Cell therapy

#Global Cell Therapy R&D Pipelines Development

#China Cell Therapy Companies Layout

1，Approved by NMPA：

• Jun 2021 FosunKite（复星凯特）CD19 200K USD;
• Sep 2021 JW Therapeutics（药明巨诺）CD19 200K USD

2，Aurora/NL Users:

• FosunKite（复星凯特）
• Unicar-therapy（优卡迪）
• ImmunoChina（艺秒神州）
• GracellBio (亘喜）
• Xiangxue Pharmaceutical（香雪制药）
• LegendBiotech（传奇生物）

#Cell Therapy Market Trends

• Car-NK:B-ALL, Breast Cancer, HCC
• TIL :Melanoma, Cervical cancer
• TCR-T: Melanoma, sarcoma
• γδ T
• Crisp- Car-T
• Car- Treg

#Car-NK Potential Advantages

1，Better Safety

No GVHD and low CRS

2，Keep natural anti-tumor cell toxicity

NKp46、NKp44 and NKp30

3，“universal” product potential

From PBMC, UCB, HESC, IPSC

#Car-NK Targets in Hematological and Solid Tumors

#TCR-T for Solid Tumors

#TCR-T develop rapidly in 2021

#TIL Advantages in Solid Tumors

• Good tumor invasion
• Targeted non-selective, tumor-specific killer T cells
• Specific recognition of tumor antigens only
• No genetic engineering, cost saving

#Flow application in cell therapy

• Immune therapy biomarkers screening and evaluation
• Cell therapy products evaluation
• Patients immune function determination
• Monitoring MRD

#Immune therapy biomarkers screening and evaluation

#Cell therapy products evaluation

• Evaluation of transfection efficiency
• Knockout efficiency evaluation
• Tumor killing effectiveness evaluation

#Patients immune function determination

• Immune function database
• TBNK population
• T cell subsets —— dynamic observation

#Guiding Opinions for Clinical Trials of Cellular Immunotherapy Products (Trial)

	Test  Items	Platform
PK	VCN, Virus Vector Copy Number	qPCR/dPCR
Car+ cell number	FCM
PD	Cytokine	ELISA/FCM
Immunogenicity	Drug resistance antibody, ADA/HAMA, Anti-Drug Antibody	ELISA/FCM
CTL, Cytotoxic T- Lymphocyte	FCM
Safety	RCL/RCR Replication Competent Lentivirus	qPCR
Virus integration site detection	NGS
Lentiviral p24 protein detection	ELISA
Car-T cell phenotyping	Lymphocyte subsets, TSCM	FCM