Xunsheng Medicine Files IPO Prospectus Highlighting Breakthroughs in HPV Therapeutic Vaccines and TIL Cell Therapy for Solid Tumors

In the early 1880s, the case of a patient with recurrent malignant sarcoma caught the attention of William Coley. During surgery, the patient unfortunately contracted an accidental Streptococcus pyogenes infection. In the absence of antibiotics, the patient had to rely solely on their own immune system to combat the pathogen. However, much to everyone's surprise and delight, after enduring several bouts of high fever, the streptococcal infection gradually subsided, and remarkably, the previously recurrent malignant sarcoma also miraculously disappeared.

While marveling at the human body's own immune system, William Coley also recognized a subtle connection between streptococcal infection and malignant sarcoma. From then on, he began utilizing streptococcal infections to treat malignant sarcomas, officially ushering in the era of human cancer immunotherapy and earning the title "Father of Cancer Immunotherapy".

Since William Coley began using Streptococcus to treat sarcoma in 1892, human understanding of immunotherapy has evolved for over a century. The advent of the prophylactic HPV vaccine in 2006 (co-invented by Chinese scientist Dr. Jian Zhou and Nobel Prize-nominated Professor Ian Frazer) made cancer immunotherapy a reality. Furthermore, the devastating global spread of the COVID-19 pandemic in 2020 has further elevated human understanding of viruses and immunotherapy to a new level, accelerating the advent of nucleic acid vaccines.

According to Clarivate Analytics data, global new drug R&D resources are heavily concentrated in the field of cancer immunotherapy. In 2019 alone, 518 cancer immunotherapy-related projects were initiated, reflecting the research community's strong emphasis on this area. Furthermore, driven by the COVID-19 pandemic, the anti-infective sector has garnered widespread attention and rapidly emerged as the most heavily funded field globally, with 541 related projects launched in 2020 alone. Against the backdrop of the pandemic, the clinical demand and investment value of immunotherapy continue to be increasingly prominent.

The Beijing-headquartered Aeonvital team promptly captured the robust growth momentum in this field and, leveraging a series of high-quality research achievements accumulated in immunotherapy-related areas, established Beijing Aeonvital Biomedical Research Co., Ltd. (hereinafter referred to as "Aeonvital") in March this year. It is understood that the company primarily features two core technology platforms,The first is a TIL cell therapy platform developed for solid tumors, and the second is a nucleic acid vaccine therapeutic platform developed for cervical cancer (HPV).

Leveraging a robust network of scientists specializing in the translational application of new drugs, Aeonvital has closely collaborated with global scientists in the fields of basic research and clinical medical technology to jointly advance new drug development from laboratory innovation to clinical application.

Tumor-infiltrating lymphocytes (Tumor infiltrating lymphocyte, TIL) refer to lymphocytes that leave the bloodstream and enter tumor tissues. They are a type of infiltrating lymphocyte isolated from tumor tissues and were discovered by immunology pioneer Steven A. Rosenberg and his team. The mechanism of TIL therapy in treating tumors involves directly killing tumor cells through the release of cytotoxins. Furthermore, by modulating host immune function, TILs can also enhance the body's cytotoxic capacity against tumor cells.

Compared with CAR-T cell therapy, TIL therapy not only offers a superior safety profile but also demonstrates significant efficacy in targeting solid tumors. Lung cancer, non-small cell cancer, colorectal cancer, breast cancer, and cervical cancer are all key indications currently under active investigation for TIL therapy, indicating an exceptionally broad future development landscape.

The primary advantage of TILs lies in their high specificity for tumor antigens. Since TILs are derived from tumor tissue, the vast majority of them can accurately recognize the tumor and deliver precise "strikes." According to reports,More than 60% of immune cells isolated from tumor tissue can recognize the tumor, whereas less than 0.5% of immune cells isolated from peripheral blood possess tumor-recognition capability.Therefore, TILs are the most potent immune cells capable of deeply infiltrating the tumor.

However, due to various factors, the immunosuppressive microenvironment within the patient's tumor tissue restricts the number and activity of tumor-infiltrating lymphocytes (TILs), thereby diminishing their cytotoxic efficacy against tumor cells and failing to prevent tumor proliferation and metastasis. Furthermore, cancer patients typically exhibit compromised immune function, with a severe deficiency in both the quantity and activity of immune cells, rendering them fundamentally unable to overcome the vast number of cancer cells.

Through years of accumulated research, the Aeonvital team is able to "activate" TILs harvested from patients,While restoring the antitumor activity of TILs, their "striking" capability against tumor cells is enhanced, thereby strengthening the cytotoxic effect of TILs on tumor cells within the patient's body.To ensure the efficacy and safety of the product, Aeonvital has strictly adhered to the relevant regulatory submission standards for cell therapy products in filing its Investigational New Drug (IND) application since the inception of its R&D. Currently, Aeonvital has partnered with the Cancer Center of the Chinese PLA General Hospital, completing the basic research and preclinical development of its TILs (Tumor-Infiltrating Lymphocytes) cell therapy product.

Infection with human papillomavirus (HPV) is recognized as a major cause of cervical cancer. In China, high-risk HPV types (16 and 18) account for nearly 90% of cervical cancer cases and cervical precancerous lesions. The peak age of infection typically ranges from 16 to 20 years, and if left untreated, it may progress to cervical cancer 15 to 20 years later.

According to WHO data, there were 570,000 new cases of cervical cancer (HPV) worldwide in 2018, resulting in 310,000 deaths. In China, approximately 130,000 new cases of cervical cancer occur annually, with 48,000 deaths. However,The number of HPV-positive patients and those with precancerous lesions far exceeds the number of cervical cancer cases; currently, the pharmaceutical market for therapeutics aimed at achieving HPV clearance remains virtually untapped.

