In China, malignant tumors have become one of the major public health challenges currently faced. In 2015, there were approximately 3.929 million new cases and about 2.338 million deaths from malignant tumors nationwide. On average, more than 10,000 people are diagnosed with cancer each day, which translates to 7.5 people being diagnosed every minute.
Pathological diagnosis is regarded as the “gold standard” for disease diagnosis and plays a crucial role in tumor diagnosis. Industry experts have pointed out that the severe situation of tumor incidence urgently calls for the improvement and development of pathological diagnosis of tumors.
On December 21, at the Digital Pathology and Precision Diagnosis Sub-forum of the 2019 Future Healthcare Top 100 Conference, Qi Hua, founder of Henan Celnovte-Bio Technology Co., Ltd. (hereinafter referred to as “Celnovte-Bio”), delivered an insightful presentation titled “Application of Tumor Pathological Diagnosis in Precision Medicine.” Following the event, VCBeat conducted a special interview with Qi Hua on this topic.

(Qi Hua, Founder of celnovte-bio)
On December 8, Joysun Biotech, a well-known domestic in vitro diagnostics (IVD) brand, announced its acquisition of Fuzhou Maixin, a brand specializing in immunohistochemical (IHC) diagnosis for tumor pathology, sparking widespread industry discussion. Industry insiders suggest that the pathology market is on the verge of entering a phase of intense competition.
Pathology is a highly significant discipline within the entire system of Western medicine. William Osler, the father of modern clinical medicine, once referred to pathology as “the foundation of medicine,” and pathologists are often called “the doctor’s doctor.”
Pathology, a vital foundational discipline with a century-long history, has evolved from purely qualitative analysis to a field that guides precision medication.
“In the past, pathologists could only make pathological diagnoses based on morphological observations under a microscope with the naked eye. Today, with the development of new technologies such as immunohistochemistry and molecular pathology, pathologists can perform pathological diagnoses at a more minute molecular level, distinguish tumor subtypes, and thereby guide clinical medication, assist physicians in decision-making, and achieve more precise personalized treatment,” said Qi Hua.
Driven by technological advancements, the vast number of cancer patients, and the external influence of national policies over the past decade, the market has been continuously expanding. The pathology industry has achieved substantial breakthroughs in its development landscape, with a market size reaching hundreds of billions of yuan.
A large market, few players, and the pressure to transform—this is the current state of pathology, and a key reason why it has been thrust into the spotlight.
“As a company dedicated to the research and development of tumor pathology diagnostic products, we have observed that an increasing number of innovative enterprises and investment institutions are recognizing the promising prospects of pathology and investing in this untapped market. The year 2020 will be filled with competition and challenges,” Qi Hua told VCBeat.
Celnovte-Bio, established in 2010, is a national high-tech enterprise dedicated to the research and development, manufacturing, services, and sales of in vitro diagnostic reagents and instruments for tumor pathology and hematologic malignancies.
“If I were to summarize the waning year of 2019, I believe the most apt description would be these four words: innovation and pragmatism,” said Qi Hua.
“Adhering to innovation, Celnovte-Bio achieved a breakthrough in secondary antibody technology in 2019. ‘The secondary antibody polymer technology was developed by Celnovte-Bio’s U.S. team. By employing next-generation chemical conjugation techniques, it enables quantitative conjugation. Its multi-layer polymerization technology significantly enhances the sensitivity of secondary antibodies and controls the molecular weight of the polymers, resulting in greater sensitivity and stability. This technology has broken the monopoly held by foreign brands,’ introduced Qi Hua.”

(On-board secondary antibody)
Leveraging breakthroughs in secondary antibody technology, Celnovte-Bio has expanded its portfolio of tumor diagnostic products to include rapid immunohistochemistry (IHC), intraoperative rapid frozen-section IHC, multiplex IHC, cytological IHC, and quantitative fluorescence IHC.

(Immunohistochemistry Series Reagents)
Furthermore, after three years of research and development, Celnovte-Bio launched its next-generation CNT330 Fully Automated Immunohistochemistry Stainer in 2019. This product holds multiple patents and is priced significantly lower than foreign brands, enabling it to serve as a domestic alternative to imports. “The CNT330 Fully Automated Immunohistochemistry Stainer features full automation, high throughput, high-resolution imaging, ease of operation, cost-effectiveness, reliability, and traceability. It has already been adopted by numerous partner hospitals,” stated Qi Hua.
In addition to the two major breakthroughs mentioned above, he introduced that celnovte-bio has established a product portfolio comprising 462 types of immunohistochemistry (IHC) primary antibodies, IHC secondary antibodies, IHC ancillary reagents, and 200 types of IHC quality control materials.

(Fully Automated Immunohistochemistry Stainer)
In addition to its portfolio of immunodiagnostic products, celnovte-bio has achieved significant breakthroughs in tumor molecular pathology diagnostics and tumor histopathological staining products.
“In the next phase, we will continue to build a complete industrial chain for tumor pathology diagnosis and treatment, striving to become a leading domestic and internationally renowned provider of pathology diagnostic products,” said Qi Hua.
Innovation coupled with diligent execution has not only spawned a wide array of products but also significantly elevated Celnovte’s reputation in the field of oncology pathology. As previously mentioned, competition in the pathology industry was poised to intensify in 2020. As a leading player among domestic manufacturers, how will Celnovte respond?
“The nine-year journey of exploration has taught us that we must have sufficient patience at every step,” said Qi Hua.
He revealed that in 2020, Celnovte-Bio would strategically position itself along two major directions. First, in terms of products, it would expand around four key areas: development of engineered antibodies targeting tumor drug targets; development of liquid biopsy reagents based on digital PCR; development of rapid intraoperative frozen section immunohistochemistry staining systems; and development of AI-powered intelligent diagnostic analysis systems.
Furthermore, Celnovte-bio will enter the screening sector and make strategic arrangements in this area. Meanwhile, it will collaborate with renowned AI companies to integrate AI products into its product portfolio, combining them with diagnostic offerings.
II. Market Perspective: Build a robust sales team to achieve nationwide product coverage; implement distinctive marketing strategies to establish brand trust.
“Recently, our nationwide sales force has been largely established. Our products now reach even remote areas such as Tibet. Compared with 2018, the number of our partners has increased from more than 50 to over 100 this year,” said Qi Hua.

(Exterior shot of Celnovte-Bio)
Qi Hua introduced that, in addition to team building, the company has adopted a user experience model for product marketing, leveraging high-quality products to establish brand trust. The goal is to enhance CelNovte’s influence in the industry through comprehensive strategic deployment.
“We have set a goal for ourselves to list on the STAR Market within three to four years. 2020 is a pivotal year that builds on our past achievements and paves the way for future growth; we will proceed steadily, increase our market share, and strive to make our products the mainstream choice in pathology departments,” said Qi Hua.