In just one year, how does Harbin Gene establish industry leadership?

"Let all tumor diseases achieve early diagnosis and treatment, so that all patients get accurate treatment." This is the ideal of Berry Gene co-founder Dr. Zhou Daixing on cancer prevention, and the original intention of the establishment of the Swiss gene.

He Rui Gene was founded in August 2017, and its predecessor was the tumor business unit of Berry Gene, a leading company in the genetic industry. Under the joint investment of Berry Gene and professional investment institutions, Herui Gene combines the advantages of “technology + channel + capital” and fully inherits the original tumor business of Berry Gene, inheriting the Berry gene tumor early. The will to screen for early treatment.

At the CSCO conference in 2018, He Rui Gene announced the pilot test of PreCar (Prespective suRveillance for very Early hepato Cellular cARcinoma). Preliminary results show that the pilot test has excellent sensitivity and specificity indicators, which not only marks the qualitative leap of the early biomechanical tumor-based screening technology, but also indicates the prospect of early warning screening for high-risk populations of liver cancer.

As early as April 2018, Herui Gene announced that it would invest at least 100 million yuan. The United Nations Liver Cancer Science Center, Shanghai Eastern Hepatobiliary Surgery Hospital and Guangzhou South Hospital launched a forward-looking 10,000-item cohort project. This is currently the only prospective cohort study project on ultra-large-scale liver cancer early screening in China, which marks a big step for early diagnosis and treatment of liver cancer in China.

This one-year-old startup has become a leader in the industry at an alarming rate. In the dialogue with its core team, it can be found that this is a team with deep deposition in technology and resources. They are meticulous in doing a great thing for the benefit of mankind.

Based on a high starting point, from investors to entrepreneurs

"By judging the entire market, we believe that genetic testing of tumors is an inevitable trend in this field." Mr. Zhou Wei, CEO of Rui Gene, told the Arterial Network, "If you want to do early diagnosis, you must invest a lot of money to make a forward-looking Queue research to verify whether a product can be industrialized."

He Rui Gene CEO Zhou Wei

At the beginning of 2018, after assisting Junlian Capital to complete the investment in the company, he joined the company and became the chief CEO, responsible for the overall operation of the company. He changed from an investor to an entrepreneur.

For Zhou Wei, making this decision is not easy. He is an early participant in the development of China's genetic testing industry and a witness to the whole process. As one of the earliest practitioners, Zhou has 17 years of work experience in this field. From the beginning of this century, he was the head of the laboratory platform of the earliest genetic testing company in China. He joined the SDIC Innovation Fund to complete investment in many representative enterprises in the industry, and then invested in Junlian Capital and joined He Rui Gene. Roles are converted multiple times among managers, investors, and entrepreneurs.

"If it weren't for this team, I might have to consider it for a long time," Zhou said. He told Arterial Network, "Through more than a decade of contact with Berry's founding team during the industry and even Junlian Capital, I am very appreciative of the team's values ​​and ways of doing things."

"The same people will be more sparked and easier to do together." On this basis, joining and Rui Gene is no longer a tangled thing in his view.

“After the completion of the genetic financing, we have been thinking about how to form a management team and who is responsible for the construction of this team.” Berry’s gene Zhou Xingxing recalled. They need someone who has a thorough understanding of the situation at home and abroad and who knows the technology at the same time.

"I don't think there is anyone more suitable than Zhou Wei." Zhou Daixing said.

As Newton proposed on the basis of Descartes's research, the famous particle of light said that the rui gene on the shoulder of the giant is bound to look farther. The accumulation of Berry's genes for many years has laid a good foundation for the Swiss genes. They are not starting from scratch, but they have assembled a group of outstanding scientists and occupied a very high starting point.

Product, technology, personnel inheritance and development

As a member of the Berry Gene, Herui Gene has obtained exclusive licenses for Berry Gene Tumor-related technology patents and product services in mainland China. Through this form of integration and convergence of the tumor business, and the Swiss gene has obtained a high starting point. The company can use its existing resources to quickly occupy the highlands of the industry and consolidate its leading position in the fields of advanced tumor liquid biopsy, tumor immune gene detection and hereditary tumor detection. At the same time, this also allows He Rui to shorten the long technology development cycle in the most critical early stage of tumor diagnosis and quickly enter the clinical validation phase.

