Car-t therapy development is in the forefront of China, which are the leading domestic enterprises?

On Wednesday local time, the FDA held a meeting of the Cancer Drug Advisory Committee (ODAC) on car-t therapy ctl019 for Novartis Finally, experts of the Advisory Committee unanimously recommended and approved the drug for the treatment of 3-25-year-old patients with relapsed or refractory acute lymphoblastic leukemia by 10:0 vote This result is exciting for the whole research field of car-t therapy Before the vote, Novartis's "rival" in the development of car-t therapy, the CEO of kit pharmaceutical, said: "today is not about business or competition, it is promoting a science and technology that is expected to bring about changes in cancer treatment." The FDA will make a final approval decision for ctl019 on October 3, while kit's car-t therapy will be reviewed by November 29 Car-t therapy is the "net red" in the field of tumor immunotherapy It is considered to be one of the most promising tumor treatment methods by using repaired immune cells to attack and destroy malignant tumors Since the end of 2013, this field has been closely watched According to the analysis of coherentmarket insights, car-t cell therapy is expected to reach US $8.5 billion in the global market in 2028, and the market space in the future is expected to be between us $35 billion and US $100 billion The United States is far ahead of China in the development of car-t therapy, the United States is far ahead of China, followed by Europe and Japan The United States is the origin of car-t technology Novartis, kit and Juno are in a leading position in the development of car-t therapy, and have taken the lead in obtaining a large number of data in a number of clinical trials, leading the trend of car-t In addition, several small biomedical companies have made some breakthroughs in their respective fields, such as cellectis (using allogeneic T cells), cbmg, etc China has also grasped the trend of the times this time According to the search results of "pediatric receptors" on the website of clinical trials.gov in the United States, at present, China has registered 109 car-t clinical research projects, which has surpassed Europe in number and is second only to the United States Among them, sibyman, bosengji, heyikang and Yuyan biology are at the forefront After 2015, Yinhe biology, Keji biology, Anke biology, Hengrui medicine, Zhongyuan Xiehe and other companies have also made great efforts to arrange car-t cell therapy Sibyman biotechnology sibyman biotechnology, a domestic enterprise in the forefront of R & D, was listed on NASDAQ in 2014, becoming the first Chinese cell biomedical technology company listed on NASDAQ in the United States Sibyman's car-t clinical research mainly cooperates with Professor Han Weidong of PLA 301 Hospital In February 2015, he purchased 4 car-t products from Professor Han Weidong of PLA General Hospital (301 Hospital) with 12 million yuan, and reserved the priority of subsequent products The clinical trials of sibyman in car-t therapy are mainly focused on clinical phase II According to the results of clinical trials published by the company at present, it is preliminarily shown that these products are relatively safe, feasible and effective It is worth mentioning that the phase I clinical data of car-t therapy "cbm-egfr 1" for EGFR target of solid tumors have achieved response on various types of solid tumors, and the R & D progress is in the international leading position As a leading domestic immunocytotherapy development company, bosengji is mainly engaged in the development of cell therapy technology (car-t, car-nk, aapcctl and aapcnk Technology) and antibody targeted drugs In June 2015, Arco biology invested 20 million yuan to establish a joint venture with Bosheng Jiqiang to specialize in car-t cell therapy technology research and industrial operation At present, there are three car-t projects in clinical phase II, including a variety of solid tumors that are difficult to cure, and the R & D progress is in a leading position in China In addition, the excellent domestic companies that develop car-t therapy are yaomingjunuo, Jikai gene, Keji biology, Fosun Kate, Hengrun Dashen, etc For Novartis, who is at the forefront of the pricing problem of car-t therapy, the pricing and accessibility problems after the approval of ctl019 cannot be ignored In response, vas Narasimhan, global head of drug development and chief medical officer of Novartis, told Bloomberg last month that the company would use stem cell transplant costs as a measure and was considering a pay as you go agreement Earlier this year, the National Institute of health and Clinical Excellence (NICE), the UK's drug cost regulator, calculated the data and found that the highest value of ctl019 in the treatment of childhood leukemia was $649000 Car-t drugs should be priced at a higher level because they are used as one-time treatment drugs and can benefit some patients who have no other treatment options If a pay as you go agreement is based on efficacy, it may attract insurers to accept higher price tags because it means that if the treatment fails, the insurer will be paid back A ranking of the world's most expensive drugs released in April showed that uniqure's gene therapy drug, glybera, topped the list with a price of $1.2 million, but weak market demand forced the company to stop selling the drug The high price drugs introduced in recent years also include spinraza, a treatment drug for spinal muscular dystrophy of Biogen (the first year's cost is $750000, and the subsequent annual average cost is half), and brineura, a drug used by biomarin company to treat extremely rare CLN2 diseases (the price is $702000).