The second CAR-T therapy declared for sale in China was eligible for the "Priority Review plus Breakthrough Drugs" double review.

Recently, according to the latest publicity of the Drug Review Center of the State Drug Administration, Zhangjiang Science City Enterprise Drug Ming Juno's Ricky Lunsai injection (tentative name, research and development code is JWCAR029, generic name "CD19 targeted chimic antigen-infused subjectivity T cells") listing application is to be included in the priority review, on the grounds that "qualified drugs", the drug market application for the formulation of adaptation for treatment after the second line or above adult patients Recurring or refractic large B-cell lymphoma, including diffuse large B-cell lymphoma non-specific, fister lymphoma-transformed diffuse large B-cell lymphoma, 3b-grade fleatic lymphoma, primary pylonic large B-cell lymphoma, high-level B-cell lymphoma with MYC and BCL-2 and/or BCL-6 refraped (double-strike/triple-strike lymphoma), not suitable for the treatment of primary central nervous system lymphoma.
is also noteworthy that JWCAR029 is also proposed to be included in the list of breakthrough treatment varieties, thus, JWCAR029 became the first in the country to obtain both the proposed priority review and the proposed breakthrough drug varieties of the first class of innovative drugs.
According to the "Breakthrough Therapeutic Drug Review Procedure (Trial)" document issued by the State Drug Administration, breakthrough therapeutic drugs are used to prevent and treat diseases that are seriously life-threatening or seriously affect the quality of life, and there is no effective means of prevention or treatment, or innovative drugs or modified new drugs with clear clinical advantages compared with existing treatments, etc., and are required to be applied for before phase III clinical trials in phases I.II.
It is understood that JWCAR029 is based on the United States Juno company JCAR017, by the drug Mingjuno independently developed CAR-T products, there are reports that JWCAR029 in China's process optimization process has some commercial considerations, JCAR017 originally in the United States process is to separate CD4 and CD8 cells using two product lines production, and finally in accordance with a 1:1 ratio mixed back into the patient body.
in China, JWCAR029 was modified to extract CD4 and CD8 cells after mixing without separation, cultured on a production line, produced, and then returned to the patient together.
, in December 2017, the drug submitted JWCAR029's IND application (clinical trial application for a new drug) through Mingju Bio, which was clinically approved in June 2018.
In December 2019, at the 61st annual meeting of the American Society of Hematology (ASH), Pythono published data from the JWCAR029 Phase I clinical trial for the treatment of adult recurrence/difficult-to-treat B-cell non-Hodgkin's lymphoma (R/R B-NHL), which showed good safety and effectiveness in a Phase I study of 32 patients and 4 climbing doses.
For patients with poor prognostic R/R invasive B-NHL, infusion JWCAR029 provided excellent and long-lasting remission, with ORR of 58.6% and CR of 55.2% for all patients at 6 months, and 45% for ALLLCL patients with all return doses: ORR of 45% and CR of 45%.
safety, JWCAR029 toxicity is controllable, no CRS or NT-related deaths occur, and the 3/4 CRS or NT has a low rate of approximately 6% (n-32).
In July of this year, the State Drug Administration submitted JWCAR029's listing application, which is the second car-T therapy to submit a listing application, unlike The kililuns, which is the world's first declared listing, following fosun Kate's (also known as Zhangjiang Science City Cell Therapy Company) declaration of Yikililunsai injections (foreign products called Yescarta).
With the accelerating process of product listing, Pharmaceutical Ming Juno has also officially started a trip to Hong Kong, it has formally submitted an IPO application to the Hong Kong Stock Exchange, it will be proposed to raise 2-300 million U.S. dollars (about 1.38-2.07 billion yuan) for product development, new potential acquisitions and the introduction of licensing opportunities, company operations and general corporate use, including research and development around JWCAR029, future sales of China market and other candidates will be the focus of the company's research and development activities.
source: Medical Valley.com!-- content presentation ends -- !-- to determine whether the login ends.