8. 产品管线-脐带间充质干细胞

8. Celzyva产品管线：脐带间充质干细胞 Celzyva Product Pipeline: Umbilical Cord Mesenchymal Stem Cells

间充质干细胞是一类重要的具医疗作用的细胞药物，2024-5年美国FDA和中国药监局(NMPA)各批准上市一款间充质干细胞药物Ryoncil (remestemcel-L-rknd)、艾米迈托赛注射液(睿铂生)。此前，也已有12项MSC疗法在日本、欧盟、韩国等地获批上市。
Mesenchymal stem cells (MSC) are an important class of cellular therapeutics with significant medical applications. In 2024 and 2025, the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) each approved a mesenchymal stem cell drug for marketing: Ryoncil (remestemcel-L-rknd) and Aimeituosai Injection (Ruibosheng), respectively. Prior to these approvals, 12 MSC therapies had already been approved for market in regions such as Japan, the European Union, and South Korea.

8.1. Celzyva脐带间充质干细胞产品总览与管线图 Overview & Pipeline Diagram of Celzyva UC-MSC Products

在中国，UC-MSC在研新药大数量地存在于各公司的研发管线中，很多已进入II或III期临床试验；同时在过去很长一段时期里，UC-MSC临床应用曾较大规模地存在于法律灰色地带，由此产生了大量UC-MSC临床信息。Celzyva基于中国大量的UCMSC临床信息，仔细筛选和立项了22个UC-MSC新药进行开发。

In China, a large number of UC-MSC drug candidates are currently under development across the pipelines of numerous companies, with many having advanced into Phase II or Phase III clinical trials. In addition, for an extended period, UC-MSCs were used clinically on a relatively large scale within a regulatory gray area, generating a substantial body of clinical information and real-world experience.

Leveraging this extensive body of UC-MSC clinical information from China, Celzyva systematically evaluated potential indications, carefully selected the most promising opportunities, and established a development portfolio of 22 UC-MSC drug candidates.

8.2. 已完成临床前研发并已获批IND的、处于I/II期临床试验阶段的人脐带间充质干细胞静脉注射液产品管线 IND-approved, Phase I/II clinical-stage human UC-MSC intravenous injection product pipeline

8.2.1. 人脐带间充质干细胞静脉注射液治疗强直性脊柱炎 Human UC-MSC IV Injection for Ankylosing Spondylitis (AS)

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8.2.2. 人脐带间充质干细胞静脉注射液治疗乙肝肝硬化 Human UC-MSC IV Injection for HBV-Related Cirrhosis

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8.2.3. 人脐带间充质干细胞静脉注射液治疗急性呼吸窘迫症 Human UC-MSC IV Injection for Acute Respiratory Distress Syndrome (ARDS)

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8.2.4. 人脐带间充质干细胞静脉注射液治疗慢性阻塞性肺疾病 Human UC-MSC IV Injection for Chronic Obstructive Pulmonary Disease (COPD)

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8.3. 2026-7年陆续完成临床前研发并获批IND的人脐带间充质干细胞静脉注射液产品管线 Human UC-MSC Intravenous Injection Product Pipeline Targeting Completion of Preclinical Studies and IND Approvals in 2026-7

8.3.1. 人脐带间充质干细胞静脉注射液治疗急性缺血性脑卒中 Human UC-MSC IV Injection for Acute Ischemic Stroke (AIS)

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8.3.2. 人脐带间充质干细胞静脉注射液治疗类风湿关节炎 Human UC-MSC IV Injection for Rheumatoid Arthritis (RA)

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8.3.3. 人脐带间充质干细胞静脉注射液治疗溃疡性结肠炎 Human UC-MSC IV Injection for Ulcerative Colitis (UC)

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8.3.4. 人脐带间充质干细胞静脉注射液治疗间质性肺病 Human UC-MSC IV Injection for Interstitial Lung Disease (ILD)

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8.3.5. 人脐带间充质干细胞静脉注射液治疗银屑病 Human UC-MSC IV Injection for Psoriasis (PsO)

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8.3.6. 人脐带间充质干细胞静脉注射液治疗硬皮病 Human UC-MSC IV Injection for Scleroderma (SSc, for Systemic Sclerosis)

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8.3.7. 人脐带间充质干细胞静脉注射液治疗卵巢早衰(无生育需求) Human UC-MSC IV Injection for Premature Ovarian Insufficiency (POI) [No fertility requirements]

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8.3.8. 人脐带间充质干细胞静脉注射液治疗老年性肌少症 Human UC-MSC IV Injection for Sarcopenia

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8.3.9. 人脐带间充质干细胞静脉注射液治疗绝经综合征 Human UC-MSC IV Injection for Menopausal Syndrome (MPS)

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8.3.10. 人脐带间充质干细胞静脉注射液治疗中重度特应性皮炎 Human UC-MSC IV Injection for Moderate-to-Severe Atopic Dermatitis (AD)

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8.3.11. 人脐带间充质干细胞静脉注射液治疗慢加急性肝衰竭 Human UC-MSC IV Injection for Acute-on-Chronic Liver Failure (ACLF)

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8.3.12. 人脐带间充质干细胞静脉注射液治疗中重度过敏性鼻炎 Human UC-MSC IV Injection for Moderate-to-Severe Allergic Rhinitis (AR)

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8.3.13. 人脐带间充质干细胞静脉注射液治疗糖尿病肾病 Human UC-MSC IV Injection for Diabetic Nephropathy (DN)

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8.3.14. 人脐带间充质干细胞静脉注射液治疗干燥综合症 Human UC-MSC IV Injection for Sjögren's Syndrome (SS)

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8.3.15. 人脐带间充质干细胞静脉注射液治疗糖尿病勃起功能障碍 Human UC-MSC IV Injection for Diabetic Erectile Dysfunction (ED)

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8.3.16. 人脐带间充质干细胞静脉注射液治疗膝骨关节炎 Human UC-MSC IV Injection for Knee Osteoarthritis (KOA)

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8.3.17. 人脐带间充质干细胞静脉注射液治疗糖尿病足溃疡 Human UC-MSC IV Injection for Diabetic Foot Ulcer (DFU)

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8.3.18. 人脐带间充质干细胞静脉注射液治疗早中期帕金森 Human UC-MSC IV Injection for Early-to-Mid stage Parkinson's Disease (PD)

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