SHANGHAI, June 19, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced that the National Medical Products Administration of China has approved golidocitinib for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) whose disease has progressed on or were refractory to at least 1 prior systemic therapy.

上海，2024年6月19日/PRNewswire/--Dizal（SSE:688192），一家致力于开发治疗癌症和免疫疾病的新药的生物制药公司，今天宣布，中国国家医药产品管理局已批准戈利多西尼用于治疗复发或难治性（r/r）外周T细胞淋巴瘤（PTCL）的成年患者，这些患者的疾病已经进展或对至少1种先前的全身治疗无效。

To date, golidocitinib is the first and only approved Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients globally..

迄今为止，golidocitinib是全球第一个也是唯一一个被批准用于r/r PTCL患者的Janus激酶1（JAK1）选择性抑制剂。。

PTCL is a heterogeneous group of aggressive T-cell/natural killer (NK) cell non-Hodgkin lymphomas (NHL). Patients with PTCL face an extremely high risk of disease relapse even if they achieved tumor remission following first-line conventional therapy. The outcome for relapsed or refractory patients is extremely poor, with a 3-year survival rate of 23% and a median overall survival (mos.) of 5.8 months.

PTCL是侵袭性T细胞/自然杀伤（NK）细胞非霍奇金淋巴瘤（NHL）的异质性组。PTCL患者即使在一线常规治疗后达到肿瘤缓解，也面临极高的疾病复发风险。复发或难治患者的预后极差，3年生存率为23%，中位总生存期（mos）为5.8个月。

Although couple of drugs have been granted conditional approval by regulatory agencies in the relapsed or refractory setting, their single agent activities have been modest, with objective response rates (ORRs) lower than 30%..

尽管在复发或难治性环境中，监管机构已经有条件批准了两种药物，但它们的单药活性并不高，客观缓解率（ORR）低于30%。。

Golidocitinib was approved based on findings from JACKPOT8 Part B (JACKPOT8B) study, the multinational pivotal study to evaluate the efficacy and safety of golidocitinib in r/r PTCL as a monotherapy. The primary endpoint was the objective response rate (ORR), assessed by an independent review committee (IRC).

Golidocitinib是根据JACKPOT8 Part B（JACKPOT8B）研究的结果批准的，JACKPOT8 Part B（JACKPOT8B）研究是一项跨国关键研究，旨在评估Golidocitinib在r/r PTCL中作为单一疗法的疗效和安全性。主要终点是客观缓解率（ORR），由独立审查委员会（IRC）评估。

Full analysis of the study was simultaneously published in The Lancet Oncology and presented in oral session at the 65th American Society of Hematology Annual Meeting and Exposition..

该研究的完整分析同时发表在《柳叶刀肿瘤学》上，并在第65届美国血液学会年会和博览会的口头会议上发表。。

In JACKPOT8B study, golidocitinib demonstrated superior and durable antitumor efficacy and a favorable safety profile in r/r PTCL patients, compared with existing treatment options. At the data cut-off date August 31, 2023, the ORR was 44.3% including a complete response (CR) rate of 23.9% per IRC. Tumor responses were observed across various PTCL subtypes.

在JACKPOT8B研究中，与现有治疗方案相比，戈利多西尼在r/r PTCL患者中表现出优异且持久的抗肿瘤疗效和良好的安全性。在2023年8月31日的数据截止日期，ORR为44.3%，其中每个IRC的完全缓解率（CR）为23.9%。在各种PTCL亚型中观察到肿瘤反应。

The median duration of response (mDoR) was 20.7 months and 53.8% of patients were still responding..

中位反应持续时间（mDoR）为20.7个月，53.8%的患者仍有反应。。

'Golidocitinib features novel mechanism and unique molecular design, positioning it as the first oral JAK1 only inhibitor for the treatment of r/r PTCL. Multiple studies have clearly demonstrated its favorable pharmacokinetic properties and significant clinical benefit,' said Jun Zhu, MD, PhD at the Department of Lymphoma, Peking University Cancer Hospital and Institute, the leading principal investigator of the JACKPOT8B study, 'Golidocitinib achieved an ORR of 44.3% and a DoR of 20.7 months in r/r PTCL.

“Golidocitinib具有新颖的机制和独特的分子设计，将其定位为第一种仅用于治疗r/r PTCL的口服JAK1抑制剂。“多项研究清楚地证明了其良好的药代动力学特性和显着的临床益处，”JACKPOT8B研究的首席首席研究员、北京大学肿瘤医院和研究所淋巴瘤科医学博士朱军（Jun Zhu）说，“戈利多西尼在r/r PTCL中的ORR为44.3%，DoR为20.7个月。

It's approval and market launch provide a much needed option for doctors to treat PTCL patients.'.

