Here is a polished English translation of the Chinese title: **CARsgen’s Kailimei® — World’s First CAR-T Cell Therapy for Solid Tumors — Approved for Market**

ShanghaiJune 22, 2026 /PRNewswire/ — CARsgen Therapeutics (Stock Code: 2171.HK), a biopharmaceutical company focused on developing innovative CAR-T cell therapies, announced today that it has received notification from the National Medical Products Administration (NMPA) approving the New Drug Application (NDA) for its independently developed Claudin18.2 autologous humanized CAR-T cell therapy product, Kailimei^® (Satricabtagene Autoleucel Injection), for the treatment of Claudin18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy. Kailimei^® is the world’s first CAR-T cell therapy product approved for the treatment of solid tumors.

Gastric cancer is one of the malignant tumors with a heavy disease burden worldwide, ranking fifth in both incidence and mortality globally, with approximately 970,000 new cases and 660,000 deaths annually^[1]. Among these, over 70% of new cases and deaths occur in Asia^[2], and Chinese gastric cancer patients account for approximately 47% of the global patient population^[3]. According to statistics from the National Cancer Center of China, in 2022, there were approximately 360,000 new cases of gastric cancer in China and 260,000 deaths, ranking fifth and third in cancer incidence and mortality in the country, respectively^[4]. Despite continuous advancements in surgical techniques and comprehensive treatment approaches, gastric cancer often has an insidious onset. Currently, the early diagnosis rate of gastric cancer in China remains below 20%, and the 5-year survival rate for advanced gastric cancer is only about 10%^[5]. Gastric cancer is characterized by high incidence, low early diagnosis rate, high heterogeneity, and high mortality. Traditional chemotherapy drugs have reached a bottleneck, targeted drug options are limited, and the proportion and extent of benefit from immunotherapy still need improvement. Therefore, there remains a significant unmet medical need for patients with unresectable or metastatic gastric cancer, urgently requiring the discovery and exploration of more precision treatments and novel anti-tumor drugs.

Claudin18.2 is a highly selective marker protein with very limited expression in normal healthy tissues, only expressed in differentiated gastric mucosal epithelial cells, while showing high expression in various malignant tumors such as gastric cancer. Kailimei^® is an autologous CAR-T cell product targeting Claudin18.2. It is genetically modified to express a CAR construct composed of a humanized Claudin18.2-specific single-chain monoclonal antibody (hu8E5-2I), a CD8α hinge region, a CD28 transmembrane domain, a CD28 intracellular signaling domain (CD28 ICD), and a CD3ζ intracellular signaling region. To the best of the Company’s knowledge, we are the first globally to successfully identify, validate, and report the solid tumor-associated antigen Claudin18.2 as an effective target for CAR-T cell therapy. To further address the challenges of the tumor microenvironment in treating solid tumors with CAR-T cell therapy, the Company has independently developed a patent-protected innovative lymphodepletion preconditioning regimen for Kailimei^®, characterized by the addition of low-dose albumin-bound paclitaxel to the traditional regimen (cyclophosphamide and fludarabine) to enhance CAR-T cell infiltration and anti-tumor efficacy. The Company has established a global patent portfolio around Kailimei^®, covering targets, indications, dosage, and preconditioning regimens.

The clinical efficacy of Kailimei^® has been recognized by top international medical journals, with results from its confirmatory randomized controlled study published in The Lancet^[6]. Clinical data show that for late-line advanced gastric or gastroesophageal junction cancer patients with extremely limited treatment options and poor prognosis, Kailimei^® demonstrates significant efficacy benefits and a favorable safety profile compared to existing treatments, offering a new therapeutic option for advanced gastric cancer patients. This major breakthrough not only establishes a new standard for solid tumor CAR-T therapy but also lays a solid scientific foundation for advancing earlier-line treatments, exploring combination therapy regimens, and expanding applications to other Claudin18.2-positive solid tumors such as pancreatic cancer and biliary tract cancer.

