Recently, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as "Hengrui Yuanzheng") completed nearly 100 million yuan in C3 round financing, with Zijin Harbor Capital continuing its investment. Other co-investors included well-known institutions such as Zhongke Sci-Tech Innovation.Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd., established in Shanghai in 2015 by Jiangsu Hengrui Pharmaceutical Group and Shenzhen Yuanzheng Cell Medical Technology Co., Ltd., is a leading immunotherapy company in China, operating in sync with international standards and specializing in solid tumor treatments. The company has developed multiple product pipelines for solid tumor patients, including MASCT, TCR-T, and TCR bispecific antibodies. Currently, the first TCR-T product, HRYZ-T101, developed through Hengrui Yuanzheng’s proprietary ReGET platform, has entered Phase I registrational clinical trials for the treatment of cervical cancer. The first patient has been successfully infused without any severe adverse reactions reported. This product is the world’s first TCR-T therapy targeting high-frequency HLA in the Chinese population, designed to treat human papillomavirus (HPV)-related cervical cancer. Meanwhile, the second Phase II registrational clinical study of Hengrui Yuanzheng’s multi-antigen autologous immune cell injection (MASCT-I) has been initiated, combining it with first-line chemotherapy for the treatment of advanced soft tissue sarcoma. Previously, MASCT-I as a monotherapy completed Phase I clinical research, and its first Phase II registrational clinical study is currently ongoing, serving as maintenance therapy for patients with advanced urothelial carcinoma who benefited from standard first-line chemotherapy.The aforementioned HRYZ-T101 injection is the second IND-approved product from Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. and also its first TCR-T cell therapy product. TCR-T is a type of TCR gene-modified T-cell technology that enhances the ability of T cells to recognize and kill tumor cells by expressing tumor-specific TCR chains in T cells. Unlike CAR molecules, which can only recognize membrane proteins, TCR molecules can identify intracellular proteins presented by tumor cells. This feature gives TCR-T technology greater advantages and potential in the treatment of solid tumors and makes it a current hotspot in the field of immune cell therapy.
Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. has independently developed a TCR screening technology platform based on reverse gene engineering (Reverse Genetic Engineering of TCR-T, ReGET), which can rapidly and efficiently isolate the TCR with optimal affinity from tumor patients who benefit from immunotherapy. It has accumulated a large amount of TCR data based on Asian population HLA typing for the development of anti-tumor TCR-T products, offering significant advantages over TCR products based on European and American population HLA typing.
Hengrui YuanzhengMASCTPipeline
MASCT is the abbreviation for Multi-Antigen Stimulated Cell Therapy Injection, a multi-antigen autologous immune cell injection, whose active components include mature autologous dendritic cells (referred to as "DC cells") loaded with 15 tumor-associated antigens and autologous effector T lymphocytes (referred to as "T cells") activated and expanded by the aforementioned DC cells.MASCTIt is a series of autologous immune cell therapy technology products for solid tumors, containing mature cells loaded with multiple antigen peptides.DCEffects of Cell and In Vitro Activation ExpansionTCells, through sequential treatment to eliminate tumors.Among them,DCCells are derived from monocytes isolated from the peripheral blood of cancer patients and loaded in vitro with15After implanting tumor-associated antigens, the antigen epitope peptides are passed throughMHC I/IIClass molecules presented toDCCell Surface.These multi-antigen-loadedDCAfter subcutaneous injection, the cells present antigen epitopes to the patient's lymphoid tissue in the body.CD8AndCD4 TCells, activating them to become effectors with anti-tumor effectsTCells, thereby clearing tumors through cytotoxic effects.In addition, a part of multi-antigen loadingDCCells were also co-cultured with patient peripheral blood mononuclear cells (PBMCs) Further co-culture, activation and expansionPBMCsTumor-specificTCells, thereby obtaining a large number of effector cells with anti-tumor effects in vitro.TCell.This part of the effectTCells are intravenously infused into the patient's body, enter the tumor tissue through blood circulation, and further exert a tumor-killing effect.MASCTCan enhance immune response and prolong the duration of benefit after standard first-line chemotherapy for cancer patients;Not involvedTGene modification of cells, with relatively mature technology, low toxicity, and high safety;Pipeline Phase I clinical safety and efficacy data are excellent,2021Year12Received Phase II clinical approval in the month;Phase I clinical indications are malignant solid tumors, and the first approved indication for Phase II clinical trials is advanced urothelial carcinoma. Multiple indications will be applied for in the future.
Team led by the founder of Hengrui Pharmaceutical GroupJiangsu Hengrui Pharmaceutical Group is the controlling shareholder of Hengrui Yuanzheng, and Hengrui Yuanzheng is also the only company in the cell therapy field that Hengrui Group has invested in. Mr. Sun Piaoyang, the founder of Hengrui Group, serves as the chairman of Hengrui Yuanzheng; Mr. Li Kejian, the general manager of Hengrui Yuanzheng, used to be the vice general manager of Hengrui Pharmaceutical; Dr. Zhou Xiangjun, the founder and chief scientist, is a medical doctor from the United States, a postdoctoral fellow at Stanford University, and a former professor at the School of Pharmacy of Shanghai Jiao Tong University; Ms. Han Yanyan, the vice general manager, is the head of drug discovery, a doctor from the Medical Faculty of Ludwig Maximilian University of Munich, Germany, and a postdoctoral fellow at the Right Bank Hospital affiliated with Technical University of Munich, Germany. She has long been engaged in cancer immunology research and has accumulated years of experience in cellular immunity and molecular immunology research; Ms. Ma Yifan, the vice general manager, is the head of process development, a life sciences doctor from Pennsylvania State University, and a former researcher and doctoral supervisor at Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences.NSFCAnd a major special project review expert of the Ministry of Science and Technology; Chief Medical Officer and Vice President Ms. Li Xiaoshuang as the clinical leader, Master of Medicine from the United States, with nearly30Years of executive work experience at foreign pharmaceutical companies such as Merck, Amgen, Novartis, and Boehringer Ingelheim, with rich...I Due DateIVClinical research and management experience; Vice General Manager Ms. Li Jin is the production head, a master's graduate from the Academy of Military Medical Sciences in China, and has conducted research on cellular immunotherapy technology at the University of London; the company's core senior executives all come from prestigious universities both domestically and overseas, possessing extensive experience in related industries. The company demonstrates balanced capabilities across R&D, production, regulatory submission, and commercialization.Collaborate clinically with multiple leading cancer hospitalsHengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. has collaborated with several leading hospitals in the oncology field, including the Affiliated Cancer Hospital of Sun Yat-sen University, Zhongshan Hospital Affiliated to Fudan University, Shanghai Cancer Center of Fudan University, Peking University Cancer Hospital, Shanghai Sixth People's Hospital, Zhejiang Cancer Hospital, and the First Affiliated Hospital of Sun Yat-sen University. Together, they have launched registered clinical trials and investigator-initiated clinical studies, securing a strong academic position and laying a solid foundation for future product commercialization.
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Disclaimer: The content is sourced from Zijin Port Capital, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd., and other sources. This article aims to share knowledge, all content is for reference only and does not constitute any advice.
