Novartis Announces NMPA Approval of Gilenya® (Fingolimod) for Pediatric and Adult RMS in China

Shanghai, July 19, 2019 /PRNewswire/ -- Today, Novartis Pharmaceuticals (China) announced that the National Medical Products Administration has approved Jilinya^® (Fingolimod) is indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in patients aged 10 years and older, which is alsoCurrently the only oneDisease-Modifying Therapies (DMTs) for Multiple Sclerosis with Pediatric Indications: Gilenya^®It was also included in the first batch of the "List of Clinically Urgent Overseas New Drugs" by the Center for Drug Evaluation of the National Medical Products Administration in 2018.

Ms. Zhang Ying, President of Novartis Pharmaceuticals (China), stated：“Reimagining the future of medicine is Novartis’ mission. I am delighted that we can bring another of Novartis’Kuan ChuangNew Product -- Jie Ling Ya^®brought to China. There are more than 30,000 patients with multiple sclerosis in China, and their needs in terms of diagnosis and treatment remain largely unmet. We believe that Jilingya^®“will bring new treatment options for doctors and patients with multiple sclerosis in China, meeting the needs of clinical treatment and improving patients’ quality of life.”

JieLingya^®Since its global launch, it has been approved in more than 80 countries, benefiting over 283,000 patients.

ChinaMultiple SclerosisThe prognosis is not optimistic, with nearly 90% of patients yet to receiveDMT

Multiple Sclerosis (MS) is a severe, lifelong, progressive, and disabling demyelinating disease of the central nervous system, predominantly affecting young and middle-aged adults aged 20–40 years. Its clinical manifestations are diverse, with common symptoms including visual impairment, diplopia, sensory disturbances in the limbs, motor deficits, ataxia, and bladder or bowel dysfunction. As a leading cause of disability among young people, MS impacts patients’ career development, partner selection, and childbearing. Patients and their families often live with the disease for decades, imposing a substantial burden on individuals, their families and caregivers, as well as on healthcare systems and society at large.

Currently, there are approximately 2.3 million MS patients worldwide。^[1]Although multiple sclerosis (MS) is classified as a rare disease in China, with an incidence rate of approximately 5 per 100,000, the current landscape of diagnosis and treatment remains far from optimal. Low disease awareness and prolonged diagnostic delays have resulted in a severe situation where patients’ treatment needs are largely unmet. According to the “Report on the Survival of Patients with Multiple Sclerosis in China,” released in 2018 by the Chinese Society of Neurology of the Chinese Medical Association, there are approximately 30,000 patients with MS in China. About two-thirds of these patients take 1–5 years to receive a confirmed diagnosis, while 12% endure diagnostic delays exceeding 6 years. Furthermore, the majority of patients do not receive standard treatment. Although disease-modifying therapies (DMTs) are recommended by both domestic and international guidelines and consensus statements as the standard of care for the relapsing-remitting phase, the utilization rate of DMTs in China is only 10%.

Meanwhile, patients face substantial psychological and financial burdens: 84% experience negative emotions, 15–18% report deteriorated relationships with family and friends after disease onset, and 13% have suicidal ideation; among patients with multiple sclerosis, 61% incur medical expenses exceeding RMB 10,000 per hospitalization due to relapses, and approximately 25% lose their work capacity after diagnosis.。^[2]

Innovative Immunomodulatory Mechanism of Action, Jielingya^®Significantly Improves Long-Term Patient Outcomes

The etiology of MS is unknown. Currently, MSConsideredIt may be a disease that disrupts the normal functions of the brain, optic nerve, and spinal cord through inflammation and tissue damage caused by multiple factors. As an S1P receptor modulator, Mayzent^®After being phosphorylated by sphingosine kinase 2 in vivo, it binds to S1P receptors on the surface of lymphocytes, altering their migration. This promotes lymphocyte entry into lymphoid tissues and prevents their egress, thereby reducing the probability of autoreactive lymphocytes re-entering circulation, preventing these cells from infiltrating the central nervous system, and achieving immunomodulatory effects.

Multiple key studies and real-world studies support Jie Lingya^®Provided robust data support for approval in China. Jie Ling Ya, involving 1,292 patients^®The TRANSFORMS study, which conducted a head-to-head comparison with interferon, demonstrated that Gilenya^®Treatment can significantly prolong the time to first recurrence, with 82.6% of patients remaining recurrence-free at Month 12. Results from the PARADIGMS study, which included 214 subjects aged 10–17 years, demonstrated that those treated with Kesimpta^®In the treated patient group, 85.7% of subjects remained free of disease recurrence after 24 months of treatment, compared to those receiving interferonBeta- In the patient group treated with 1a, only 38.8% of subjects remained free of disease recurrence.

Based on outstanding clinical study data and efficacy performance, Jie Lingya^®Approval in China is expected to enhance our capacity to manage multiple sclerosis (MS) and achieve the primary treatment goal of “no evidence of disease activity” (NEDA), encompassing “no relapses, no magnetic resonance imaging (MRI) lesions, no brain atrophy, and no disability progression.” Furthermore, it holds promise for reshaping the overall therapeutic strategy for MS, becoming the preferred treatment regimen for patients with relapsing multiple sclerosis (RMS) and enabling more patients to regain new hope through the application of innovative medications.

In addition to this Jie Lingya^®In addition to its approval in China, Novartis has been deeply engaged in neurological diseases for many years and boasts a rich product portfolio in the field of multiple sclerosis (MS). On March 26 this year, Mayzent (siponimod), Novartis’ second product for MS, received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis (SPMS), marking the first such approval in 15 years.The FirstDrugs that can be used to treat SPMS. Its application for market approval in China was accepted on February 18, 2019, and it was included in the priority review channel by the National Medical Products Administration (NMPA) on May 7. In addition, Novartis’s investigational drug ofatumumab, targeting B cells in the field of MS, is currently undergoing clinical trials. The successive emergence of these innovative drugs will further consolidate Novartis’s advantage in the MS market.

About Jie Lingya^®(Fingolimod) in China

July 12, 2019, Jielingya^®(Fingolimod) has been officially approved in China for the treatment of relapsing forms of multiple sclerosis (RMS) in patients aged 10 years and older. To date, Gilenya^®(Fingolimod) has been approved in more than 80 countries, with over 283,000 patients treated to date, and was included in the first batch of the “List of Overseas New Drugs Urgently Needed for Clinical Use” in 2018.

^[1].MS in Focus January 2014 (http://www.msif.org/wp-content/uploads/2014/09/MS-in-focus-23-Information-and-communication-English.pdf) Accessed Nov 2014.
^[2].Chinese Society of Neurology, Chinese Medical Association: 2018 “Survival Report for Patients with Multiple Sclerosis in China”