) Investment Co., Ltd. Beijing Branch in China.