Dilane Bio: Pioneering Fungal Molecular Diagnostics with Three Class III NMPA Approvals
In recent years, with the widespread use of broad-spectrum antibiotics, antineoplastic agents, glucocorticoids, and immunosuppressants, along with the advancement of organ transplantation, bone marrow transplantation, and catheterization techniques, as well as the rising incidence of chronic diseases such as AIDS and diabetes, the incidence of fungal infections has shown a sharp upward trend. As the prevalence of invasive fungal diseases increases, fungal infections pose an ever-greater threat to human health.
Currently, the most common deep fungal infections in clinical practice are caused by Candida, Aspergillus, Cryptococcus neoformans, Pneumocystis jirovecii, and other pathogens. Deep fungal infections are highly virulent and can affect nearly all internal organs and systems, with respiratory tract infections being the most prevalent. According to incomplete statistics, approximately 1.8 million patients worldwide die directly from fungal infections each year; about 12.5 million suffer from fungal-induced allergic asthma; roughly 4.75 million have acute or chronic pulmonary aspergillosis; approximately 1 million have acute invasive candidiasis; and around 600,000 have Pneumocystis jirovecii pneumonia. This substantial patient population has made molecular diagnosis of infectious diseases the largest single segment within China’s molecular diagnostics market.
According to relevant data, the infectious disease testing segment grew from RMB 2 billion in 2015 to RMB 5 billion in 2019, representing a compound annual growth rate (CAGR) of 25.2%. Due to the outbreak of the COVID-19 pandemic, the market size is projected to reach RMB 14.4 billion by 2024. Respiratory pathogens primarily include Mycobacterium tuberculosis and non-tuberculous mycobacteria, SARS-CoV-2, various fungi, influenza A and B viruses, Mycoplasma pneumoniae, Chlamydia, as well as other common bacteria such as Legionella and Nocardia. The molecular diagnostics market for respiratory diseases in China increased from RMB 96 million in 2015 to RMB 239 million in 2019. By 2024, China’s molecular diagnostics market for respiratory diseases is expected to reach RMB 2.7 billion (excluding testing for SARS-CoV-2).
“Invasive fungal infections are characterized by high infection and mortality rates, coupled with low diagnosis and treatment rates. This situation stems partly from insufficient attention paid to fungal infections in hospitals, and partly from inadequate diagnostic capabilities.”Hangzhou Dylan Biotechnology Co., Ltd.(abbreviated as“Dylan Biotech”）Dr. Fang Yuan, FounderIn an interview with VCBeat (WeChat: vcbeat), the company stated that its mainThe business focus is on fungal infection detection, and three Class III medical device registration certificates have already been obtained.Achieved significant breakthroughs in the field of molecular diagnostics.
Currently, the diagnosis of invasive fungal diseases mainly relies onDirect microscopy, culture method, imaging, histopathology, G test, and GM testetc. All these techniques have certain limitations, which restrict the clinical application of traditional methods in the diagnosis of invasive fungal diseases.
In February 2022, the Chinese "Expert Consensus on Clinical Application of Laboratory Diagnostic Methods for Invasive Fungal Diseases" included fluorescent PCR for fungal nucleic acid detection as a strongly recommended testing method for the first time.
Overview of Mainstream Diagnostic Methods for Invasive Fungal Diseases, Graphic by VCBeat
Real-time fluorescence quantitative PCR, with its advantages of non-invasive sampling and the ability to perform early, rapid, sensitive, and specific laboratory detection of fungal infections, improves diagnostic rates in patients with fungal infections and provides an effective adjunct for the early treatment of invasive fungal infections. As such, it has become an important complement to traditional diagnostic methods for invasive fungal diseases and represents one of the future directions in this field.
Hangzhou Dylan Biotechnology, established in 2012, isOne of the few domestic companies specializing in the development of molecular diagnostic products for fungi. It employs real-timeQuantitative Fluorescent PCR Method,It provides significant assistance for rapid clinical diagnosis. The application of molecular diagnostics can effectively improve the confirmed diagnosis rate of fungal infections, and this type of diagnosis hasHigh sensitivity, high specificity, rapid and non-invasive detectioncharacteristics. Currently, Hangzhou Dylan Biotechnology possesses3 Invention Patents, and haveThree fungal nucleic acid detection kit products have obtained NMPA Class III IVD product registration certificates.
