▎Edited by the WuXi AppTec content team

This Year1Month31Day,TCR-TTherapyAfami-celBiologics License Application (BLA) ObtainFDAAcceptanceAnd obtainedPriority ReviewQualification, intended for the treatment of advanced synovial sarcoma. And already have products approvedCAR-TCompared to the therapy,TCRIt can recognize not only tumor surface antigens but also intracellular antigens. ThereforeTCR-TTherapy Has Greater Potential in Treating Solid Tumors。

If Afami-cel's BLA process goes smoothly, itsExpected to become the world's first approved TCR-T therapy, which is highly pioneering. This undoubtedly also provides valuable experience and great confidence for other participants in the TCR-T field. China's TCR-T R&D enterprises are making rapid progress.Among them, GuangDong XIANGXUE LIFE SCIENCES LTD and Guangzhou Laien Biological Medicine Co., Ltd. are in leading positions, with pipelines entering Phase 2 clinical trials.This article will combine the company's official website and other publicly disclosed data to review representative TCR-T R&D companies in China for readers' reference.

#01

XLifeSc (Xiangxue Life Sciences) is one of the global companies applying high-affinity T-cell receptors (TCR) for new drug development. The company is committed to developing genetically modified T cells through technical platforms such as target identification technology, T-cell cloning technology, TCR optimization technology, T-cell modification technology, and T-cell expansion technology, aiming to enhance the affinity and stability of T cells towards tumor antigens for better efficacy and fewer side effects.

The most advanced pipeline currently is TAEST-16001, a TCR-T cell therapy product developed by the company that uses NY-ESO-1 antigen-specific high-affinity T cell receptor transduction. It targets soft tissue sarcoma patients with the HLA-A*02:01 tissue genotype and positive expression of the tumor antigen NY-ESO-1, and has now entered Phase 2 clinical trials. The results of the Phase 1 clinical study of TAEST-16001 have been published in Cell Reports Medicine, showing its efficacy against tumors.Objective Response Rate (ORR) reaches 41.7%, with a median progression-free survival (mPFS) of 7.2 months and a median duration of response (mDOR) of 13.1 months. Its safety and efficacy have been preliminarily validated.

In addition, Xiangxue Life Sciences has multiple TCR-T products targeting different solid tumors in preclinical development.

▲Xiangxue Life Sciences Product Pipeline (Source: Company Official Website)

Public information shows that Xiangxue Life Sciences has received one round of strategic investment. This financing introduced the strategic investor, Huagai Healthcare.

▲Financing History of XIANGXUE LIFE SCIENCES (Source: PharmaData)

#02

Guangzhou Laien Biological Medicine Co., Ltd. was incubated from the Agency for Science, Technology and Research (A*STAR) in 2015. The company's China headquarters is located in Guangzhou's Sino-Singapore Knowledge City. As a developer of cellular immunotherapy, the company focuses on the research and commercialization of novel TCR-T cell immunotherapy, specializing in treating virus-related cancers and viral infections by harnessing the body’s own immune system.

The company's first product, LioCyx-M, is an HBV-specific TCR-T cell therapy.Encoding TCR through mRNA technology, useFor the treatment of hepatocellular carcinoma. LioCyx-M is currently in Phase 2 clinical trials. In the completed Phase 1 clinical trial targeting recurrent or refractory hepatitis B-related liver cancer patients who underwent hepatectomy or radiofrequency ablation, it demonstrated good safety: no cytokine storms or neurotoxicity occurred, and tumor responses were observed.The disease control rate was 60%., with a median duration of response of 27.7 months and a median overall survival of 33.1 months. Based on these clinical results, the product has received Fast Track designation from the U.S. FDA.

In addition, based on its core product LioCyx-M, Guangzhou Laien Biological Medicine Co., Ltd. further develops different TCR discovery platforms, autologous TCR-T cell platforms, allogeneic TCR cell platforms, and gene editing technologies around the TCR-T cell platform technology. The company expands into various solid tumor indications including nasopharyngeal cancer, gastric cancer, and infectious diseases such as chronic hepatitis B infection and organ transplant-related infections.

▲Lion TCR Product Pipeline (Source: Company Official Website)

According to publicly available information, Guangzhou Laien Biological Medicine Co., Ltd. has secured two major rounds of financing; the latest round, the B2 round, was completed in June 2023, led by the Guangzhou Industrial Investment Group. The funds will primarily be used to support the advancement of the company’s clinical trials, the construction of a GMP cell facility in Guangzhou, and the expansion of its R&D pipeline.

▲Part of Laien Biopharm's financing history (Image source: collated from public information)

#03

Founded in 2016, Beijing Tiankeya Biotechnology Co., Ltd. is a biopharmaceutical innovation company dedicated to conquering cancer and committed to helping patients and doctors manage tumors as chronic diseases, with the ultimate goal of achieving a cure. The company focuses on the research, development, and industrialization of tumor immunotherapy cell treatments, possessing four world-leading technology platforms: the TCR screening platform (TRUST), CHECK-T platform, TURBO-T platform, and NK platform. Among these, the company’s unique TRUST platform is an AI-powered high-throughput single-cell screening platform that simultaneously conducts transcriptomic and functional analyses. It significantly reduces false positives, shortens drug development time, lowers costs, and addresses the biggest bottleneck in TCR-T product development.

Currently, the company has three TCR-T drug pipelines that have entered the clinical trial stage. Among them, E202 is a TCR-T therapy loaded with anti-PD-1 antibody for the treatment of HPV-positive advanced cervical cancer, and it is currently in Phase 1/2 clinical trials. TC-E202 T cells can express HPV16 E6 TCR and simultaneously secrete.Anti-PD-1 single-chain antibody,Activate T cells to kill tumors while secreting PD-1 single-chain antibodiesEffectively reverses the immunosuppressive tumor microenvironment and increases T cell infiltration. N201 is a TCR-T therapy modified with immunosuppressive molecules, currently in Phase 1 clinical trials for the treatment of solid tumors.

