XellSmart
XellSmart (士泽生物) is a Suzhou-based clinical-stage biopharma developing allogeneic off-the-shelf iPSC-derived cell therapies for Parkinson's disease, ALS, and spinal cord injury, serving CNS disease patients with nine FDA/NMPA IND clearances and the first FDA Orphan Drug Designation for a Chinese iPSC-derived cell drug.
- Company typePrivate
- Founded2021
- HeadquartersSuzhou, China
- Headcount51–100
- GTM typeB2B
- OfferingServices
What XellSmart does
XellSmart (士泽生物) is a Suzhou-headquartered, clinical-stage Chinese biopharmaceutical company founded in 2021 by Dr. Li Xiang that develops clinical-grade, allogeneic off-the-shelf iPSC (induced pluripotent stem cell)-derived cell therapies for central nervous system (CNS) diseases that currently lack effective disease-modifying treatments. The company operates two product candidates: XS411 injection, an allogeneic iPSC-derived dopaminergic neural progenitor cell therapy for Parkinson's disease (currently in Chinese Phase I and US registrational Phase II trials), and XS228 injection, an iPSC-derived subtype-specific spinal cord neural progenitor cell therapy for ALS and spinal cord injury (with FDA Orphan Drug Designation for ALS, the first ever awarded to a Chinese self-developed iPSC-derived cell drug). XellSmart has built four integrated core technology platforms covering iPSC reprogramming, gene editing, directed neural differentiation, and a next-generation immune-privileged iPSC cell line developed in partnership with a national stem cell resource bank, supported by 40+ global patents and a >5,000 sqm R&D and B+A-grade GMP manufacturing facility.
XellSmart firmographics
Firmographics- Name
- XellSmart
- Legal name
- 士泽生物医药(苏州)有限公司 / 士泽生物医药(上海)有限公司 (XellSmart Biomedical Co., Ltd.)
- Website
- https://xellsmart.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- XellSmart (士泽生物) is a Suzhou-based clinical-stage biopharma developing allogeneic off-the-shelf iPSC-derived cell therapies for Parkinson's disease, ALS, and spinal cord injury, serving CNS disease patients with nine FDA/NMPA IND clearances and the first FDA Orphan Drug Designation for a Chinese iPSC-derived cell drug.
- Ownership category
- akta.pro rank
Where XellSmart is headquartered
LocationHeadquarters
- HQ city
- Suzhou
- HQ country
- China
- HQ region
- Asia
Offices2 records
Markets served
XellSmart business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Infrastructure, Operations
Revenue model
- iPSC Cell Therapy Pipeline: XellSmart is a pre-revenue clinical-stage biopharmaceutical company developing allogeneic off-the-shelf iPSC-derived cell therapies for CNS diseases. The company has not yet commercialized any products. Revenue will derive from therapeutic product sales following regulatory approval, with potential for premium pricing supported by orphan drug designations and breakthrough therapy designations.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
XellSmart product offering
Product offeringCore offering
XellSmart develops clinical-grade, allogeneic off-the-shelf induced pluripotent stem cell (iPSC)-derived cell therapies targeting central nervous system (CNS) diseases. Its lead clinical assets are XS411 Injection, an iPSC-derived dopaminergic neural progenitor cell therapy for Parkinson's disease, and XS228 Injection, a subtype-specific neural progenitor cell therapy for ALS (amyotrophic lateral sclerosis) and spinal cord injury. The company has secured nine FDA and NMPA IND clearances, including four consecutive dual-jurisdiction approvals, and has initiated Phase I/II registrational clinical trials across Parkinson's disease, ALS, spinal cord injury, and MSA-P indications in both China and the United States.
Product overview
XellSmart develops clinical-grade allogeneic off-the-shelf iPSC-derived cell drugs for treating central nervous system (CNS) diseases. The company's core products include XS411 injection (dopaminergic neural progenitor cells for Parkinson's disease) and XS228 injection (neural progenitor cells for ALS and spinal cord injury). Both products are manufactured using proprietary iPSC technology platforms and have received multiple regulatory approvals from FDA and NMPA for clinical trials.