Hangzhou Dylan Biotechnology Co., Ltd. – Actual Site Photos
In his book *Outliers*, Gladwell points out, “The reason geniuses appear extraordinary is not because they possess superior innate talent, but because they have made continuous efforts. Ten thousand hours of deliberate practice is a necessary condition for anyone to transform from ordinary to world-class mastery.”
Just as it is with individuals, so it is with enterprises. Hangzhou Dylan Biotechnology Co., Ltd. has dedicated itself for a decade to a field that was entirely blank in China at the time.
Dylan Biotech Facility: Actual Photos
Over the past decade, Hangzhou Dylan Biotechnology Co., Ltd. has establishedR&D Laboratories and Quality Control Labs Covering Over 600 Square Meters, covering an area of850 m² GMP Cleanroom FacilityandDedicated Production Line for Fluorescent PCR Reagents. Possessing a stable production line and the conditions for mass production has laid a solid foundation for Hangzhou Dylan Biotechnology, which is about to enter its harvest period.
Over the past decade, the company has expanded its product development focus to areas closely related to fungal diseases, such as dermatophytes and gynecological fungal infections. It has established a comprehensive series of fungal detection products, including in vitro diagnostic reagents such as: Fungal Nucleic Acid Detection Kit (Fluorescent PCR Method), Fungal Nucleic Acid Extraction and Purification Kit, Fungal Immunofluorescence Staining Solution (One-Step Method), and Histopathological Staining Solution (Fungal Fluorescence).
The above three products have each obtained Class III IVD product registration certificates.
Among them,Fungal Real-Time Quantitative PCR Nucleic Acid Detection Series ProductsandRapid Fungal Nucleic Acid Extraction KitIt is the flagship product of Hangzhou Dylan Biotechnology.
Fungal Real-Time Quantitative PCR Nucleic Acid Detection Series Products,Adopting real-timeFluorescence Quantitative PCR MethodandTaqMan Probe Technology. It can simultaneously detect Aspergillus pathogens such as Aspergillus fumigatus, Aspergillus flavus, and Aspergillus niger, covering the early detection of most Aspergillus infections (including acute/allergic, chronic, and invasive aspergillosis). FeaturesRapid detection, high sensitivity, strong specificity, more accurate results, and more intuitive presentationand other advantages.
It is suitable for screening of clinical allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), differential diagnosis of parenchymal lung diseases such as chronic pulmonary aspergillosis (CPA), lung tumors, and pulmonary tuberculosis when infection occurs, as well as auxiliary diagnosis of invasive pulmonary aspergillosis (IPA) in immunocompromised populations or long-term hospitalized patients, including those with chronic obstructive pulmonary disease (COPD), diabetes, or undergoing tumor chemotherapy and radiotherapy.
RxNAF Rapid Fungal Nucleic Acid Extraction Kit,For use with fungal nucleic acid detection kits. Specifically designed for fungal nucleic acid extraction, the extracted DNA can be directly used for subsequent nucleic acid amplification without purification. This product is a kit exclusively developed and commercialized by Hangzhou Dylan Biotechnology Co., Ltd.
The pursuit of technological excellence has enabled Hangzhou Dylan Biotechnology Co., Ltd. to receive numerous certifications and awards over the past decade—including being named a “Cuckoo Plan Enterprise” by Hangzhou City in 2015; obtaining certification as a “Hangzhou Enterprise High-Tech R&D Center” in 2020; being recognized as a “National High-Tech Enterprise” in the same year; receiving approval in 2021 to establish the “Expert Workstation of Hangzhou Dylan Biotechnology Co., Ltd.”; becoming a member unit of the “Zhejiang Provincial Life and Health Industry Innovation Committee”; and serving as a council member unit of the Hangzhou Binjiang District “Biopharmaceutical Innovation Alliance” (BIA), among other honors.
Hangzhou Dylan Biotechnology’s remarkable achievements are in no small part attributable to its founder, Fang Yuan.
Dr. Fang Yuan
Dr. Fang Yuan, Chairman of the Board and General Manager, is the company's primary founder. He holds a Ph.D. from Peking University Health Science Center and completed his postdoctoral fellowship at Oregon Health & Science University (OHSU) in the United States. During his 17 years in the U.S., he led and initiated multiple research grant projects funded by the NIH and NSF, and published 21 SCI-indexed papers. He previously served as a Research Assistant Professor at OHSU and as a Researcher in the Molecular Pathology R&D Department at Invitrogen Corporation.