▲Tiankeya Product Pipeline (Source: Company Official Website)

Since its establishment, with its leading technology platforms and product pipeline R&D, Beijing Tiankeya Biotechnology Co., Ltd. has raised hundreds of millions of yuan in financing. The latest round of financing, exceeding 300 million yuan, was led by AstraZeneca-CICC Healthcare Investment Fund and Jianxin (Beijing) Investment Fund. The funds will be used to accelerate the company's immunotherapy cell product development, expand the product pipeline, and support clinical development and commercialization preparation for its core products in China and the United States.

▲Part of Tiankeya's financing history (Source: Jike Medicine Data)

#04

Founded in 2018, Huaxia Yingtai(Beijing)Biotechnology Co., Ltd. is an innovative enterprise with a global vision that focuses on the development of gene-edited T-cell immunotherapy products and is committed to addressing unmet clinical needs such as advanced cancer. The company ownsSTAR-T and enTCR-T: Two Major T Cell Engineering Technology PlatformsThe product pipeline covers diseases related to hematological tumors, solid tumors, and virus infections. Among them, the proprietary Synthetic T Cell Receptor and Antigen Receptor (STAR-T) cell therapy technology platform exhibits characteristics of natural T cells, including dual-targeting capability, low toxicity, slow exhaustion, and strong infiltration, making it more likely to achieve a breakthrough in the treatment of solid tumors. The company’s unique enTCR-T platform includes specialized TCR sequence acquisition, functional validation, and the preparation of multi-HLA-type TCR-T products, overcoming the technical bottleneck of obtaining specific functional sequences for TCR-T.

The CD19/CD20 dual-target STAR product YTS101, which is currently in the fastest progress, is in Phase 1 clinical trials for the treatment of lymphoma. Additionally, another product targeting LILRB4, YTS104, has received orphan drug designation from the U.S. FDA for the indication of acute myeloid leukemia.

▲Huaxia Yingtai Product Pipeline (Source: Company Official Website)

According to publicly available information, Huaxia Yingtai(Beijing)Biotechnology Co., Ltd. has received multiple rounds of financing, accumulating over 300 million RMB in funding.

▲Huaxia Yingtai (Beijing) Biotechnology Co., Ltd. - Partial Financing History (Image Source: Collated from Public Information)

#05

Founded in 2015, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. is a biopharmaceutical company that focuses on the development of products related to immunotherapy cell treatment technologies for solid tumors. The company's R&D pipeline covers MASCT, TCR-T immunotherapy cells, and TCR bispecific antibodies. In the field of TCR-T, the company has independently developedTCR Screening Technology Platform Based on Reverse Genetic Engineering (ReGET)，which can rapidly and efficiently isolate TCR with optimal affinity from tumor patients who can benefit from immunotherapy, for the development of anti-tumor TCR-T products.

The first product developed based on Hengrui Yuanzheng's self-developed ReGET platformTargeting the Chinese populationHigh-frequency HLA TCR-T Cell Therapy PipelineHRYZ-T101It has entered Phase 1 clinical trials and is intended for the treatment of solid tumors positive for human papillomavirus subtype 18 (HPV18). Currently, most TCR-T clinical studies targeting HPV mainly focus on HPV 16 E6, with HLA typing primarily concentrated in Caucasian populations; however, HRYZ-T101 targets HPV 18 E7 and uses HLA typing that occurs at a higher frequency in the Chinese population, making HRYZ-T101 a potentially better treatment option for Chinese patients.

▲Hengrui Yuanzheng Product Pipeline (Source: Company Official Website)

In January this year, Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. completed a nearly 100-million-yuan C3 round of financing. Zijin Harbor Capital continued to invest due to its confidence in the company's strength in the immunotherapy field, and well-known institutions such as Zhongke Chuangzhi followed with additional investments.

▲Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. Partial Financing History (Image Source: Collated from Public Information)

#06

Beijing Kerui Biological Technology Co., Ltd. was co-founded by several Peking University alumni and returned overseas students, and is committed to the development of innovative drugs based on T-cell receptors (TCR). The company's self-developed SMART-TCR affinity optimization platform integratesBig Data Deep Mining, AI-Assisted TCR Protein Drug Structure DesignTechnologies that can significantly improve the success rate and efficiency of TCR affinity optimization have broken through the development barriers of TCR innovative drugs. Kerui Biological Technology focuses on developing various indications for treating tumors, chronic infections, and autoimmune diseases through two types of products: TCR cell therapy and soluble TCR protein drugs.

The TCR-T cell pipeline that has progressed the fastest in the company is CRTE7A2, which targets HPV16-positive solid tumors. In November 2023, it received the implied permission for a new drug clinical trial (IND) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and has now entered Phase 1 clinical research.

▲Product Pipeline of Kerui Bio (Source: Company Official Website)

Beijing Kerui Biological Technology Co., Ltd. has completed multiple rounds of early-stage financing and secured a Pre-A+ round funding worth hundreds of millions in November 2022, which will facilitate the advancement of the company’s multiple innovative TCR-T cell therapy products and soluble TCR protein drug pipelines.

▲Part of Kerui Bio's financing history (Source: Jike Pharma Data)

Overall, TCR-T therapy presents both challenges and opportunities. With the active advancement of various research and development enterprises, more patients will benefit, and more investment institutions will contribute to the development of this field.

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