Current situation of global and Chinese cancer: the number of new cancer patients in the world continues to grow. In 2030, the number of new cancer patients in the world will reach 24 million, while that in China will exceed 5.8 million, accounting for nearly 1 / 4. As an efficient broad-spectrum antitumor drug, PD-1 / PD-L1 inhibitor has epoch-making significance in the history of antitumor. Since its listing, it has rapidly penetrated into the global tumor drug market, and its sales will continue to grow.
PD-1 / PD-L1 action mechanism: anti-PD-1 antibody binds to PD-1 on the surface of T cells, and anti-PD-L1 antibody binds to PD-L1 produced by tumor cells, so as to prevent the recognition and binding of PD-1 and PD-L1, block the "muddle through" of tumor cells at T cells, and make T cells kill tumor cells.
Overseas approved sales of PD-1 / PD-L1: at present, 6 PD-1 / PD-L1 products and more than 80 tumor indications have been approved in the overseas market. Four PD-1 models are MSD (drug K), Squibb (drug o), Pfizer / Merck (drug B), Sanofi / regenerant (drug L) and two PD-L1 models are Roche (drug t) and AstraZeneca respectively (drug I). The annual cost in the United States is twice that in Europe. Drug K leads PD-1 / PD-L1 products and has accumulated sales of US $50 billion since its listing. With the expiration of the patent of drug king xiumeile in the United States in 2022, drug K is expected to win the new drug king in 2022. The global sales of drug o have accumulated US $40.1 billion.
PD-1 / PD-L1 patents: BMS and MSD reached a settlement on the global patent war of PD-1 antibody. MSD will pay BMS US $625 million in the first phase, and will continue to pay 6.5% (2017-2023) and 2.5% (2024-2026) license fees based on the global sales of K drug from 2017 to 2026.
Approval of PD-1 / PD-L1 products in China: nmpa has approved a total of 12 PD-1 / PD-L1 products, involving 11 cancer species and 44 indications, including 8 domestic and 4 imported.
Medical insurance of PD-1 / PD-L1 products: in 2022, all PD-1 / PD-L1 products participating in medical insurance were domestic products, including PD-1 products of Xinda, Junshi, Baiji Shenzhou and Hengrui, and the prices of the four companies increased in turn.
Domestic PD-1 / PD-L1 products going to sea: six domestic PD-1 products have been listed, and three have cooperated with large multinational pharmaceutical enterprises to jointly promote the development, production and commercialization of PD-1 monoclonal antibody in many countries. PD-1 / PD-L1 products that are about to be approved for listing have long been distributed in overseas markets.
Research status of PD-1 / PD-L1: according to ficintelligence data, in recent 5 years, the technical types of PD-1 targets around the world focus on monoclonal antibodies and double antibodies. In addition, there are also layouts in cells, gene therapy, peptides and proteins. According to insight data, there are nearly 70 PD-1 / PD-L1 products in clinical stage in China.
