JW Therapeutics Announces NMPA Acceptance of the Supplemental Biological License Application for Carteyva® in Patients with Relapsed or Refractory Mantle Cell Lymphoma

JW Therapeutics an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China accepted the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL). This is the third marketing application on Carteyva® submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of patients r/r MCL. Carteyva® was granted, by NMPA, Breakthrough Therapy Designation in Mar 2022, as well as Priority Review in Dec. 2023.

MCL is a rare and heterogeneous B cell non-Hodgkin lymphoma which is currently incurable with existing therapies^[1]. MCL, associated with a poor prognosis, mainly occurs in elderly men who were not diagnosed until advanced stage^[2]. Significant progress has been made in the last decade as the treatment paradigm has shifted from traditional chemoimmunotherapy toward targeted therapies such as bruton tyrosine kinase inhibitors (BTKi). Despite the use of BTKi in r/r MCL has improved their survival outcomes, many patients will ultimately relapse with shortened remission durations (6~10 months) ^[3]. Notwithstanding the above, there are still unmet medical needs for a safe, effective novel approach to overcome the limitations of current treatments of r/r MCL.

The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva^® in adult participants with r/r MCL in China. In the study, participants with r/r MCL who had been treated with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis were included. After being treated with lymphodepleting chemotherapy, participants received relma-cel (100×10⁶ CAR+ T cells). As of Oct 25, 2023, a total of 59 participants received relma-cel infusion. Of 56 efficacy evaluable participants, relma-cel demonstrated remarkable clinical responses achieving high rates of objective response rate (ORR) and complete response rate (CRR) (3 months best ORR 81.36%, 3 months best CRR 66.10%) and the incidence of severe (grade ≥ 3) cytokine release syndrome (CRS) was 6.8%, the incidence of severe (grade ≥ 3) neurotoxicity (NT) was 6.8%.

Mark J. Gilbert, MD, Chief Medical Officer of JW Therapeutics, noted: "We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of participants with r/r MCL have achieved complete remission after treatment with relma-cel, and the overall safety data demonstrated that the treatment was generally well tolerate. Carteyva^® is expected to become the first commercial CAR-T cell product for the treatment of r/r MCL in China."

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!