Shanghai Securities Journal Interview with Lin Changqing | Hotgen Biotech Anchors Its Core Biotechnology Strengths While Advancing Global Expansion and Deepening Its Presence in the Industry

As the first IVD (in vitro diagnostics) company listed on the STAR Market of the Shanghai Stock Exchange, Hotgen Biotech is following the national strategy for biomanufacturing and advancing naturally from in vitro diagnostics toward biopharmaceuticals.

Lin Changqing, Chairman of Hotgen Biotech

   

In a recent interview with Shanghai Securities Journal, Lin Changqing, Chairman of Hotgen Biotech, said that the Company's transformation is not an expansion into an unrelated field, but a natural extension of its core biotechnology strengths. While pursuing a long-term strategy in innovative pharmaceuticals, Hotgen Biotech is also leveraging global expansion to create new growth opportunities and steadily advancing in the long-term development of the biopharmaceutical industry.

 

Building on Core Technologies and Aligning with Industry Trends

 

Biomanufacturing has been identified as a strategic emerging industry for China's development over the next decade. As one of the fields with the highest technological barriers within biomanufacturing, biopharmaceuticals have become a key area for industrial upgrading. In Lin Changqing's view, Hotgen Biotech's expansion from in vitro diagnostics into biopharmaceuticals is essentially a natural extension of the application of biotechnology.

 

“The core technology shared by in vitro diagnostics and antibody therapeutics is monoclonal antibodies. The former is used for diagnostic testing, while the latter is used to treat diseases. Within biotechnology, there is no rigid division between medical-device-based in vitro diagnostics and biopharmaceuticals,” Lin Changqing emphasized. “They are essentially different fruits growing on the same tree.”

 

This recognition of the common technological foundation has enabled Hotgen Biotech to pursue its strategic development with greater confidence. Over the past several years, the Company has continued to invest in basic research, publishing multiple papers in leading journals, including Nature family journals, while building a robust R&D system.

 

At the same time, the STAR Market and Hong Kong Stock Exchange's Chapter 18A listing mechanism have opened new financing channels for unprofitable biotechnology companies. China's decades-long accumulation of scientific and technological talent and its increasingly mature industrial foundation have also created favorable conditions for Hotgen Biotech's strategic upgrade.

 

“By aligning with China's pursuit of high-quality development and technological self-reliance and strength, while following the underlying trajectory of technological evolution, this transformation is naturally positioned to gain recognition from both the industry and capital markets,” Lin Changqing said.

 

Innovative drug development is often described by the “three 10s” rule: an investment of US$1 billion, a 10-year development period, and a 10% success rate. Industry reports in recent years suggest that the investment threshold and challenges may be even greater. Hotgen Biotech has made extensive preparations for this demanding path.

   

“We remain committed to a long-term strategy and focus on First-in-Class (FIC) drug development, with the goal of achieving global firsts. This is both a challenge and a key to differentiated competition,” Lin Changqing said.

 

Focusing on Frontier Fields and Building a Differentiated Pipeline

  

Upon entering Hotgen Biotech's exhibition hall, what immediately catches the eye is not the Company's diverse portfolio of products, but a large-scale R&D roadmap displayed on the wall. From early screening for liver cancer to antibody therapeutics for myocardial infarction and small nucleic acid therapeutics, it clearly illustrates the Company's innovation trajectory.

 

“We have always focused on ‘uniqueness and primacy,’” Lin Changqing said, pointing to the section dedicated to early liver cancer screening.

 

Technological innovation is at the core of Hotgen Biotech's identity. When the Company was listed on the STAR Market in 2019, its up-converting phosphor technology had already received the Second Prize of the National Science and Technology Invention Award, making it one of the few methodologies in the IVD field at the time to receive this prestigious national recognition.

  

In the IVD field, Hotgen Biotech has maintained a strong focus on early liver cancer screening. Its liver cancer triple-test panel and glycan-based exosome detection technologies are at the international forefront. In response to China's relatively high prevalence of hepatitis B and its globally high incidence and mortality rates of liver cancer, these three categories of products have been widely used for screening high-risk populations and incorporated into expert consensus recommendations. They help patients achieve earlier detection and treatment while also generating substantial healthcare cost savings.

