Yunnan Baiyao's First Therapeutic Radiopharmaceutical INR102 Granted Clinical Trial Approval

On April 9, Yunnan Baiyao issued an announcement stating that its wholly-owned subsidiary, Yunhe Pharmaceutical (Tianjin) Co., Ltd. (“Yunhe Pharmaceutical”), recently received the “Notice of Approval for Drug Clinical Trials” (Notice No.: 2025LP01012) from the National Medical Products Administration (NMPA). Upon review, the clinical trial application for Yunhe Pharmaceutical’s INR102 injection (hereinafter referred to as “the Product”) was found to comply with the relevant requirements for drug registration, and approval was granted to conduct clinical trials for prostate cancer. INR102 is a PSMA-targeting radiopharmaceutical and represents Yunnan Baiyao’s first innovative therapeutic radiopharmaceutical product developed in-house. To date, approximately RMB 23.325 million has been invested in the research and development of INR102.

INR102 is a Class 1 chemical innovative radiopharmaceutical therapeutic developed by Yunhe Pharmaceutical, intended for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously received androgen receptor pathway inhibitors and taxane-based chemotherapy. The active molecular structure of INR102 comprises a targeting ligand and the radioisotope lutetium-177. The targeting ligand specifically binds to PSMA-positive cancer cells, and the lutetium-177 emits beta rays during its decay process, causing DNA damage in cancer cells and ultimately inducing cell death.

Lutetium-177 is currently the most promising and market-dynamic theranostic radionuclide, suitable for preparing radiopharmaceuticals with tumor-targeting capabilities for both diagnostic and therapeutic purposes. In recent years, it has been widely applied in research and clinical practice of targeted radionuclide therapy in developed countries in Europe and the United States, achieving favorable outcomes.

Novartis’s two blockbuster drugs, Pluvicto and Lutathera, as well as Yunnan Baiyao’s INR102, which has received clinical trial approval, are all lutetium-177-labeled radiopharmaceuticals. In addition, multiple Chinese companies, including China Isotope & Radiation Corporation, Dongcheng Pharmaceutical, Hengrui Medicine, Zhihe Biopharma, and Hexin Pharmaceutical, have established pipelines related to lutetium-177. There are three main reasons why lutetium-177-labeled drugs have gained such significant attention.

First,Lutetium-177 has a half-life of 6.67 days (decaying to Hafnium-177 via beta decay) and emits three types of beta particles with different energies during the decay process. Due to the relatively low energy of its beta particles, with an average tissue penetration range of 670 μm, Lutetium-177 causes milder bone marrow suppression when irradiating lesions, making it safer than other therapeutic radionuclides. Clinical trials abroad have demonstrated that multiple Lutetium-177-labeled radiopharmaceuticals offer unique advantages in tumor therapy, particularly for the eradication of small-volume tumors and metastatic lesions.

Second,During its decay, Lutetium-177 also emits gamma rays with low energies of 112.9 keV (6.4%) and 208.4 keV (11.0%), which can be utilized for single-photon emission computed tomography/computed tomography (SPECT/CT) imaging to monitor the distribution and metabolism of radiopharmaceuticals in the body.

Third,Lutetium-177 has a half-life of approximately 6.7 days, which meets the time requirements for drug production and transportation, thereby improving the accessibility of the therapy.

Furthermore, for various cancers, particularly advanced or metastatic cases, Lutetium-177 radionuclide therapy can significantly improve patients' quality of life. Currently, the therapeutic value of Lutetium-177 has been validated in the treatment of prostate cancer and neuroendocrine tumors.

It has become a trend for traditional Chinese medicine enterprises to seek breakthroughs through cross-industry expansion, and Yunnan Baiyao has long pioneered successful precedents in this regard. Its transformation from traditional Chinese medicine to the broader health sector, including its entry into the daily chemical products market, stands as a classic success story. Nuclear medicine represents Yunnan Baiyao’s next strategic frontier.

