美通社

2024-08-27 17:00

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

SHANGHAI, Aug. 27, 2024 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), 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 has approved 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 approval on Carteyva® submitted by JW Therapeutics, and is the first cell therapy product approved in China for the treatment of patients with 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 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 patients with r/r MCL in China. In the study, patients 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, patients received Carteyva® (100×106 CAR+ T cells). As of August 7th, 2023, a total of 59 patients received Carteyva® infusion. Of 59 efficacy evaluable patients, Carteyva® demonstrated remarkable clinical responses achieving high rates of objective response rate (ORR) and complete response rate (CRR) (best ORR 81.36%, best CRR 67.80%) 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%.

Sophia Yang, Senior Vice President and Head of Regulatory, Research & Development of JW Therapeutics, noted: "We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with r/r MCL have achieved complete remission after treatment with Carteyva®, and the overall safety data demonstrated that the treatment was generally well-tolerated. Carteyva® becomes the first commercial CAR-T cell product for the treatment of r/r MCL in China."

References

  1. The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version). Chin J Hematol.2016, 37(9):735-741.
  2. Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518.
  3. Burkart M, Karmali R. Relapsed/Refractory Mantle Cell Lymphoma: Beyond BTK Inhibitors. J Pers Med. 2022 Mar 1;12(3):376.

About Relmacabtagene Autoleucel Injection

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by the China National Medical Products Administration (NMPA) for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma ("r/r MCL") after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors ("BTKi"), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

About JW Therapeutics

JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.

Forward-Looking Statements

The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

source: JW Therapeutics

【你點睇?】皇馬巴塞傳奇表演賽爆簽名會風波,26人買涉$20萬套票僅見部份球星15分鐘,你認為事件哪方須負較大責任?► 立即投票

人氣文章
財經新聞
評論
專題
專業版
HV2
精裝版
SV2
串流版
IQ 登入
強化版
TQ
強化版
MQ

【etnet 30周年】多重慶祝活動一浪接一浪,好禮連環賞!

【etnet30周年連環賞】睇住賞Maxcare美天復康寶(升級版) (價值HK$1,680)

etnet榮獲HKEX Awards 2023 「最佳證券數據供應商」大獎

回顧24 展望25

大國博弈

貨幣攻略

說說心理話

聖誕新年特輯

Watche Trends 2024

北上食買玩

Artcation

秋冬養生食療

消委會報告

山今養生智慧

輕鬆護老