A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis

Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.

Start Date01 Jun 2024

Sponsor / Collaborator

Shanghai Renji Hospital

[+1]

NCT06365671 / Not yet recruitingPhase 2IIT

A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors

Start Date01 Apr 2024

Sponsor / Collaborator

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

NCT06297408 / Not yet recruitingPhase 1

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus Single Arm Phase I and Phase II Randomized Controlled Open, Multicenter Study

To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

Start Date01 Mar 2024

Sponsor / Collaborator

Shanghai Ming Ju Biotechnology Co. Ltd.

100 Clinical Results associated with Relmacabtagene autoleucel

100 Translational Medicine associated with Relmacabtagene autoleucel

100 Patents (Medical) associated with Relmacabtagene autoleucel

Literatures (Medical) associated with Relmacabtagene autoleucel

01 Sep 2023·Value in health regional issues

Cost-Effectiveness Analysis of Relmacabtagene Autoleucel for Relapsed or Refractory Large B-Cell Lymphoma in China

Article

Author: Su, Wen ; Jiang, Yifan ; Wu, Qiong ; Xuan, Jianwei ; Zuo, Chenyu ; Man, Yu ; Lin, Ziyi ; Yao, Xing

OBJECTIVES:

Relmacabtagene autoleucel (relma-cel) was recently approved in China for treating relapsed or refractory large B-cell lymphoma (r/r LBCL). We conducted a cost-effectiveness analysis from the perspective of Chinese healthcare system.

METHODS:

A mixture-cure model was developed to project life-years (LYs), quality-adjusted LYs (QALYs), and overall direct cost with a lifetime horizon for patients with r/r LBCL treated with relma-cel versus salvage chemotherapy. Patient-level data from RELIANCE trial and published data from Collaborative Trial in Relapsed Aggressive Lymphoma extension study were used to inform the model. The incremental cost-effectiveness ratio (ICER) was estimated and cost-effectiveness was evaluated at the willingness-to-pay threshold of 3 times the national gross domestic product per capita.

RESULTS:

The model projected that treatment with relma-cel was associated with incremental gains of 5.11 LYs and 5.26 QALYs compared with salvage chemotherapy at an increased cost of ¥1 067 430 (∼$154 152), resulting in an ICER of ¥203 137 (∼$29 435) per QALY. The model was most sensitive to the uncertainty around the estimated cure rate. The ICER of relma-cel was within the willingness-to-pay threshold in the base case and the probability of relma-cel treatment being considered cost-effective was approximately 74%.

CONCLUSIONS:

Compared with salvage chemotherapy, treatment with relma-cel for r/r LBCL in patients who have failed at least 2 lines of systemic therapy is within the cost-effective range from the perspective of Chinese healthcare system and represents a good use of healthcare resources.

01 Sep 2023·Applied health economics and health policy

Value for Money of CAR-T Cell Therapy for Patients with Diffuse Large B-cell Lymphoma in China: Evidence from a Cost-Effectiveness Analysis.

Article

Author: Comans, Tracy ; Dong, Hengjin ; Wang, Yannan ; Zhou, Yuping ; Keramat, Syed Afroz ; Wu, Weijia ; Yang, Yi ; Balasooriya, Namal N ; Zhao, Zixuan

OBJECTIVE:

This research assesses the cost effectiveness of Axicabtagene ciloleucel (Axi-cel), Tisagenlecleucel (Tis-cel), Relmacabtagene autoleucel (Rel-cel) and Lisocabtagene maraleucel (Lis-cel) against standard of care (SOC) for patients with diffuse large B-cell lymphoma (DLBCL) in the first-line setting (1L), second-line setting (2L) and third-line or later setting (3L+).

METHODS:

Markov modelling based on a flexible survival model was adopted to evaluate four chimeric antigen receptor T-cell (CAR-T) therapies compared with SOC for patients with diffuse large B-cell lymphoma (DLBCL). The clinical inputs and utility values of the model were derived from the most recent clinical trials and the health care costs from a Chinese provincial clinical center. Costs and quality-adjusted life years (QALYs) were used to derive incremental cost-effectiveness ratios (ICERs) from the Chinese health care system perspective.

