Recently, Wuhan Binhuai Biotechnology Co., Ltd. (hereinafter referred to as Binhuai Bio) submitted its listing application to the main board of the Hong Kong Stock Exchange, with Huatai International, CMB International, and Bank of China International acting as co-sponsors. This initiative marks a new phase in the company’s development and injects strong momentum into its global strategic layout. As a biotechnology firm focused on oncolytic virus therapy, Binhuai Bio has been dedicated to the research and commercialization of innovative cancer immunotherapy since its establishment in 2010. Dr. Liu Binlei, the founder and chairman of the board, possesses over 30 years of expertise in tumor immunology and oncolytic virology and was a core member of the original research team for IMLYGIC® (T-VEC), the first oncolytic virus drug approved by the FDA, playing a key role in its development.
Since its inception, the company has completed 13 rounds of financing, raising over 1.5 billion yuan, with investors including Yangtze River Pharmaceutical Group, Jiuzhoutong, as well as renowned institutions like CICC Capital and XN Ventures. Following its 2023 funding round, the company's valuation reached 3.22 billion yuan, reflecting the market's high recognition of its technological path and commercial prospects. With the continued rise of oncolytic virus therapy, can Binhuai Bio, with its relatively scarce core products, attract investors in the Hong Kong market?
From a financial perspective, Binhuai Bio is currently in a strategic investment phase. The revenue for the fiscal years 2023 and 2024, as well as for the first six months ending June 30 in 2024 and 2025, was 981,000 yuan, 1.725 million yuan, 250,000 yuan, and 140,000 yuan respectively (unit: RMB); meanwhile, the losses for the same period were approximately 110 million yuan, 113 million yuan, 43.748 million yuan, and 44.215 million yuan. Like many early-stage biotech companies, this loss is primarily due to high-intensity R&D investments. In 2023, R&D expenses reached 107 million yuan, accounting for 92% of total expenditures; in 2024, the proportion remains above 85%, with funds mainly utilized for the global phase III clinical trial of the core product BS001 and the clinical advancement of BS006. According to reports, as of June 30, 2025, the company had cash and cash equivalents of 166 million yuan. Despite a net loss of 113 million yuan in 2024, the net cash flow from operating activities narrowed from a loss of 127 million yuan in 2023 to 79.13 million yuan, indicating continuous optimization in the company’s financial management. Should the IPO fundraising proceed successfully, it would effectively support the global phase III trial of BS001 and subsequent pipeline development, providing crucial assistance for the company's move toward commercialization.
To date, Binhuai Bio has established a rich and diversified pipeline, including three strategic series—oncolytic viruses, nucleic acid therapies, and protein biologics—comprising five products at various stages of development, many of which have the potential to be the first of their kind globally. Among them, the core product BS001 (OH2 injection) is particularly noteworthy. As the world's first oncolytic virus candidate using HSV-2 as the viral backbone to reach the clinical stage and enter critical phase III trials, BS001 has the potential to become a pioneering new drug globally. It selectively replicates within tumor cells to directly induce oncolysis and secretes human granulocyte-macrophage colony-stimulating factor (hGM-CSF), activating a systemic immune response. In early clinical trials, BS001 demonstrated good safety and preliminary efficacy: the objective response rate for patients with advanced melanoma reached 34.48%, and for patients who developed resistance to PD-1 therapy, the objective response rate was even higher at 42.1%. Completed phase Ia/Ib trials indicated a median overall survival extension of 31.06 months; however, as treatment continues, the final overall survival time has yet to be reached but is expected to extend further.
