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?】TikTok美國禁令生效前大批「TikTok難民」湧入小紅書,你認為該現象會否對中美文化交流帶來正面影響?特朗普暫緩禁令後小紅書熱潮會否持續?► 立即投票

人氣文章
最近7天
1
高息定存 | 6個月港元定存3.8厘新高,188日快閃優惠3.68厘
2
高息定存 | 富邦推快閃定存優惠3個月3.9厘,華僑188日3.68厘
3
專訪|林本利系列專訪逢周五登場,股市篇:勿驚美股調整,港股那些可以放心買那些勿沾手(有片)
4
高息定存 | 工銀亞洲推3個月5厘息搶新客,招商永隆推快閃優惠
5
回顧展望-新股復燃 | 政策市激發IPO 惟六成新股破發損行情
6
回顧展望-國際形勢 | 全球動盪戰火連天,特朗普時代重臨
7
【FOCUS】零售寒冬襲京滬港,逆市奇葩值借鏡
8
港股 | 蕭猷華:恒指料退守至18600點,宜逢低吸納
9
神州經脈 | 工業利潤降幅收窄,低空經濟發展司成立,滬指全周升
10
神州經脈 | 換手機可獲政府補貼,政策利率將降,滬指周挫逾5%
11
內銀股 | 人行再提擇機減息降準,內銀獲中金唱好,應該點部署?
12
神州經脈 | PMI遜預期,滬指全年止跌回升,人幣年度貶幅擴
13
新股掛牌 | 布魯可首日掛牌升41%,每手賺7395元
14
回顧展望-人幣走貶 | 關稅殺到,先貶為敬,人幣明年勢見7.5
15
高息定存 | 一周高息合集,銀行年尾搶資金,大眾3個月3.6厘
16
大國博弈 | 【FOCUS】騰訊商湯寧德重挫,CMC清單劍指軍民融合
17
高息定存 | 一周高息合集,恒生1個月定存4厘,工銀亞洲3個月最高5厘
18
加州山火 | 【FOCUS】洛杉磯烈火焚城,天災背後藏人禍
19
回顧展望-A股自強 | 憧憬國策利好,機構對明年股市走勢樂觀
20
高息定存 | 渣打特選客6個月3.48厘,建行亞洲推1個月6.18厘高息吸客
21
藍圖2.0 | 旅遊發展藍圖2.0提四大策略,推特色項目智慧旅遊並開拓客源
22
電動車 | 寧德時代:擬發行H股香港上市
23
港股 | 蕭猷華:恒指春節前可挑戰21500點
24
去旅行 | 攜程:首十一月香港用戶平均出境航班次數增至1.9次
25
港股 | 蕭猷華:恒指春節前目標21500點
26
高息定存 | 一周高息合集,銀行高息吸客,低門檻10萬享6.18厘,3個月最高5厘
27
神州經脈 | 基金賣股票據報受限,滬指連跌四日,人行穩匯率
28
微盟 | 炒完微信小店,微盟(2013)遭三名主要股東急沽持股套現
29
專訪|洪灝:美股更大跌幅在前面,恐需習慣4%通脹(有片)
30
習近平應約與特朗普通電話,特:冀盡快與習見面
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!

【蛇年行大運 新年好賞「飾」】etnet賞太歲開運趨吉避凶神器

etnet榮獲HKEX Awards 2023 「最佳證券數據供應商」大獎

大國博弈

貨幣攻略

說說心理話

聖誕新年特輯

Watch Trends 2024

北上食買玩

Art Month 2024

秋天養生食療

山今養生智慧

輕鬆護老