Differentiator
Problem solved
Functional benefit
Brands
- XS411注射液 (XS411 Injection): 异体通用现货型iPSC衍生多巴胺能神经前体细胞注射液，用于治疗原发性帕金森病和早发性帕金森病，国家I类新药。
- XS228注射液 (XS228 Injection)
Products and services
- XS411 Injection (XS411注射液) Clinical-grade allogeneic off-the-shelf iPSC-derived dopaminergic neural progenitor cell therapy for treatment of Parkinson's disease (both primary and early-onset forms). The drug has received dual IND clearance from both US FDA and China NMPA for registrational clinical trials. Multiple Parkinson's patients have been treated with >18 months follow-up data showing improvements in off-time and MDS-UPDRS scores with good safety profile.
- XS228 Injection (XS228注射液) Global first iPSC-derived subtype-specific neural progenitor cell therapy targeting ALS (amyotrophic lateral sclerosis) and spinal cord injury (SCI). First Chinese self-developed iPSC cell therapy to receive FDA orphan drug designation globally and the world's first iPSC-derived cell drug with orphan drug status for ALS. In spinal cord injury, patients have shown motor function improvement as early as 12 days after dosing (right upper limb improved from grade 0 to microflexion, right lower limb from grade 0 to grade 4-5).
Quantifiable outcome
- 帕金森病患者经XS411细胞移植后，开关期时间及MDS-UPDRS评分显著改善，多例患者随访超过18个月，显示出良好安全性。
- +2 more outcomes
Companies that use XellSmart
Customer profileNamed customers8 records
Segments4 records
Ideal customer profiles2 records
XellSmart technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
XellSmart partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core and minor.
- Beijing Tiantan Hospital / 北京天坛医院core国家级神经疾病医学中心，牵头XS411注射液注册临床I期试验用于治疗原发性帕金森病。
- Peking Union Medical College Hospital / 北京协和医院core联合中心参与XS411注射液注册临床I期试验，由王任直主任、包新杰主任、王含主任团队执行。
- Fudan University Huashan Hospital / 复旦大学附属华山医院core国家级神经疾病医学中心，牵头开展随机双盲对照设计注册临床I/II期试验用于治疗早发性帕金森病，获国家脑科学计划重大专项支持。
- Sun Yat-sen University Third Affiliated Hospital / 中山大学附属第三医院core牵头开展全球首例iPSC衍生亚型神经前体细胞治疗脊髓损伤注册临床I期试验，由戎利民院长团队执行。
- Dalian Medical University First Affiliated Hospital / 大连医科大学附属第一医院core联合中心参与XS228注射液治疗脊髓损伤注册临床试验，由刘晶院长团队执行。
- Soochow University Second Affiliated Hospital / 苏州大学附属第二医院core联合中心参与早发性帕金森病注册临床I/II期试验，由刘春风主任牵头。
- Peking University Third Hospital / 北京大学第三医院core牵头开展XS228注射液注册临床I/II期试验用于治疗渐冻症(ALS)，由樊东升主任团队执行。
- Roche Accelerator (罗氏中国加速器)core从200多家申请者中脱颖而出，成为15家罗氏中国加速器成员企业之一。罗氏为士泽生物提供全球专业顾问团队及配套科学资源，加速推动iPS衍生细胞药治疗CNS疾病的研发和产业化。
- Shanghai East Hospital / 上海市东方医院core国家首批干细胞临床研究备案机构，完成中国首例iPSC衍生细胞治疗帕金森病及全球首例渐冻症治疗。刘中民院士团队牵头合作。
- 中国药品监督管理研究会细胞与基因治疗产品监管研究专业委员会minor担任委员单位，参与CGT产品监管政策研究和行业标准制定。
- 中国干细胞产业联盟minor担任副理事长单位，李翔博士担任副理事长。
- 国家干细胞资源库core与国家级干细胞资源库达成战略合作，共同推进新一代创新性iPS细胞系的授权开发与成果转化，支持全球领先的免疫豁免iPSC细胞系的商业化。
Scale indicators7 records
Recent moves7 records
Expansion highlights6 records
XellSmart competitors and assessment
Company assessmentDirect peers
- BlueRock Therapeutics: Bayer-owned clinical-stage cell therapy company developing iPSC-derived dopaminergic cell therapies for Parkinson's disease (bemdaneprocel). BlueRock is the most direct competitor to XellSmart's XS411, targeting the same indication with similar iPSC-derived neural progenitor cell technology but with deeper capital and earlier FDA positioning.
- Aspen Neuroscience: U.S.-based clinical-stage company developing iPSC-derived autologous cell therapies for Parkinson's disease (ANPD001). While autologous rather than allogeneic, Aspen is a directly comparable CNS-focused iPSC cell therapy peer targeting the same patient population as XS411.