At the beginning of the establishment of Ruirui Gene, the team size has reached 150 people. Most of these members are research backbones and market elites of the Berry Gene Original Tumors Division. Their existence not only guarantees the sales operation of the products in the middle and late stages of the company, but also provides vitality for the company's future technology research and development. From the first day of its establishment, the company can fully participate in the first line of the battle.

“These arrangements are based on the trust given by the founding shareholders of Herui Gene and the deep-sightedness of shareholders in the context of rapid changes in the tumor genetic testing market.” Zhou Wei said, “We have a good starting point and foundation, and we will also use These resources are being used to accelerate innovation. At present, all the business segments of Ruirui Gene have new technologies and new product delivery."

Using big data to deepen the cancer business

For other applications of relative genomics, tumor diagnosis and early screening are more difficult, but they are quite similar in nature to the former. Since the development of the second-generation sequencing technology, sequencing technology has long been a problem, and the bigger difficulty is the stage before and after the data is generated.

ctDNA accounts for only a small fraction of free DNA in peripheral blood. Before the data is generated, how to accurately detect and quantify trace ctDNA is a problem that must be solved by relying on ctDNA for tumor detection. BSRART's self-developed cSMART and cSMART 2.0 technologies allow for the labeling, cyclization, amplification and high-throughput sequencing of free DNA fragments in peripheral blood. With a unique technical approach, the detection sensitivity can reach 1/10000.

After the data is generated, the biggest problem is to analyze and interpret the data. In particular, complex diseases such as tumors require the support of big data and super-computing capabilities.

While integrating the public database, Berry Gene will also annotate and interpret the genetic data of the self-established genome-wide database of millions of Chinese people and the database of more than 10,000 Chinese cancer patients, combined with the artificial intelligence learning technology currently under development.

The Berry Gene Digital Life Park under construction will bring together cutting-edge technology research and development, big data, clinical trials, gene sequencing , sample storage, cloud computing, artificial intelligence, gene editing/treatment and other related links, including early tumors. Disease genetic testing, including diagnosis, provides faster, more accurate big data support, as well as comprehensive disease treatment services based on big data.

Received a capital increase of 800 million yuan to provide protection for research and development of cancer detection

In November 2017, Herui signed an agreement with Junlian Capital, Boyu Investment, Qiming Venture Capital, Acer Capital and other strategic investors to obtain a capital increase of 800 million yuan for the research and development of early tumor diagnosis and other oncology business. Operational investment, this is also the largest single investment in the field of domestic tumor genetic testing.

Undoubtedly, such a high amount of financing can be obtained in the months of establishment, a large part of which stems from the investor's recognition of the company's genetic technology, team and goals. It should be noted that most of these strategic investors have been investors of Berry Gene. They have a deeper understanding of the team's business philosophy, execution and technical know-how in the long-term tracking and cooperation process. Such investment decisions are more rational than the average investment institution.

The financing amount not only provided financial support for the follow-up tumor early screening research of Ruirui Gene, but with the entry of investors, Berry Gene accounted for less than 20% of the shares of Rui Gene. This means that the company is legally a relatively independent business entity.

Zhou Daixing said: "Herui Gene will independently make decisions and develop. In terms of technology, resources and talents, the two sides can carry out various forms of cooperation on an equal and fair basis." It is understood that although the current Berry gene is not The largest shareholder of the gene, but the company still retains the priority repurchase rights of the Swiss gene.

Investing billions of dollars to initiate a prospective cohort study to implement a cancer screening strategy

Whether it is in technology, team, resources or funding, and Rui Gene has occupied the best of time, place and people. This also makes them different from other tumor screening companies, with a very high starting point. They did not expect it, and took the first step in a down-to-earth manner.

China is a big liver disease country and a big liver cancer country. According to data released by the World Health Organization in 2014, Chinese patients account for more than 50% of the world's new annual liver cancer patients. In particular, there are 93 million hepatitis B virus carriers and 6 million cirrhosis patients in China, and they are high-risk groups of liver cancer in the long run.

