2026 / 07 / 10
Good News | Anweituo's Innovative Drug Secures Key Approval to Reduce Postoperative Solid Tumor Recurrence Risk
Recently, Anweituo (Yantai) Biomedical Technology Co., Ltd., a company based in Blue Pharma Valley · Life Island Park, has reported another major advance in cancer immunotherapy. Its independently developed investigational therapy, ReT01 ACT injection, has received IND clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for a new indication: the prevention of postoperative recurrence of solid tumors. This approval marks a critical step forward for the innovative cell therapy. Building on its existing indication for advanced solid tumors, the clearance extends the therapy’s reach into a full-cycle treatment chain that combines late-stage salvage therapy with post-surgical consolidation — and adds a new highlight to Yantai’s biomedical innovation landscape.
Anweituo (Yantai) Biomedical Technology Co., Ltd. draws on the deep technical expertise and R&D heritage of its parent company, Xunsheng Biotech, to focus on cutting-edge tumor immunotherapy. ReT01 ACT injection is the company’s core TIL (tumor-infiltrating lymphocyte) cell therapy product, initially developed for advanced solid tumors such as cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. It obtained its first IND approval from the NMPA as early as July 2023 and smoothly entered Phase II clinical trials in early 2026. The newly added indication for preventing postoperative solid tumor recurrence represents a pivotal upgrade in the drug’s development, enabling ReT01 ACT to leap from a single therapeutic indication to a dual “treatment plus prevention” profile.
Postoperative recurrence and metastasis of solid tumors have long been a clinical challenge and a core factor affecting patients’ long-term survival. Compared with conventional adjuvant therapy, TIL cell therapy offers unique advantages: precise targeting, potent antitumor activity, a manageable safety profile, and durable immune memory. ReT01 ACT injection works by extracting a patient’s own tumor-infiltrating lymphocytes, precisely activating and efficiently expanding them ex vivo, and then reinfusing them into the patient. This approach not only precisely eliminates residual tumor cells but also helps the body establish a long-term antitumor immune mechanism, reducing the risk of recurrence at its source.
From the landing of high-quality biomedical projects such as Anweituo to the realization of dual indications — late-stage solid tumor treatment and postoperative recurrence prevention — for ReT01 ACT injection, Blue Pharma Valley · Life Island Park is leveraging a full-chain innovation ecosystem to empower and accelerate company growth. To date, 31 Class 1 innovative drugs from the park have secured a total of 42 clinical trial approvals domestically and internationally, a number that leads the province.
Moving forward, Blue Pharma Valley · Life Island Park will take this breakthrough as a fresh starting point to further deepen its focus on cutting-edge fields like cell therapy. Anchored in its closed-loop vertical ecosystem, the park will provide resident companies with more precise policy support, more efficient resource connections, and more specialized technical backing. It aims to help more innovative drug programs accelerate toward clinical approvals and industrialization, contributing even greater “Pharma Valley strength” to the high-quality development of Yantai’s biomedical industry and to safeguarding public health.
Anweituo (Yantai) Biomedical Technology Co., Ltd. draws on the deep technical expertise and R&D heritage of its parent company, Xunsheng Biotech, to focus on cutting-edge tumor immunotherapy. ReT01 ACT injection is the company’s core TIL (tumor-infiltrating lymphocyte) cell therapy product, initially developed for advanced solid tumors such as cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. It obtained its first IND approval from the NMPA as early as July 2023 and smoothly entered Phase II clinical trials in early 2026. The newly added indication for preventing postoperative solid tumor recurrence represents a pivotal upgrade in the drug’s development, enabling ReT01 ACT to leap from a single therapeutic indication to a dual “treatment plus prevention” profile.
Postoperative recurrence and metastasis of solid tumors have long been a clinical challenge and a core factor affecting patients’ long-term survival. Compared with conventional adjuvant therapy, TIL cell therapy offers unique advantages: precise targeting, potent antitumor activity, a manageable safety profile, and durable immune memory. ReT01 ACT injection works by extracting a patient’s own tumor-infiltrating lymphocytes, precisely activating and efficiently expanding them ex vivo, and then reinfusing them into the patient. This approach not only precisely eliminates residual tumor cells but also helps the body establish a long-term antitumor immune mechanism, reducing the risk of recurrence at its source.
From the landing of high-quality biomedical projects such as Anweituo to the realization of dual indications — late-stage solid tumor treatment and postoperative recurrence prevention — for ReT01 ACT injection, Blue Pharma Valley · Life Island Park is leveraging a full-chain innovation ecosystem to empower and accelerate company growth. To date, 31 Class 1 innovative drugs from the park have secured a total of 42 clinical trial approvals domestically and internationally, a number that leads the province.
Moving forward, Blue Pharma Valley · Life Island Park will take this breakthrough as a fresh starting point to further deepen its focus on cutting-edge fields like cell therapy. Anchored in its closed-loop vertical ecosystem, the park will provide resident companies with more precise policy support, more efficient resource connections, and more specialized technical backing. It aims to help more innovative drug programs accelerate toward clinical approvals and industrialization, contributing even greater “Pharma Valley strength” to the high-quality development of Yantai’s biomedical industry and to safeguarding public health.