Two Drugs Filed for Market Approval in China, One Granted Clinical Trial Clearance: Novartis, Shionogi Among Filers

According to the CDE official website, two drugs have been submitted for marketing authorization in China, and one has been approved for clinical trials! These are Novartis' Erenumab Injection, a new drug for Parkinson's disease treatment Safinamide, and Shionogi's novel antibiotic.

Two Products Submitted for Marketing Authorization in China

Novartis: Erenumab Injection Submitted for Marketing Approval in China

CDE official website shows that Novartis' Erenumab Injection marketing application has been accepted for the prevention of migraine in adults.

Erenumab is a fully human monoclonal antibody jointly developed by Amgen and Novartis to prevent migraines by blocking the activity of calcitonin gene-related peptide (CGRP). In May 2018, Erenumab was approved by the FDA for marketing, becoming the world's first approved antibody drug targeting the CGRP receptor; it was launched in the EU in July 2018.

Migraine is a common chronic neurovascular disease, characterized by recurrent, unilateral or bilateral pulsating severe headaches that often occur on one side of the head. It is accompanied by nausea, vomiting, and sensitivity to light, sound, and odors. Approximately one-third of patients may experience neurological aura symptoms before an attack. It has been defined by the World Health Organization as one of the most disabling chronic diseases. The prevalence of migraine in China is 9.3%, with over 130 million patients, making it the country with the largest number of migraine sufferers globally. Standardized preventive treatment can effectively enhance the treatment outcomes during the acute phase, reduce the frequency and severity of attacks, and minimize the impact on work and daily life.

Safinamide Submitted for Marketing Approval in China

The CDE official website announced that a new drug of Class 5.1 named Safinamide Tablets has submitted a marketing application in China and been accepted. According to public data, Safinamide was developed by Newron Pharmaceuticals and is commercialized by Zambon Company S.P.A., Meiji Seika Pharma Co., Ltd., Eisai Co., Ltd., and Supernus Pharmaceuticals, Inc. In March 2017, the FDA approved Safinamide Tablets (brand name: Xadago) as an adjunctive treatment for Parkinson's disease patients who are currently taking Levodopa/Carbidopa and experiencing "off" episodes.

Public data shows that safinamide is a new chemical entity with a unique mechanism of action, including selective and reversible monoamine oxidase B (MAO-B) inhibition and blockade of voltage-dependent sodium channels, thereby modulating abnormal glutamate release. In addition, MAO-B degrades dopamine, which is crucial for signal transmission in brain regions and important for smooth voluntary movement. Therefore, safinamide is expected to prevent dopamine from being degraded by MAO-B, alleviating motor function decline during the "off" periods in Parkinson's disease patients. Clinical trials have demonstrated that safinamide can control motor symptoms and motor complications in Parkinson’s disease patients in the short term and maintain its efficacy for two years.

1 drug approved for clinical trials in China

Shionogi: New Antibiotic Approved for Clinical Trials in China

CDE Official Website Announcement: Shionogi's Class 5.1 New Drug, Cefiderocol for Injection, Receives Clinical Trial Implied Permission for Use in Adult Patients with Limited Treatment Options and Infections Caused by Aerobic Gram-Negative Pathogens. Public data indicates that this is a novel cephalosporin antibiotic with a siderophore component, which has already been approved overseas for multiple indications, including the treatment of various infections caused by Gram-negative bacteria.

Public information shows that cefiderocol has a unique mechanism that enables the drug to penetrate the cell membranes of Gram-negative bacterial pathogens, including various multidrug-resistant (MDR) strains. The recent approval of cefiderocol for clinical trials in China indicates that this product is also about to enter clinical development in the country. According to public data, cefiderocol is currently undergoing Phase 3 clinical trials in the United States and Europe for infections caused by multidrug-resistant Gram-negative bacteria in pediatric patients.

Editor: Qijin

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