just! The State Food and Drug Administration announced that the first domestic PD-1 was listed.

Medical Network on December 18th, Xi Dapu Ben! The first domestic PD-1 antibody drug was launched.

On December 17, the State Food and Drug Administration issued an announcement to approve the first domestic PD-1 monoclonal antibody, Treipril monoclonal antibody injection (trade name: Tuoyi).

According to the State Food and Drug Administration announcement, which is China's independent research and development company, with innovative medicines biological products completely independent intellectual property rights, for the treatment of locally advanced after the previous standard treatment failure or metastatic melanoma.

The approved Treipril monoclonal antibody is a fully humanized monoclonal antibody against PD-1 receptor developed by Suzhou Zhonghe Biomedical Co., Ltd., which can block PD-1 of T lymphocytes. It is combined with PD-L1 on the surface of tumor cells to relieve the immune suppression of immune cells by tumor cells, so that the immune cells can re-exist anti-tumor cell immunity and kill tumor cells.

▍ Reported to be approved, less than 10 months

Triripril monoclonal antibody, as the first domestically produced monoclonal antibody against PD-1 approved by China, was supported by major national science and technology projects.

This product has been in clinical research since the beginning of 2016. More than 20 clinical trials have been underway, including clinical trials conducted simultaneously in the United States. In March 2018, the State Drug Administration officially accepted the application for listing and listing of this product, and included it in the priority review and approval category for accelerated review and approval.

The National Drug Evaluation Center, the Drug Evaluation and Inspection Center, and the China Food and Drug Control Research Institute and other relevant units work together to actively communicate with the reporting unit, timely resolve technical problems encountered in the review, and prioritize technical review, on-site inspection, and Laboratory tests, based on the applicant's completed phase II study of Chinese advanced melanoma and the safety data of 7 clinical studies, on conditional approval of the listing of this product on December 17. It took less than 10 months from the filing to the approval of the listing.

What is PD-1 antibody?

It is understood that at present, research hotspots in the field of tumor immunotherapy mainly focus on inhibitors such as anti-programmed death-1 (PD-1) receptors, which are different from traditional chemotherapy and targeted therapy, mainly by overcoming Immunosuppression in the patient's body, reactivation of the patient's own immune cells to kill the tumor, is a new anti-tumor treatment concept.

The main "anti-cancer warrior" in the human immune system is called "T-cell", and its surface has different functional receptors, similar to "throttle" and "brake". The drug called "checkpoint blocker" can be loosened. Open the brakes and step on the gas pedal to fight the tumor. PD-1 is the key, as a cell membrane protein receptor, its function is to inhibit the activation of T cells under normal conditions, which is a normal auto-stable mechanism of the immune system.

But many tumor cells use this to keep the "brakes" working, so that T cell function is inhibited, and PD-1 antibodies can block this pathway, allowing these cells to continue to kill tumor cells.

What is the role of ▍PD-1 antibody?

The clinical anticancer effect brought by PD-1 antibody is unprecedented.

It is understood that it can control the cancer progression of 50% of patients with skin cancer and cure about 10% of patients with skin cancer.

On August 20, 2015, nearly 91-year-old former US President Jimmy Carter announced that he had diagnosed advanced melanoma, and the four tumors that were transferred to the brain were about 2 mm in size, ready to bid farewell to the world. Fortunately, at this time, the drug was born. Under the treatment of PD-1 drug, the tumor miraculously disappeared after 3 months. Until today, there are no signs of recurrence.

Related data show that melanoma has shown a rapid growth trend in recent years in China, and it is one of the most malignant tumors with the fastest growth rate. The annual incidence of new cases is about 20,000, and the mortality rate is also increasing rapidly year by year. It has become a serious threat to our people. One of the health diseases.

In terms of treatment, melanoma patients with first-line treatment failure currently lack an effective standard treatment regimen. Clinical trials of Treiprilumab showed an objective response rate of 17.3% for patients with unresectable or metastatic melanoma who had previously failed systemic therapy, a disease control rate of 57.5%, and a 1-year survival rate of 69.3%. .

The approval of the listing of Treipril monoclonal antibody has positive significance for solving the clinical drug selection of cancer patients in China.