Hedron Therapeutics and ARTBIO Announce Exclusive Strategic Collaboration to Advance AB001 and ²¹²Pb AlphaDirect™ Technology Development and Commercialization

February 20, 2024, Shanghai, China and Cambridge, USA- Shanghai Hezhou Pharmaceutical Co., Ltd. (hereinafter referred to as “Hezhou Pharma”) announced today that it has entered into an exclusive strategic collaboration with ARTBIO, Inc. (hereinafter referred to as “ARTBIO”). Hezhou Pharma is a biotechnology company focused on the discovery, development, and industrialization of novel targeted radioligand drugs, while ARTBIO is a clinical-stage radiopharmaceutical company dedicated to the research and development of novel alpha-emitting radionuclide radioligand therapies.

Under the agreement signed by both parties, Hezhou Pharmaceutical will serve as ARTBIO’s exclusive strategic partner, utilizing the AlphaDirect™ radionuclide separation and purification technology to produce lead-212 (²¹²Pb). This innovative technology will fill a gap in the international market. Meanwhile, Hezhou Pharmaceutical will obtain the rights to develop and commercialize AB001 in Greater China (including Mainland China, Hong Kong SAR, Macau SAR, and Taiwan). AB001 is an alpha-emitting radioligand therapeutic targeting prostate-specific membrane antigen (PSMA) and has currently entered the clinical development stage. Furthermore, Hezhou Pharmaceutical will have the right to use the AlphaDirect™ technology to independently develop ²¹²Pb-based radioligand therapeutics with proprietary intellectual property rights for undisclosed targets on a global scale. Both parties may also engage in mutual in-licensing of each other’s products in the future to accelerate the global commercialization process.

Dr. Ben Yong, Executive CEO of Shanghai Hezhou Pharmaceutical Co., Ltd., stated:“Alpha-emitting radionuclide ligand therapeutics represent a new chapter in radiopharmaceuticals. Building on the research achievements of Professor Cheng Zhen, Co-founder of Hezhou Pharmaceutical and researcher at the Shanghai Institute of Materia Medica, we have established multiple innovative pipelines for radiopharmaceutical development. AlphaDirect™ is a globally leading ²¹²Pb radionuclide separation and purification technology platform, poised to address the critical bottleneck in China’s radionuclide supply. We are delighted to leverage AlphaDirect™ technology to advance Hezhou Pharmaceutical’s highly innovative ²¹²Pb radioligand therapy pipeline, and we look forward to collaborating with the ARTBIO team to bring more breakthrough alpha-emitting radionuclide ligand therapies to cancer patients.”

Dr. Emanuele Ostuni, CEO of ARTBIO, stated:“We are thrilled to establish such a close and strategically significant partnership with Hezhou Pharmaceutical in China. This collaboration will accelerate the global adoption of ARTBIO’s novel alpha-emitting radioligand therapies, bringing innovative treatment options to cancer patients worldwide at an earlier stage.”

AlphaDirect™ is ARTBIO’s pioneering technology for the separation and purification of the ²¹²Pb radionuclide. By leveraging raw materials with stable supply and controllable costs, it enables the consistent production of high-purity ²¹²Pb, thereby minimizing supply chain risks and production costs associated with alpha-emitting radionuclides.AlphaDirect™ is a compact, portable generator technology with global patent coverage, enabling the scaled production and delivery of radioligand therapies to clinical centers through a patient-centric, distributed hub-and-spoke operational model.

AB001 is a ²¹²Pb-labeled radioligand therapeutic with best-in-class potential, capable of selectively delivering alpha particles to PSMA-positive cells. AB001 has completed a Phase 0 clinical trial (NCT05725070) to evaluate the safety and imaging characteristics of microdoses of AB001 in patients with metastatic castration-resistant prostate cancer (mCRPC). Preclinical studies have demonstrated that AB001 exhibits significant antitumor activity in mouse models of prostate cancer, including delayed tumor growth and improved survival rates, with no long-term radiation toxicity observed at efficacious therapeutic doses. Compared with ¹⁷⁷Lu-PSMA-617, AB001 demonstrates higher tumor uptake and lower uptake in the kidneys and salivary glands.

Hezhou Pharmaceutical is a radiopharmaceutical company focused on the research and development, innovation, and industrialization of innovative targeted radioligand therapies. Hezhou Pharmaceutical is committed to leveraging its leading technology platform to develop targeted radiopharmaceutical therapies for patients in China and worldwide.

ARTBIO is a clinical-stage radiopharmaceutical company dedicated to developing novel alpha-emitting radioligand therapies, offering innovative options for cancer treatment. By selecting the optimal alpha emitter (²¹²Pb) and tumor-specific targets, ARTBIO develops the safest and most effective therapeutic approaches. Its proprietary AlphaDirect™ technology is a world-first ²¹²Pb separation and purification platform that enables efficient and reliable production and distribution of alpha-emitting radiopharmaceuticals through a decentralized manufacturing model. ARTBIO is advancing multiple pipeline programs concurrently, with its lead candidate, AB001, currently undergoing first-in-human clinical trials. Backed by nearly a century of pioneering work in radiotherapy from the University of Oslo and The Norwegian Radium Hospital, ARTBIO possesses a profound scientific foundation.