In 2020, four car-t enterprises will apply for and be approved at the same time, and six enterprises will raise more than 3.2 billion yuan in total

A few days ago, according to the official website of the State Drug Administration (nmpa), the application for the listing of Fosun Kate car-t product akilunsai injection has entered the stage of administrative approval. In terms of the current new drug review process, it can be said that this car-t cell therapy product is only one step away from being approved, and it is expected to become the first domestic and the fourth global car-t therapy product.

At present, there are three kinds of car-t immune cell therapy drugs on the market in the world, kymria of Novartis and yescarta of kite company were approved in 2017, and then tecartus (kte-x19) of kit company's cd19car-t cell therapy was approved on July 24, 2020. Since kymria and yescarta products came into the market, with the increase of market sales year after year, the layout of major enterprises in the world has also gone up, especially in China.

In 2020, the acceptance and review data will increase significantly

According to relevant reports, since 2017, CDE has accepted 81 cell therapy products, and 47 varieties have obtained clinical approval or clinical trial license, accounting for 58%. Moreover, some enterprises have not started to review and issue subsidies, and the final proportion should be improved.

According to CDE data alone, at least 27 domestic enterprises have direct distribution in car-t field, and 23 acceptance numbers have been approved (accounting for 33.33% of the total number of cell therapy products accepted). Fosun Kate and Yao Ming junuo have submitted listing applications. In addition, car-t therapy of Nanjing legend has won the first breakthrough treatment qualification in China on August 5, 2020, and has not been approved Moreover, Nanjing legend has submitted an application for listing to FDA, and it is estimated that the domestic application for listing has been on the agenda.

Among them, 11 enterprises and 14 acceptance numbers will apply for clinical treatment in 2020 alone. The six acceptance numbers of Genxi biology, borreida, precision biology and Keji pharmaceutical were approved in the same year, with a total duration of about 70-90 days. Compared with the previous three years, the approval time was significantly shortened, and the efficiency was significantly improved.

But at the same time, it is also worrying that many varieties have been accepted early but not approved yet. Only 7 enterprises and 12 varieties (acceptance number) accepted in 2018 have not been approved so far. Considering the oversaturated competition of car-t track, it is likely that many of them have been abandoned by enterprises, and the situation is not optimistic.

In general, after the craze in 2018, the cooling down in 2019 and the rational return in 2020, the products of front-end enterprises have gradually come to market. However, the overcrowded and homogenized track makes car-t similar to PD-1 in saturation state, and the R & D of back-end enterprises becomes more and more difficult. Fortunately, with many changes in the car-t field in the middle of 2020, enterprises can, according to their own advantages, promote a reasonable layout of R & D direction, reduce homogenization, and effectively improve innovation ability.

Car-t financing is powerful, and listed companies are highly sought after

Relevant data show that in 2020, there will be 51 financing events with financing amount of more than 100 million yuan in domestic biopharmaceutical field, and the total financing amount will reach 29.77629 billion yuan. Among them, the total amount of financing in the field of cell and gene therapy reached 5.889 billion yuan, accounting for 20% of the total amount. Higher than that were the more popular antibodies and vaccines, which ranked first and second in the financing share of biomedicine with 15.13 billion yuan and 6.088 billion yuan respectively. But the increasing proportion year by year also fully proves the confidence of the capital market in the field of cell and gene therapy.

As an indispensable part in the field of cell and gene, the major investment of car-t therapy in 2020 is also remarkable. Most of the financing is focused on the enterprises with the top R & D pipeline. Six enterprises, including Pharma junuo, Hengrun Dasheng, Genxi biology, technology biology, prekin and Heyuan biology, have raised a total amount of more than 3.2 billion yuan in 2020. We believe that these enterprises will continue to develop in the future With the continuous injection of capital market resources, it will undertake the important task of developing car-t global market to a great extent.

In addition, the major listed companies are also keen on the frontier layout of car-t field, and investors are chasing the major "car-t concept stocks". So far, 17 listed companies have been on the "car-t" ship. I believe that with the gradual deepening of the layout in the future, the capital market forces in the field will play a decisive role.

Although car-t is good, there are also many problems

In recent years, car-t cell immunotherapy has brought the hope of "curing cancer" to countless patients, but car-t therapy has outstanding effectiveness, at the same time, it also has many problems to be solved, high treatment costs and serious side effects are all the problems.

According to relevant data, the treatment cost of Novartis kymriah is 475000 US dollars per time, equivalent to 3.3 million RMB yuan; Kate yeskarta is 373000 US dollars per time, equivalent to 2.6 million RMB yuan. This series of figures alone is doomed that countless patients can not really enjoy the effects of similar drugs, and in addition, it can not guarantee complete effectiveness, no recurrence and no side effects?

Therefore, the R & D and listing of car-t may also be doomed to be a long way off. But in any case, car-t cell therapy is the focus in the field of immune cell therapy, which is beyond doubt, and has great hope to become the best direction in the field of tumor therapy. At present, China has become the second largest country of car-t clinical trials in the world. In the future, we hope that academia, enterprises and government can work together to solve many problems in the field of car-t, so as to benefit more cancer patients.