The development and approval of Kailimei^® not only reflect the Company’s R&D capabilities but also serve as a concentrated validation of the effectiveness of China’s innovative drug full-chain policy ecosystem and regulatory reforms. Benefiting from the deepening reform of the drug review and approval system and the implementation of supportive policies for the entire chain of innovative drugs, the world’s first CAR-T cell therapy product for solid tumors has been pioneered in China. Throughout this process, the scientific guidance and critical support from regulatory authorities have been consistent. Facing urgent clinical needs and technical challenges, expert teams from the Center for Drug Evaluation (CDE) of the NMPA and its Yangtze River Delta sub-center adhered to scientific principles, conducting multiple rounds of forward-looking communications with the Company before the initiation of key clinical trials, providing professional guidance on critical aspects such as trial design. During the clinical trial period, they continued to offer professional support in areas such as pharmaceutical science and non-clinical studies. It is this “research-review linkage, full-process empowerment” regulatory model that ensured the efficient progress of the project, producing high-quality clinical data that withstands international peer review. Due to its outstanding clinical value and excellent trial data, the product was subsequently granted Breakthrough Therapy Designation and priority review status. Meanwhile, the Shanghai Medical Products Administration, with a service philosophy of actively embracing innovation, provided the Company with precise and efficient technical guidance, actively built bridging connections, and vigorously promoted key stages such as manufacturing permits, sampling inspections, and GMP compliance audits, effectively supporting the market launch process. These measures fully demonstrate the regulatory authorities’ firm stance and professional commitment to supporting true innovation and serving true value, as well as the strong support of China’s distinctive scientific regulatory system for locally developed original drugs to go global.

The clinical research on Satricabtagene Autoleucel Injection was led by Professor Lin Shen’s team from Peking University Cancer Hospital. Professor Shen stated: “For patients with advanced gastric or gastroesophageal junction adenocarcinoma who have failed multiple prior lines of therapy, previous treatment options were extremely limited, and prognosis was very poor. The approval of Satricabtagene Autoleucel Injection provides us with a new and effective treatment weapon. This product brings clinically meaningful and significant benefits to such patients, with efficacy that is difficult to achieve with existing treatments. More importantly, as a CAR-T product, Satricabtagene Autoleucel gives patients the opportunity to break free from the burden of frequent hospital visits for treatment, achieving a leap from ‘prolonging survival’ to ‘improving quality of life.’ As the world’s first successfully approved solid tumor CAR-T therapy, Satricabtagene Autoleucel not only fills the gap in late-line treatment for advanced gastric cancer but also ushers in a new era of cell therapy for solid tumors. This breakthrough lays a critical foundation for advancing earlier-line treatments and combination therapy strategies, with the potential to reshape the treatment landscape for gastric cancer and even gastrointestinal tumors. We believe that with the promotion of clinical application, this innovative therapy will light up new hope for the lives of many gastric cancer patients.”

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said: “The approval of Kailimei^® is a significant milestone in the transition of CAR-T cell therapy from hematological malignancies to solid tumors. This would not have been possible without the trust and support of the patients and their families who participated in the clinical trials, the research teams, partners, regulatory agencies, and relevant departments. We will go all out to advance the clinical application and market access of Kailimei^®, ensuring that this innovative therapy can benefit Chinese patients in a timely and widespread manner. At the same time, we will strive to expand this product to more countries and regions to meet additional medical needs. Furthermore, we are exploring sequential first-line treatment for advanced gastric cancer and postoperative adjuvant therapy, aiming to help more patients achieve deeper therapeutic benefits and even the possibility of a cure.”

About Kailimei^®

Kailimei^® is a world-first-in-class autologous CAR-T cell therapy product targeting the Claudin18.2 protein, used for the treatment of Claudin18.2-positive solid tumors. Kailimei^® was approved for marketing by the National Medical Products Administration in June 2026 for the treatment of Claudin18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy, becoming the world’s first approved solid tumor CAR-T cell therapy product.

About CARsgen Therapeutics

CARsgen Therapeutics (Stock Code: 2171.HK) is a biopharmaceutical company focused on developing innovative CAR-T cell therapies to address unmet clinical needs, including but not limited to hematological malignancies, solid tumors, and autoimmune diseases. The Company has established end-to-end capabilities for CAR-T cell research and development, from target discovery, preclinical research, and product clinical development to commercial-scale manufacturing. Through independently developed new technologies and a product pipeline with global rights, the Company aims to address challenges in existing CAR-T cell therapies, such as improving safety, enhancing efficacy in solid tumor treatment, and reducing treatment costs. CARsgen’s mission is to become a global leader in the biopharmaceutical field, providing innovative and differentiated cell therapies for cancer and other diseases worldwide, making cancer and other diseases curable.

Forward-Looking Statements

All statements in this press release that are not historical facts or related to current facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs, and expectations regarding future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. Therefore, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements. The forward-looking events discussed in this press release may not occur. These risks and uncertainties include, but are not limited to, the details set forth under the heading “Key Risks and Uncertainties” in our most recent annual report, interim report, and other announcements and reports published on our company website at https://www.carsgen.com. We make no representation or warranty, nor should any reliance be placed on, the achievement or reasonableness of any projections, targets, estimates, or forecasts contained in this press release.

References

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