On December 14, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Hengrui Pharmaceutical's Class 1 new drug SHR0302 sustained-release tablets were approved for clinical use, and it is planned to develop ** systemic lupus erythematosus. According to Frost & Sullivan, the market size of China's systemic lupus erythematosus drug market has increased to US$400 million in 2021 and is expected to exceed US$3 billion in 2030. What are the listed companies in China? What is the current situation and prospect of the best drugs for this disease in China?
According to public information, nearly ten listed companies such as Kangnuoya, CSPC Pharmaceutical Group, Zhixiang Jintai, Ascentage Pharmaceutical, InnoCare, and Zelgen Pharmaceutical have layouts in systemic lupus erythematosus, and JW Therapeutics and other companies are also promoting the research of CAR-T*** systemic lupus erythematosus.
Zhang Xiao, chief physician of the Department of Rheumatology of Guangdong Provincial People's Hospital and vice president of the Rheumatology Professional Committee of the Chinese Medical Doctor Association, pointed out in an interview with the People's Health Client that there have been three changes in the current domestic treatment of systemic lupus erythematosus: "First of all, although hormones are basic drugs, they are now conceptually advocated to reduce hormones to the minimum dose after the condition is stabilized, or even hormone-free state; secondly, in terms of immunosuppressants, the long-term maintenance of immunosuppressants has been reduced as much as possible; The third and biggest change is that we now have targeted drugs. ”
Yu Qinghong, vice chairman of the Rheumatology and Immunology Branch of the Chinese Medical Biological Immunology Society and chief physician of the Department of Rheumatology and Immunology of Zhujiang Hospital of Southern Medical University, also pointed out to the people's health client that the best methods for lupus erythematosus in China have been greatly improved in the past ten years. He introduced that the current ** drugs for lupus erythematosus are mainly divided into the following categories:
First of all, hormonal drugs with strong anti-inflammatory and immunosuppressive effects, while exerting their strong immunosuppressive effects, if used in large quantities for a long time, they will affect organs, and the new guidelines recommend that the use of such drugs should be reduced as much as possible after exerting anti-inflammatory effects to avoid their continuous damage;
The second category is immunological drugs, which are mainly used to solve the problem of excessive immune function in patients with lupus erythematosus;
The third category is antimalarial drugs, which are immunomodulators, which are mainly characterized by a soft anti-inflammatory effect and a reduction of photoallergies;
The last category is the emerging biologics (targeted agents) in recent years, which have opened the era of targeted lupus, and the more classic drugs have been successfully used for refractory lupus erythematosus.
Although the application of these drugs has greatly improved the effect of the disease, they are all drugs that play an effective role in the middle of the disease, and cannot solve all the problems of the disease, such as drug dependence and even organ damage.
Referring to the future development focus of lupus erythematosus drugs, Yu Qinghong said: "In the future, biologics will be the focus of lupus erythematosus drug research and development, on the one hand, it is a small molecule drug, its target is very clear, and it is an oral drug, which has the advantages of convenient to take, portability, accurate efficacy and avoiding adverse reactions of other similar drugs, and at the same time, such drugs are chemical molecular drugs with low cost. As a disease that requires long-term or even lifelong management, convenient, effective, safe and cost-effective drugs are worth looking forward to. ”
At the same time, he also emphasized that there is a significant difference between the clinical and thorough treatment of systemic lupus erythematosus disease, and the drug is expected to solve the problem of the disease in the future, but its root causes, such as pathogenesis and blocking methods, still need to be further explored.