RESULTS:

The ICER of Axi-cel (1L) versus SOC was approximately Chinese Yuan (CNY) 2,125,311 per QALY. The ICER for Axi-cel (2L), Tis-cel (2L) and Liso-cel (2L)) versus SOC in transplant-eligible patients were approximately CNY363,977, CNY32,066,781 and CNY347,746 per quality-adjusted life year (QALY), respectively. The ICER for Liso-cel (2L) versus SOC in transplant-ineligible patients was approximately CNY1,233,972 per QALY. The ICERs for Axi-cel (3L+), Tis-cel (3L+), Rel-cel (3L+) and Liso-cel (3L+) versus SOC were approximately CNY346,009, CNY654,344, CNY280,964 and CNY436,858 per QALY, respectively. In the scenario analysis using mixture cure models, the long-term survival benefit for CAR-T and SOC groups was found higher, and only Rel-cel (3L+) was found to be cost effective.

CONCLUSION:

Our results demonstrated that CAR-T treatments are not cost effective in any-line settings for DLBCL patients at the WHO-recommended willingness-to-pay threshold (CNY257,241 per QALY) in the base-case analysis. Price reduction of CAR-T therapies is the main approach for lowering ICERs and ensuring that the drug costs are proportional to patient health benefits.

01 May 2023·Cytotherapy

Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study

Article

Author: Yang, Su ; Guo, Ye ; Song, Yuqin ; Wang, Chris ; Ma, Laura ; Zou, Dehui ; Ying, Zhitao ; Liu, Hui ; Zhou, Daobin ; Zhu, Jun ; Qin, Yun ; Zhang, Mingzhi ; Yang, Haiyan ; Wu, Jianqiu ; Li, Wenyu ; Wang, Zhao ; Zhou, Zisong

BACKGROUND AIMS:

The RELIANCE study has demonstrated the activity and safety of relmacabtagene autoleucel (relma-cel) (JW Therapeutics [Shanghai] Co, Ltd, Shanghai, China), a CD19-targeted chimeric antigen receptor T-cell product, in patients with heavily pre-treated relapsed/refractory large B-cell lymphoma (r/r LBCL). This study aimed to report the updated 2-year data of the RELIANCE study.

METHODS:

The RELIANCE study (NCT04089215) was an open-label, multi-center, randomized, phase 1/2 registrational clinical trial conducted at 10 clinical sites in China. Adult patients with heavily pre-treated r/r LBCL were enrolled and received lymphodepletion chemotherapy followed by infusion of 100 × 10⁶ or 150 × 10⁶ relma-cel. The primary endpoint was objective response rate (ORR) at 3 months, as assessed by investigators. Secondary endpoints were duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety profiles.

RESULTS:

From November 2017 to January 2022, a total of 68 patients were enrolled, and 59 patients received relma-cel infusion. As of March 29, 2022, a total of 59 patients had a median follow-up of 17.9 months (range, 0.3-25.6). ORR was 77.59% (95% confidence interval [CI], 64.73-87.49) and complete response rate was 53.45% (95% CI, 39.87-66.66). Median DoR was 20.3 months (95% CI, 4.86-not reached [NR]) and median PFS was 7.0 months (95% CI, 4.76-24.15). Median OS was NR and 1-year and 2-year OS rates were 75.0% and 69.3%, respectively. Three (5.1%) patients experienced grade ≥3 cytokine release syndrome and two (3.4%) patients had grade ≥3 neurotoxicity.

CONCLUSIONS:

The updated data of the RELIANCE study demonstrate durable response with and manageable safety profile of relma-cel in patients with heavily pre-treated r/r LBCL.

