Genetron Health Enters Exclusive Strategic Partnership with Takeda Tianqing, a Subsidiary of China Biopharmaceutical, to Advance Commercialization of HCCscreen™ for Liver Cancer Early Detection
[Nanjing, January 6, 2021] Genetron Health (NASDAQ: GTH) announced today that it has entered into an agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“Chia Tai Tianqing”), a subsidiary of Sino Biopharmaceutical Limited, regarding HCCscreen, an early-screening product for hepatocellular carcinoma based on liquid biopsy technology.TMSigned an exclusive strategic cooperation agreement in China. This time, Genetron Health joined hands with top domestic pharmaceutical companies to open up the hospital market, achieving HCCscreen on the basis of existing physical examination institutions and government livelihood projects.TMThree Major Commercial Pathways to Further Enhance HCCscreenTMPenetration and Prevalence of Early Cancer Screening in the Chinese Market
Through this collaboration, both parties will leverage their respective strengths to jointly promote HCCscreen in designated regions of China over the next three years.TM, the services target high-risk populations for liver cancer, including hepatitis B virus carriers and patients with other liver diseases: Genetron Health will provide product manufacturing and laboratory operational services for this collaboration; while Chia Tai Tianqing possesses mature sales experience and nationwide hospital market resources for liver disease medications, which will become HCCscreenTMA strong guarantee for rapidly penetrating the hospital market, helping to accelerate revenue generation for this product.
China Biopharmaceutical is one of China’s leading biopharmaceutical companies, with a product portfolio covering liver diseases, oncology, orthopedics, infectious diseases, respiratory conditions, and cardiovascular and cerebrovascular disorders. In 2019, the company’s sales exceeded RMB 24 billion, with liver disease medications accounting for nearly one-quarter of total revenue. Chia Tai Tianqing, the largest subsidiary of China Biopharmaceutical, specializes in the research, development, and manufacturing of drugs for liver diseases and cancer. It boasts a sales team of more than 7,000 professionals, serving over 2,000 general hospitals and specialized liver disease hospitals, and holds more than 35% of the market share in China’s antiviral drug segment for hepatitis.
Xie Chengrun, Chairman of the Board of Chia Tai Tianqing Pharmaceutical Group, stated, “We are delighted to collaborate with Genetron Health, as both companies are committed to developing innovative diagnostic and therapeutic products for liver diseases and tumors. Genetron Health’s HCCscreenTMIts globally leading performance in early liver cancer screening holds significant appeal for both us and our customers. We believe that Chia Tai Tianqing’s strong professional expertise and network resources in the liver disease market can empower HCCscreenTMprovide strong support for market expansion. More importantly, we are delighted to introduce an innovative product for patients with liver disease in China, thereby benefiting more individuals at risk of liver cancer and alleviating their potential heavy burden.”
Genetron Health possesses cutting-edge global technological R&D and innovation capabilities, and is the only company participating in the national major science and technology projects for the early screening research and development of liver cancer, lung cancer, and gastrointestinal cancers. Its independently developed liquid biopsy product for early screening of hepatocellular carcinoma, HCCscreenTMOn September 30, 2020, it received the U.S. FDA’s “Breakthrough Device Designation.” Wang Sizhen, Co-founder and CEO of Genetron Health, stated, “Genetron Health remains committed to the development of innovative technological products and the exploration of novel commercial pathways. HCCscreen™ has garnered positive market feedback during its preliminary collaborations with health examination institutions and government public welfare programs. In expanding into the hospital market, Chia Tai Tianqing is Genetron Health’s ideal partner. We look forward to this new collaboration bringing benefits to more liver disease patients and accelerating the reduction of liver cancer mortality rates in China.”
September 2020, Genetron Health HCCscreenTMReceived the U.S. Food and Drug Administration (FDA) “Breakthrough Device Designation” and recently began commercialization in China as a laboratory-developed test (LDT).
Globally, liver cancer ranks fourth in mortality and sixth in incidence among all cancers.[1]. China ranks first globally in the number of liver cancer cases, accounting for nearly half of the global total. There are approximately 393,000 new cases of liver cancer and about 369,000 deaths from liver cancer in China each year.[2]According to Frost & Sullivan’s 2019 survey data, there are approximately 120 million people in China at high risk for liver cancer, of whom about 74 million are hepatitis B virus carriers.
