Novartis' Ofatumumab (Kesimpta®) Receives First Prescription in China, Marking Launch of Breakthrough MS Therapy

Shanghai, March 24, 2022 /PR Newswire/ -- Ofatumumab (brand name: Kesimpta), the world's only fully human CD20 monoclonal antibody customized for patients with multiple sclerosis^® ) The first prescription was issued in China today, marking the official launch of a groundbreaking innovative drug for the treatment of multiple sclerosis worldwide.

Ofatumumab was approved by the National Medical Products Administration in December 2021 for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. Studies show that, compared with the active control group, ofatumumab significantly reduces the annual relapse rate and the overall risk of disability progression, with a good safety profile, and is considered to have the potential to become the preferred treatment for RMS.^[1]。

Professor Dong Qiang, Director of the Neurology Department at Huashan Hospital Affiliated with Fudan University, stated: "As a first-line therapy during the remission period, disease-modifying drugs can help patients effectively reduce disease relapses and control disease progression by modulating immune-inflammatory responses. Ofatumumab not only achieves a balance between efficacy and safety but also offers a relatively convenient mode of administration. Today, I am very pleased to see that many patients across China have been among the first to access ofatumumab. I hope more patients can return to a healthy and free life through active treatment."

Targeted Precision, PioneeringMSA New Era of Treatment

Multiple Sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system. Multiple studies have shown that B cells and their produced autoantibodies play a more significant role in the pathogenesis of MS. Ocrelizumab works by binding to two unique epitopes on CD20-expressing B cells, inducing the lysis and depletion of pathogenic B cells. While achieving precise treatment, it preserves the B cell reconstitution function and the immune surveillance function of plasma cells.^[2]。

The approval of Ocrelizumab was based on the results of two Phase III clinical trials, ASCLEPIOS I and ASCLEPIOS II. The studies included more than 1,800 patients, and the results showed that, compared with the active control group, Ocrelizumab reduced Gd+T1 lesions by 98%.^[3]In the second year of treatment with Ofaatumab, nearly 90% of patients achieved the composite treatment goal of no relapse, no new or enlarging MRI lesions, and no disability progression. From the perspective of long-term disease control, the ASCLEPIOS study showed that the annual relapse rate in the Ofaatumab group was 0.11, equivalent to one relapse every 10 years.

Three Innovative Drugs Launched in Three Years, NovartisMSThe exploration has never stopped.

Novartis has always been committed to bringing breakthrough innovative treatment solutions to patients. In recent years, Novartis has never stopped exploring in the field of multiple sclerosis treatment, successively introducing three innovative drugs in China within three years. They are: Fingolimod, the world's first first-line treatment for multiple sclerosis in children aged 10 years and above and adults; Siponimod, the world’s first and currently the only oral disease-modifying treatment that achieves neuro-repair in patients with active secondary progressive multiple sclerosis (RMS) and slows disability progression; and Ofatumumab, the world’s first and currently the only B-cell therapy that allows patients to self-administer once a month via subcutaneous injection.

The successive launches of these three innovative drugs have filled multiple gaps in the treatment of multiple sclerosis, contributing to the comprehensive coverage and management of the entire patient population and the full course of the disease in China, further demonstrating Novartis' commitment to patients in China.

In order to benefit Chinese patients at the earliest time, after Ofatumumab was approved for marketing in China and passed the drug inspection, the first batch of drugs has been sent to 32 cities across China, including Beijing, Shanghai, and Guangzhou.^[4]。

*ThisThe purpose of the information is to communicate the latest developments and research progress in the pharmaceutical field, intended solely for healthcare professionals, and should not be considered as a drug recommendation.
*The information involved in this material is for reference only. For specific diagnosis and treatment, please follow the advice or guidance of doctors or other healthcare professionals.

[1] Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; February 27-29, 2020; West Palm Beach, FL.

[2] Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: ECTRIMS; September 2016; London, UK.

[3] Hauser SL, et al. Presented at ECTRIMS 2019. OP336. 90% Corresponding - Data on file. OMB157G (ofatumumab) OMB157G 5.3.5.3. Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.

[4] The 32 cities include Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou, Wuhan, Shenyang, Chongqing, Zhengzhou, Xi'an, Changchun, Nanchang, Guiyang, Suzhou, Zhuhai, etc.