- Century Therapeutics: Clinical-stage biotech developing allogeneic iPSC-derived cell therapies engineered with multiple gene edits to enhance persistence and evade immune rejection. Comparable platform architecture (iPSC + gene editing + directed differentiation) to XellSmart, though primarily focused on oncology rather than CNS.
- Fate Therapeutics: Pioneer in iPSC-derived off-the-shelf NK and T-cell cancer immunotherapies. Directly comparable for the allogeneic iPSC platform, GMP manufacturing know-how, and multi-program clinical pipeline structure, though operating in oncology rather than CNS indications.
- BrainStorm Cell Therapeutics: Clinical-stage cell therapy company developing autologous MSC-NTF cells for neurodegenerative diseases including ALS (NurOwn). Directly comparable therapeutic-area overlap (ALS, CNS) and cell therapy modality, though using a different cell source (MSC vs. iPSC-derived neural).
Emerging players
- Sana Biotechnology: U.S.-based cell and gene therapy company with platforms spanning iPSC-derived cells, in vivo gene editing, and ex vivo cell engineering. Notably, XellSmart founder Dr. Li Xiang previously worked at Sana, and the two share scientific lineage in cell engineering approaches to disease.
- Neurophth Therapeutics: China-based clinical-stage gene therapy company developing AAV-based treatments for ophthalmologic and CNS diseases. Comparable as a Chinese biotech tackling CNS disorders with advanced therapeutic modalities, though using gene therapy rather than iPSC-derived cell therapy.
Regional players
- Helixmith (formerly ViroMed): Korean clinical-stage biotech developing gene therapies for CNS and cardiovascular indications (including Engensis for diabetic neuropathy). Comparable as an Asia-headquartered advanced therapy biotech focused on CNS, but operating in a different modality (gene therapy vs. cell therapy).
Broad incumbents
- Bayer (Pharmaceutical Division): Global pharmaceutical major and parent of BlueRock Therapeutics, with established CNS, neurology, and rare disease commercial infrastructure. Represents the largest incumbent competing in the iPSC cell therapy space via BlueRock and could be a potential strategic acquirer or partner for XellSmart.
- Sumitomo Pharma (formerly Sumitomo Dainippon Pharma): Japanese global pharma with significant CNS / neurology franchise (latuda, etc.) and active regenerative medicine strategy, including iPSC-derived cell therapy investments. Relevant as a major Asia-headquartered incumbent with CNS commercial reach and cell therapy strategic interest.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
XellSmart compliance and trust
Trust signalCompliance7 records
XellSmart financial estimates
Financial estimateRevenue estimate
Valuation estimate
XellSmart leadership team
Management profileNumber of profiles
Profiles1 record
XellSmart funding detail
Funding detailFunding overview
Funding rounds6 records
Investors43 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
XellSmart M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about XellSmart
What does XellSmart do?
XellSmart develops clinical-grade, allogeneic off-the-shelf induced pluripotent stem cell (iPSC)-derived cell therapies targeting central nervous system (CNS) diseases. Its lead clinical assets are XS411 Injection, an iPSC-derived dopaminergic neural progenitor cell therapy for Parkinson's disease, and XS228 Injection, a subtype-specific neural progenitor cell therapy for ALS (amyotrophic lateral sclerosis) and spinal cord injury. The company has secured nine FDA and NMPA IND clearances, including four consecutive dual-jurisdiction approvals, and has initiated Phase I/II registrational clinical trials across Parkinson's disease, ALS, spinal cord injury, and MSA-P indications in both China and the United States.
Is XellSmart a public or private company?
XellSmart is a private company. It is classified as venture growth investor backed and is currently operating.
When was XellSmart founded?
XellSmart was founded in 2021. It employs 51 to 100 people.
Where is XellSmart based?
XellSmart is headquartered in Suzhou, China, in the Asia region.
How does XellSmart make money?
One revenue line is on record: iPSC Cell Therapy Pipeline.
Who are XellSmart's main competitors?
Direct peers on record are BlueRock Therapeutics, Aspen Neuroscience, Century Therapeutics, Fate Therapeutics and BrainStorm Cell Therapeutics. Emerging players are Sana Biotechnology and Neurophth Therapeutics. Helixmith (formerly ViroMed) is listed as a regional player. Broad incumbents are Bayer (Pharmaceutical Division) and Sumitomo Pharma (formerly Sumitomo Dainippon Pharma).
Does XellSmart have an API?
No public API is recorded for XellSmart.