- Relapsed and refractory peripheral T-cell lymphoma (r/r PTCL) has a high degree of malignancy, strong heterogeneity, complex pathogenesis, and poor prognosis with a 3-year survival rate of only 23%.
- There has been no innovative drug launched for r/r PTCL in the past ten years. Currently, monotherapy treatment has bottleneck efficacy and urgently needs breakthrough therapeutic solutions.
- Gao Ruizhe.It is the world's first and only new mechanism for PTCL treatment that acts on the JAK/STAT pathway.
- Gao Ruizhe.Monotherapy treatment of PTCL breaks through the treatment bottleneck: deep remission, comprehensive benefits, and longer survival.
SHANGHAI, June 19, 2024 / PRNewswire / -- DiZhe Pharmaceuticals Co., Ltd. (stock code: 688192.SH) announced that its independently developed Class I new drug—the first and only highly selective JAK1 inhibitor Gao Ruizhe in the field of lymphomaGabrixta (generic name: girocetinib capsules) has been officially approved by the National Medical Products Administration (NMPA) for monotherapy in adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one line of systemic treatment.
Comprehensively breakthroughPTCLTreatment bottleneck: deep remission, comprehensive benefits, longer survival
Gao Ruizhe.This approval and launch in China is based on the key global registration clinical study JACKPOT8 Part B, which aims to evaluate the efficacy and safety of Gao Ruizhe in treating r/r PTCL, with the main endpoint as the objective response rate (ORR) evaluated by an independent image evaluation committee (IRC). The study results were orally presented at the 65th Annual Meeting of the American Society of Hematology (ASH) in 2023 and simultaneously published in The Lancet Oncology (IF: 54.4).The study results show that Gao Ruizhe monotherapy treatment r/r PTCL:Deep remission:ORR confirmed by IRC reached 44.3%, and complete remission (CR) rate reached 23.9%, which are nearly twice as effective as previous targeted treatment strategies.
Gao RuizheMonotherapy treatment for r/r PTCL:
- Deep remission:ORR confirmed by IRC reached 44.3%, and complete remission (CR) rate reached 23.9%, which are nearly twice as effective as previous targeted treatment strategies.
- Comprehensive benefits:Tumor remission was observed in different subtypes of PTCL, meeting the treatment needs of PTCL subtypes that could not be covered by previous drugs.
- Longer survival:The median duration of response (DoR) is as long as 20.7 months (DoR of other existing therapies is less than 12 months).
JACKPOT8Professor Zhu Jun of Peking University Cancer Hospital, the main investigator of the study, said:Gao Ruizhe's approved listing is expected to break through the bottleneck of PTCL treatment and bring a new pattern to PTCL diagnosis and treatment."Giricizumab, with a new mechanism and new structure, is the world's first oral JAK1 highly selective inhibitor targeting PTCL, with good pharmacokinetic properties. It is the only JAK inhibitor that has made breakthroughs in the lymphoma field through its mechanism and clinical results, demonstrating its potential to benefit all subtypes of PTCL. The ORR of single-agent treatment for r/r PTCL reached 44.3%, and the DoR reached 20.7 months. The approval and launch of Giricizumab is expected to break through the treatment bottlenecks of PTCL and bring a new pattern to the diagnosis and treatment of PTCL."Innovative drugs such as Gao Ruizhe's are expected to break through the bottleneck of PTCL treatment, bringing a new pattern to PTCL diagnosis and treatment.
New mechanism, new structure, breakthrough:PTCL:10-year dilemma of "no innovative drugs" in the PTCL field:
PTCL is a malignant tumor originating from mature T/NK cells behind the thymus, with the lowest survival rate among all non-Hodgkin's lymphomas. The first-line standard treatment is CHOP-based quadruple chemotherapy, and patients with remission after treatment have a high risk of recurrence. The prognosis for r/r PTCL patients is extremely poor, and the effect of previous monotherapy for this group is very limited, with a 3-year survival rate of only 23% and a median overall survival (OS) of only 5.8 months. In addition, there has been no innovative drug launched in this field in the past decade, and there is an urgent need for innovative breakthroughs in clinical treatment bottlenecks.Dizocilpine was the first to discover and verify that the JAK/STAT pathway is a high-potential intervention target for the treatment of PTCL, creating the world's first targeted JAK/STAT pathway treatment for PTCL.
