Yunnan Baiyao's INR101 Injection Receives IND Approval, Accelerating Nuclear Medicine Pipeline Expansion

On May 9, 2024, the INR101 injection developed by Yunhe Pharmaceutical (Tianjin) Co., Ltd. (“Yunhe Pharmaceutical”), a wholly-owned subsidiary of Yunnan Baiyao Group Co., Ltd. (“Yunnan Baiyao”), 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 radioactive diagnostic drug developed by Yunhe Pharmaceutical, indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer.

As a century-old traditional pharmaceutical enterprise and well-established brand in China, Yunnan Baiyao has kept pace with the times by strategically laying out its innovative drug development centered on radiopharmaceuticals since 2022.The approval of the INR101 injection for clinical trials marks the formal entry of Yunnan Baiyao’s radiopharmaceutical R&D from early-stage planning into the clinical trial phase, representing significant progress in the company’s business layout within the radiopharmaceutical sector.

The radiopharmaceutical market is experiencing rapid growth. According to data compiled by Huajing Industry Research Institute, the global radiopharmaceutical market size reached USD 7.124 billion in 2021, representing a year-on-year increase of 8.05%. Data from BBC Research indicates that the global radiopharmaceutical market was valued at approximately USD 9.3 billion in 2020, with a projected compound annual growth rate (CAGR) of 11.6% from 2022 to 2026, reaching a market size of USD 17.5 billion by 2026. According to statistics from the "White Paper on the Radiopharmaceutical Industry" released by VCBeat in 2023, a total of 69 investment institutions have established positions in China's radiopharmaceutical sector, completing 30 financing rounds with a total amount exceeding RMB 3.165 billion.

Radiopharmaceuticals play a uniquely important role in the diagnosis and treatment of malignant tumors, cardiovascular and cerebrovascular diseases, and central nervous system disorders, with broad applications. Compared with conventional drugs, they offer distinct advantages such as visualizability, quantifiability, and integrated theranostics. Yunnan Baiyao has keenly recognized the development potential of radiopharmaceuticals in addressing unmet clinical needs among patients in China. In January 2022, Yunnan Baiyao disclosed that, to further enrich its R&D pipeline and continuously enhance its existing traditional Chinese medicine R&D capabilities, it would gradually build advanced R&D capabilities for biological and chemical pharmaceutical products. In June 2022, aligning with national strategic demands for medical isotopes and leveraging Peking University’s strengths in nuclear medicine research, Yunnan Baiyao established the Innovative Drug Center under its Central Research Institute. The center focuses on oncology, immunology, and other fields, aiming to develop an innovative drug R&D pipeline centered on precision theranostics and distinctive radiopharmaceuticals. In September 2022, Yunnan Baiyao licensed 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.

Radiopharmaceutical R&D is a hotbed for pharmaceutical innovation, yet high barriers to entry continue to pose significant challenges across raw material supply, research and development, clinical development, and manufacturing. In response, Yunnan Baiyao is leveraging its core strengths to streamline key links in the radiopharmaceutical R&D process and accelerate industry advancement. Currently, Yunnan Baiyao is strengthening its foundational innovation capabilities while actively establishing and deepening strategic collaborations with stakeholders across the radiopharmaceutical value chain—including industry partners, research institutes, radiopharmaceutical companies, and medical institutions—to expedite its layout across the upstream, midstream, and downstream segments of the sector.

In February 2023, the “Peking University–Yunnan Baiyao International Medical Research Center,” jointly established by Yunnan Baiyao and Peking University, was officially launched. The two parties are jointly exploring innovative models of industry-academia collaboration in research and development, working together to drive source innovation. Leveraging Peking University’s leading capabilities in drug development innovation, Yunnan Baiyao fully utilizes the university’s big data resources and cutting-edge technologies such as bioinformatics analysis to efficiently discover new drug targets. Meanwhile, through close industry-academia collaboration, they have established comprehensive systems for developability assessment, in vitro activity evaluation, animal modeling and in vivo evaluation, and clinical research evaluation, thereby creating a big data-driven platform for source innovation in R&D.

In July 2023, Yunnan Baiyao established Yunhe Pharmaceutical (Tianjin) Co., Ltd. as a wholly-owned subsidiary, dedicated to advancing the research and development (R&D) and commercialization of innovative radiopharmaceuticals. Yunhe Pharmaceutical plans to construct a 6,000-square-meter radiopharmaceutical R&D center in Tianjin, serving as a key base for promoting radiopharmaceutical innovation. In early January 2024, Yunhe Pharmaceutical received approval for the Environmental Impact Report Form for its Tianjin radiopharmaceutical R&D center project (involving the new construction, use, and sale of radioactive drugs), officially commencing construction. This facility will effectively support the development of the company’s innovative radiopharmaceutical pipeline in the future.

As of now, INR101, the first diagnostic radiopharmaceutical developed by Yunnan Baiyao, has received implicit approval for clinical trials. The innovative radiopharmaceutical INR102, designed for the treatment of prostate cancer, has completed early efficacy validation in animal models and initiated pharmaceutical studies. Research on candidate molecules for projects such as INR202 and INR203 has also been progressively launched.

In the future, Yunnan Baiyao will fully leverage internal and external resources to continuously advance the research, development, and commercialization of radiopharmaceuticals. By aligning with the characteristics of domestic clinical research, the company will consistently introduce innovative products and precision diagnosis and treatment solutions to meet patients’ growing clinical needs.