Ed Biotech has always focused on research and innovation, steadily moving forward on the path of precise diagnosis of tumors, allowing precision medical products to better play the role of a "compass" and alleviate patients' pain. Recently, a reporter from Shanghai Securities News came to the Xiamen headquarters of Ed Biotech to listen to their stories of forging ahead and helping China's precision medicine industry rise to new heights.

Take the difficult yet correct path

Xiamen Haicang District, Aide Biological Dust free Production Workshop.

We can produce 30 types of Class III diagnostic products here, with a daily production capacity of over 100000 people. These products cover various types of cancer with precision medical conditions, and most of them are domestically approved, some of which are even internationally pioneering.

When the reporter met with the company's general manager Luo Jiemin, this "post-80s" PhD had just returned from the academic annual meeting of the Chinese Society of Clinical Oncology (CSCO). He told reporters, "As one of the earliest companies in the world to engage in precise tumor detection, we have always been on par with the international community in the field of precision diagnosis and treatment of tumors, and even lead in some specific technological products

Zheng Limou, founder and chairman of Ed Biotech, which is engaged in the research and development of anti-tumor new drugs, believes that precision medicine has gradually become a consensus in tumor treatment.

In 2008, the concept of precision medicine guided by genetic testing for targeted medication emerged overseas, but in China, it is still in the traditional medical stage, and cancer patients mainly extend their lives through chemotherapy and radiotherapy.

Our generation, with the expectation of revitalizing the motherland, has left the country with a strong dream of building a strong nation, "said Zheng Limou, which has strengthened his determination to return to China and start his own business.

In the same year, the first domestic biopharmaceutical enterprise focusing on the development of molecular diagnostic products for cancer precision medicine was born in Xiamen. The company is named AmoyDx, and its Chinese name is Ed Biotech.

However, after less than a year and a half of operation, the company encountered an unexpected change: the investors not only did not receive the promised follow-up funds, but also had to withdraw a phase of funds. Although Zheng Limou never gave up running, the harsh reality before him was harsh. Faced with the emerging field of precision diagnosis and treatment, few investors are willing to be the first to eat the crab

I am well aware that genetic testing can effectively prevent drug misuse and abuse. "Zheng Limou firmly believes that this is a" difficult but correct "thing.

If you don't have money, then go ahead on your own. "Zheng Limou used his years of savings to invest everything in the development of the enterprise.

If there is still a gap, then borrow it. "With years of accumulated connections, he traveled around, explaining his technology and ideas.

Finally, Ed Biotech overcame the initial financial difficulties of entrepreneurship. In 2010, the first batch of genetic testing products developed and produced by the company, EGFR, KRAS, and BRAF, were approved for market by the National Medical Products Administration (NMPA).

In the same year, Ed collaborated with the Chinese Medical Association, multinational pharmaceutical companies, and others to conduct EGFR gene testing training courses nationwide. This forward-looking measure has directly or indirectly contributed to the development of China's precision diagnosis and treatment industry for cancer.

Each detection site requires tens of thousands of experiments to be conducted

In 2012, Ed Biotech reached a strategic partnership with multinational pharmaceutical company Pfizer for companion diagnostics, marking the company's achievement of internationally recognized leading levels in the industry.

In 2017 and 2021, ROS1 gene products and lung cancer 11 gene products were successively approved and included in local medical insurance in countries such as Japan. This is the first time that China's tumor companion diagnostic products have been approved and included in medical insurance in developed countries.

While many companies are looking for ways to gain more market share on the sales side, Ed Biotech has always focused on innovation and breakthroughs.

The research and development expenses of Ed Biotech have consistently maintained stable growth. We invest over 15% of our annual revenue into research and development, overcoming one technical challenge after another, "said Luo Jiemin.

For example, in the field of PCR (polymerase chain reaction), EdBio has broken through the bottleneck of simultaneous detection of multiple genes using DNA and RNA, and developed the PCR-11 gene product, which is an important first-line detection product for advanced non-small cell lung cancer patients.

In the field of algorithms, Edbio has solved the "bottleneck" problem by independently innovating the ADx GSS algorithm, breaking Myriad's monopoly. The HRD detection product developed based on this algorithm has been recognized as an innovative medical device by the National Medical Products Administration.

Behind the pursuit of innovation is an unwritten red line principle - all products must be fully demonstrated at the beginning of project approval to determine whether they can bring true clinical value to patients.

Unlike traditional chemotherapy with toxic side effects, precision medicine can provide precise treatment plans through precise analysis of tumor genes. This can not only improve the efficacy and enhance the quality of life of patients, but also prevent the misuse and abuse of drugs, reducing the waste of medical resources caused by ineffective and incorrect treatments.

Ed Biotech's products are the first step in providing medication guidance and achieving precise treatment for cancer drugs. Our work concerns the lives of patients and cannot tolerate any mistakes. Every detection site in each kit requires tens of thousands of experiments, "said Luo Jiemin.

Empowering drug research and development

The first EGFR product used to guide targeted therapy for lung cancer in China, the first BRCA product used to guide PARP inhibitor medication, the first domestically produced PD-L1 product for adjuvant diagnosis of immunotherapy, the first MSI product for adjuvant diagnosis of pan cancer immunotherapy, and the first IDH product for adjuvant diagnosis of hematological tumors, all of which belong to EdBio, continue to be the "first" products.

Over the years, Ed has independently developed and approved 30 types of single gene and multi gene tumor diagnostic products, making it one of the most comprehensive and leading enterprises in the industry in terms of product variety.

At present, in providing compliant solutions for clinical tumor companion diagnosis, EdBio has almost always been at the forefront, achieving a leading position in the entire technology platform. "Luo Jiemin is confident that EdBio's level in precision medicine has entered the international forefront.

How to achieve the goal of 'reaching one hundred feet and making further progress'? In front of Ed Biotech is a new journey of collaborating with pharmaceutical companies to continuously empower drug research and development.

On June 24th of this year, the innovative targeted drug Gu Mei Ti Ni tablets developed by Chinese company Haihe Pharmaceutical were approved for market by the Japanese Ministry of Health, Labour and Welfare; Less than a month later, Aihuijie (MET exon 14 jump mutation companion diagnostic reagent) developed by Edbio was simultaneously approved by the Japanese Ministry of Health, Labour and Welfare as a companion diagnostic reagent for Gumetinib tablets in Japan; On September 13th, Aihuijie obtained approval from the National Medical Products Administration.

The innovative targeted drugs and original accompanying diagnostic reagents developed by two Chinese companies have been approved for market almost simultaneously, which is a major breakthrough for Chinese companies to achieve internationalization in the field of precision medicine.

There are dozens of pharmaceutical companies collaborating with Ed Biosciences globally, "said Zheng Limou." The development of therapeutic drugs and corresponding accompanying diagnostic reagents are two independent research and development tasks, but they promote each other. By accelerating the development of innovative therapeutic drugs and accompanying diagnostic reagents, both parties will further improve research and development efficiency, reduce research and development costs, and thereby enhance drug accessibility - allowing patients to safely obtain appropriate and high-quality drugs at affordable prices.