Medical network - July 14 local time Wednesday, the FDA for Novartis (Novartis) CAR - T therapy CTL019 cancer drugs advisory committee (ODAC) meeting. Finally, the advisory committee on experts with 10:0 voted unanimously to recommend approval of the drug for the treatment of 3 ~ 25 patients with recurrent or refractory acute lymphoblastic leukemia.
The results to make the CAR - T therapy research field excited. Before the vote, novartis T therapy on the development in the CAR - "rival" Kite pharmaceutical CEO said: "today is not about business or competition, this is in a science and technology is expected to bring about change for cancer treatment."
FDA will on October 3rd to CTL019 final approval decision, the Kite pharmaceutical CAR - T therapy the review deadline for November 29.
CAR - T therapy is a "web celebrity" in the field of cancer immunotherapy, through the use of the repair of immune cells attack and destroy malignant tumor, is considered to be one of the most promising cancer treatments. At the end of 2013 to now, the field is closely watched.
According to the Coherent Market Insights analysis, CAR - T cell therapy is expected to global Market scale will reach $2028 in 8.5 billion, the future Market space is expected to between $35 billion to $100 billion.
The United States is ahead China followed by
On the development of the cure for CAR - T, far ahead in the United States, China, followed by Europe and Japan lags significantly. Is CAR - T technology originated in the United States, novartis, Kite and Juno in the development of CAR - T therapy in a leading position, and has set up a file in the number of clinical trials first received a large amount of data, leading the trend of the CAR - T. There are several small biological medicine companies also made a breakthrough in their respective areas, respectively, such as Cellectis (using allogeneic T cells), CBMG, etc.
The Chinese also grasp the trend of The Times. According to the Clinical Trials, the site of the Chimeric receptor "search results, China currently registered to carry out the CAR - 109 T Clinical research projects, has in number more than Europe, second only to America. Among them, west than man, born ji, unity, and the biological space research at the forefront, after 2015, the Milky Way's biological, economic source in biological, anke biotechnology and hengrui pharmaceutical, Concorde or CAR companies are also big layout - T cell therapy.
Walk on the research frontier of domestic enterprises
1, west biotechnology than man
West beaman biotechnology listed on nasdaq in 2014, became the first in the United States listed on nasdaq cell biological medicine science and technology company of China. West beaman CAR - T clinical research mainly for the east, with the people's liberation army 301 hospital Korea in 12 million acquired in February 2015, the people's liberation army general hospital (301) Korea east professor group four CAR - T products, and keep follow-up prior permission of the products.
West than man in the CAR - T therapy clinical trials have focused on clinical Ⅱ period, from the current company published clinical trials, preliminary showed that these products are relatively safe, feasible and effective. It is worth mentioning that the therapy for solid tumor EGFR target CAR - T "CBM - EGFR. 1" Ⅰ period clinical data, in the various types of solid tumor response, is an international leading research and development progress.
2, bo ji
Bo was born, as a leading domestic immune cell therapy development company, the main business for the development of cell therapy technology (CAR - T, CAR - NK, aAPCCTL and aAPCNK technology) and antibody targeted drugs. In June 2015, anke biotechnology invested 20 million yuan and bo win-win co-operation, joint venture, specializing in CAR - T cells treatment technology research and industrialization of operation. Bo was born, there are three CAR - T project in clinical Ⅱ period, which includes the more difficult to cure a variety of solid tumors, research progress in the domestic leading position.
In addition, the development of domestic excellent CAR - T therapy drug companies, and giant, Ming JiKaiJi because of dhi, families, fosun Kate, constant, etc.
The CAR - T therapy pricing problem
For the walk in the forefront of novartis, cannot ignore CTL019 approved after pricing and availability problems. The novartis global drug development and chief medical officer, gas, Racine, han (Vas Narasimhan) last month told bloomberg that the company would stem cell transplantation as a measure of the cost, also considering the effect of pay agreement.
Earlier this year, the British drug costs regulators national institute for health and clinical excellence (NICE) to calculate discovery of relevant data, in the treatment of childhood leukemia, CTL019 maximum value of $649000.
CAR - T drugs should be given a higher price level, because it is used as a one-time treatment, and can bring benefit to some patients with no other treatment options. If, on the basis of the curative effect of payment agreement could appeal to the insurance company to accept a higher price tag, because it means that, if the treatment failure, the insurance company will get reimbursement.
Released in April this year, according to a ranking of the world's most expensive drugs uniQure Glybera gene therapy drug company for $1.2 million to occupy the top, but the market demand downturn has forced the company will terminate the drug sales.
Come up with the high price of drugs in recent years include the health (Biogen) of spinal muscular atrophy treatment Spinraza ($750000 in the first year, the average annual cost for the half), BioMarin company drugs used to treat the super rare CLN2 diseases Brineura ($702000). |