While prophylactic HPV vaccines are highly effective at preventing HPV infection, they provide no therapeutic benefit for patients with existing infections. Furthermore, due to manufacturing capacity constraints, the prophylactic HPV vaccine market in China—particularly for the 9-valent HPV vaccine—is experiencing a severe supply shortage, making it exceptionally difficult to obtain even a single dose. Consequently, women who have been unable to receive the prophylactic vaccine or who are already infected with HPV remain at risk.

The development of therapeutic HPV vaccines is an ideal strategy for controlling existing HPV infections and treating HPV-associated cancers and precancerous lesions.Targeting this market gap, Aeonvital collaborated with relevant domestic HPV clinical experts and university researchers to establish China's first therapeutic nucleic acid vaccine platform for HPV.

According toAn Zhang, Founder & CTO of the Aeonvital TeamIntroduction: The DNA vaccine platform established by Aeonvital holds independent intellectual property rights. The bacterial strains and vectors (free of antibiotic resistance) utilized for vaccine development are independently constructed by the Aeonvital team, which not only ensures vaccine safety at the source but also significantly reduces production costs.

Whether by advancing TIL cell therapy to effectively combat solid tumors, actively filling the gap in China's therapeutic HPV vaccine development market, or establishing the country's first therapeutic nucleic acid vaccine platform, Aeonvital has achieved remarkably rapid growth since its founding six months ago, driven by its steadfast focus on addressing clinical needs and market pain points.

UseAeonvital Founder & Chairman Liu HongchuanIn his words, it is "flying close to the ground." He believes that the pragmatic and grounded efforts of Aeonvital's research team form the foundation for the company's rapid advancement of its product pipeline. He expressed high praise for the execution capability of the company's core team.

Starting his career as a pharmaceutical sales representative and having won the national sales champion title multiple times during his tenure at AstraZeneca, Liu Hongchuan, who later rose to the position of Vice President at Sinopharm Group China National Pharmaceutical Import & Export Co., Ltd., has accumulated over three decades of hands-on experience in the pharmaceutical industry. He holds profound insights into execution. For a startup, the strength of its execution is a critical factor for the industry to assess whether the company can quickly establish a foothold and thrive in the market.

Beyond her role as a founder, serving as the company's CTO also entails that An Zhang will be responsible for formulating product development strategies and overseeing product research. This is closely tied to her academic and industry background. It is fair to say that Aeonvital's strategic layout in TIL cell therapy and the development of its HPV therapeutic vaccines are largely attributable to An Zhang's prior research and extensive industry expertise.

In scientific research, An Zhang once led a team conducting research on TIL (tumor-infiltrating lymphocyte)-based cancer immunotherapeutics; during his/her tenure in the research team of Professor Ian Frazer (a Nobel Prize-nominated professor and inventor of the cervical cancer vaccine), An Zhang was responsible for the research and development of therapeutic nucleic acid vaccines, and successfully submitted a clinical trial application for DNA-based therapeutic vaccines alongside Professor Frazer.

In the industry sector, since 1995, An Zhang has successively held senior positions at international pharmaceutical companies such as Bayer, Johnson & Johnson, and Medtronic. Overseeing new drug development, clinical research, and regulatory submissions, he ultimately advanced to the position of Senior Director for the Asia-Pacific region at a multinational pharmaceutical company, successfully securing clinical trial and New Drug Application (NDA) approvals for over 20 Class I innovative drugs.

Additionally,Dr. Jianming (James) Tang, CSO of Aeonvitalis a Tenured Professor of Medicine and Epidemiology at the UAB Heersink School of Medicine (UAB), University of Alabama at Birmingham, with a long-standing research focus on medical immunology and related molecular biological mechanisms, and possesses profound expertise in immunotherapy-related fields;Dr. Yuzhu Dong, Director of Vaccine R&D at AeonvitalIs a postdoctoral fellow in Molecular Biology at the University of Wisconsin, with over 20 years of accumulated research experience in molecular biology and new drug development;Dr. Lei Liu, Director of the Nucleic Acid Vaccine Platform, AeonvitalGraduated from Peking University with a major in Molecular Biology, possesses extensive experience in basic research and new drug development, and is primarily responsible for the development of the company’s nucleic acid vaccine platform.Director of Immune Cell Research and Development, AeonvitalDr. Li FengGraduated from the Institute of Microbiology, Chinese Academy of Sciences, and has been engaged in the research and development of immunotherapeutics and cellular products since graduation.

Represented by Professor Lin Zhibin, Professor of Immunopharmacology at Peking University and Honorary Chairman of the Chinese Pharmacological Society, and Professor Wei Lihui, Chief Physician of Gynecology at Peking University People's Hospital and Vice President of the Obstetrics and Gynecology Branch of the Chinese Medical Doctor Association, the senior scientific advisory team has provided Aeonvital with crucial strategic guidance, particularly regarding product development and commercialization.

To maintain its cutting-edge advantage in product development, Aeonvital has actively established close partnerships with numerous renowned hospitals, research institutes, and enterprises of all sizes both domestically and internationally. Among these, close clinical collaboration stands as a defining hallmark of Aeonvital. Liu Hongchuan stated that whether developing TILs cell products or advancing therapeutic nucleic acid vaccines, both endeavors rely indispensably on the concurrent support of clinical resources.

From product exploration and development, to optimization, and ultimately to finalization and implementation, clinical observation and research run throughout the entire process. This embodies the core development philosophy of Aeonvital—"From clinical practice, to clinical practice."