Anti-covid-19 drugs, anti-cancer drugs, rare disease drugs... 83 new drugs were approved in 2021

(Health Times reporter Wang Zhenya)

From January 1, 2021 to December 31, 2021, the Health Times reporter counted that last year, the State Food and Drug Administration approved a total of 83 new drugs for listing, and the number of new drugs hit a new high since the 2016 drug review and approval reform. It has 51 new drugs in China and 32 new drugs in imports.

Under the epidemic prevention situation, new coronavirus drugs and vaccines are also given priority to listing, and last year, the new crown vaccine was approved 3 times, and the new crown drug was approved one.

There are vaccines and medicines for epidemic prevention

In 2021, China conditionally approved 3 new crown vaccines and 1 new crown neutralizing antibody, and 3 vaccines were from Beijing Kexing Zhongwei, Sinopharm Zhongsheng Wuhan Company, and the Military Medical Institute of the Academy of Military Sciences/CanSino. As of January 6, 2022, China has reported a cumulative total of 2.88 billion doses of COVID-19 vaccine.

China's new crown drugs are developed by Tengsheng Bo Pharmaceutical. The combination therapy of the new crown neutralizing antibody amphavir monoclonal antibody / romizumab was approved, achieving a breakthrough of zero domestic new crown drugs in China. Clinical trial results showed significant reductions in hospitalization and mortality, both early and late in the treatment.

Two new CAR-T therapy drugs were approved

2021 can be described as the first year of Car-T therapy in China. Not only because the expensive price of "1.2 million a needle" has aroused social concern, but more importantly, China has been approved 2 CAR-T drugs, breaking the zero breakthrough of CAR-T drugs.

Fosun Kate's Agilense Injection is the first CAR-T therapy drug approved for marketing in China, priced at 1.2 million injections, which was not included in the medical insurance directory this year. Gilead/Kite Pharma develops Agironse Injection, the first CAR-T therapy for non-Hodgkin lymphoma.

"A new drug, from the market to enter the health insurance is a slow process." Huang Haiwen, chief physician of the Department of Hematology of the First Affiliated Hospital of Soochow University, believes that it is not surprising that Agironsai and Ricky Orense have not entered the medical insurance this year, but as long as the domestic CAR-T is approved for listing, the price will come down. For example, PD-1 monoclonal antibody is a good example, and many people now use PD-1 monoclonal antibody in the clinic.

Four PD-(L)1 drugs were approved

In 2018, since China's first PD-1 drug was approved for marketing, in the past 3 years, dozens of pharmaceutical companies have gathered to develop PD-1/PD-L1 drugs, resulting in serious homogenization competition, and up to now, 12 PD-1/PD-L1 drugs have been listed in China.

However, last year, there were still 4 PD-1/PD-L1 drugs approved, and the industry regarded them as "second-tier products", all of which were developed by local companies. They are from Chia Tai Tianqing/Kangfang Biologics, Yuheng Biologics, Thought Di/Corning Jereh/Simcere Pharmaceuticals, and CStone Pharmaceuticals.

At present, the first echelon of 4 domestic PD-1 drugs have entered the medical insurance, and the lowest price in the world. The result of the fierce competition in the PD-1 drug track is that domestic patients use PD-1 drugs at the lowest price in the world.

But its field is "internal volume" is serious, in order to promote itself, from the beginning of the PD-1 manufacturer's "we are the fastest", then "we have the most indications (the heaviest)", to "we have the highest price in medicare", and finally to today's "we have the lowest production cost". Industry experts believe that behind the evolution of the PD-1 drug commercialization slogan is the gradual deterioration of the market.

Nineteen new drugs were approved for medical insurance in the same year

At a press conference held by the National Medical Insurance Bureau on November 3, Liu Guoen, a professor of economics at the National Development Research Institute of Peking University, proposed that the speed of china's new drug inclusion in medical insurance is unprecedented.

Among the 83 new drugs approved last year, 19 drugs have been approved and entered the medical insurance in the same year, including 13 domestic new drugs and 6 imported new drugs. Including multiple sclerosis drugs, HIV infection drugs, liver cancer drugs, etc.

Liu Guoen introduced that the average cycle of a new drug from approval to listing to inclusion in medical insurance has been shortened to one year and two months.