News (Medical) associated with Relmacabtagene autoleucel

30 May 2024

·www.prnewswire.com

Preliminary Clinical Data on Relma-Cel Injection in Adults with Active Systemic Lupus Erythematosus in China at the Eular 2024 Congress

SHANGHAI, May 30, 2024 /PRNewswire/ -- JW (Cayman) Therapeutics Co. Ltd (the "Company" or "JW Therapeutics", together with its subsidiaries, the "Group"), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, presented the preliminary clinical data on relmacabtagene autoleucel ("relma-cel") injection in adults with active systemic lupus erythematosus ("SLE") in China at the 2024 European Alliance of Associations for Rheumatology Congress ("EULAR 2024"). Updates on safety and efficacy of relma-cel in adults with SLE in China (abstract number: 3246; Poster number: POS0054) SLE is a chronic autoimmune disease causing widespread inflammation and tissue damage in the affected organs. There are about one million SLE patients in China, ranking the first worldwide in total numbers and the second in incidence rate. Current conventional therapies include corticosteroids, antimalarial drugs, non-steroidal anti-inflammatory drugs (NSAIDs), cytotoxic drugs and immunosuppressive/modulatory agents. However, conventional treatments are poorly tolerated over time, which affects the clinical efficacy, thus leading to poor disease control with organ damage and further affecting prognosis and long-term survival, especially in patients with moderately to severely active SLE who require high doses of corticosteroids and immunosuppressants. This is a single-arm, open-label, multi-center dose escalation study (NCT05765006) in China. Participants will receive an intravenous infusion of CAR-T cells at doses of 25×10^6(25M), 50×10^6(50M), 75×10^6(75M), or 100×10^6(100M), to evaluate the safety and efficacy of relma-cel in SLE patients. As of April 8, 2024, a total of 12 patients enrolled and received the single infusion of relma-cel. Safety, pharmacokinetics and pharmacodynamics ("PK/PD") and efficacy assessments were conducted across low, medium, and high dosage groups, with the longest follow-up duration of more than 9 months. At EULAR 2024, we presented data from patients in the low-dose group with relatively longer follow-up period, up to the data cutoff date of December 18, 2023. Three patients with active SLE received single intravenous infusion of relma-cel at the dose level of 25M and completed at least 4-months follow-up. All the three patients were female with multiorgan involvement and previously exposed to high-dose steroids and several immunosuppressive treatments. Two had a medical history of more than ten years, and two patients received biological agents. After relma-cel administration, clinical signs and symptoms of SLE patients continued to be improved: SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) ("SRI-4") score dramatically decreased from 8~14 to 0/1, and all the three patients achieved SRI-4 while two patients reached the more stringent lupus low disease activity status (LLDAS). As of the data cut-off, all the three patients no longer used corticosteroids nor immunosuppressants. PK/PD data once again confirmed the proliferation of relma-cel in vivo and complete depletion of peripheral blood B cells. In addition, relma-cel demonstrated manageable safety profile. Cytokine release syndrome ("CRS") occurred in two patients (one had Grade 1 and another had Grade 3). No neurotoxicity (NT) occurred. Cytopenia occurred in two patients. Infection, macrophage activation syndrome (MAS), and effusion were observed in one single patient. The patients completely recovered around Day 60 with appropriate treatments. The above three patients are still under study follow-up. Over the follow-up time exceeding 6-months, all three patients demonstrated ongoing improvements in both disease activity and clinical symptoms. Our preliminary data showed that relma-cel, even at a dosage significantly lower than that of hematological tumors, can effectively induce profound and lasting remissions in patients with moderate to severe SLE, while maintaining