On May 30, 2018, Genscript Biotech Corporation Co., Ltd. (1548.HK) announced that the company's clinical trial of CAR-T immune cell therapy for multiple myeloma has been approved by FDA. This is Ji Kingsley.Since obtaining the first clinical approval of CAR-T therapy for CFDA in ChinaAnother milestone in progressIt is the first clinical trial application approved by FDA in the history of CAR-T therapy in China.
Affected by this, Kingsley rose more than 7% in morning trading.
Guojin Securities believes that the significance of Kingsley's CAR-T clinical approval in the United States is:
Technology accumulation and rapid transformation, Kingsley builds a new milestone in China's CAR-T
The company announced that its subsidiary has obtained FDA approval from the United States through its partner Johnson & Johnson subsidiary Janssen Biotech, Inc, to conduct phase 1b/2 clinical trials of its CAR-T cell therapy LCAR-B38M (JNJ-68284528) for patients with recurrent / refractory multiple myeloma to evaluate the safety and efficacy of the product. 1b/2 clinical trials are expected to start recruiting patients in the second half of 2018.
Guojin Securities believes that as the first winner of CAR-T therapy in China to declare clinical success in both CFDA and FDA in the United States, there is no doubt that there are partners working together; more importantly, as the world's largest gene synthesis company, Kingsley's early technology accumulation, front-end biological CRO experience and keen CART field selection are more important factors.
Guojin Securities predicts that CAR-T targeting BCMA is only the beginning of the company's success. Based on the mature global experience of the company's new partner (Johnson & Johnson), the market opportunity of the company's formal clinical trials, and its own advanced nano-antibody platform, not only the success of clinical trials of BCMA target CAR-T is expected, but also follow-up research and development pipelines of more indications and new targets of immunotherapy. The high probability will also continue to enrich.
The combination of powerful and cooperative development is rapidly becoming a clear trend in the field of global biomedical innovation, including immune cell therapy:
The company's leading advance in the field of CAR-T, in addition to the solid professional foundation of the founder and team, the accumulation of technology and experience in the CRO field, accurate selection and rapid clinical transformation, but also the victory of the company's fast-break strategy of global combination with pharmaceutical giants like Johnson & Johnson (this is completed within 6 months after the announcement of cooperation between the two sides, the US clinical application in the frontier field of biomedicine).
As we predicted, when the disruptive innovation moves to the center of the stage, the giants are never absent; the historical stage of CAR-T has evolved from three start-ups (Giant, Kate, and a CART pipeline of Novartis) to the stage of the Big three (Xinji-Giant, Gilead-Kate, Novartis-more pipelines and upstream enterprises of the new joint industrial chain).When the rapidly advancing biomedical frontier technology is proved to be effective and has been legally transformed into application, all the giants will not be absent.Immune cell therapy is one of them, and the tip of the iceberg, CAR-T for hematological tumors, will be the fastest relatively mature therapy to move forward. We thinkThe combination of enterprises related to immune cell therapy at home and abroad will appear more and faster, and paying close attention to and correctly interpreting such information such as cooperative mergers and acquisitions will have a significant impact on investment.
The approval of Kingsley's American IND increases the certainty of the further promotion of the entire cell therapy industry in China.
Nanjing Legend, a subsidiary of Kingsley Research and Development CAR-T, which takes Nanjing as its research and development base and China as its preclinical large number of animal trials and human clinical studies initiated by researchers, can obtain FDA approval to conduct human clinical trials in the United States when there are only two CAR-T therapies on the market and a small number of CAR-T clinical approvals. This incident itself has proved the rapid and professional level of clinical transformation of CAR-T therapy in China.
From the first time in the history of the China Food and Drug Administration (CDE) to subversely determine the regulatory path of cell therapy as a drug on the market, in December 2017, it accepted China's first clinical trial application for CAR-T therapy (submitted by Jinsrui). Today, CDE has accepted 23 clinical trial applications for CAR-T-related therapy from scratch. Among them, Kingsley was approved clinically in March, while the other three-Boshengji (Anke Biology), Hengrun Dasheng, and Mingju Bio (Mingju Nuo) have entered the stage of comprehensive evaluation (toxicology, clinical, pharmaceutical review has been completed), approved or in the near future.