World's First TCR-T Cell Therapy Approved as 17 Chinese Companies Accelerate Development

Today,AdaptimmuneAnnouncementItsTCR-TCell TherapyAfami-celHas already obtained the United StatesFDAApproved for marketing, for the treatment ofAdvanced Synovial Sarcoma。It is worth mentioning that this isThe world's first approved and marketedTCR-TCell Therapy, which is a significant milestone with great importance, brings hope to patients in the late stageSynovial SarcomaPatient brings"Transformative" treatment methods, while also filling theTCR-TThe空白 in the track has boosted industry confidence.

The BLA submission and approval of Afami-cel for marketing are based on the clinical data from the pivotal trial SPEARHEAD-1: for patients with metastatic or unresectable synovial sarcoma.The overall response rate (ORR) was 39%, with a median duration of response of approximately 12 months.Patients with synovial sarcoma who had previously received two or more therapies had a median overall survival (OS) of less than 12 months, while those treated with Afami-cel had a median OS of approximately 17 months, which is better than the historical control data. Two years after receiving Afami-cel treatment, 70% of responders were still alive.

Before Afami-cel was approved, Adaptimmune had already been preparing for the commercial launch of Afami-cel. The number of authorized treatment centers had expanded from the initial 6-10 to over 30, and,100% of the clients for commercial and medical affairs teams are in place.Adrian Rawcliffe, CEO of Adaptimmune, believes that approximately 400 patients in the U.S. are eligible for Afami-cel treatment each year. He is confident in the company's ability to maintain supply until the "sales peak" of cell therapy.

In addition, following the approval of Afami-cel, Adaptimmune plans to launch lete-cel for synovial sarcoma and myxoid round cell liposarcoma (MRCLS) in 2026. This is a TCR-T cell therapy targeting NY-ESO-1, currently in phase 2 clinical trials. Previously, clinical research data on lete-cel showed that out of 73 patients treated with lete-cel, 45 were evaluable, with an ORR reaching 40%, including 2 cases of CR and 16 cases of PR. Notably,It is predicted that the peak sales of Afami-cel and lete-cel could reach $400 million.。

The approval and market launch of the world's first TCR-T cell therapy have invigorated the industry, while in China, the development of TCR-T cell therapies is also accelerating.According to incomplete statistics, there are 17 companies in China that have laid out TCR-T cell therapy., most of which have entered the clinical research stage. Among them,XIANGXUE LIFE SCIENCESTAEST16001 has entered Phase 2 clinical trials, with rapid progress. The interim summary data of its first clinical indication, advanced soft tissue sarcoma, was published at ASCO in June this year. According to RECIST 1.1, the best overall response rate assessed by the Independent Radiology Review Committee (IRC) was 50% (4/8). This therapy has recently been included in the list of breakthrough treatments.

▲ TCR-T Companies in China（Image Source:MedCareer整理）

In ResearchTCR-TThe targets of cell therapy tend to be diversified, among which the selectionHPVThe number of entrants ranks among the top;In terms of indications, targetingHPVA larger number of related tumors and liver cancer;In the aspect of candidate product development, the company has adopted a wealth of innovative technologies, including the use ofmRNATechnologies such as gene editing technology help improve the safety and efficacy of candidate products, while also conducting dual exploration into viral and non-viral vectors.Overall, in ChinaTCR-TCell therapy is booming, the firstTCR-TThe approval and market launch of cell therapy also means that the regulatory pathway has been successfully navigated, which will bring more commercialization experience and is also conducive to China.TCR-TThe Development of Cell Therapy.

GuangDong XIANGXUE LIFE SCIENCES, Lion TCR, Biotheus, Scicommerce, TianKeYa, HuaXia YingTai, HengRui YuanZheng, KeRui Bio, KeShiHua Bio, and XinJing ZhiYuan have all entered the clinical research stage.Bintie BioIX001 TCR-TInjection SolutionINDThe application has been submitted this year.7Month ObtainedCDEAccepted, Dingcheng Peptide SourceDCTY1102Injection SolutionINDApplied this year5Month ObtainedCDEAcceptance.

BiotheusBRL03 is the fourth-generation TCR-T cell therapy, developed based on its proprietary innovative technology platform IDENTIFIER.^®Developed to ensure that the screened TCRs have higher affinity and specificity, capable of targeting multiple solid tumors. Another self-developed platform, MSE-T, provides BRL03 with additional functional module components, reducing cell exhaustion to enhance the durability of anti-tumor effects.

Currently, this candidate product has completed dual IND submissions and approvals in both China and the U.S. Notably, BRL03 is the world’s first TCR-T candidate product independently developed by Biotheus for solid tumors such as lung cancer and gastric cancer. Its Phase 1 clinical trial also enrolled the first participant in June this year, with plans to complete enrollment of all Phase 1 participants by the end of this year. In previous IIT studies, BRL03 has demonstrated good safety and preliminary efficacy.

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Stellar BiotechnologiesSCG142 is a next-generation chimeric switch receptor-enhanced TCR-T cell therapy. The core technology utilizes Starcell Bio's proprietary GianTCRTM technology platform to successfully screen and isolate naturally high-affinity HPV-specific TCRs, which are combined with chimeric switch receptors to enhance T-cell proliferation and tumor suppression capabilities. In July this year, the candidate product was approved for Phase 1/2 clinical trials in the United States.

In TCR-T cell therapy targeting viral antigens,Lion BiotechnologiesLioCyx-M004, which is at the forefront of progress, is the world's first TCR-T targeting HBV antigens. It utilizes mRNA-encoded TCR introduced into T cells via electroporation, making LioCyx-M004 safer and more controllable, and supports multiple administrations.

Among the candidate products in the preclinical research stage,Stellar BiopharmaceuticalsDevelopment of LNP drug delivery systems with extrahepatic targeting can precisely achieve organ-specific and specific subcellular type delivery. The "Novel mRNA-LNP Targeted Delivery Technology for In-situ CAR-T and TCR-T Therapy Applications" has been successfully selected as a "Major Project" in the 2023 National Biomedicine Innovation Center's Cell Therapy "Challenge Leader" technical breakthroughs initiative.

CoremedZuo Chijian's team, in collaboration with Zhang Yan and Song Xianmin's research team from the First People's Hospital of Shanghai Jiaotong University School of Medicine/Shanghai First People's Hospital, published an article in Molecular Therapy, reporting for the first time the use of circular mRNA (cmRNA) to prepare TCR-T cell therapy for treating human cytomegalovirus (CMV) infection after hematopoietic stem cell transplantation. On days 7 and 11 post-electroporation, approximately 80% and 50% of T cells expressed the exogenous TCR receptor, respectively.

TCR-T Cell Therapy Enterprises in China Driving Innovation, International Collaboration, and Regulatory SupportTCR-T cell therapy enterprises in China are not only driving continuous technological innovation and breakthroughs but also accelerating integration with the international market. Multiple companies have made significant progress in their domestic research products and have initiated international multicenter clinical trials. On the policy front, support for cell therapy in China is continuously strengthening. Regulatory authorities are optimizing approval processes and improving laws and regulations to provide a more favorable environment for the development and future commercialization of TCR-T cell therapies. Additionally, the government is increasing investment in the cell therapy industry, encouraging companies to boost R&D spending, and promoting technological innovation and industrial upgrading.

Looking ahead, with the successful launch of the world's first TCR-T cell therapy and the continuous efforts of companies in China, the field of TCR-T cell therapy is expected to experience explosive growth globally. It is anticipated that more TCR-T cell therapy products will be approved for marketing in the coming years, offering patients a wider range of more precise treatment options.