Shuwen Biotech Co. Ltd.

Led by U.S. and European diagnostic industry veterans, Shuwen Biotech is engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide doctors and their patients with a comprehensive menu of the most innovative products and services for improved disease prediction, screening, diagnosis, prognosis and treatment in the areas of cancer, maternal fetal medicine, acute care, and preventive testing.
Shuwen presently offers, in China, molecular diagnostic kits and LDT services for personalized medicine in oncology. Through international collaboration and in-licensing, we now have a pipeline of diagnostic assays based on patents and technologies licensed from some of the best research institutions and diagnostic companies in the U.S. and Europe.

Our Capabilities

Assay Development: Shuwen has an experienced team with expertise in diagnostic assay development and registration in China.

Manufacturing: Shuwen has built its own diagnostic kit manufacturing facilities that meet regulatory requirements.

LDT Service: We have the capabilities of developing LDTs and offering testing services through a CAP accredited reference lab.

Marketing: Shuwen markets its diagnostic kits and services to physicians and patients in hospitals and pharmaceutical companies in their clinical trials through established marketing channels covering all of China, including the 300 largest hospitals.

Partnerships

While pursuing a comprehensive business strategy that emphasizes international collaboration and in-licensing, Shuwen strives to be the preferred partner in China for innovative diagnostic companies outside of China. We have the best capability in diagnostic patents, and have comprehensive IP strategies that will ensure the best return on both our investment and those of our licensors and partners.

Shuwen has an initial focus on oncology, enabling the best management of cancer patient care at each stage of disease progression. We strive to provide China with comprehensive diagnostics menus for each cancer type including tests for predisposition, screening, diagnosis, classification, prognosis, theranostics and therapeutic monitoring.

The following clinical testing services are being offered to physicians and patients in China through a CAP accredited reference lab:

EGFR Mutation Analysis (29 mutations in exons 18, 19, 20 and 21)
EML4-ALK Fusion Analysis
KRAS Mutation Analysis (codons 12 and 13)
BRAF Mutation Analysis (V600E)
various other molecular diagnostic assays
clinical chemistry
immunoassays

Services in development pipeline include:

FGFR1 Gene Amplification Detection
PIK3CA Mutation Analysis
ROS1 Gene Rearrangement Analysis
Analysis of a proprietary marker for TKI sensitivity in a variety of cancers
Microsatellite Instability (MSI) Analysis
Analysis of proprietary biomarkers for colorectal cancer theranostics

We seek to add additional IVDs and reference lab tests for China.

2010