36氪 was informed that Shanghai Kunyuan Biotechnology Co., Ltd. (hereinafter referred to as “Kunyuan Bio”) has completed the B+ round of financing of 300 million yuan. This round of financing was led by Fengshi Capital, followed by funds from Galaxy Yuanhui, Guojing Investment, Junci Investment, Gandao Investment, Bai Shide, and Brilliance Meijing, and Shengxiang Bio as a strategic investor. This round of financing is mainly used to further expand the company’s tumor early screening product research and development pipeline, and continue to promote the registered production, commercialization and international market development of each product.
Founded in 2014, Kunyuan Gene focuses on the research and development and clinical application of a new generation of genetic testing and molecular diagnostic technologies, and develops a series of solutions around the prevention, occurrence and development of high-incidence tumors – involving risk assessment, early screening, and medication guidance and full-cycle services for postoperative monitoring, especially the development and application of non-invasive early screening and diagnosis technologies for tumors based on the patented methylation detection platform.
Up to now, the company’s product pipeline has covered pan-cancer, lung, colorectal, liver, gastric, esophageal, pancreatic, thyroid cancer and other high-incidence cancers. It is reported that Chang Aike® is an original product in China for early screening of colorectal cancer blood polygene methylation detection, and the research results have been published in the international journal “Gastroenterology” in the field of gastrointestinal diseases. PanSeer®, a circulating tumor DNA (ctDNA) methylation pan-cancer screening technology independently developed by Kunyuan Bio, is the first in the world to realize the validation of the pan-cancer early screening technology in a large natural population cohort.
In November 2021, Kunyuan Biotechnology, together with Fudan University and 11 domestic top three hospitals, launched the “Blessing Project” early screening research on pan-cancer species in Chinese populations in Shanghai . The study is expected to enroll more than 60,000 people, covering 10 provinces and municipalities in East China, North China, South China, and Southwest China. PanSeer® is expected to be commercialized by the end of 2023.
Early tumor screening is a subdivision field that has received much attention in recent years. The “Healthy China Action (2019-2030)” proposes that by 2030, the 5-year survival rate of the country’s overall cancer will not be lower than 46.6%. Early tumor screening is of great significance for cancer prevention and control, which can effectively reduce the burden of medical expenditures and improve survival rates. At present, the market has entered a period of rapid growth from the cultivation period, and has huge development potential.
As a result, a number of companies took the lead in entering the market to seize industry opportunities: among them, Nuohui Health, a fast-growing company, has gone public in Hong Kong, and listed tumor genetic testing companies “Gemini” Burning Rock Medicine and Genetron Health have also deployed early tumor screening business. Berry The gene-incubated Herui gene is also working on the early screening of multiple cancer species. In contrast, Kunyuan Bio has two characteristics: one is to focus on ctDNA methylation technology, and the other is to deploy early screening of pan-cancer species.
For the past 30 years, DNA methylation has been recognized as a promising biomarker for cancer detection. Compared with other gene defect patterns, DNA methylation is one of the earliest discovered epigenetic modification pathways, and its abnormal methylation pattern is highly specific in different tumor tissues. The characteristic methylation “fingerprint” pattern can be used for early diagnosis and staging of cancer, efficacy evaluation, recurrence monitoring and prognosis judgment. In the application of ctDNA methylation detection in cancer diagnosis and treatment, based on blood samples, it can overcome the limitations of solid tumor tissue samples to a certain extent, for example: (1) ctDNA has a short half-life in blood and can reflect the dynamic changes of tumors in real time; (2) It can overcome the heterogeneity of tumor tissue sampling; (3) repeat biopsies can track the clonal evolution of tumors; (4) can identify metastatic tumors, etc.
Due to the simultaneous detection of multiple cancers, the pan-cancer early screening technology is generally considered to be the next generation of cancer early screening technology, and it is also a hot spot of international research. At present, industry leaders such as GRIAL and Thrive have carried out large-scale prospective studies on early screening of pan-cancer species. However, pan-cancer screening often has lower sensitivity, specificity, and NPV values than expected, and requires product development relying on multi-omics technology – each additional cancer type often requires an increase in the corresponding omics and dimensions, which means an increase in costs. This in turn affects the subsequent commercialization, which is also a problem that the company must focus on breaking through.
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