DiscoveRing and validating the JAK/STAT pathway as a high-potential intervention target for treating PTCL, Di Zhe initiated the innovative treatment of PTCL.targetingJAK/STATpathway treatmentPTCLThe new mechanism of action.At the same time, the unique "two hydrogen bonds and one salt bridge" innovative molecular structure design achieves high ruxolitinib selectivity relative to other members of the JAK family (up to 200-400 times) and long half-life, which greatly improves treatment safety and tolerability while achieving sustained and stable strong inhibition of PTCL.Founder, chairman, and CEO of DiZhe Medicine, Dr. Zhang Xiaolin said, "I am delighted to see high ruxolitinib, as the world's first and only high-selectivity JAK1 inhibitor for the treatment of PTCL, receive approval for market launch in China, which allows Chinese patients to be the first to benefit from this globally innovative therapy. This is the second global first/potential best-in-class innovative drug launched by DiZhe in one year. With its new mechanism of action, high ruxolitinib can effectively treat various subtypes of PTCL, filling the gap in previous drug therapy for multiple subtypes. DiZhe Medicine always insists on original innovation and is committed to launching globally first-in-class and with breakthrough potential innovative therapies to meet unmet clinical needs worldwide. High ruxolitinib has received "Fast Track" designation from the United States Food and Drug Administration (FDA), and we will accelerate global development processes to provide better treatment options for more patients worldwide."RuxolitinibJAK1High selectivity(Relative to other members of the JAK family, up to 200-400 times)Long half-lifeWhile achieving sustained and stable strong inhibition of PTCL, it greatly improves treatment safety and tolerability.
Founder, chairman, and CEO of DiZhe Medicine, Dr. Zhang Xiaolin said,
"I am delighted to see high ruxolitinibas the world's first and only high-selectivity JAK1 inhibitor for the treatment of PTCL, receive approval for market launch in China, which allows Chinese patients to be the first to benefit from this globally innovative therapy. This is the second global first/potential best-in-class innovative drug launched by DiZhe in one year. With its new mechanism of action, high ruxolitinib can effectively treat various subtypes of PTCL, filling the gap in previous drug therapy for multiple subtypes. DiZhe Medicine always insists on original innovation and is committed to launching globally first-in-class and with breakthrough potential innovative therapies to meet unmet clinical needs worldwide. High ruxolitinibcan effectively treat various subtypes of PTCL, filling the gap in previous drug therapy for multiple subtypes. DiZhe Medicine always insists on original innovation and is committed to launching globally first-in-class and with breakthrough potential innovative therapies to meet unmet clinical needs worldwide. High ruxolitinib has received "Fast Track" designation from the United States Food and Drug Administration (FDA), and we will accelerate global development processes to provide better treatment options for more patients worldwide."has received "Fast Track" designation from the United States Food and Drug Administration (FDA), and we will accelerate global development processes to provide better treatment options for more patients worldwide.
With advantages in efficacy and safety, high ruxolitinib has been selected for 6 oral reports at international top academic conferences such as ASCO, ASH, and ICML for 4 consecutive years, and related research results have been published in international authoritative journals such as Annals of Oncology (IF: 51.8) and The Lancet Oncology (IF: 54.4). In April of this year, high ruxolitinibas an innovative drug included in the National Medical Products Administration (NMPA) priority review program, received a level Ⅱ recommendation in the 2024 CSCO lymphoma diagnosis and treatment guidelines.Annals of OncologyThe Lancet OncologyLancet Oncology(IF: 54.4)as the world's first and only high-selectivity JAK1 inhibitor for the treatment of PTCL, has received approval for market launch in China, which allows Chinese patients to be the first to benefit from this globally innovative therapy.
About Gao Ruizhe.(Gloricidin).
Gao RuizheIt is a highly selective Janus kinase 1 (JAK1) inhibitor independently developed by Dizal. It is the world's first and only new mechanism therapeutic drug for PTCL that acts on JAK/STAT pathway. In June 2024, it was approved by the National Medical Products Administration for the first launch in China. It is a monotherapy suitable for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least first-line systemic therapy.
About Dizal Pharma
Dizal Pharma (Stock Code: 688192.SH) is an innovative biomedical enterprise focused on researching, developing, and commercializing innovative therapies in the areas of malignant tumors and immunological diseases. The company insists on the research and development philosophy of original innovation, aiming to launch globally pioneering drugs (First-in-class) and therapies with breakthrough potential, and filling the clinical needs not met globally. Based on the industry-leading translational science and new drug molecule design and screening technology platform, the company has established six product pipelines with global competitiveness, two of which are leading products in the world's critical clinical trial stages, both of which have been approved and launched in China. For more information, please follow our WeChat official account: Dizal Pharma, or visit www.dizalpharma.com.
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