a favorable safety profile. These encouraging results bolster JW Therapeutics' potentials for further clinical development in SLE and other autoimmune diseases. Up to date, the investigator-initiated trial ("IIT") is actively ongoing to accumulate data from a larger cohort with longer follow-up periods. To summarize the efficacy data for nine patients at different dose levels (three cases in the 25M dosage group, three cases in the 50M dosage group, and three cases in the 75M dosage group), 100% patients achieved an SRI-4 response at 3-month after relma-cel infusion. Notably, for those four patients (three cases from the 25M group and one from the 50M group) followed up for at least six months, still maintained a 100% SRI-4 response rate. Among all patients who received relma-cel infusion (three cases in the 25M group, three cases in the 50M group, and six cases in the 75M group), eleven patients (91.67%) stopped using traditional corticosteroids and immunosuppressants. This has not only alleviated the medication burden on patients but also minimized potential side effects. Additionally, significant improvements in organ damage have been observed in most patients, with remarkable reductions in SLE disease activity and anti-double-stranded DNA (dsDNA) antibody levels, as well as a notable decrease in the 24-hour urinary protein levels post-infusion. And 100% patients achieved rapid complete peripheral B-cell depletion after the infusion, with a median time of four days to onset. Across all dosage groups, CAR-T cells rapidly expanded, reaching peak levels around Day 8, and a clear dose-response relationship was observed. Patients in the higher dosage groups exhibited higher peak pharmacokinetic (PK) values, and longer-lasting duration of B-cell depletion. Patients in all dosage groups showed good safety and tolerability, with only one case of Grade 3 CRS and no instances of Grade 3 or above neurotoxicity. Additionally, only two patients experienced Grade 3 infections, and all adverse events resolved following appropriate treatment. The preliminary data from this IIT indicated that relma-cel could achieve deep and durable disease remission in patients with moderate to severe SLE, with a favorable safety profile. Based on the available/published clinical trial data, this study stands out among all clinical studies of CAR-T therapy in SLE due to its largest number of patients enrolled and the longest follow-up period, offering us robust efficacy, PK/PD, and safety data. As the pioneering commercial CAR-T therapy to receive the first Investigational New Drug (IND) approval for SLE treatment, relma-cel shows promising prospects for swift progression to the Biologics License Application (BLA) stage. We anticipate further communications with regulatory authorities to hasten the commercialization of this groundbreaking treatment and offer a transformative therapeutic option to those living with SLE. Dr. Mark J. Gilbert, Chief Medical Officer of JW therapeutics, said, "Despite the recent emergence of novel biologics and therapies for SLE, many SLE patients still do not respond to available treatments, and there is currently no reliable treatment strategy to achieve drug-free remissions or even to cure the disease. The short-term follow-up data from this study have preliminarily shown that low-dose relma-cel injection has a favorable safety profile in SLE patients, and is able to bring about deep remission, especially enabling patients to achieve low disease activity or even drug-free remission, which makes its application in the treatment of SLE a promising prospect." 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, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, and 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), 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 (Stock Code: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class 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 worldwide, and leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit . 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: . SOURCE JW Therapeutics

