Huashan Chen Tojun, Bohai: Sinimod brings the cutting-edge therapy to patients with multiple sclerosis in China, and the development of new drugs can be breakthrough in four directions.

Multiple Sclerosis, MS) is an autoimmune neuro-inflammatory disease caused by the immune system "out-of-control" immune cells to attack the central nervous system, resulting in myelin damage to the central nervous system, which in turn causes damage to the spinal cord, brain and optic nerve function, because the nervous system is also partially repaired on its own, so it shows recurrent physical weakness, sensory abnormalities, vision problems, bladder or intestinal dysfunction, language disorders or cognitive impairment and other complex clinical symptoms.
When nerve damage accumulates to a certain extent and takes an average of 10-15 years, MS enters a state of continuous progress, with the condition slowly worsening over time, which can eventually lead to severe disability, loss of self-care and other consequences.
May 7, Novartis' new generation of multiple sclerosis oral drug Sinimod (commodity name: 10,000) was approved in China, achieving a simultaneous global launch.
Compared to previously clinically used disease correction therapy (DMT), Sinimod's greatest bright spot is the oral DMT drug that helps patients with early signs of disease progression control central inflammation and promote myelin regeneration, making it the world's first and only oral DMT drug that can achieve neuroresusced, delaying progression in disability in patients with multiple recurrences of the disease.
On August 25, Novart announced that Sinimod had issued its first prescription in China, and that the first batch of drugs had been fully implemented in more than 30 hospitals in 29 cities across the country, including Beijing, Shanghai and Guangzhou, marking the official entry of the landmark drug into clinical use in China, where MS patients can use the latest treatments in sync with international patients.
more easily penetrate the blood-brain barrier, promote myelin regeneration, and achieve nerve repair MS is the most common central nervous demyelination disease.
inflammation and neurodegenerative lesions can damage myelin and axons from the start, but the compensation repair mechanism may mask the initial clinical signs of this damage, making it difficult to detect disease progression at an early stage.
with repeated MS episodes, central inflammation and neurodegenerative lesions become more prominent.
compensation repair mechanism is exhausted, irreversible gray and white damage occurs.
this process, the degree of disability gradually progresses, leading to a decline in activity and cognitive impairment, and ultimately a loss of self-care.
From a treatment strategy perspective, whether it's patients with relapsed relapsed remission (RR) MS with early progression signals or active secondary progressive (SP) MS patients, the use of drugs that control central inflammation and nerve repair is undoubtedly a more cost-effective option for patients.
is precisely the drug that meets the stage of progress, thanks in large part to Sinimod's unique molecular design and mechanism of action.
Sinimod's molecular structure, on the one hand, improves affinity: optimizes the pro-lipid group, enhances the drug's ability to pass through the cell membrane phospholipid bimolecular layer, making it easier to pass through the blood-brain barrier;
S1P1 subjects are mainly distributed in the central astrological glial cells and small glial cells, preclinical studies confirmed that Sinimod through the blood-brain barrier into the central binding with S1P1 subjects, so that S1P1 subjects down to reduce the growth of astrological glial cells and small glial cells, reduce central inflammation; S1P5 subjects are highly expressed on the centrally mature less protrusion glial cells, and the S1P5 binding of Sinimod and less dendrient glial cells produces functional agitation to promote myelin regeneration, and the above mechanism enables Sinimod to have excellent central anti-inflammatory and promote neuromal myelin repair.
EXPAND study, a randomized, double-blind, parallel group, placebo-controlled clinical study conducted in 292 clinical centers in 31 countries around the world, is the largest clinical trial to achieve positive results in patients with secondary progressive MS.
results showed that Sinimod significantly reduced the risk of confirming progression in disability by 21% over a three-month period compared to placebo, and excelped in controlling brain atrophy in patients, significantly reducing gray mass atrophy by 63% by 24 months, and the extended study further showed that Sinimod continued to delay progression in disability and cognitive impairment for at least five years, confirming Sinimod's significant and long-term benefits in delaying progression of the disease.
Professor Chen Xijun, Deputy Director of the Institute of Neurology of Fudan University, Chief Physician of Neurology at Huashan Hospital affiliated with Fudan University, and Head of Neuroimmune Sub-Professional, said, "As medical workers, we should actively try new drugs and therapies, fully grasp the mechanisms and characteristics of new drugs, Huashan Hospital participated in the global synchronization of EXPAND research, and was fortunate to cultivate and witness the validation and approval of Sinimod's efficacy in clinical trials with other MS experts in China."
patients in the RRMS progression phase need to focus on stimulating nerve repair and delaying the treatment of disability.
is the first oral DMT drug in the world to be proven to meet this treatment target in progressing RRMS patients, giving patients the options and survival hope of cutting-edge treatment options that are synchronized with the world.
" pays attention to the early progression signals of MS, active treatment delays the deterioration of disability MS patients are usually diagnosed for the first time in 20 to 40 years of age, of which about 85% are RRMS at the time of initial diagnosis.
A significant proportion of these young adults will be converted to progressive MS within 6 to 10 years, and neurofunctional disabilities will continue to deteriorate, leading to a significant increase in the rate of cognitive impairment and walking assistance, which will undoubtedly place a huge burden on families and society.
, identifying early signs of progress in patients with RRMS and taking more aggressive treatment options early can slow progress and help patients gain more independent activity and walking time.
