Progress and development of major national science and technology projects in the field of medicine and health

Medical Network July 4th The National Health and Health Committee released the progress and development of major national science and technology projects in the field of medicine and health, including new drug creation special and infectious disease special items, as follows:

New drug creation special project

Under the support of major new drug creation technology special project (hereinafter referred to as “new drug special project”), PD-1 monoclonal antibody (Karelizumab, trade name: Ai Litu) independently developed by Chinese pharmaceutical company Hengrui Medicine was published in 2019. On May 28, the company was approved by the State Drug Administration (NMPA) for listing. The indication for carelibizumab is recurrent/refractory classic Hodgkin's lymphoma (CHL).

CHL is a B-cell malignant lymphoma. Although first-line treatments such as combination chemotherapy and radiotherapy have a good clinical benefit for the treatment of CHL, 15%-20% of patients still relapse after first-line treatment. New therapeutic drugs are needed. The results of clinical trials show that carelizumab has obvious clinical effect on patients with relapsed/refractory CHL. Its listing has brought more treatment options to patients with CHL. It is a major breakthrough in the research and development of innovative drugs in the field of immunotherapy in China. It has effectively accelerated the process of transforming China's pharmaceutical R&D from imitation to creation and the pharmaceutical industry from a big country to a strong country.

With the support of the new drug specialization, on May 31, 2019, the world-first (First-in-class), a class 1 new drug with complete independent intellectual property rights developed by Tianji Medicine - Benweimod Cream (trade name) : Xinbike) approved by the NMPA for approval through the priority review process for topical treatment of mild to moderately stable psoriasis vulgaris in adults. Benwmod is a non-hormone small molecule chemical that works by inhibiting T cell tyrosine protein kinases, interfering with/blocking the release of cytokines and inflammatory mediators.

The results of Phase III large-scale clinical studies conducted in China show that Benvenode's cream is safe and effective in the treatment of psoriasis, and can be applied to the skin. Therefore, there is no systemic adverse reaction related to treatment, and it has an effect. Significant advantages such as fast, long-lasting effect, low recurrence rate after drug withdrawal, and long remission period. The launch of Benemomod Cream will provide a new medical treatment for adults with mild to moderately stable psoriasis vulgaris.

Infectious disease special

A team of researchers from the China Center for Disease Control and Prevention, Peking University and international scholars, recently published in Nature Communications, showed that CD8+ T cells extracted and amplified when HIV vaccines are used to induce peak cellular immune responses are available. Reduce or completely inhibit the virus rebound after stopping the drug, and the animal with significant immune effect can inhibit the viral load below the detection level for more than 2 months. Further studies found that the effect of immunosuppression was dose-dependent with the CTL response to the HIV-1 Env gene epitope in the transfused cells.

The multi-function response, killing ability, activation level and Tcm differentiation of Env-specific CD8+ T cells in animals with fully controlled virus rebound were significantly stronger than those in which the virus rebounded partially. Knocking out the above-mentioned CD8+ T cells with good immunosuppressive effects, the viral load can be quickly rebounded to the pre-immunotherapy level, thereby confirming that CD8+ T cells mediate viral control. This study demonstrates for the first time in a rhesus monkey model of antiviral and immunological combination therapy that vaccine-induced CTL adoptive immunotherapy can control viral rebound after antiviral therapy withdrawal, providing a new strategy for AIDS functional cure research. .

Zhu Shishu, the Fifth Medical Center of the People's Liberation Army General Hospital (formerly the Third Hospital of the People's Liberation Army), conducted a real-world cohort study, which confirmed that infants under 1 year of age, persistent ALT elevation, and high HBV viral load were confirmed. The effectiveness and safety of antiviral therapy for infant hepatitis B. The findings were recently published online in the Journal of Hepatology. Most children with HBV infection in infants and young children are asymptomatic and ALT normal, but there are very few children in the clinic who will have hepatitis attack and elevated transaminase. On the other hand, the most serious problem for HBV infection in infants and young children is that they Most will turn chronic.

However, for the clinical problem of hepatitis B (higher ALT) in infancy, whether the antiviral treatment should be solved, the current research data is still very scarce, and correspondingly, there is no expert consensus or guidance. The results of this study initially answered this question, and the results showed that early antiviral therapy in infants with hepatitis B can achieve rapid decline and significant clearance of HBsAg. Further trials of a larger cohort will follow to validate the results of this study.