Janssen China Announces Launch of DARZALEX® (Daratumumab Injection), the World’s First Anti-CD38 Monoclonal Antibody, in China for Relapsed and Refractory Multiple Myeloma

BEIJING, Oct. 15, 2019 /PRNewswire/ -- Janssen Pharmaceutical Ltd., Xian Janssen, the pharmaceutical subsidiary of Johnson & Johnson in China, announced today that Darzalex, its globally first CD38 monoclonal antibody targeted therapy,^®(Daratumumab Injection) has been launched in China for the treatment of adult patients with relapsed and refractory multiple myeloma as monotherapy, who have previously received treatments including proteasome inhibitors and immunomodulatory agents and experienced disease progression during or after their last therapy.

Multiple Myeloma (MM) is an incurable hematologic malignancy.^[1], originating in the bone marrow, characterized by abnormal proliferation of malignant plasma cells^[2]Professor Chen Wenming, Director of the Department of Hematology and Oncology at Beijing Chaoyang Hospital, Capital Medical University, pointed out: “China sees 27,800 new cases of multiple myeloma annually, with an incidence rate that has surpassed acute leukemia, ranking it as the second most common hematologic malignancy.”^[3]. Despite significant advances in the treatment of multiple myeloma in recent years, with existing therapeutic agents including proteasome inhibitors and immunomodulatory drugs, the majority of patients still face the challenges of relapse or drug resistance.^[4],[5], the prognosis is not optimistic.” Studies have shown that long-term survival in patients with multiple myeloma is closely related to whether they can achieve high-quality remission.^[6]Complete Remission Rate of Current Treatment Regimens for Relapsed and Refractory Multiple Myeloma（>/=CR) was unsatisfactory, with a median overall survival of only 9 months^[7]。

In addition to the inherent complexity of the disease, patients and their families often have a significant lack of awareness regarding multiple myeloma. Due to the absence of systematic education and access to authoritative, reliable information, early disease signals are frequently overlooked. As the condition worsens, the dual burden of physical and psychological suffering increasingly undermines patients’ confidence in treatment.

“Patients experiencing relapse or developing resistance to existing treatment regimens, along with their families, bear a heavy physical and psychological burden. Therefore, they have a strong desire for novel therapeutic agents with different mechanisms of action and better tolerability,” said Hong Fei, founder of the patient organization Myeloma Home.

Zhao Ke^®is global andChina's FirstDarzalex^®Featuring a unique dual mechanism: on one hand, it directly binds to CD38, inducing myeloma cell death through multiple mechanisms to achieve rapid response; on the other hand, it modulates the immune microenvironment by activating CD8+ cytotoxic T cells and CD4+ helper T cells, thereby sustaining myeloma cell death.^{[8],[9],[10],[11]}。

Professor Jing Hongmei, Director of the Department of Hematology at Peking University Third Hospital, stated, “The ultimate treatment goal for multiple myeloma is long-term survival. The advent of daratumumab, with its innovative dual mechanism of action, provides patients with better therapeutic options to achieve deeper responses and longer survival, holding the promise of redefining the treatment landscape for multiple myeloma in China. Although multiple myeloma is currently incurable, the emergence of innovative treatment regimens that ultimately enable patients to attain a life expectancy equal to that of the non-myeloma population would effectively mean that functional cure has been achieved for patients with multiple myeloma.”

Li Bin, Head of the Medical Affairs Department at Xian Janssen, stated: “AsChina's FirstThe approved CD38 monoclonal antibody targeted therapy for multiple myeloma, Zhaoke®, has demonstrated significant efficacy and safety in international and domestic clinical trials, providing a safe and effective treatment option with a novel mechanism of action for patients in China with relapsed and refractory multiple myeloma.

Pooled analysis results from two international clinical studies showed that in patients with multiple myeloma who had previously received multiple lines of therapy, treatment with daratumumab monotherapy at a dose of 16 mg/kg extended the median overall survival to 20 months. The best overall response was assessed as stable disease or better in 83% of patients, and the overall response rate was 31%.^[12]. Clinical study results in China show that Zhaoké^®The clinical efficacy and safety of monotherapy in Chinese patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy are generally consistent with those observed in global clinical studies.^[13],[9]。

“At Janssen, we are committed to ‘creating a future free of multiple myeloma’ and strive tirelessly toward this goal. ZHAO Ke”^®“The arrival of this therapy has renewed hope for patients with relapsed and refractory multiple myeloma who have been anxiously awaiting new treatments, as well as their families, helping to prolong survival and improve quality of life.” Emphasized Asgar Rangoonwala, President of Xian Janssen, “Addressing the unmet treatment needs of patients remains our top priority. While accelerating the introduction of innovative medicines, we aim to collaborate with government bodies, healthcare institutions, patient organizations, and other stakeholders to continuously enhance drug accessibility, ensuring that innovation truly reaches and benefits patients in China, thereby contributing to the ‘Healthy China 2030’ initiative.”

Currently, Zhaoko^®Now available in China, covering cities such as Beijing, Shanghai, Guangzhou, and Hangzhou. The China Cancer Foundation has officially launched the Zhaokex Patient Assistance Program to help patients improve their treatment outcomes, achieve longer survival times, and enhance the quality of life for those with multiple myeloma.

^[1] National Cancer Institute. “NCI Dictionary of Cancer Terms: Refractory.” Available at: ^{https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245.} Accessed August 2018.
^[2] American Society of Clinical Oncology. Multiple myeloma: overview.
Available at: ^{http://www.cancer.net/cancer-types/multiple-myeloma/overview}
Last accessed February 2016.
^[3]Zhang Hui, Jiang Hua, Hou Jian. Correlation analysis of cell morphology and clinical features in multiple myeloma. Chinese Journal of Physicians' Postgraduate Education. 2012,35(12): 47
^[4] Mayo Clinic. Monoclonal antibody drugs for cancer: how they work. Available at: ^{http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808} Last accessed February 2016.
^[5] Multiple Myeloma Research Foundation. “Glossary.” Available at: ^{http://www.themmrf.org/multiple-myeloma-knowledge-center/glossary/.} Accessed February 2016.
^[6]Hou Jian, Liu Xi. Treatment Goals for Multiple Myeloma in the Era of New Drugs*[J]. Chinese Journal of Clinical Oncology, 2014, 41(13):823-826
^[7] Kumar et al 2012. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia 26: 149–157.
^[8] Khagi Y, et al. Onco Targets Ther. 2014; 7: 1095–100.
^[9] Overdijk MB, et al. J Immunol. 2016; 197(3): 807–13.
^[10] van de Donk NWC. Cells. Immunol Lett. 2018 Jul;199:16-22.
^[11] Krejcik J et al. Blood. 2016; 128(3): 384–94.
^[12] Usmani S, Weiss B, Bahlis NJ, et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2015;126(23):abstract 29.
^[13] Daratumumab for Injection Package Insert, 2019.