HCCscreenTMCore technology is derived from Genetron Health’s independently developed innovative technology, Mutation Capsule.TM, this technology can simultaneously detect multiple methylation and gene mutation profiles of cell-free DNA in peripheral blood. Genetron Health further validated HCCscreen in a prospective cohort study of 4,500 patients positive for the Australian antigen.TM, and completed testing on 2,000 patients. Preliminary data from 297 patients at one of the centers showed that HCCscreenTMachieved a sensitivity of 92% and a specificity of 93%, whereas ultrasound combined with alpha-fetoprotein testing yielded a sensitivity of 67% and a specificity of 99%. HCCscreenTMAchieved a positive predictive value of 35% and a negative predictive value of 99.6%. In the preliminary data results from these 297 patients, classified by tumor size, 7 out of 12 hepatocellular carcinoma (HCC) patients had tumors smaller than 3 cm; HCCscreenTMThe successful detection of all tumors smaller than 3 cm demonstrates its excellent performance in detecting early-stage liver cancer.
In November 2020, Genetron Health announced its HCCscreenTMSelected for the Wuxi Huishan District Regional Demonstration Project on “Comprehensive Prevention and Control through Early Liver Cancer Screening,” initiated by the People’s Government of Huishan District, Wuxi City, under the guidance of the National Cancer Center. This project aims to enhance public awareness of early cancer screening and promote the large-scale adoption of early screening technologies, thereby establishing Wuxi as a model city for comprehensive cancer prevention and control in China. To this end, over the next three years and under the guidance of the National Cancer Center, Huishan District will serve as a hub to achieve full coverage of liver cancer screening among high-risk populations in Wuxi.
Genetron Health (NASDAQ: GTH) is a global leader in precision oncology, dedicated to advancing cancer genomics research and applications. The company strives to transform cancer diagnosis and treatment by leveraging advanced molecular biology and big data analytics. Genetron Health has established a comprehensive portfolio of products and services spanning the entire cancer care continuum—from early screening, diagnosis, and therapeutic recommendations to monitoring and prognostic management. Furthermore, the company actively collaborates with partners across the industry value chain to expand innovative applications and scenarios for molecular diagnostic technologies.
China Biopharmaceutical was listed on the Hong Kong Stock Exchange in 2000 and is one of China’s leading biopharmaceutical companies, with a therapeutic portfolio covering liver diseases, oncology, orthopedics, infectious diseases, respiratory conditions, and cardiovascular and cerebrovascular disorders. In 2019, the company’s sales exceeded RMB 24 billion, with liver-related medications accounting for nearly one-quarter of total revenue. China Biopharmaceutical ranked among the “Top 50 Pharmaceutical Companies in 2020”[3]Ranked 42nd, it is one of the few Chinese companies included on the list. The company was also named by Forbes magazine as one of the “Asia’s 200 Best Under A Billion” for 2019.[4], and the only Chinese biopharmaceutical company selected.
References:
1. Villanueva, A. Hepatocellular Carcinoma. N. Engl. J. Med. 2019, 380, 1450–1462.
2. Globocan 2018. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Information on this website is not incorporated into this update and should not be considered part of this update. We have included any website as an inactive textual reference only.
3. https://www.pharmexec.com/view/pharm-execs-top-50-companies-2020
4. https://www.forbes.com/asia-over-billion/list/
Safe Harbor Statement
This press release contains forward-looking statements as defined under federal securities laws, including statements regarding the joint venture’s business plans, operational prospects, and revenue expectations for HCCscreen™. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such statements are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve inherent risks, uncertainties, and numerous factors that may cause actual results to differ significantly from those described in any forward-looking statement. Other statements containing words such as “anticipate,” “believe,” “expect,” “plan,” and similar expressions also constitute forward-looking descriptions. Additional information regarding these and other risks and uncertainties is included in the company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release should not be construed as representing the company’s views as of any date after the date of this announcement. Genetron Health anticipates that future events and developments may cause its assumptions and expectations to change; however, except as required by applicable law, the company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.