At the same time, liver cancer is an occult cancer. Most patients have advanced to advanced stages in the diagnosis of cancer, and the treatment effect and 5-year survival rate are seriously affected. Therefore, in the planning of the early screening of the Swiss gene tumor, the first to bear the brunt is liver cancer.

"From the technical practice and clinical cognition of He Rui, it is unrealistic to want to use a technology to overcome all cancers. So we did not choose pan-cancer early screening from the beginning, but cut into cancers with Chinese characteristics. Point." Zhou Wei told the arterial network.

On April 22, 2018, He Rui Gene invested 100 million RMB to launch the PreCar project with the National Hepatocellular Science Center/National Hepatobiliary Surgery Hospital of the Naval Medical University and Guangzhou Nanfang Hospital. This indicates that Herui Gene is the only company in China that is currently testing its own technical solutions through a prospective cohort of ultra-large-scale tumors.

"The discovery based solely on laboratory retrospective data cannot be directly extended to early-stage screening for high-risk populations of liver cancer. Dynamic observations based on large-scale prospective cohort studies are needed to effectively solve the problem of early tumor screening." Researcher, National Center for Liver Cancer Science Chen Lei told the arterial network.

In other words, early diagnosis and treatment of tumors can effectively prolong the survival time of patients and improve the quality of patients. But leaving the large-scale prospective cohort study, the clinical realization of early tumor screening is impossible to talk about.

“Therefore, a large-scale forward-looking queue can be established as early as possible to get the lead in early screening research,” he added.

The project will target more than 10,000 high-risk groups of liver cancer (about 5,000 patients with cirrhosis and about 5,000 patients with hepatitis B), establish a follow-up monitoring cohort, conduct a 3-year prospective cohort study, and rely on high-throughput genome sequencing technologies. Screening, identification and application of very early warning markers for peripheral blood cancer. The overall experiment is expected to be completed in 2021. This is one of the largest early screening and early warning projects in China's cancer, especially in the field of liver cancer.

He Rui Gene is responsible for providing technology and funding in the PreCar project. The cooperative hospital will assist Ruirui to complete the clinical work, including judging whether the patient meets the enrollment conditions and follow-up monitoring.

The pilot experiment, as a retrospective study, began as early as 2018, with the aim of building a technical platform for the next 10,000 people. The entire pilot study involved 1,500 people, including more than 500 patients.

The preliminary disclosures show that the sensitivity can exceed 90% with a specificity of up to 95%, and even with a specificity standard up to 99%, a sensitivity of 87% can be achieved stably. This breakthrough advances a major step in the genetic testing of tumors from laboratory to clinical applications.

For these data, Zhou Wei explained, “Specificity refers to the ratio of negative samples detected by the disease-free control group. For example, if there are 100 healthy people without cancer, the test results show 99 healthy, 1 person With cancer, the specificity is 99%. On the other hand, if there are 100 tumor patients, 90 patients are identified by the test, then the sensitivity is 90%."

At the same time, Zhou Wei also talked about the future plan of Ruirui Gene for the whole project. He said, "We will follow up on the relatively determined technology platform to track the incidence of high-risk groups and complete a three-year forward-looking study. Based on rigorous technology and reliable data, we will consider the registration of related products."

In the future, based on the early diagnosis of liver cancer, He Rui Gene plans to launch several early screening and diagnosis research projects for malignant tumors, set new industry standards, and further help establish China's international leading position in early diagnosis and treatment of cancer.

Since its establishment, Herui Gene has always regarded early tumor diagnosis as its strategic direction and its mission. Zhou Daixing once told the Arterial Network in an interview that he hopes that in the next five or ten years, they can do two things: for the three types of birth defects caused by stupidity and death, before the child is born, the parent can Informed; in the early stages of a tumor that can still be cured, patients can be informed by genetic testing.

For the previous goal, the Berry gene has been initially implemented and is still trying to do more and better. For the early screening of tumors, Berry's member companies and Swiss genes will rely on the technical accumulation of tumor gene detection and related research work for many years, according to the clinical needs of the Chinese population, targeted investment, and ultimately achieve high The phrase that the management team has repeatedly mentioned - to make all tumor diseases achieve early diagnosis and treatment, so that all patients can be treated with precision.

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