Genuine Biotech Attended the 2026 Xipu Conference, Showcasing Clinical Progress in Its Innovative Radiopharmaceutical Pipeline

Recently, the 19th Health Industry Ecosystem Conference—2026 Xipu Conference—was held in Bo’ao, Hainan. Under the theme "Entering the AI Era: Paradigm Revolution and Path Choices in the Health Industry", the conference brought together over 60,000 industry professionals. Dr. Guo Changyue, Chief Medical Officer of Genuine Biotech, was invited to attend the conference and delivered a keynote speech titled "Peptide Radiopharmaceuticals Targeting GRPR: Innovation and Future". He shared insights into GRPR as an emerging target in the precision diagnosis and treatment of prostate and breast cancers, and provided an update on the Company's latest R&D progress for ZS-2004, a GRPR-targeting theranostic radioligand.

Pursuing a New Precision Medicine Target

In the clinical management of prostate cancer, localizing small lesions in patients with biochemical recurrence (BCR) has long been a major challenge in precision diagnosis and treatment. With the advances in molecular imaging and targeted radionuclide therapy, PSMA has emerged as a key diagnostic and therapeutic target for prostate cancer. However, heterogeneity in target expression may still exist across different patients, disease stages, and individual lesions.

GRPR (gastrin-releasing peptide receptor) offers another potential avenue for precision diagnosis and treatment of prostate cancer. Existing studies have shown that GRPR and PSMA expression in prostate cancer exhibit certain complementary characteristics: GRPR expression tends to be more prominent in some early-stage, localized prostate cancers, while PSMA expression may be relatively low; as the disease progresses, the expression patterns of the two markers may also shift accordingly. For patients who are PSMA-negative or have low PSMA expression, GRPR may provide a new window for molecular imaging and targeted therapy.

Connecting diagnostic and therapeutic radionuclides to the same targeting molecule to enable patient screening, lesion localization, and precision treatment is a key direction in the development of "theranostics" in radiopharmaceuticals.

ZS-2004, a radioligand under development by Genuine Biotech that targets GRPR, is designed for molecular imaging diagnosis and targeted radionuclide therapy of malignant tumors with high GRPR expression. GRPR is highly expressed in various solid tumors such as prostate cancer and breast cancer, and is a potential target for precision oncology diagnosis and treatment. Currently, no GRPR-targeting drugs have been approved for marketing globally.

ZS-2004 utilizes the expression profile of GRPR in tumor tissues by integrating diagnostic and therapeutic functions into a single targeted molecular platform: when conjugated with a diagnostic radionuclide, it enables PET/SPECT molecular imaging and screening of potential responders; when conjugated with the therapeutic radionuclide lutetium-177, it delivers beta radiation more precisely to tumor tissues, exerting anti-tumor effects through radiation-induced DNA damage, thereby enabling a closed-loop "theranostic" precision treatment approach.

Preclinical Studies Validated, IIT Initiates Preliminary Exploration

To date, ZS-2004 has completed multiple preclinical validation studies.

In a PC-3 mouse tumor model, in vivo PET/SPECT imaging showed significant accumulation of ZS-2004 at the tumor site with a favorable tumor-to-non-target tissue ratio, supporting the visualization of tumor lesions. Biodistribution studies further demonstrated that the drug is preferentially taken up by tumor tissues, with relatively limited retention in normal tissues and organs.

In anti-tumor efficacy studies, ZS-2004 exhibited significant tumor growth inhibition in a PC-3 cell line-derived xenograft mouse model. In the high-dose group, ZS-2004 administered once every two weeks for a total of three doses achieved a tumor growth inhibition (TGI) rate of 96.9% on day 52.

Non-clinical safety evaluation results indicated that ZS-2004 was generally well tolerated. In mouse models, no significant systemic toxicity was observed even at the highest administered dose, which was approximately 98 times the human-equivalent dose of the maximum expected clinical therapeutic dose.

At the conference, Dr. Guo Changyue further shared the latest clinical exploration progress of ZS-2004. The investigator-initiated trial (IIT) has been officially launched, with the initial phase focusing primarily on diagnostic imaging. The first subject was enrolled on May 29, 2026.

Preliminary observations from seven prostate cancer patients to date indicate that ⁶⁸Ga-ZS2004 (the diagnostic nuclide form of ZS-2004) is well tolerated within the 3–7 mCi dose range, with no adverse events reported. In head-to-head imaging comparisons with ⁶⁸Ga-PSMA, ⁶⁸Ga-ZS2004 demonstrated higher uptake levels (SUVmax) in certain lesions. These preliminary findings suggest that GRPR-targeted imaging may complement existing PSMA-based diagnostic pathways and offer a new diagnostic option for patients who are PSMA-negative or have low PSMA expression.

Given the current small sample size, the clinical diagnostic value, safety profile, and target patient population for ZS-2004 still require further validation through larger-scale clinical studies.

Looking ahead, Genuine Biotech will leverage ZS-2004 as a key starting point to accelerate subsequent clinical research and continue exploring its precision diagnostic and therapeutic potential across different tumor types. In parallel, the Company will further strengthen its presence in the RDC field, continuously enhance its peptide radiopharmaceutical R&D capabilities and product portfolio, and deliver more innovative diagnostic and treatment options to patients.