"Sinoful Medical" Secures 128 Million Yuan in Series B+ Financing, Digital PCR Integrated Machine Enters the European and American Markets | Exclusive from 36Kr
36Kr exclusively learned that Sinoful Medical, an enterprise in the field of precision medicine, has recently completed a Series B+ financing round of 128 million yuan. This round of financing is led by Hui Mei Capital, with Kai Feng Ventures and Nanwan Bai'ao as co-investors. The raised funds will be mainly used for the market promotion of digital PCR products, the development of related reagent product lines, and the large-scale expansion of overseas markets.
Sinoful Medical was established in 2018, focusing on the industrialization of the third-generation droplet digital PCR equipment, providing fast, sensitive, accurate, and intelligent molecular diagnostic solutions.
In recent years, with the popularization and application of the concept of precision medicine, from early screening, companion diagnosis, to subsequent relapse detection, efficacy evaluation, and other whole-process links of tumor diagnosis and treatment, higher requirements have been put forward for the precise detection of molecular targets. Digital PCR is an absolute quantitative detection technology based on single-molecule nucleic acid amplification and counting. Compared with the traditional quantitative PCR technology, it has the advantages of absolute quantification, high sensitivity, and accuracy. It is the current development hotspot in the molecular diagnosis industry and is gradually becoming a strong competitor in clinical scenarios such as infection, hematological malignancies, and liquid biopsy of solid tumors.
From the perspective of product research and development, the integration and automation of digital PCR instruments have always been the pursuit direction of global medical device manufacturers. In 2022, with its independently developed "vibration injection" technology (Attached the previous report link), Sinoful Medical has successfully built an innovative digital PCR platform that does not require microfluidic consumables, and completed the development of the core product "DQ24 Digital PCR Integrated Machine", becoming one of the few enterprises in the industry to break through this bottleneck at that time.
This time, taking the opportunity of completing a new round of financing, we once again interviewed Sheng Guangji, the founder and CEO of Sinoful Medical, to talk about what the company has done in the past two years.
Sheng Guangji introduced that after completing technological innovation, Sinoful Medical's energy is mainly focused on the registration and certification of digital PCR products and the development of supporting reagent kits. In the past two years, the supervision in the domestic IVD field has been continuously tightened, and obtaining a registration certificate and compliance with hospital admission have become the prerequisites for the large-scale promotion of related products in the clinical end. The registration path of digital PCR instruments is gradually becoming clear. In 2022, the National Medical Products Administration updated the classification management catalogue of medical devices, clearly managing digital PCR equipment as Class III medical devices, and providing a clear guidance on the regulatory requirements and registration path of digital PCR.
"In 2022, we obtained the green channel certification for innovative medical devices from the NMPA and carried out related clinical verification work. Currently, the clinical trial has been completed, and it is expected that the first domestic digital PCR equipment registration certificate will be officially obtained soon; the overseas declaration is also being carried out simultaneously. DQ24 and its supporting detection kits have successively obtained the certifications of the EU CE and the US FDA in 2022 and 2023, and it is also the only digital PCR platform in the world (the other is Bio-Rad QXDx AutoDG) approved by the FDA." Sheng Guangji said.
In addition, in the development of reagent kits, the principle followed by Sinoful Medical is "strong clinical demand and high technical barriers". Currently, it mainly focuses on clinical scenarios such as solid tumors, hematological malignancies, and prenatal screening.
When talking about the reason for this layout, Sheng Guangji mentioned that the development of digital PCR instruments in China is in an early stage. "We hope to prove the technical advantages of the digital PCR platform in clinical scenarios to the market and partners through several initial application scenarios as 'benchmarks'."
The first reagent kit developed for the digital PCR equipment of Sinoful Medical is selected for the quantitative detection of fusion genes in chronic myeloid leukemia, which is a disease with a relatively mature treatment method. Patients can achieve long-term survival with the disease by taking medications as prescribed. Accurately quantitatively detecting the content of fusion genes in the blood samples of patients and timely adjusting the treatment plan play a decisive role in evaluating the progress of the disease. Highly sensitive fusion gene detection can even guide patients to safely stop taking medications, which has significant clinical value.
It is understood that Sinoful Medical has now completed the construction of a full-chain production system from the precision processing of core components, the assembly and manufacturing of the whole machine equipment, to the injection molding of consumables and the manufacturing of molds, and the research and development and production of IVD reagent kits. It has a 10,000-square-meter GMP workshop certified by ISO13485, achieving "vertical integration of the entire industry chain", and has certain advantages in quality control and cost control.
This also lays the foundation for Sinoful Medical in the global market competition. Going global is an unavoidable topic for IVD enterprises in the past two years. Considering the product positioning of digital PCR equipment, Sinoful Medical first targets the medical markets in advanced developed countries such as Europe, the United States, Japan, etc.
Sheng Guangji introduced: "At this stage, the threshold for innovative medical devices to enter the markets of developed countries mainly lies in intellectual property rights. It is the basis for the product to have independent intellectual property rights and a global patent layout. Otherwise, legal disputes may far exceed the benefits."
Currently, the "vibration injection" technology patent of Sinoful Medical has been authorized in the global mainstream markets such as China, the United States, Europe, Japan, Canada, etc. While breaking the monopoly of overseas manufacturers on the droplet technology route, it has realized the integration and automation of droplet generation, amplification detection, and data analysis. The product form is more user-friendly compared to foreign competitors. In clinical scenarios, "the learning cost of the new platform for customers is close to zero, and the operational experience is basically the same as that of qPCR".