Reports indicate that BS001 has been granted breakthrough therapy designation by the China National Medical Products Administration and has received orphan drug designation and fast track status from the FDA, underscoring its global competitiveness. The company is currently exploring BS001 as a monotherapy and in combination with major drugs (especially in conjunction with PD-1 inhibitors) for various solid tumor indications, including melanoma, colorectal cancer, glioblastoma, soft tissue sarcoma, and biliary tract cancer. Another key product, BS006, is the world's first dual-specific oncolytic virus to enter clinical phases, utilizing recombinant type II herpes simplex virus (HSV2) as a vector. Through advanced genetic engineering techniques, it efficiently expresses PD-L1/CD3 dual-specific T cell engager (TCE) molecules, establishing a triple synergistic mechanism for combating tumors. Currently, BS006 has entered phase I clinical trials in the United States, becoming the first TCE-expressing HSV oncolytic virus in clinical development globally, and received IND approval from the Chinese National Medical Products Administration in August 2025. Additionally, Binhuai Bio's product lineup includes nucleic acid therapies represented by BR003 and BS051, as well as protein biologics represented by BR016. Among these, BR003 is a LNP-encapsulated IL-2 analog therapy boasting molecular selectivity, systemic delivery, and broad anti-tumor efficacy, with good safety profiles.
According to Frost & Sullivan data, Binhuai Bio possesses unique vertically integrated CMC and commercial-scale production capabilities in the industry, making it one of the few companies in China to achieve full-loop management of oncolytic virus development and production. Moreover, it is the only company in the country holding a type A drug manufacturing license for oncolytic virus drugs, providing solid assurance for its subsequent large-scale production and commercialization.
The oncolytic virus sector is gaining traction, representing an emerging cancer treatment approach that selectively infects and kills cancer cells through natural or genetically modified viruses while activating the immune system to eliminate tumors, showcasing unique therapeutic potential. Particularly notable is its significant synergistic effect when used in conjunction with immune checkpoint inhibitors. Looking back at the industry's development history, Amgen’s T-VEC received FDA approval for melanoma treatment in 2015, becoming the first approved oncolytic virus therapy globally. This attracted strategic interests from leading global pharmaceutical companies such as Bristol Myers Squibb (BMS), Merck, and Johnson & Johnson. However, due to challenges such as effective delivery of the virus in the body, a lack of biomarkers, the complexity of attributing therapeutic effects, and stringent evaluation standards, successful companies in the oncolytic virus field remain scarce. Since T-VEC's approval, the FDA has not yet approved any new oncolytic virus therapies, and T-VEC’s commercialization performance has also not met expectations, with global annual sales falling back to the range of $20-30 million.
The rather bumpy development trajectory illustrates that the oncolytic virus therapy market remains a vast blue ocean with ample growth potential. In early 2024, CG Oncology entered NASDAQ with its phase III oncolytic virus therapy for bladder cancer, experiencing a 100% surge in stock price on its debut, with its market cap briefly surpassing $2.2 billion, reigniting market enthusiasm. Since the beginning of 2025, the oncolytic sector has seen noteworthy advancements: Professor Liang Tingbo's team from Zhejiang University successfully developed the world's first third-generation oncolytic virus VG161, achieving breakthrough results in the treatment of refractory liver cancer; recently, Yinuo Micro Pharmaceuticals, which submitted its prospectus to the Hong Kong market, also focuses on oncolytic virus therapy and attracted numerous prestigious investment institutions such as Hillhouse Capital and Huagai Capital before going public, driving continued growth in the oncolytic virus sector.
Moreover, data shows that domestic innovative pharmaceutical companies are increasingly becoming strong competitors in the oncolytic virus field. According to data from ClinicalTrials, of the over 200 oncolytic virus-related clinical trials currently underway globally, half are from China, with many studies advancing to mid-to-late clinical stages, including Yinuo Micro’s MVR-T3011, Funoke's VG161, YH01 from Yinghui Pharma, Tianda Gene's ADV-TK, and Aoyuan Hedley's OrienX010, among others.
In this thriving field, Binhuai Bio has built a unique competitive advantage through its globally leading HSV-2 carrier platform. The company not only possesses a robust and globally promising product pipeline but has also established a scarce vertically integrated industrial capability that lays a solid foundation for future commercialization. Looking ahead, as oncolytic virus technology continues to mature and the company's R&D progresses rapidly, Binhuai Bio is poised to leverage its technological leadership and comprehensive industrial chain layout to seize market share in this blue ocean market, welcoming simultaneous upward resonance in performance and valuation.