In the field of medicine, the treatment of central nervous system (CNS) diseases has always been a major challenge for scientists and clinicians. According to the prediction of the World Health Organization (WHO), CNS diseases are predicted to become the second leading cause of mortality on a global scale in the next 20 years, subsequent to cardiovascular disease. This has not only revealed the increasingly severe situation of CNS diseases, but also underscored the pressing need for the R&D of novel and effective therapeutic drugs. Globally, despite the deep involvement of major transnational pharmaceutical companies such as Eli Lilly and Johnson & Johnson in this field for many years, the success rate of R&D of CNS drugs is significantly lower than those in other therapeutic areas, only around 6%. Behind this figure are multiple challenges such as complex pathogenesis, difficult breakthrough of blood-brain barrier, and dual consideration of therapeutic effect and safety.

However, it is against this background that China's R&D of new drugs for CNSquietly shows strong competitiveness and a broad development prospects. In recent years, bolstered by advancements in domestic research capabilities, optimized policy environments, and enhanced corporate innovation, China has gradually shifted from a follower to a competitor in CNS new drug development, even taking the lead in certain areas. This article aims to explore the current state, challenges, and opportunities in the development of CNS new drugs in China while analyzing future growth trends.

From "Old Drugs Dominating" to "New Drug Emergence"

For a long time, the CNS treatment market in China has been dominated by original drugs of foreign companies and their generics, especially in the field of anti-depression and anti-psychotics, where classic old drugs such as fluoxetine and venlafaxine have long been dominated the top. Although old drugs have to some extent relieved patients' symptoms, their limitations such as singular mechanism of action and obvious side effects make it difficult to meet the diverse needs in clinical practice. Therefore, it has become a consensus in the pharmaceutical industry to develop novel, efficient, and safe new drugs for CNS.

In recent years, China's pharmaceutical companies have made significant breakthroughs in this field. Taking Luye Pharma as an example, the company's self-developed anti-depression class 1 innovative drug Ruoxinlin (Toludesvenlafaxine Hydrochloride Extended-Release Tablets) was successfully launched in early 2023, marking the emergence of the first original drug for the anti-depression that is self-developed and possesses independent intellectual property right. Ruoxinlin, as an innovative triple reuptake inhibitor, has shown comprehensive and stable therapeutic effect for depression. It can not only significantly relieve the anxiety of patients, but also effectively improve symptoms such as emotional blocking, fatigue, and anhedonia, as well as enhance cognitive abilities of patients. Of particular significance is that Ruoxinlin has shown good safety and tolerability in clinical practice, providing patients with a more comfortable treatment experience. The marketing of this innovative drug not only broke the monopoly of original drugs of foreign companies in the field of CNS, but also set a new benchmark for China's R&D of new drugs for CNS.

In addition to Ruoxinlin, Luye Pharma has also strategically developed a variety of new drugs such as RYKINDO (risperidone microspheres injection) for schizophrenia and ERZOFRI (paliperidone palmitate sustained release suspension injection) in the field of CNS, which have been approved for marketing at home and abroad, and shown good clinical efficacy and market prospects. Furthermore, Luye Pharma has also developed a series of product portfolio including Jinyouping (rotigotine microspheres for injection), etc., targeting diseases with large number of unmet needs such as Parkinson's disease and Alzheimer's disease. The R&D and marketing of these new drugs has enriched CNS treatment market in China, and provided more therapeutic options for global patients as well.

From the "Comfort Zone of Generics" to the "Blue Ocean of Innovative Drugs"

Despite the significant improvement China have made in the R&D of new drugs for CNS, numerous challenges still remain. First of all, pathogenesis of the CNS diseases is complex and hard to clarify, which brings great difficulty to the R&D of new drugs. Secondly, the existence of blood-brain barrier makes it difficult for drugs to enter the CNS and exert their effects, which is also one of the important reasons for the low success rate of the R&D of CNS drugs. Furthermore, the efficacy and safety of CNS drugs are difficult to balance, and finding a way to ensure efficacy while reducing side effects is a critical issue that needs to be addressed in the R&D of new drugs.

However, challenges coexists with opportunities. With the growing emphasis on CNS diseases globally and the increasing demand from patients, the market of CNS new drugs shows tremendous potential for development. A market research institute predicts that the global market for CNS drugs will maintain a rapid growth trend in the coming years. This provides a broad space for development and market opportunities for China's R&D of new drugs for CNS.

To seize this opportunity, Chinese pharmaceutical companies should continuously enhance their scientific research and innovative abilities and deepen the cooperation and communication with domestic and international scientific research institutions so that the R&D level of new drugs will be improved. Government should, at the same time, increase support for the R&D of CNS new drugs and optimize the policy environment, providing more policy dividends and market space for pharmaceutical companies. In addition, it is also an important way for China to improve its R&D level of new drugs by strengthening international cooperation. Through the cooperation and communication with worldwide leading pharmaceutical companies, Chinese pharmaceutical companies will have the opportunity to draw on their advanced R&D experience and technological methods to enhance their own competitiveness.

From A "Follower" to A "Leader"

Looking ahead, there is potential for China to transition from being a "follower" to a "leader" in CNS new drug development. With continuous advancements in research capabilities and ongoing optimization of the policy environment, Chinese pharmaceutical companies will be capable of developing more innovative drugs with independent intellectual property rights in the CNS domain. These new drugs will not only meet the therapeutic needs of domestic patients but also have the potential to compete on the international stage alongside global pharmaceutical giants. To achieve this goal, Chinese pharmaceutical companies need to increase their investment in research, focusing on innovation and foresight in new drug development. Emphasis should be placed on multidisciplinary and cross-disciplinary collaboration to address the challenges in CNS drug R&D. Additionally, enhancing talent cultivation and team building to form high-quality, specialized R&D teams is essential.

On the policy front, the government should continue to bolster support for the R&D of CNS new drugs by implementing more favorable policies to encourage pharmaceutical companies to increase their R&D investments. Furthermore, strengthening cooperation and communication with international organizations, and actively participating in the formulation and revision of international standards, are crucial for enhancing China's international influence and voice in CNS drug development.

In sum, China's CNS drug R&D is experiencing rapid growth and holds significant potential. With the continued enhancement of research capabilities and improvement of the policy environment, Chinese pharmaceutical companies are poised to achieve more breakthroughs in the CNS field, offering high-quality treatment options to patients worldwide.

References:

1.  National Medical Products Administration. Blue Book on China's Drug Administration (2022). Beijing: China Medical Science Press, 2023.

2.  Luye Pharma. Introduction To Central Nervous System Product Pipeline of Luye Pharma. Internal Files, 2023.

About the Author

Prof. Zhang

A cultivator in the medical field, dedicated to health research, illuminating the path to health with professional knowledge, writing each medical article with care and love.