(U.S. time), the U.S. Food and Drug Administration (FDA) officially approved the Investigational New Drug (IND) application submitted by XellSmart Biopharmaceutical (Suzhou) Co., Ltd. for its universal allogeneic off-the-shelf iPS-derived dopaminergic neural progenitor cell therapy for the treatment of Parkinson's disease (PD), the second most common neurodegenerative disease worldwide.

美国时间，苏州赛元生物科技有限公司针对帕金森病（PD）开发的通用型异体iPS衍生多巴胺神经前体细胞疗法的临床试验申请（IND），正式获得美国食品药品监督管理局（FDA）批准。帕金森病是全球第二大常见的神经退行性疾病。

Concurrently, the FDA also granted XellSmart a special exemption to support the clinical trial of XellSmart's cell therapy for PD in the US..

同时，FDA还授予XellSmart特殊豁免，以支持XellSmart在美国进行的PD细胞治疗临床试验。

The approval of XellSmart's clinical trial, along with the special exemption granted, signifies the FDA's recognition of XellSmart's well-established clinical-grade iPSC-derived cell drug development, production, and quality control systems, as well as its completed preclinical safety and efficacy studies.

XellSmart临床试验的批准以及特别豁免的授予，标志着FDA对XellSmart成熟的临床级iPSC衍生细胞药物开发、生产与质量控制系统，及其已完成的临床前安全性和有效性研究的认可。

This approval serves as a strong validation of the scientific rigor, professional expertise, and clinical value of XellSmart's cell therapy for Parkinson's disease..

该批准强有力地验证了XellSmart帕金森病细胞疗法的科学严谨性、专业性和临床价值。

Additionally, XellSmart's allogeneic, off-the-shelf iPSC-derived dopaminergic neural progenitor cell injection ('XS-411 Injection') has also been approved by

此外，XellSmart的同种异体、现成的iPSC衍生的多巴胺能神经祖细胞注射剂（“XS-411注射剂”）也已获得批准。

China's

中国的

National Medical Products Administration (NMPA) to enter Phase I clinical trials.

国家药品监督管理局（NMPA）进入I期临床试验。

China

中国

has the largest population of Parkinson's disease patients globally, with an estimated 5 million cases projected by 2030. The clinical trial approvals from both the U.S. FDA and

全球帕金森病患者人数最多的国家，预计到2030年将达500万例。该药物已获得美国食品药品监督管理局（FDA）和

China's

中国的

NMPA offer hope that XellSmart's XS-411 could potentially benefit Parkinson's disease patients not only in

NMPA 提供了希望，XellSmart 的 XS-411 不仅可能使帕金森病患者受益，

China

中国

and the U.S. but also worldwide.

不仅在美国，而且在全世界。

Pioneering Achievements in XellSmart's iPSC-Derived Cell Therapies to treat PD

XellSmart的iPSC衍生细胞疗法治疗PD的开创性成就

In 2024, XellSmart successfully conducted a clinical study of GMP-grade iPSC-derived cell therapy for treating Parkinson's disease patients in

2024年，XellSmart成功开展了符合GMP标准的iPSC衍生细胞疗法治疗帕金森病患者的临床研究。

China

中国

. This study was officially approved by

本研究已得到正式批准

China's

中国的

National Health Commission, making

国家卫生健康委员会，制定

XellSmart the first to complete an iPSC-derived cell therapy for Parkinson's disease in

XellSmart 首个完成用于帕金森病的 iPSC 衍生细胞疗法的公司

China

中国

.

。

In the clinical study, GMP-grade XS411 cells were transplanted into the striatal putamen of multiple patients with moderate to moderate-to-severe Parkinson's disease. To date, these patients have been followed for 6 to 12 months, with no adverse events related to XS411 reported. All treated patients showed significant improvements in key efficacy indicators, including increased ON time, reduced MDS-UPDRS scores, and enhancements in non-motor functions.

在临床研究中，将符合GMP标准的XS411细胞移植到多名中度至中重度帕金森病患者的纹状体壳核中。截至目前，这些患者已接受6至12个月的随访，未报告与XS411相关的不良事件。所有接受治疗的患者在关键疗效指标上均显示出显著改善，包括开启时间延长、MDS-UPDRS评分降低以及非运动功能的提升。

These positive early-stage clinical results provide promising evidence supporting the continued development of XellSmart's XS411 for Parkinson's disease patients..

这些积极的早期临床结果为继续开发XellSmart的XS411用于帕金森病患者提供了有希望的证据。

Pioneering Achievements in XellSmart's FIC Cell Therapies to treat ALS

XellSmart的FIC细胞疗法治疗ALS的开创性成就

XellSmart has developed XS228, the world's first-in-class, off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapy for ALS, which has been granted Orphan Drug Designation by the U.S. FDA. This designation provides market exclusivity, priority review, and special regulatory supports under the U.S.

XellSmart 开发了 XS228，这是世界上首个用于治疗 ALS 的现成的、同种异体的、临床级别的 iPSC 衍生细胞疗法，并已被美国 FDA 授予孤儿药资格。该资格在美国提供市场独占权、优先审查和特殊的监管支持。

Orphan Drug Act..

