Neuroprotective drugs play a pivotal role in clinical treatment. Their primary function is to block the pathways of nerve cell death, thereby significantly improving the neurological deficits in patients. In China, there are various types of neuroprotective drugs for ischemic stroke, mainly including neurotrophic agents and free radical scavengers, such as butylphthalide, edaravone dexborneol, and edaravone. Notably, these three drugs have been included in the National Medical Insurance Catalog, but the use of edaravone is restricted to patients with amyotrophic lateral sclerosis.

In recent years, the Chinese government has continuously strengthened supervision over drug use. On January 13, 2023, the National Health Commission officially released the Second Batch of National Key Monitoring Catalog for Rational Drug Use. This catalog aims to impose stricter management on drugs that have irrational use issues in clinical practice and abnormally high usage costs. In this catalog, except for cerebroprotein hydrolysate and cytidine disodium triphosphate for injection (Naoshen Jitai), butylphthalide, and edaravone dexborneol, all other neuroprotective drugs for ischemic stroke are included in the management scope.

Data shows that before 2019, the market size of neuroprotective drugs for treating ischemic stroke in China once exceeded 20 billion yuan. However, after entering 2020, affected by the dual impact of key policy monitoring and the COVID-19 pandemic, the market size shrank sharply to 12.737 billion yuan, a year-on-year decrease of 41.69%. Nevertheless, butylphthalide achieved steady sales growth amid this market adversity, with a compound annual growth rate (CAGR) as high as 14.75%. The dual effects of butylphthalide in treating ischemic stroke—reconstructing microcirculation and protecting mitochondria—have significantly increased its market share.

At the same time, since its launch in 2020, edaravone dexborneol has quickly become an innovative drug in the global stroke treatment field, relying on its strong market growth momentum and positive impact on more than 3 million patients. Especially in public hospitals, its sales volume has shown a steady growth trend, reaching a high of 2.19 billion yuan in 2023. In contrast, as edaravone was included in the key monitoring drug catalog, its medical insurance reimbursement scope was restricted, leading to a sharp decline in sales. Edaravone dexborneol, however, successfully entered the Category B of the National Medical Insurance Catalog through medical insurance negotiations for the treatment of patients with acute ischemic stroke. After its launch, its sales volume climbed rapidly and its market share continued to expand.

It is worth mentioning that the edaravone dexborneol sublingual tablets, jointly developed by Simcere Pharmaceutical and Ningdan New Drug (a direct-investment enterprise of our venture capital group), achieved a major breakthrough in 2024. This sublingual tablet dosage form can disintegrate quickly and be absorbed through the sublingual venous plexus, thereby improving the bioavailability of the drug. In August 2024, the drug obtained the "Breakthrough Therapy" designation from the U.S. FDA, becoming the first innovative drug in the global stroke treatment field. On December 1 of the same year, the drug was officially approved for marketing by the National Medical Products Administration, providing a broader treatment option for cerebral protection in patients with acute ischemic stroke. Particularly in the early stage of patients and cerebral protection after discharge, the drug has shown promising market prospects.

At present, the competitive pattern of neuroprotective drugs for ischemic stroke is becoming increasingly fierce. A number of enterprises are committed to the clinical development of new neuroprotective drugs. In addition to traditional antioxidant free radical scavengers, these also include new mechanism drugs such as NMDA receptor antagonists, ApoE mimics, and Nrf2 activators. For example, safinamide developed by Purolite Pharmaceuticals has entered the Phase III clinical trial stage. As a moderate-intensity NMDA receptor antagonist and a potent antioxidant, safinamide has dual neuroprotective effects, which can block both NMDA receptor-mediated excitotoxicity and the body's oxidative stress response. According to the patent data of Purolite Pharmaceuticals, the neuroprotective effect of safinamide can last for more than 28 days, providing patients with extensive neuroprotective effects.

In addition, CN-105, jointly developed by Kunpeng Peptide and Duke University, has also attracted much attention. CN-105 is an apolipoprotein E (ApoE) mimic and has currently entered the Phase II clinical trial stage. It can improve the prognosis of cerebral hemorrhage, bringing new treatment hope to patients with cerebral hemorrhage.

The situation of prevention and treatment of ischemic stroke in China remains severe. Its high incidence, high recurrence rate, high disability rate, and high mortality rate have brought a heavy burden to patients, families, and society. As an important part of the treatment of ischemic stroke, neuroprotective drugs bring new treatment hope to patients by blocking nerve cell death and improving neurological deficits.

In recent years, progress has been made in the research and development as well as application of neuroprotective drugs. Drugs such as butylphthalide and edaravone dexborneol have shown good clinical efficacy. Especially edaravone dexborneol, its unique sublingual tablet dosage form can quickly improve drug bioavailability, providing patients with a more convenient and effective treatment option. At the same time, the successful launch and application of these drugs have also promoted the continuous development of the neuroprotective drug market. However, existing neuroprotective drugs still cannot fully meet clinical needs. With the increasingly strict supervision of drug use by the state, the rational use of neuroprotective drugs and compliance with regulatory policies are also particularly important. Rational drug use can maximize the efficacy of drugs while reducing unnecessary medical expenses and potential side effects.

It is worth noting that the research field of neuroprotective drugs is constantly expanding. A variety of new mechanism drugs, such as NMDA receptor antagonists, ApoE mimics, and Nrf2 activators, have entered the clinical development stage, providing new possibilities for the treatment of ischemic stroke. Through different mechanisms of action, these drugs provide more diversified options for treatment and are expected to bring more comprehensive therapeutic effects to patients.

Looking forward to the future, China still faces many challenges in the field of neuroprotective drugs for ischemic stroke, but at the same time, it also has huge development opportunities. With the continuous deepening of new drug research and development and the gradual advancement of clinical trials, we have reason to believe that more innovative drugs will be launched in the future, providing patients with more effective and safer treatment plans.