The pharmaceutical network made significant progress in the anti-tumor drug market on July 21. The FDA's expert advisory committee on oncology (ODAC) has agreed to approve Tisagenlecleucel (ctl-019), a licensed novartis CAR. The FDA will make the final approval decision by October 3. Ctl-019 will become the world's first new car-t therapy, which will have a significant impact on industry development.
According to a number of industry experts, there is a relatively small gap between China and developed countries in Europe and the United States, according to a number of industry experts. Immunotherapy is expected to be a hot investment in cancer market. Domestic enterprises have accumulated rich experience in the field of common cell therapy, and can realize large-scale application in a short time.
In the aspect of a-share listed companies, haixin shares, xiangxue pharmaceutical, zhongzhu holdings, and conen bei have all cooperated with research institutes to develop the research and development of cellular immunotherapy. In March 2014, the national health and family planning commission (NHFPC) issued a notice on the declaration of the 2015 annual project of major new drug innovation technology, which clearly identified pd-1, pd-l1 and ctla-4 as important new targets for tumor immunity.
The team of xiangxue pharmaceutical group aimed to study the effective targeting of malignant solid tumor cells mainly from lung cancer, liver cancer and melanoma.
Owned subsidiary stock-holding company in hubei qianjiang pharmaceutical co., LTD., and the United States TNI biological technology co., LTD. Signed a cooperation agreement, joint development of pancreatic cancer anticancer drugs "1018" in preclinical studies. "1018" in essence is a kind of polypeptide, is to identify and trigger the immune cell surface receptors to activate the immune cells, thereby remove immunosuppressive effect of cancer cells, into the category of antibody therapy in tumor immunotherapy. "In 1018" has been done in the United States Ⅰ, Ⅱ phase of clinical trial, Ⅲ phase of clinical trial was the FDA approval.
Haixin haixin equity holdings subsidiary biotechnology and second military medical university cooperative research and development of "antigen sensitization dendritic cells (APDC)", is China's first independent research and development for the state food and drug administration approval, for the treatment of advanced colorectal cancer vaccines.
However, there is still no formal clinical application of cellular immunotherapy technology in the domestic market. The APDC of haixin shares is a therapeutic tumor vaccine for patients with advanced colorectal cancer. The project was approved by the national drug administration (CFDA) phase III clinical trial approval in July 2012 and is currently the only immune-cell treatment program regulated by the CFDA. The project began clinical trials in 2002 and entered phase III clinical trials in 2012 for 10 years. |