它的批准和市场推出为医生治疗PTCL患者提供了急需的选择。”。

Dizal was the first to identify and validate targeting the JAK/STAT pathway as a promising therapeutic approach for PTCL, leading to the development of golidocitinib as the world's first JAK1 only inhibitor. With > 200 to 400-fold selectivity over other JAK family members and ideal pharmacokinetic properties, golidocitinib exerts potent antitumor efficacy with a favorable safety profile..

Dizal是第一个鉴定和验证靶向JAK/STAT途径作为PTCL有前途的治疗方法的人，导致了戈利多西尼作为世界上第一种仅JAK1抑制剂的发展。与其他JAK家族成员相比，golidocitinib具有>200至400倍的选择性和理想的药代动力学特性，可发挥有效的抗肿瘤功效，并具有良好的安全性。。

'We are thrilled to bring golidocitinib, the world's first JAK1 only inhibitor, to patients in China, marking the second approved innovative drug from Dizal,' said Xiaolin Zhang, PhD, CEO of Dizal. 'Golidocitinib yields good antitumor efficacy across different subtypes of PTCL, which differentiate golidocitinib from other targeted therapies.

Dizal首席执行官张晓林（Xiaolin Zhang）博士说，我们很高兴将世界上第一种仅JAK1抑制剂golidocitinib带给中国患者，这是Dizal第二种获得批准的创新药物Golidocitinib在PTCL的不同亚型中产生良好的抗肿瘤功效，这将Golidocitinib与其他靶向疗法区分开来。

At Dizal, we aspire to discover and develop first-in-class and groundbreaking new medicines to address unmet medical needs around the world. With the US FDA Fast Track designation, we are expediting global development of golidocitinib to bring this exciting drug to patients worldwide.'.

在迪扎尔，我们渴望发现和开发一流和开创性的新药，以解决世界各地未满足的医疗需求。随着美国FDA快速通道的指定，我们正在加速戈利多西尼的全球开发，将这种令人兴奋的药物带给全世界的患者。”。

With superior efficacy and safety profile, golidocitinib has been widely acknowledged at prestigious international congresses including ASCO, EHA, ICML, and ASH, with six oral presentations over four consecutive years. The results of the multinational study JACKPOT8 were published in Annals of Oncology and The Lancet Oncology..

golidocitinib具有优异的疗效和安全性，在包括ASCO，EHA，ICML和ASH在内的著名国际大会上得到了广泛认可，连续四年进行了六次口头演讲。多国研究JACKPOT8的结果发表在《肿瘤学年鉴》和《柳叶刀肿瘤学》上。。

About golidocitinib (DZD4205)

关于戈利多西替尼（DZD4205）

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL)..

Golidocitinib目前是第一个也是唯一一个被评估用于治疗r/r PTCL的Janus激酶1（JAK1）选择性抑制剂。2024年6月，golidocitinib被中国国家医药产品管理局（NMPA）批准用于治疗复发或难治性外周T细胞淋巴瘤（r/r PTCL）的成年患者。。

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S.

在2023年8月31日的数据截止日期，戈利多西替尼已显示出强大而持久的抗肿瘤功效，ORR为44.3%。超过50%的肿瘤缓解患者达到完全缓解，CRR为23.9%。根据IRC评估，mDoR达到20.7个月。Golidocitinib被美国授予快速通道称号。

FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4)..

FDA于2022年2月用于治疗r/r PTCL。2023年9月，CDE接受了其NDA，并对治疗r/r PTCL给予了优先审查。golidocitinib（JACKPOT8 PART A）的I期临床数据发表在《肿瘤学年鉴》（影响因子：51.8）上，golidocitinib治疗r/r PTCL的全球关键试验数据（JACKPOT PART B）发表在《柳叶刀肿瘤学》（影响因子：54.4）上。。

About Dizal

关于Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide.

Dizal是一家生物制药公司，致力于发现，开发和商业化用于治疗癌症和免疫疾病的差异化疗法。该公司旨在开发一流和开创性的新药，并进一步满足全球未满足的医疗需求。

Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China. .

它植根于转化科学和分子设计，建立了具有国际竞争力的投资组合，拥有全球关键研究中的两项领先资产，这两项研究均已在中国推出。。