STOCKHOLM, July 2, 2024 /PRNewswire/ -- Sobi® today announced the initiation of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SEL-212. The submission is based on the results of the DISSOLVE I and II pivotal studies. SEL-212 is an innovative biologic therapy in development for the treatment of chronic refractory gout, a debilitating condition characterised by the persistent and painful buildup of urate crystals in the joints..

斯德哥尔摩，2024年7月2日/PRNewswire/--Sobi®今天宣布开始向美国食品和药物管理局（FDA）申请SEL-212的滚动生物制剂许可证（BLA）。提交的内容基于溶解I和II关键研究的结果。SEL-212是一种正在开发的创新生物疗法，用于治疗慢性难治性痛风，这是一种以关节中尿酸盐晶体持续和痛苦累积为特征的衰弱性疾病。。

This significant milestone follows the FDA's Fast Track designation of SEL-212 in March 2024, underscoring the urgent need for new treatment options for patients with chronic refractory gout. The FDA's Fast Track program is intended to facilitate the development and expedite the review of medicines that treat serious conditions and fill an unmet medical need..

这一重要里程碑是在2024年3月FDA快速指定SEL-212之后，强调迫切需要为慢性难治性痛风患者提供新的治疗选择。FDA的快速通道计划旨在促进治疗严重疾病和满足未满足医疗需求的药物的开发和加速审查。。

'We are very pleased to initiate the rolling submission of the BLA for SEL-212, bringing Sobi one step closer to providing a potential new, effective treatment option for patients with chronic refractory gout,' said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs, and Chief Medical Officer at Sobi.

“我们很高兴启动SEL-212的BLA滚动提交，使Sobi更接近为慢性难治性痛风患者提供潜在的新的有效治疗选择，”Sobi研究、开发和医疗事务负责人兼首席医疗官、MBA医学博士Lydia Abad Franch说。

'The Fast Track designation confirms the previously released SEL-212 phase 3 clinical data, highlighting the significant need for innovative therapies in this space and reinforcing our commitment to transforming the lives of patients with rare diseases.'.

“快速通道指定证实了先前发布的SEL-212 3期临床数据，突出了在这一领域对创新疗法的重大需求，并加强了我们对改变罕见疾病患者生活的承诺。”。

SEL-212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which can lead to gout flares and joint deformity when left untreated. Sobi licensed SEL-212 from Selecta Biosciences (now Cartesian Therapeutics) in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China..

SEL-212是一种新型的研究性联合用药，旨在降低慢性难治性痛风患者的血清尿酸（SU）水平，潜在地减少有害组织尿酸盐沉积，如果不及时治疗，可能导致痛风发作和关节畸形。Sobi于2020年6月从Selecta Biosciences（现为Cartesian Therapeutics）获得SEL-212许可，负责中国以外所有市场的开发、监管和商业活动。。

About SEL-212

关于SEL-212

SEL-212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, Selecta's proprietary pegylated uricase, co-administered with ImmTOR™, designed to mitigate the formation of anti-drug antibodies (ADAs).

SEL-212是一种新型的研究性联合用药，旨在降低慢性难治性痛风患者的血清尿酸（SU）水平，潜在地减少有害的组织尿酸盐沉积，如果不及时治疗，可能导致痛风发作和关节畸形。SEL-212由pegadricase（Selecta专有的聚乙二醇化尿酸酶）组成，与ImmTOR™共同给药，旨在减轻抗药物抗体（ADA）的形成。

ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout..

ADA的发展是由于对生物药物产生不必要的免疫反应，降低了它们的疗效和耐受性，这仍然是多种治疗方式和疾病状态（包括慢性难治性痛风）的问题。。

About Chronic refractory gout

关于慢性难治性痛风

Gout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain.

痛风是最常见的炎性关节炎，美国有830多万人被诊断出患有痛风，这是由体内高水平的尿酸引起的，尿酸在关节和其他组织周围积聚，并可能导致眩晕，导致剧烈疼痛。

Approximately 200,000 people in the United States suffer from chronic gout refractory to conventional medicines, a painful and debilitating condition in people with SU levels above 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi.

美国约有200000人患有常规药物难治的慢性痛风，SU水平高于6 mg/dL的人会感到痛苦和虚弱，因此每年会出现几次眩晕，并可能形成结节状尿酸晶体，称为痛风石。

Elevated SU levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints..

SU水平升高与心脏、血管系统、新陈代谢、肾脏和关节疾病有关。。

About Cartesian Therapeutics

关于笛卡尔疗法

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company's lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in phase 2b clinical development for patients with generalised myasthenia gravis. Additional phase 2 studies are planned in systemic lupus erythematosus under an allowed IND, as well as basket trials in additional autoimmune indications.

Cartesian Therapeutics是一家临床阶段公司，开创了用于治疗自身免疫性疾病的mRNA细胞疗法。该公司的主要资产Descartes-08是针对全身性重症肌无力患者的2b期临床开发中潜在的一流mRNA CAR-T。在允许的IND下，计划在系统性红斑狼疮中进行其他2期研究，以及在其他自身免疫适应症中进行篮式试验。

The Company's clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T..

该公司的临床阶段管道还包括下一代自体抗BCMA mRNA CAR-T笛卡尔-15。。

About Sobi®

关于索比®

Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia.

Sobi®是一家专业的国际生物制药公司，致力于改变患有罕见疾病和衰弱疾病的人们的生活。在血液学，免疫学和专科护理领域提供可靠的创新药物。Sobi在欧洲、北美、中东、亚洲和澳大利亚拥有约1800名员工。

In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn..

2023年，收入达到221亿瑞典克朗。Sobi的股票（STO:Sobi）在纳斯达克斯德哥尔摩上市。有关Sobi的更多信息，请访问Sobi.com和LinkedIn。。