Clinical ResultImmunotherapyDrug ApprovalClinical StudyBreakthrough Therapy

26 Mar 2024

·www.fiercepharma.com

Big Pharma CEOs gather in Beijing to ⁠show continued interest in China, offer policy advice

CEOs of Novartis, AstraZeneca, Bristol Myers Squibb, Sinopharm, Takeda, Amway and Organon weighed in on healthcare during the China Development Forum 2024. The CEOs of AstraZeneca, Bayer, Bristol Myers Squibb, GSK, Novartis, Pfizer and Takeda came together in Beijing to show the companies’ continued interest in China and to offer their advice for the country’s healthcare industry. Pfizer CEO Albert Bourla, while complimenting China’s large market opportunity, urged the Chinese government to further improve its protection of intellectual property, according to a Pfizer social media post (Chinese). Bourla made the comment Sunday during a one-on-one dialogue with Li Daokui, an economist at Tsinghua University who is known as a key adviser to China’s core leadership, at the annual China Development Forum (CDF). Back in 2019, Li had stated that Beijing could block exports of medicines as a countermeasure to the U.S.’s trade war. The 2024 CDF conference marked perhaps the largest gathering of multinational pharma CEOs in China since the pandemic. The CEOs’ attendance comes as several U.S. lawmakers, through the draft BIOSECURE Act, aim to ban certain Chinese firms labeled as “foreign adversary biotech companies of U.S. national security concern” from getting federal contracts. Pfizer remains committed to improving the health of the Chinese people, the company said in the release. The New York pharma previously devised a goal to include China in its initial round of drug filings by including the country in all its pivotal phase 3 trials by 2027. “I’m encouraged by opportunities to continue to expand the biopharmaceutical industry in China,” Bourla said Wednesday in a separate meeting organized by the Chinese Ministry of Commerce to attract foreign investment, as quoted by Bloomberg. “I’m particularly inspired by the prospect of holistic, innovative drug development here.” Besides Bourla, AZ’s CEO Pascal Soriot, Bristol Myers’ CEO Chris Boerner, Novartis’ CEO Vas Narasimhan, Takeda’s CEO Christophe Weber and Organon’s CEO Kevin Ali joined the helmsmen of Sinopharm and Amway on a CDF panel on health. Intellectual property and data protection were also on Narasimhan’s mind. He suggested that China refine its early resolution mechanisms for patent disputes, which have been on a trial run since 2021, to include more patent types, Caixin reports. He also urged local authorities to accelerate the implementation of patent compensation for new drugs, which would make up for a product’s regulatory review period, and of pediatric and orphan drug market exclusivity. Narasimhan, while commending China’s progress in simplifying regulatory processes, argued that review of drugs based on novel technologies should be better aligned with standard international practices. The Novartis CEO highlighted the company’s leadership in radioligand therapies. During his speech, Boerner called for a better payment mechanism in China, including a tiered healthcare coverage system and the seamless adoption of drugs at hospitals following reimbursement policies, according to a BMS social media post (Chinese). He proposed more incentives to reward first- or best-in-class drugs, plus more alignment in drug prices between China and other major markets, Caixin reports. Some foreign-made drugs, including BMS’s PD-1 inhibitor Opdivo, have not reached national reimbursement deals in China due to pricing disagreements. Thanks to its high price, relma-cel, a CD19 CAR-T therapy made by BMS-WuXi Apptec joint venture, JW Therapeutics, is also not covered by national insurance in China. The one-time blood cancer treatment generated 170 million Chinese yuan ($24 million) in 2023 sales. Only with a complete value chain supporting innovation will Chinese patients enjoy the most of China’s booming innovative drug industry, Boerner said, according to Caixin. Former China FDA chief Bi Jingquan made similar points during a standalone speech at CDF about optimizing China’s innovative drug environment. Bi was credited for spearheading China’s push to boost innovative drugs before resigning from his drug regulator job in 2018 following a local firm’s vaccine data fabrication scandal. Continued investments in biopharma are made possible by the notion that innovative drug prices are the result of global competition, Bi said, according to state-run Xinhua news agency (Chinese). Meanwhile, China’s current national drug insurance system is based on a generics market. It’s built to ensure universal coverage of essential medicines and therefore doesn’t have much additional capacity to manage an influx of innovative drugs, Bi noted. Therefore, China must promote commercial medical insurance and support payments for innovative drugs with a tiered system, he added. Bi’s speech during a state-sponsored event could be viewed as an indication of what’s in the works among China’s policymakers. A few days ago, rumors surfaced that authorities were devising a comprehensive plan to support the development of new innovative drugs in China. A widely reported but yet unverified government draft document mentioned several measures, including more support for investment in and better insurance coverage for innovative drugs. Also at CDF, GSK’s CEO Emma Walmsley joined Abbot Laboratories’ Robert Ford and Medtronic’s Geoff Martha, plus a few other CEOs, on a second panel on health. Bayer CEO Bill Anderson was on another Sunday panel about environmental policy.

VaccinePhase 3

04 Jan 2024

·www.prnewswire.com

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

SHANGHAI, Jan. 4, 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 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." 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 (trade name: Carteyva®) Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: 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 former subsidiary of Bristol Myers Squibb). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, 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 . 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: . SOURCE JW Therapeutics

