Sunway Biotech Co.,Ltd

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　H103(AD-HE)

　H103 is the second product in our pipeline. It is designed to treat cancer with systemic effects. H103 represents the second-generation oncolytic adenovirus agents as it contains the human HSP70 gene that is expressed in virally-infected tumor cells following injection; thus no additional heating of the tumor is required. Actually, H103 adenovirus was constructed by inserting the human HSP70 gene, under the control of the cytomegalovirus promoter, into the H101 genome to ensure that HSP over expression would occur. Experiments have shown that H103 efficiently expresses HSP70 in tumors cells and thereby produces anti-tumor activity at distant, non-injected tumor sites. Sunway Biotech Co.,Ltd has completed preclinical safety studies for H103 and the Phase I, dose-escalation study has been closed. Preliminary results are promising. Sunway Biotech Co.,Ltd applied for a PCT patent for its H103.

Summary of the key features and clinical status of H101, H102, H103

	H101	H102	H103
Adenovirus	√	√	√
E1B-55kDa deletion	√	√	√
E3 deletion	√	√	√
Selective replication in hepatocellular carcinoma with AFP over expression		√
Selective replication in tumors tissue	√	√	√
HSP70 gene inserted			√
TOIT efficacy	√	Not tested	√
Preclinical studies	√	√	√
Phase I in head and neck cancer	√		Initiated
Phase II in head and neck cancer	√
Phase III in head and neck cancer	√
NDA filed	In China
Non-small-cell lung cancer	Phase I/II

Pipeline development strategy: What’s next?

　Going forward, Sunway Biotech Co.,Ltd will focus on the development of its products. The principal strategy for the clinical development programs will be based on market needs and Sunway Biotech’s core clinical competency in NSCLC, HNSCC. In the interim, the company will continue to develop its expertise in colon cancer metastatic to liver, breast cancer, and hepatocellular carcinoma based on large market needs. The company will also conduct most of its exploratory clinical programs in China and use its well-developed protocols to guide the design of overseas studies. Sunway Biotech Co. Ltd will focus in its future efforts in developing H101, H102, H103 in China.