Biotech Unicorn New Horizon Health Receives China’s First Early Cancer Screening Approval from NMPA

Leading Chinese cancer screening company New Horizon Health on Nov. 25 announced that their flagship product, ColoClear, has been approved by the National Medical Products Administration (NMPA) for the screening of Colorectal Cancer (CRC) and precancerous lesion, making New Horizon the first company across China to obtain such approval.

ColoClear is a home-based cancer screening test that could save a typical patient at risk for CRC from colonoscopy, an invasive and painful testing procedure that usually includes months of waiting for a scheduled spot and a cumcersome and unpleasant bowel-cleansing process before the procedure is performed.

In contrast, the multi-target FIT-DNA method developed by New Horizon Health specifically detects CRC-linked genetic alterations in Asian population and allows the user to take a small stool sample at home and then ship to New Horizon’s central testing laboratories located in Hangzhou, where the company’s headquarter is based, as well as in Beijing and Guangzhou.

“We are very pleased and excited about the regulatory approval of ColoClear for CRC screening. In the past 7 years, we have been laser-focused on cancer screening and early detection, particularly on colorectal cancer, with an overall investment exceeding $100 million,” said Yeqing Zhu, CEO of the company at a press conference, “it took our team 30 months to conduct the large-scale, multi-center prospective registrational clinical study before finally obtaining the NMPA approval. This is a significant milestone not only for New Horizon, but also the cancer screening and early detection industry in China.”

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According to the NMPA website, a single test by ColoClear can detect 95.5% of colorectal cancer, and a negative result indicates a negative predictive value (NPV) of 99.6%, which is regarded as one of the most convincing indicators for an effective screening test.

The key to the prevention of colorectal cancer is more about early diagnosis and early treatment, according to Dr. Ping Zhao, chairman of Cancer Foundation of China. “Five-year survival rate with early diagnosis and timely intervention can surpass 90%,” Dr. Zhao said.

The economic burden of CRC treatment is also drastically higher if the disease is discovered too late. The treatment cost at the precancerous lesion stage is only a few thousand yuan in China while the late stage CRC treatment could easily cost a family over 250,000 yuan.

Dr. Yiyou Chen, chief scientist of New Horizon, donated 1 million yuan on behalf of the company to the Zheng Shu Cancer Education Fund at the conference on Nov. 25, paying respect and tribute to professor Shu Zheng, China’s clinical research pioneer in colorectal cancer screening.