“Initially, I aimed to address the shortage of tumor companion diagnostic reagents. However, after conducting in-depth market research and communicating with frontline clinicians, I discovered that the diagnosis of medically significant pathogenic fungi in China faces substantial challenges, with pronounced clinical pain points and a significant market gap. The lack of adequate diagnostic products exacerbates these difficulties, making the treatment of fungal infections particularly challenging.” Speaking about the impetus for his startup, Fang Yuan stated, “The sensitivity and specificity of existing traditional diagnostic methods are unsatisfactory. There is an urgent need to develop a novel molecular diagnostic method and product for the rapid clinical diagnosis of fungal infections, thereby resolving the longstanding difficulties in diagnosing medical mycoses.”
Thus, after 17 years in the United States, Fang Yuan resolutely resigned from his faculty position at a U.S. university and returned to China in 2012 to found Dylan Biotechnology, building a teamStrong Technology, Strong Business, Strong Approvala formidable force.
Vice President and Director Zhang Renyou, one of the company's co-founders, holds a bachelor's degree in Clinical Medicine from Southeast University and serves as an Associate Chief Physician and Department Director. In 1999, he resigned from his public-sector position to pursue opportunities in the private sector. He previously held senior executive roles at Siemens Healthineers China, where he established the company's channel sales network in the Chinese market. He later served as Sales Director for Stago China, restructuring the sales team and distribution network, which resulted in a more than five-fold increase in sales performance over seven years. He possesses extensive experience in marketing promotion and sales management. Additionally, he has served as Investment Director at an investment firm, demonstrating profound insight into startup companies. In July 2020, he joined Hangzhou Dylan Biotechnology Co., Ltd. as a co-founder upon invitation.Currently, I am primarily responsible for establishing the market sales team and building the channel sales network.Mr. Zhang’s conviction is that Chinese innovative enterprises must be market-demand oriented, conduct R&D with diligence, strictly control product quality, and provide meticulous after-sales service; this era will undoubtedly foster a cohort of outstanding Chinese enterprises and entrepreneurs.
Liu Fuxiang, Director of System Compliance,With a strong regulatory affairs background and nearly a decade of experience in the IVD molecular diagnostics industry, possesses in-depth knowledge of NMPA registration review processes and full lifecycle quality management. Has led and participated in the design, development, and commercial translation of more than ten IVD products, securing Class III medical device registration certificates from the National Medical Products Administration (NMPA). Product portfolio spans infectious disease molecular diagnostics, pharmacogenomics, tumor genetic screening, and companion diagnostics, leveraging methodologies including Real-time qPCR, NGS, and FISH platforms. Demonstrates extensive expertise in team management and practical project registration execution.Currently primarily responsible for compliance-related work throughout the entire product lifecycle and regulatory registration submissions for new product pipelines.
Currently, the companyNearly 30 people, with R&D and regulatory affairs personnel accounting for half of the company's workforce.
Regarding the future plans for Dylan Biotechnology, Fang Yuan stated, “In the future, we will proceed in three steps.Sales:Accelerate market sales deployment, establish a sales management team, and expedite the hospital listing of projects;In terms of promotion,Strengthen collaboration with the clinical academic community to jointly educate the market;In terms of R&D,"Accelerate the development of new products, striving to launch 1-2 new products annually, and continuously strengthen Hangzhou Dylan Biotechnology's position in the fungal nucleic acid testing industry."
In terms of commercialization, the primary payers for Hangzhou Dylan Biotechnology Co., Ltd. are currently distributors, with its main sales model being distribution.
According to Fang Yuan, Hangzhou Dylan Biotechnology Co., Ltd. has currently partnered withThe First Affiliated Hospital of Nanchang University, the First Affiliated Hospital of Chongqing Medical University, Wuhan Pulmonary Hospital, the First Hospital of Hebei Medical University, Shandong Public Health Clinical Center (formerly Shandong Chest Hospital), and more than 200 other hospitals across China, andFive nationwide chain third-party independent laboratory institutions, including Guangzhou KingMed Diagnostics and Wuhan Kangsheng GlobalEstablished a cooperative partnership. The company expects to achieve profitability within three years.
In terms of financing, Hangzhou Dylan Biotechnology currently has two main areas of need: one isSeeking Collaboration on Sales Channels and Market Resources; on the other hand, the company isSeeking the Next Round of Financing, for use inProduct optimization, new product R&D, and market promotion.