VCBeat has learned that recently,Suzhou Haowei Micro-Medical Technology Co., Ltd. Completes Initial Closing of Series B Financing Worth Tens of Millions of Yuan. The round was led by ADDOR, with Suzhou Wuzhong Financial Holding Co., Ltd. participating as a co-investor. Bitola Capital served as the exclusive long-term financial advisor. The proceeds will be used for product commercialization, as well as clinical development and R&D of next-generation medical microsphere products.HaoWei Microspheres was established in 2021, focusing on the research and development of diversified medical microsphere products to deeply empower various clinical application scenarios. Since its inception, HaoWei Microspheres has been committed to building a platform centered on core microsphere technologies: relying on in-house R&D capabilities, it maintains strict control over the entire process, from the synthesis and screening of biomaterials to the preparation and formation of microspheres. As different clinical applications have varying requirements for microsphere materials, and these differentiated materials are not available through off-the-shelf procurement channels, HaoWei Microspheres’ self-built microsphere technology platform demonstrates unique advantages. It not only flexibly adapts to diverse clinical scenarios but also breaks free from constraints imposed by external supply chains, allowing the company to seize first-mover advantage and secure a favorable position in industry competition.The successful establishment of a foundational technology platform for microspheres hinges on an outstanding core team. The core team at Haowei Microbiology has accumulated years of R&D and process expertise in the field of drug-loaded microspheres. The team successfully commercialized China’s first drug-loaded embolization microsphere, achieving market sales exceeding RMB 1 billion.Leveraging its robust core team and proprietary underlying technology platform, Haowei Microbiology has formulated three major commercialization strategies. The first is to empower the field of vascular intervention with microsphere technology, with specific products including microspheres for vascular intervention in malignant tumors, microspheres for vascular intervention in benign tumors, balloon occlusion catheters designed to facilitate microsphere-based interventional procedures, and steerable microcatheters. To date, Haowei Microbiology’s uniform-sized Unipearls®Drug-eluting embolic microspheres received marketing approval from the FDA in November 2023 and from the NMPA in August 2024. HiFlamingo®The balloon occlusion catheter received NMPA marketing approval in April 2024, HiSwan®Adjustable Steerable Microcatheter Coming Soon.Haowei Microbiology is fully committed to driving the iterative upgrade of drug-eluting embolic microspheres. Clinical studies conducted by Haowei Microbiology comparing its second-generation drug-eluting microspheres with the first generation in the treatment of colorectal cancer liver metastases have demonstrated that the second-generation uniform-sized drug-eluting microspheres offer superior efficacy and safety. Within the grand landscape of vascular intervention, the company has two additional key pipelines: biodegradable microspheres and radioactive microspheres.In addition to providing embolization effects comparable to non-degradable drug-eluting microspheres, biodegradable microspheres enable controlled drug release. They spontaneously degrade after completing their embolization task, leaving no residue in the patient’s body, thereby further enhancing treatment safety and reducing physiological burden. Beyond their application in malignant tumor embolization, these products hold significant value in treating benign conditions such as uterine fibroids and benign prostatic hyperplasia, allowing for disease treatment while preserving fertility in both women and men.Radioactive microspheres exhibit even more pronounced cytotoxic effects against malignant tumors. Numerous clinical guidelines published since the 21st century have laid a solid foundation for the efficacy and safety of radioembolization in treating primary and metastatic liver cancers. The radioactive microspheres developed by Haowei Microbiology aim to address several critical challenges. First, improvements in microsphere materials are being made to reduce their specific gravity, matching their density to that of blood. This allows them to remain suspended in the bloodstream for longer periods, thereby extending their therapeutic action. Second, the radioactivity of the radionuclides loaded onto the microspheres is being increased to enhance treatment efficacy. Finally, the platform aims to achieve loading with multiple types of radionuclides, expanding beyond the currently available Yttrium-90 (Y-90) microspheres to include others such as Lutetium-177 (Lu-177), which has shown promising results in the treatment of neuroendocrine tumors and prostate cancer.The second major commercialization strategy involves drug-loaded sustained-release microspheres, a formulation technology characterized by high technical barriers. Encapsulating drugs into microspheres can further extend the drug’s half-life, bypass the first-pass effect, stabilize plasma drug concentrations, and improve patient compliance, holding significant importance for clinical treatment. Currently, the main sustained-release microsphere formulations in the domestic market include triptorelin microspheres, leuprorelin microspheres, octreotide microspheres, and risperidone microspheres. Most marketed products are from foreign companies. Only a few domestic manufacturers, such as Livzon, Luye, and Best, are present in this field. The limited number of domestic enterprises capable of registering sustained-release microsphere formulations as innovative drugs highlights the significant challenges in R&D for this dosage form. However, Haowei, with its long-term dedication to microsphere R&D, possesses inherent advantages in entering this sector. Currently, Haowei Microbiology has achieved milestone progress in multiple product pipelines for the treatment of arthritis, depression, and tumors.The third major commercialization strategy is the pipeline of consumer-oriented cash-flow products, including injectable regenerative medical aesthetic microspheres and various life-beauty materials. Since Haowei Microbial’s microsphere underlying technology platform was built starting from material synthesis, the company has mastered the core processes for upstream materials. It possesses foundational technologies for the modification and processing of various synthetic and natural polymer biodegradable materials, enabling it to rapidly develop and combine differentiated clinical application products tailored to the characteristics of different materials. Whether in the markets for medical aesthetic microspheres, hemostatic materials, or skincare products, the market size is projected to exceed RMB 10 billion in the near future.In terms of product commercialization progress, Haowei Microbiology has entered into a long-term strategic sales partnership with Yifan Pharmaceutical, and both parties will work together to explore the tumor intervention market. As of the end of December 2024, Haowei Microbiology's Unipearls®Non-degradable drug-eluting microspheres successfully won the bid in the inter-provincial alliance centralized procurement led by Gansu Province. The product has been adopted by nearly 100 hospitals, and the company’s high-quality products combined with highly competitive marketing strategies will further accelerate the commercialization process of Haowei Microbiology.As society ages and consumption patterns continue to evolve, demand for medical-grade and consumer-grade microsphere products is rising steadily in both clinical and consumer sectors. For Haowei Microbiology, which has built its core platform on medical microsphere technology, integrating R&D and manufacturing resources will significantly reduce development and production costs. The platform’s continuous technological accumulation will further enable the company to develop more differentiated and innovative products. Coupled with broad prospects for clinical applications, these factors will inject sustained momentum into the company, driving stronger growth potential.
