Frost & Sullivan (Frost & Sullivan, abbreviated as 'Frost & Sullivan') officially released the 'Blue Book on the Development of China's Oncolytic Virus Industry' (hereinafter referred to as the 'Blue Book') on July 28, 2023. The aim is to conduct an in-depth analysis of the current development status, competitive landscape, capital interest, R&D barriers, etc., of the oncolytic virus industry, track the development context of the industry and technology, tap into the potential for industry development, analyze the driving factors behind market development, and hope to sort out the current industrial situation and reflect future growth trends for participants in the oncolytic virus industry.
Oncolytic viruses are a class of viruses that have the ability to replicate and can break down and destroy tumors. By exploiting the virus's specific selection for tumor cells, they selectively infect tumor tissue without killing normal cells and replicate extensively within tumor cells, ultimately causing the tumor cells to lyse. The progeny viruses released after lysing continue to infect adjacent tumor cells. At the same time, after the death of tumor cells, they release tumor-associated antigens, inducing a systemic anti-tumor immune response that leads to the regression of distant tumors that have not been exposed to the virus. Currently, oncolytic virus drugs have undergone clinical trials in multiple solid tumor fields, including melanoma, head and neck cancer, bladder cancer, prostate cancer,GlioblastomaMalignant tumors.

Source: Analysis by Frost & Sullivan
The 'Blue Book' conducts an in-depth analysis of common types of oncolytic viruses, the development history of oncolytic virus therapies, optimization paths, and production processes. It also compares the regulatory frameworks for oncolytic viruses in different countries. For more detailed content, please refer to the complete version of the Blue Book.
2ListedOncolytic virus productand ongoing pipelines
As of now, four oncolytic virus drugs have been approved for marketing. The products currently available in the market are Ankerui.®Imlygic®Delytact®As of April 2023, 60 oncolytic virus drugs are in clinical trial stages worldwide, among which 17 drugs are undergoing clinical trials in China.

Source: Analysis by Frost & Sullivan
The Blue Book elaborates on the viral treatment principles and indications of four approved on-label tumor-killing virus products globally, as well as on the global andChinese Oncolytic VirusThe drugs under research are statistically analyzed from four dimensions: virus type, indication layout, R&D progress, and treatment methods (combination therapy/single drug). For more detailed content, please refer to the full version of the Blue Book.
3Oncolytic virus combination therapy
Nearly half of the global clinical trials for oncolytic virus drugs are combined therapies. When oncolytic virus therapy is used in combination with chemotherapy drugs, immune checkpoint inhibitors, and other therapies, it has a synergistic effect, further improving the effectiveness of tumor treatment. Oncolytic viruses can not only serve as an anti-tumor weapon but also as a key switch to activate the anti-tumor immune response, promoting the entry of immune cells into tumors and inducing and stimulating innate and tumor-specific adaptive immunity.
The Blue Book elaborates on combination therapies based on oncolytic viruses and analyzes clinical trial data of oncolytic virus combined with chemotherapy/immune checkpoint inhibitors. For more detailed content, please refer to the full version of the Blue Book.
4Oncolytic virus drug market size
In 2021, the total global market for oncolytic virus treatment drugs reached $600 million, while the Chinese market for oncolytic virus treatment drugs totaled RMB 200 million. The oncolytic virus treatment drug market still maintained rapid growth.

Source: Analysis by Frost & Sullivan

Source: Analysis by Frost & Sullivan
The 'Blue Book' analyzes the market scale, driving forces, and development trends of oncolytic viruses in China. For more detailed content, please refer to the complete version of the Blue Book.
5Oncolytic virus therapy capital market performance
In recent years, pharmaceutical companies have absorbed the advanced technologies and experiences of target companies through various capital transaction forms such as acquisitions and authorizations, and positioned themselves in the field of oncolytic viruses.

In addition, several listed companies in China have positioned themselves in the oncolytic virus sector. Some of the R&D enterprises involved in oncolytic virus drugs have received substantial funding. For more detailed information, please refer to the full version of the Blue Book.

6Introduction to Some Companies in the Oncolytic Virus Field
01BinHui Biology
The company was established in 2010 and is led by Imlygic, an oncolytic virus that has been approved for marketing in the United States by the FDA®Founded by Dr. Liu Binlei, a key member of the original research team, the company is a high-tech enterprise specializing in the research, development, production, and technical services of new biologics. The company has established an immunotherapy platform for oncolytic viruses (oHSV2) with independent intellectual property rights and industry-leading capabilities. It collaborates with multiple platforms including nucleic acid drugs, protein drugs, and cell therapy to develop Class I biologics. The company's lead oncolytic virus product, BS001 (OH2) injection, has successively obtained approval from the NMPA and FDA for clinical trials, becoming the world's first oncolytic virus to enter clinical research using type II herpes simplex virus as a vector. At the same time, BS001 has been included in the breakthrough therapy category by the CDE and has received orphan drug designation and fast track qualification from the FDA. The company has established production processes recognized by both the NMPA and FDA, integrating production and research to fully meet the needs of clinical research and industrialization. It has become an industry pioneer in the collaborative exploration of multi-platform technologies for tumor immunotherapy.
02Yinuo Wei
The company is a technology-oriented firm dedicated to developing synthetic biologic vector delivery platforms. It has built an OVPENS (Open Vector+ Potent, Enabling, Novel & Safe) platform that integrates complete scientific logic, R&D technology, and production processes. Based on this, the company has developed three sub-platforms: oncolytic viruses, tumor vaccines, and bioengineered exosomes. These platforms are used to support the early R&D, clinical research, and commercialization cooperation of Best-in-Class single-drug pipelines and combination therapies, meeting the clinical needs in both oncology and non-oncology fields.
03Kangwanda
Dr. Hu Fang, the founder, once led the team to complete the full-process research and development of China's oncolytic virus drug 'Ankerei'. The company has been committed to independent research and development since 2016, receiving support from strategic capital such as CMC Venture Capital, China Resources Group, and Biotec Industrial Fund. It has assembled a full-process new drug discovery team with international R&D experience, creating three core technology platforms for the development of novel oncolytic virus drugs, including poxvirus, adenovirus, and herpes simplex virus. The platform has clear independent intellectual property rights and a new generation of oncolytic virus project pipelines. In addition, Kangwanda has established a systematic immunotherapy research and development platform, combining oncolytic virus drugs with other immunotherapy technologies to develop efficient combined innovative therapies, striving to create breakthrough clinical efficacy in cancer treatment.
04Hengyi Biology
The company is a pharmaceutical R&D enterprise rooted in China, looking towards global markets, adhering to patient-centeredness, and continuously innovating. Since its establishment in 2018, the company has built a research pipeline with significant clinical differentiation and synergistic effects in major disease areas such as oncology, autoimmunity, and metabolism. The overall layout of the product pipeline is reasonable, showing an obvious gradient from early to mid- and late-stage clinical trials. Multiple ongoing projects have made substantial progress and are about to enter commercialization. Under the leadership of Dr. Li Yuannian, a national high-level talent expert, the company has formed a core team with rich experience in innovative drug R&D and multidisciplinary knowledge reserves. It possesses advanced new drug R&D technologies independently established and comprehensive R&D capabilities covering all stages of new drug development. Among the company's shareholders include Sequoia Capital, Qiming Venture Capital, Tiger Medicine, Temasek, TF Capital, Yingke Capital,Yunfeng FundWell-known domestic and international investment institutions.