《孤儿药法案》

In 2024, XellSmart received official approval from

2024年，XellSmart获得官方批准

China's

中国的

National Health Commission to conduct a clinical study of XS228 for ALS in

国家卫生健康委员会将对XS228治疗ALS进行临床研究。

China

中国

, including

，包括

the world's first case of allogeneic, off-the-shelf iPSC-derived cell transplantation in an ALS patient.

世界上首例ALS患者接受的异体、现成的iPSC衍生细胞移植。

Clinical follow-up results showed that XS228 is safe and effectively slows disease progression compared to the current standard of care.

临床随访结果显示，XS228 是安全的，并且与目前的标准治疗相比，可有效减缓疾病进展。

XellSmart's off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapy (XS228) for ALS has been approved by the FDA to enter Phase I clinical trials, making it the first-in-class regenerative neural cell therapy for ALS.

XellSmart的现成的、同种异体的、临床级iPSC衍生细胞疗法（XS228）用于治疗ALS，已获得FDA批准进入I期临床试验，这使其成为ALS的首个再生神经细胞疗法。

These milestones position XellSmart as a global leader in advancing innovative iPSC-derived regenerative cell therapies for CNS diseases, including Parkinson's disease and ALS.

这些里程碑使 XellSmart 成为推进中枢神经系统疾病（包括帕金森病和 ALS）创新 iPSC 衍生再生细胞疗法的全球领导者。

marks World Parkinson's Disease Day. We named our clinical-grade iPS-derived dopaminergic neural progenitor cell therapy 'XellSmart-411 Injection' (XS-411) as a constant reminder to stay true to our mission and remain dedicated to our original aspiration.

标志着世界帕金森病日。我们将临床级别的iPS衍生多巴胺能神经祖细胞疗法命名为“XellSmart-411注射液”（XS-411），以此作为对我们使命的恒久提醒，始终不忘初心，坚持奉献。

XellSmart is committed to developing universal, off-the-shelf, allogeneic, clinical-grade iPSC-derived regenerative cell therapies to address CNS diseases with significant unmet clinical needs.

XellSmart致力于开发通用型、现成的、同种异体的、临床级别的iPSC衍生再生细胞疗法，以应对中枢神经系统疾病中存在显著未满足临床需求的情况。

The FDA's unconditional approval of the INDs for XellSmart's XS411 and XS228 products, targeting Parkinson's disease and ALS, paves the way for these therapies to advance into clinical trials in

美国食品药品监督管理局（FDA）对XellSmart公司的XS411和XS228产品针对帕金森病和肌萎缩侧索硬化症（ALS）的试验性新药申请（IND）给予了无条件批准，为这些疗法进入临床试验铺平了道路。

XellSmart remains firmly committed to providing allogeneic, off-the-shelf, iPSC-derived regenerative cell therapies to patients with CNS diseases worldwide.'

XellSmart 坚定致力于为全球中枢神经系统疾病患者提供同种异体、现成的、iPSC 衍生的再生细胞疗法。

About XellSmart

关于XellSmart

XellSmart is dedicated to developing universal, off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapies to address Parkinson's disease and other CNS diseases that currently lack effective clinical solutions.

XellSmart致力于开发通用的、现成的、同种异体的、临床级的iPSC衍生细胞疗法，以应对帕金森病和其他目前缺乏有效临床解决方案的中枢神经系统疾病。

XellSmart has built a highly skilled, full-time team with extensive international expertise and established a portfolio of proprietary, cutting-edge technologies and platforms to drive sustained innovation in iPSC-derived cell therapies for CNS diseases.

XellSmart组建了一支高度专业、全职的团队，拥有广泛的国际专业知识，并建立了一系列自主产权的尖端技术与平台，以推动中枢神经系统疾病领域iPSC衍生细胞疗法的持续创新。

XellSmart operates >5,000+ square meter facility comprising an advanced R&D center, GMP production facility, and quality control center. XellSmart has successfully achieved large-scale manufacturing of multiple GMP-grade iPSC-derived neural progenitor cell therapies.

XellSmart运营着一个超过5000平方米的设施，包括先进的研发中心、GMP生产设施和质量控制中心。XellSmart已成功实现多种GMP级iPSC衍生神经祖细胞疗法的大规模生产。

XellSmart's allogeneic iPSC-derived cell therapies, XS411 and XS228, targeting Parkinson's disease and ALS, have been approved to enter Phase I clinical trials in both

XellSmart的同种异体iPSC衍生细胞疗法XS411和XS228，针对帕金森病和ALS，已获准进入一期临床试验。

To date, XellSmart has secured six rounds of financing from top-tier investors, including Frees Fund, Qiming Venture Partners, Lilly Asia Ventures, Sequoia China, and others, underscoring strong market confidence in its innovative therapies and growth potential.

迄今为止，智翔金泰已获得包括礼来亚洲基金、启明创投、红杉中国等顶级投资机构的六轮融资，充分显示了市场对其创新疗法和增长潜力的高度认可。