China's first! Legendary bioCAR-T therapy is to be included in the breakthrough treatment variety.

On August 5, CDE's official website announced the first proposed breakthrough treatment variety, LCAR-B38M CAR-T cell self-retransfusion preparation for Nanjing Legendary Bio (LCAR-B38M cell preparation).
note that this is the first update in the "Breakthrough Treatment Publicity" column since the National Drug Administration released the Breakthrough Therapeutic Drug Review Procedure (Trial) on July 8.
, legendary creatures submitted applications for breakthrough therapy on July 10, according to public information.
LCAR-B38M is a CAR-T therapy developed by Legendary Creatures that targets B-cell mature antigens (BCMA), which has a novel structure and contains a 4-1BB costulation domain and two BCMA targets Monomethic antibodies used in adult patients who have previously received treatment options that include protease inhibitors, immunomodulants, and anti-CD38 antibodies, as well as relapses or refractic multiple myelomas that progress during or after the last treatment.
June 2017, the LCAR-B38M stunned the field with a 100% objective mitigation rate at the ASCO Annual Meeting.
of the same year, Legendary signed a global partnership and licensing agreement with Johnson and Johnson's Jansen to jointly develop and commercialize LCAR-B38M/JNJ-4828.
Yang Sen paid a $350 million down payment and subsequent milestone payment to Nanjing Legendary Bio, setting a record for the largest down payment and optimal conditions for cooperation between Chinese pharmaceutical companies at that time.
the next two years, the LCAR-B38M went well and was fruitful.
2018, it received approval for China's first CAR-T clinical trial application, FDA IND approval, FDA-granted orphan drug eligibility and breakthrough therapy recognition, and priority drug eligibility (PRIME) from the European Medicines Agency in 2019.
December 2019, at the 61st annual meeting of the American Society of Hematology (ASH), the two companies released for the first time the latest clinical data from the IB/II CARTITUTE-1 study on the effectiveness and safety of LCAR-B38M.
results showed that LCAR-B38M showed excellent efficacy in treating 29 patients with relapsed or refraped multiple myeloma (R/R MM) and achieved a total remission rate (ORR) of 100% at a medium follow-up time of 6 months.
69 percent of these patients achieved full or better remission, and 86 percent achieved very good partial or better remission.
at this year's ASCO annual meeting, the two companies updated data from the LCAR-B38M trial: at a medium follow-up time of 11.5 months, all patients responded to treatment and responded in depth for a long time.
, ORR remained 100%, 86% of patients achieved strict complete remission, and 9 months of progression-free survival rate was 86%.
excellent clinical data, making the LCAR-B38M a strong competitor in the CAR-T market.
companies will submit LCAR-B38M listing applications in the U.S. by the end of this year and in China in 2021, according to the company's legendary bio-prospecting.
the drug is intended to be included in the breakthrough therapy, will further accelerate the process of listing in China.
public information shows that there are currently two pharmaceutical companies submitted breakthrough therapy applications: on July 17, Li's large pharmaceutical company submitted PD-L1 single anti-ZKAB001 cervical cancer adaptation breakthrough therapy application;
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