 

The DNA methylation product for liver cancer developed by Oriomics Gene, a strategic investment company of Hotgen Biotech, has obtained an NMPA Class III registration certificate. It is the first multi-omics DNA-based early screening product in China for high-risk populations for liver cancer, establishing a full-cycle early monitoring system covering hepatitis, liver fibrosis, cirrhosis, and liver cancer.

    

Building on its solid foundation in diagnostics, Hotgen Biotech has naturally extended its innovation into the therapeutic field. After entering innovative biopharmaceuticals, the Company has continued to uphold its principle of “uniqueness and primacy,” focusing on unmet clinical needs.

 

Sungen Biomed, a company in which Hotgen Biotech holds a majority stake, has developed Dujipimab, the world's first antibody therapeutic for myocardial infarction. The drug has completed Phase I clinical trials and is preparing to initiate Phase II. It represents the world's first clinical research program for an antibody therapeutic specifically targeting myocardial protection.

 

Innovative Drug R&D Laboratory of Beijing Sungen Biomed

   

“We are committed to achieving the goal of ‘first discovery by Chinese scientists, first translation by a Chinese company, and first clinical development by a Chinese hospital,’ so that Chinese innovative pharmaceuticals can serve patients worldwide,” Lin Changqing said.

 

The Company has identified cardiovascular and cerebrovascular diseases as a key area in its antibody therapeutic development strategy, while also actively expanding into small nucleic acid therapeutics. The former represents a field with limited global supply of innovative drugs, significant R&D challenges, and substantial market potential. The latter has the potential to transform traditional treatment paradigms, with therapies that may achieve sustained efficacy through only one or two doses per year, making them a potentially important direction for the next revolution in the pharmaceutical industry.

  

Anchoring the Global Market and Advancing Accessible Healthcare

   

As the seeds of innovation take root in China, the vast global market has become a natural direction for further growth. Hotgen Biotech began its overseas expansion in 2019 and has since achieved significant progress. The Company has obtained more than 600 overseas regulatory certifications, established an office in Thailand and a subsidiary in India, and successfully entered markets across Southeast Asia, South Asia, the Middle East, Latin America, and other regions, gaining broad market recognition.

 

“Previously, healthcare product choices in developing countries were often limited to products from Europe, the United States, and Japan, but their high prices presented a major challenge. Chinese products can offer comparable quality at more competitive prices, providing these markets with a better choice,” Lin Changqing said.

 

He emphasized that overseas expansion is not merely a market development strategy, but also a way to fulfill the Company's responsibility to advance the vision of a global community of health for all, enabling more people in developing countries to benefit from accessible and affordable healthcare services.

 

Regarding the key factors for successful global expansion, Lin Changqing believes that international regulatory certifications are the foundation, high-quality and cost-effective products are the core competitive advantage, and an accurate understanding of local market needs is essential for long-term development.

 

“We have built strong technological capabilities and accumulated extensive regulatory certifications. Going forward, we will further intensify our efforts to develop overseas markets and bring Chinese IVD and biopharmaceutical products to a broader global market,” he said.

  

Lin Changqing then took the reporter to a photograph of the Company's former premises. In 2005, at the age of 29, he began his entrepreneurial journey in a small laboratory in Beijing's Fengtai Science and Technology Park.

 

After two decades of entrepreneurship, Lin Changqing's commitment to biotechnology has never wavered.

 

“‘Re’ in Hotgen represents our passion for biotechnology. We have always believed that science and technology can drive industrial evolution and contribute to national prosperity,” he said.

  

In his view, outstanding entrepreneurs must not only follow trends, but also anticipate them. From in vitro diagnostics to innovative pharmaceuticals, and from focusing on the domestic market to expanding globally, every strategic decision made by Hotgen Biotech is closely aligned with national strategies, industry trends, and clinical needs.

  

Faced with the high investment and high risks associated with innovative drug development, Lin Changqing acknowledged that the pressure is real, but said he has never considered retreating.

  

“‘Jing’ in Hotgen represents both vision and prospects. At this critical stage in the implementation of China's biomanufacturing strategy, we must keep our feet on the ground to deepen our work while also looking ahead to the road ahead.”

 

As night began to fall outside the windows, the lights in the laboratories remained bright. As Hotgen Biotech steadily advances its innovative pharmaceutical pipeline and deepens its global expansion, this technology-driven company is striving to establish a distinct Chinese presence on the global biopharmaceutical landscape.