THE EXPAND study also showed that the use of Sinimod therapy in patients with advanced RRMS significantly reduced the risk of confirming progression of disability by 26% compared to placebo.
multi-state model predicts that Sinimod can delay a patient's time in a wheelchair by 4.3 years.
above data demonstrate the role of Sinimod in delaying the worsening of disease in patients with progressing MS.
Fudan University affiliated Huashan Hospital Neurology, specializing in MS and optic neurospinal cord disease (NMOSD) and other central nervous system demyelination disease, Dr. Bohai pointed out that although the worsening of the disease in MS patients is more prominent after progress, but in fact in each of the early episodes there is also a slow deterioration of the disease, but will be covered by symptom relief.
In particular, the incidence and awareness of MS in China is low, second- and third-tier cities and primary doctors are also prevalent MS diagnosis inexperient problem, coupled with the complexity of MS symptoms, resulting in clinically easy to miss diagnosis or misdiagnosis, misdiagnosis.
the current challenges of early diagnosis of MS in China, more attention should be paid to early signs of progress and more popular science publicity and professional lectures.
, "Although MS has internationally recognized diagnostic criteria, it is necessary to exclude many other diseases and rely heavily on the experience of doctors, " Dr. Yu said.
From the clinical symptoms, the early emergence of walking dysfunction, free-kicking disorders, urinary disorders, cognitive dysfunction and other signals, suggesting that the patient may be in a state of MS progression, can be used regular EDSS score comparison or MSProDiscus tools to further evaluate and diagnose, to help doctors to determine whether to start the relevant drug treatment as early as possible.
" Dr. Bohai once had a patient more than 2 years ago diagnosed MS, symptoms after the impact of methyl strong pine dragon (hormone) significantly improved, in fact, at this time the treatment is not over, should be given DMT treatment, but the local doctors and patients did not pay attention to, until two years later walking gradually labored, and finally can only rely on their own efforts to move ten steps to our hospital outpatient consultation.
more than two years is a real waste of valuable treatment time, but also witnessed the disease from recurrence to secondary progression of the evolution.
the increasingly rich treatment methods of MS in China, the level of diagnosis and treatment still needs to be improved globally, MS clinical treatment methods continue to enrich and innovate.
From beta interferon to sinimod, the effect of the drug to reduce MS recurrence has been increased from 30% to more than 50%, and the administration method, from the next injection of beta interferon to the oral therapy represented by fingomod, to the home-based drug monoantigen, the convenience of treatment has been continuously improved, the quality of life greatly improved.
19 disease-correcting therapies for MS have been approved worldwide, and the GLOBAL drug market for MS has exceeded $22 billion in 2019.
The Chinese government has given strong policy support to MS in recent years, greatly improving the accessability of MS drugs in China, including the inclusion of MS in the list of rare diseases, the inclusion of three innovative therapies such as fingomod in the list of clinically urgently needed drugs, and the priority review channel for approval on the market.
With Sinimod's simultaneous global launch, china already has three oral DMT drugs for MS available for clinical selection, and the 2020 national health-care directory is adjusted to show that more MS drugs are expected to enter the country through negotiations.
of drug supply and treatment methods will further improve the treatment environment of MS in China, and bring about an improvement in the quality of life of patients.
However, Professor Chen Pointed out that MS as a whole is still a disease that is easily overlooked by the public in China, especially if the early symptoms are not obvious, and patients do not pay attention to some early signs of progression after the treatment is alleviated, thus misdiagnosing the timing of treatment.
same time, many of the diseases that need to be identified with MS belong to the category of difficult and rare diseases, MS identification diagnosis is more difficult, intervention and treatment have a lot of uncertainty.
Coupled with the lack of experience of Chinese primary doctors, such as it is easy to misdiagnose the acute onset of MS patients as cerebrovascular disease, there is a high rate of misdiagnosis on MS, about two-thirds of patients diagnosed time took 1-5 years, 12% of patients diagnosed time spent more than 6 years, so MS is more difficult to achieve early detection, early diagnosis and treatment.
As to how to promote the progress of MS clinical diagnosis and treatment in China, Professor Chen Zhijun believes that on the one hand, it is necessary to establish multidisciplinary joint (MDT) clinics for autoimmune systems and infectious diseases to provide strong joint, one-stop, individualized clinics.
On the other hand, strengthen the cooperation between regional neurology and radiology departments to radiate the model of MDT clinics throughout the region, so that when suspected cases are encountered in hospitals within the Federation, timely and core hospital consultations or referrals can be made to shorten the time of diagnosis of patients.
Huashan Hospital has been promoting this practice since 2016 and has provided quality medical services to nearly 500 patients and has been radiated to the Yangtze River Delta region.
new drug research and development has been a weapon to promote the progress of clinical treatment of diseases, Professor Chen Zhijun also from the perspective of meeting future clinical needs for MS new drug research and development made several recommendations.
I think: 1) All the drugs of the past are concerned with the external inflammation of MS patients and how to reduce recurrence, Sinimod is currently the only oral drug in China that can reduce recurrence and delay progression, but only one drug obviously can not meet the needs of all patients, the future needs more different treatment angles of innovative drugs.
2) Although there are many drugs to manage the recurrence of inflammation outside of MS, the effectiveness of these drugs can continue to improve, especially in China, many of the drugs to reduce recurrence are still moderate in potency, lack of some drugs that can effectively reduce recurrence, especially those targeted at T cells; 3) Need some more accurate MS treatment drugs, the target can be more specific, specifically for "out-of-control" cells, conducive to reducing the occurrence of side effects;
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