As early as January 2022, Yunnan Baiyao disclosed that, to further enrich its R&D pipeline and continuously enhance its existing capabilities in traditional Chinese medicine (TCM) research and development, it would gradually build advanced capabilities for the research and development of biological and chemical pharmaceutical products. In June 2022, aligning with national strategic needs for medical radioisotopes and leveraging Peking University’s strengths in nuclear medicine research, Yunnan Baiyao established the Innovative Drug Center under its Central Research Institute. The center focused on areas such as oncology and immunology, aiming to develop an innovative drug R&D pipeline centered on precision diagnosis and therapy, with a particular emphasis on proprietary radiopharmaceuticals. In September 2022, Yunnan Baiyao acquired patents related to prostate-specific membrane antigen (PSMA)-targeted radiopharmaceuticals from Peking University First Hospital and the Beijing Institute for Cancer Research, officially launching its radiopharmaceutical R&D initiatives.

In July 2023, Yunnan Baiyao established its wholly-owned subsidiary, Yunhe Pharmaceutical (Tianjin) Co., Ltd., dedicated to advancing the research and development and commercialization of innovative radiopharmaceuticals. The project covers a construction area of over 6,000 square meters, including 2,000 square meters of radioactive workspaces. It is equipped with advanced instruments and facilities such as various analytical instruments, small animal imaging systems, R&D hot cells, and pilot production lines, enabling capabilities in new drug screening, drug development, and the production and supply of clinical trial materials.

In May 2024, Yunhe Pharmaceutical’s INR101 injection received implicit approval for clinical trials from the Center for Drug Evaluation of the National Medical Products Administration. INR101 injection is a Class 1 chemical innovative radiopharmaceutical diagnostic agent developed by Yunhe Pharmaceutical, indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer.

In October 2024, Yunhe Pharmaceutical (Tianjin) Co., Ltd. successfully obtained the Radiation Safety License issued by the Tianjin Municipal Bureau of Ecological Environment. The acquisition of this license signifies that the Yunnan Baiyao Nuclear Medicine R&D Center (Tianjin) Project is now officially qualified to use radioactive isotopes and ray-generating devices, enabling it to carry out activities such as the research and development of radiopharmaceuticals and the production of clinical samples. This achievement marks a significant milestone in Yunnan Baiyao’s innovative drug research and development efforts.

In March 2025, INR101, the first diagnostic radiopharmaceutical developed by Yunnan Baiyao, had two multicenter, open-label, prospective Phase III clinical trials registered in China: one aimed at evaluating the diagnostic efficacy and safety of INR101 injection for PET/CT imaging in subjects with suspected recurrence after radical treatment for prostate cancer; the other aimed at assessing the diagnostic performance and safety of INR101 injection for PET/CT imaging in detecting pelvic lymph node metastasis in prostate cancer patients prior to surgery.

It is evident that nuclear medicine represents a long-term strategic priority for Yunnan Baiyao. In its 2023 annual report, the company also stated that it has long focused on translating innovative drug R&D achievements into commercial applications. On one hand, it concentrates on its advantageous and exclusive traditional Chinese medicine (TCM) varieties to develop high-demand TCM products; on the other hand, with nuclear medicine as the core focus, it is deploying resources across the development of multiple innovative drugs.

Currently, Yunnan Baiyao is strengthening its foundational innovation capabilities while actively establishing and deepening strategic collaborations with relevant stakeholders across the radiopharmaceutical industry chain, including research institutes, radiopharmaceutical companies, and medical institutions. This effort aims to accelerate its layout across the upstream, midstream, and downstream segments of the radiopharmaceutical sector. As a century-old established brand, Yunnan Baiyao may be a “newcomer” to the radiopharmaceutical field, but since entering the market in 2022, it has rapidly achieved multiple milestone accomplishments. We look forward to Yunnan Baiyao’s continued success in this new domain, bringing more accessible therapeutic products to patients.

Reference: “INR101 Injection IND Application Approved, Yunnan Baiyao Accelerates Layout in the Field of Nuclear Medicine”