[exclusive] cancer immunotherapy new upstart, car-t new progress in China: ucadi clinical application acceptance first, Nanjing legend clinical phase II, Keji biological solid tumor breakthrough innovation

Car-t cell immunotherapy, as one of the new methods of tumor immunotherapy, has attracted the attention of the industry in recent years Car-t cell immunotherapy was first proposed by gross in the late 1980s Up to now, four generations of car-t have been developed Because the second generation of car-t has more clinical data support, high stability and mature technology, most of the enterprise car-t products are explored and researched on the basis of the second generation of car-t basic technology In 2017, car-t cell therapy entered the stage of hyperthermia Novartis and kitepharma respectively launched the first and second car-t in the world, which ushered in a new era of car-t cell therapy It's worth mentioning that car-t products only took six months from being declared to be on the market to being approved, which is beyond imagination With the rapid development of car-t in the world, China is also stepping up the promotion The guiding principles for research and evaluation of cell therapy products (Trial) issued by CFDA on December 22, 2017 marks the official opening of China's cell therapy products as a standardized clinical drug attribute, greatly promoting the development of China's cell therapy industry In April 2019, the State Food and Drug Administration launched China's scientific action plan for drug regulation, which included cell and gene therapy as one of the key development objects, so that the domestic cell therapy ushered in a golden development period According to incomplete statistics of public data, there are more than 400 registration of clinical trials of car-t therapy in the world, among which China's registered clinical trials of car-t therapy are second only to the United States (the United States is the first country to register car-t therapy trials), about 158, accounting for about 1 / 3 of the world According to the statistics of drug registration and acceptance database, up to now, CDE has accepted 32 clinical application acceptance numbers of car-t products, involving 21 enterprises such as Fosun Kate, Shanghai Mingju biology, Keji biomedicine, etc Among them, ucadi biomedical currently has the largest number of applications (based on the acceptance number, the same below), 5 of which have been approved and are in the "issued" status; the second is Hengrun Dashen biological, 2 of which have been approved; Shanghai Keji pharmaceutical, saibiman biological, Heyuan biological, Beijing Yimiao medical, and Guangzhou Baiji gene 5 enterprises apply for 2; including Nanjing legend biological, Chengcheng At present, one application has been accepted by 14 enterprises including duyinhe biology, Shanghai Mingju biology, etc It is worth mentioning that although only one car-t product has been applied for clinical registration, the product is the first car-t product that has been applied for and accepted by CDE according to the "class 1 new drug for therapeutic biological products" in China, and has obtained the priority review qualification It was approved as a clinical bed on March 12, 2018, becoming the first car-t therapy that has been approved according to the drug application for clinical trials The product of Nanjing legend biology was accepted on December 8, 2017 and approved for clinical use on March 12, 2018 It took only three months It can be seen that the review and approval speed of innovative drugs is accelerating 13 products have been approved for clinical use, and 2 products have entered phase II In addition to the approved clinical trials of car-t products of Nanjing legend biology, 12 have also been approved clinical trials, and the car-t products of Chengdu Galaxy biology, Keji biology and Hengrun Dasheng biology are special approval and priority review as those of Nanjing legend biology Among them, car-t products of Chengdu Galaxy biology are the first products in China that have been accepted for CD19 target and included in the priority review 。 In addition, although the car-t product of Shanghai cell therapy has not been included in the special approval or priority review, it was also approved in January this year, and is the first approved clinical non viral carrier car-t cell therapy product in China Car-t products have been approved for clinical details According to the statistics of China clinical database of Yaozhi, car-t products of Shanghai Mingju biology and Nanjing legend have entered clinical phase II In addition to the above two approved clinical products, the products of Innolux in Shenzhen, Hualong biology in Henan and Tianrui biology in Tianjin have also entered the phase II clinical trial At present, the products entering clinical phase II are basically used for recurrence of refractory B-cell non Hodgkin's lymphoma, multiple myeloma, leukemia and other blood tumors The details can be seen in the following table: details of car-t products entering clinical phase II car-t extends from hematoma to solid tumor, and the results are gratifying According to the report of Great Wall Securities, 75% of car-t projects under research are intended to be used for leukemia, lymphoma and other blood tumors, and a small part of them are aimed at solid tumors such as liver cancer and lung cancer It has been pointed out that extending from haematoma to solid tumor will be a major trend of car-t research According to Southwest Securities report, the global hematoma market is nearly 30 billion US dollars, China's 10 billion yuan, the solid tumor market is over 100 billion, and the market space is huge Therefore, in recent years, the global scientific research on car-t therapy for solid tumors is constantly innovating and breaking through Recently, a clinical data of car-t cells in the treatment of gastric and pancreatic cancer solid tumors was released in the abstract of 2009 ASCO, with an effective rate of 33.3%, safe and tolerable, which strongly proves the application of car-t cells in solid tumors At the same time, domestic enterprises are also constantly tackling the research of car-t in solid tumors, especially Keji biology, which focuses on the application of car-t in solid tumors In 2015, science and Technology Biology carried out the world's first car-t cell clinical experiment for HCC in Renji Hospital Affiliated to Shanghai Jiaotong University School of medicine; in 2018, science and Technology Biology released the clinical data of car-t cell treatment for gastric cancer / pancreatic cancer at the car-tcr summit in Boston, USA: among the 12 patients who received treatment, 8 patients showed different degrees of tumor regression, especially in one of the 12 patients According to the recist1.1 standard, 5 out of 6 patients in the improved treatment subgroup achieved objective remission (including 1 to be confirmed objective remission), including 1 complete remission There has been a breakthrough In January this year, Keji biology announced that the clinical trial application for GPC3 targeted car-t cells for GPC3 positive solid tumors has passed the tacit license (acceptance No cxsl1700203) issued by the drug review center of the State Drug Administration, becoming the first car-t cell drug clinical trial license for solid tumors in China It is believed that with the progress of technology, the persistence of researchers, and the assistance of national policies, car-t will conquer more hematomas and solid tumors, bringing good news for cancer patients Attachment: CDE accepts the declaration details of car-t product ind note: the data in this article are all manual search If there is any omission, please supplement the information source: yaozhi.com, enterprise announcement and other network public information data sources: yaozhi.com, Southwest Securities, Great Wall Securities, etc