ImmunotherapyDrug ApprovalClinical ResultBreakthrough TherapyCell Therapy

100 Deals associated with Relmacabtagene autoleucel

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Follicular Lymphoma	CN	JW Therapeutics (Shanghai) Co., Ltd.	30 Sep 2022
Diffuse Large B-Cell Lymphoma	CN	JW Therapeutics (Shanghai) Co., Ltd.	01 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	NDA/BLA	CN	JW Therapeutics (Shanghai) Co., Ltd.	04 Jan 2024
Mantle cell lymphoma recurrent	NDA/BLA	CN	JW Therapeutics (Suzhou) Co., Ltd.	04 Jan 2024
Mantle cell lymphoma refractory	NDA/BLA	CN	JW Therapeutics (Shanghai) Co., Ltd.	04 Jan 2024
Mantle cell lymphoma refractory	NDA/BLA	CN	JW Therapeutics (Suzhou) Co., Ltd.	04 Jan 2024
Large B-cell lymphoma	Phase 3	CN	JW Therapeutics (Suzhou) Co., Ltd.	30 Jan 2022
Systemic Lupus Erythematosus	Phase 2	CN	JW Therapeutics (Shanghai) Co., Ltd.	25 Dec 2023
Scleroderma, Systemic	Phase 1	CN	Shanghai Ming Ju Biotechnology Co. Ltd.	01 Jun 2024
Small Lymphocytic Lymphoma	Phase 1	CN	Shanghai Ming Ju Biotechnology Co. Ltd.	20 Jun 2022
Recurrent B Acute Lymphoblastic Leukemia	Phase 1	CN	Shanghai Ming Ju Biotechnology Co. Ltd.	11 May 2022
Refractory B Acute Lymphoblastic Leukemia	Phase 1	CN	Shanghai Ming Ju Biotechnology Co. Ltd.	11 May 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05765006 (EULAR2024) Manual	Phase 1	Systemic Lupus Erythematosus	3	RELMACABTAGENE AUTOLEUCEL	qgrgcpkift(krsrinmwlm) = kqeesumgbf soelthlcrf (fdssaemfnd ) View more	Positive	12 Jun 2024
NCT05727683 (EHA2024) Manual	Phase 1	Pre B-cell acute lymphoblastic leukemia	6	Relma-cel	zvyywckgyh(acetpjcptl) = The most common TEAE were cytopenias (6/6) and CRS (6/6). with none of ≥ grade 3 CRS. 2 patients experienced neurotoxicity (NT), with 1 of grade 4 NT. skzijimpfg (mtgoareden ) View more	Negative	14 May 2024
PRNewswire Manual	Not Applicable	Mantle-Cell Lymphoma	59	Carteyva	ohhhdcydbk(vnbflwkhec) = tjykjpgomn gynbmlmdfr (wcwdmfyyrd ) View more	Positive	04 Jan 2024
ASH2023	Phase 2	Mantle-Cell Lymphoma	66	Relmacabtagene Autoleucel (relma-cel)	pagjingdmv(sasjkgpjvv) = fbaytkobtw ygdootlxkp (npomeqcdjn ) View more	Positive	10 Dec 2023
NCT04089215 (RELIANCE study, Pubmed)	Phase 1/2	Large B-cell lymphoma CD19-targeted	68	100 × 10^6 relma-cel	xctyfobxqh(yzcpxhcfqx) = skizkfoeyv sajqebvaji (vxruzqufhf, 64.73 - 87.49) View more	Positive	01 Feb 2023
NCT04089215 (RELIANCE, Corporate Publications) Manual	Phase 3	Refractory Follicular Lymphoma	-	Relmacabtagene autoleucel	maomaobyxl(oftkqlhvlc) = xpglfmgcax smnrjromii (socjjyfwaj ) View more	Positive	10 Oct 2022
NCT04812691 (ASCO2022) Manual	Phase 1	Large B-cell lymphoma Second line	14	Relmacabtagene autoleucel	zwktwjnonr(muqkwmtdtf) = xelpjpieum hwdknjcigz (weqjgysyjk, 3.2 - NA) View more	Positive	02 Jun 2022
NCT03344367 (JWCAR029-001, ASCO2022)	Phase 1	B-cell lymphoma refractory	23	JWCAR029	fkbwpibidn(xutvrnehed) = techhoopot ckzrytxunu (xqqhabdhuk ) View more	-	02 Jun 2022
NCT04089215 (RELIANCE, ASCO2022)	Phase 2	Diffuse large B-cell lymphoma recurrent	59	relmacabtagene autoleucel (Carteyva 100x10^6 CAR+T cells)	nxzsdjipne(tacvmspnmh) = viwxzjqzhf fcucnyvoly (atdyexukry ) View more	Positive	02 Jun 2022
CSCO2021	Not Applicable	Large B-cell lymphoma	59	relma-cel	eevlxrouxb(wclupqcucx) = xmkumgltno wregcylibl (thhnmlxbqt ) View more	Positive	25 Sep 2021
CSCO2021	Not Applicable	Large B-cell lymphoma	59	relma-cel (liso-cel)	eevlxrouxb(wclupqcucx) = wyfrpojjmz wregcylibl (thhnmlxbqt ) View more	Positive	25 Sep 2021

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