On January 6, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company") (Nasdaq: GTH), a leading precision oncology company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ("CTTQ"), a subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX: 1177), reported an exclusive strategic partnership agreement for HCCscreen, Genetron Health’s blood-based early screening test for hepatocellular carcinoma ("HCC") in China (Press release, Genetron Health Technologies, JAN 6, 2021, View Source [SID1234573573]). This partnership targets the hospital market in China, with a focus on combatting liver disease, and marks Genetron Health’s third key commercialization initiative of HCCscreen in the country, complementing its existing sales and marketing strategies through public health programs and medical examination centers.
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Under the agreement, the companies will work together exclusively to co-market and co-promote HCCscreen in the hospital market, covering designated territories in China. The parties intend to target high-risk individuals for HCC, which include HBV-positive carriers, as well as other liver disease patients. CTTQ brings an experienced sales force and valuable hospital relationships to the partnership, while Genetron Health provides manufacturing and laboratory operations for its innovative product, HCCscreen, along with its direct-to-consumer marketing expertise. Genetron Health will pay CTTQ a promotional fee based on a percentage of revenues generated from the collaboration. Contingent on certain sales and other requirements, the exclusivity period is expected to last three years. As a result of the agreement, Genetron Health expects HCCscreen revenues to further accelerate in China.
Sino Biopharm is one of the leading biopharmaceutical companies in China, with therapeutic areas spanning liver disease, oncology, orthopedics, infectious, respiratory, and cardiovascular and cerebrovascular diseases. Sino Biopharm recorded sales exceeding RMB 24 billion in 2019, of which liver drugs accounted for almost a quarter. CTTQ is Sino Biopharm’s largest subsidiary, which focuses primarily on liver disease and oncology drugs R&D and manufacturing. In China, CTTQ had over 35% market share based on total hepatitis antiviral drug sales in 2018, according to IMS. In addition, CTTQ has a sales team of over 7,000 representatives and a network of over 2,000 general and liver disease-focused hospitals. Designated as a national key high-tech enterprise, CTTQ spends around 10-12% of revenues annually on research and development.
"We are excited to partner with Genetron Health as both companies are committed to developing innovative products for liver disease and oncology. HCCscreen presents an attractive opportunity to us because of its target uses in high-risk individuals for the early detection of HCC," said Eric Tse, Chairman of CTTQ. "We believe that our specialty, capabilities and network in the liver disease market represent a major sweet spot for this product. And more importantly, we are excited to introduce an innovative product that can potentially alleviate the heavy burden on liver cancer patients in China."
"Genetron Health strives to innovate while continuing to explore the commercialization roadmap for our products. For HCCscreen, we have achieved success in expanding sales channels through medical examination centers and government procurement projects. Today’s announcement marks a new channel focusing on the hospital market, and represents the third key commercialization initiative we have embarked on. CTTQ is an ideal partner for HCCscreen because of its liver drug franchise and significant sales and marketing strengths. We expect this strategic partnership to bring us closer to our goal of lowering liver cancer-related death rates in China," said Sizhen Wang, co-founder and CEO of Genetron Health.
About HCCscreen and Liver Cancer
In September 2020, Genetron Health received the U.S. Food and Drug Administration ("FDA")’s Breakthrough Device designation for HCCscreen, and the product has been commercialized recently as a lab developed test ("LDT") in China.
Globally, liver cancer is the fourth most common cause of cancer-related death and the sixth in terms of incidence1. China represents the largest market, accounting for almost half of the global incidences. New incidence in China was estimated to be around 393,000 per year, with 369,000 deaths2. Market data by Frost and Sullivan estimated that as of 2019, among the 120 million high risk liver cancer population in China, around 74 million were HBV carriers.
Powered by Genetron Health’s innovative and proprietary Mutation Capsule technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens, HCCscreen is currently being tested in its ongoing prospective study with 4,500 HBsAg+ individuals in HCC. As of the date of this announcement, 2,000 patients have already completed the study, and preliminary data from 297 patients at one center has demonstrated over 92% sensitivity, 93% specificity, compared to 67% and 99%, respectively in the ultrasound plus alpha-fetoprotein (AFP) arm. HCCscreen also achieved a 35% positive predictive value and 99.6% negative predictive value. Furthermore, stratifying by tumor sizes, of the 12 patients identified with HCC in the preliminary dataset, seven patients had tumor sizes of less than 3 centimeters, and HCCscreen successfully detected them all, indicating its ability in detecting early-stage HCC.
In November 2020, Genetron Health announced that HCCscreen was selected by the National Cancer Center and Wuxi municipal government in China for use in the "Liver Cancer Early Screening Comprehensive Prevention and Control Project", a public health initiative (the "Project"). The goal of the Project is to increase the awareness of liver cancer early screening, and to become a pilot city model in China. For the Project, Wuxi is committed to administering 150,000 tests over a period of three years.