Navigating the Deep Waters of Innovative Radiopharmaceuticals: Xiantong Pharma's Strategic Path Forward

Nuclear medicine, by virtue of its technological uniqueness, demonstrates broader practical applications and imaginative potential in both diagnostic and therapeutic fields. Meanwhile, high professional specialization, strong interdependence across the upstream and downstream industry chains, and the need for breakthroughs in policy support and talent supply have collectively established significant barriers to entry in the nuclear medicine sector. With clinical demand clearly present and radionuclide technologies poised for advancement, where should the entry point be, and how should progress be driven?

Recent Advances in Radiopharmaceuticals

In November, Chengdu Newreat and Nanjing Anji Biotechnology jointly signed the "Strategic Cooperation Agreement on the Development of Innovative Peptide-Radionuclide Conjugate (PRC) Drugs," launching a collaborative development project valued at over RMB 100 million; Shanghai Folian acquired the U.S.-based Focus-X for $245 million, marking a cross-border transaction in the field of radiopharmaceuticals and peptides.

Nuclear medicine has attracted more cross-disciplinary players, gradually breaking out of its niche sector.

As one of the earliest pioneers in China to transition into innovative radiopharmaceuticals, APT Pharma has submitted a New Drug Application (NDA) for its diagnostic radiopharmaceutical targeting amyloid-beta (Aβ), which is expected to be approved next year, thereby filling the gap in nuclear medicine-based diagnosis of Alzheimer’s disease (AD) in China. Meanwhile, XTR008, the first peptide receptor radionuclide therapy (PRRT) drug in China, has entered Phase III clinical trials. Behind these achievements, what strategic trade-offs and challenges has APT Pharma navigated?This is not only a milestone for the company, but also a microcosm of industry development.

December 27 (Tuesday) 20:00-21:30,VCBeat’s New Medicine, in collaboration with Atompharma, hosted an online panel discussion. Experts from clinical practice, investment, and upstream and downstream sectors of the industry were invited to explore the advantages of radiopharmaceuticals in diagnosis and therapy, as well as strategic considerations for their advancement. The discussion covered in-depth topics including radiopharmaceutical R&D, clinical trials, regulatory submission and registration, and sector development, with the aim of contributing to the growth of the industry.

Live streaming platform: [VCBeat New Medicine Video Account], reserve before reading

Add the assistant on WeChat, submit a question of interest, and join the nuclear medicine discussion group.

Liu Chuanwen

Managing Director, New Jun Capital

Responsible for mergers and acquisitions and equity investments in the healthcare sector. Previously served as General Manager of Guangdong Junqi Pharmaceutical Technology Co., Ltd., Deputy General Manager of Shanghai Jielong Biological Products Co., Ltd., and Senior Investment Manager in the Investment Department of Yutong Group.

Wu Haowei 

CEO, Midu Bio

Master’s degree in Pharmaceutical Engineering and Science from the University of Leeds, UK; over ten years of experience in innovative drug R&D and CRO operations; involved in the design of preclinical and clinical studies for dozens of innovative drugs, including multiple radiopharmaceuticals. Has led teams to obtain clinical trial approvals in China for six radiopharmaceuticals, including three Class 1.1 innovative drugs. Served as the principal investigator for the first domestic localization study of an original 18F-labeled radiopharmaceutical in China, and participated in organizing the first Phase III clinical trial of an 18F-labeled radiopharmaceutical in China.

Wang Peng

Vice President, Xiantong Medicine

Primarily responsible for new drug R&D, project management, and regulatory registration. Possesses 14 years of experience at the China Food and Drug Administration (CFDA) and the Center for Drug Evaluation (CDE), having participated in the research and formulation of certain drug registration policies, with a thorough understanding of China’s drug regulatory laws, regulations, and policy directions. This includes 7 years of experience in technical drug review at the CDE, during which over 300 review reports were authored annually, demonstrating familiarity with relevant regulations and guidelines for drug development and evaluation; and 5 years of comprehensive management experience at the CDE, overseeing the integrated management and coordination of internal review operations and participating in the research and development of key CDE management standards. Served as a Visiting Scholar at the Center for Translational Medicine, University of Maryland, Baltimore, from 2012 to 2013. Joined Atom Medicine in 2016 and has since accumulated over six years of experience in the R&D management of radiopharmaceuticals, with a strong grasp of domestic and international advancements in radiopharmaceutical development.

Xu Bailing

Xiantong Medicine Diagnostic Products CMO

Visiting Professor, University of Missouri, Columbia, USA;National Yang Ming University - Adjunct Professor;Journal of Nuclear Cardiology (US) - Editorial Board Member;Member of the International Expert Advisory Committee, American Society of Nuclear Cardiology.A nuclear cardiology expert who has witnessed and participated in the full developmental course of nuclear cardiology in the United States. His main research interests include the clinical application of new imaging technologies such as SPECT myocardial blood flow quantification, PET myocardial blood flow quantification, and PET myocardial metabolism quantification, as well as clinical trials of innovative PET imaging agents. He currently serves as the Chief Medical Officer (CMO) of Diagnostic Products at Pienton International Pharmaceutical Technology Co., Ltd. (Pienton Pharma), and is the principal investigator for the clinical trials of two novel cardiovascular PET imaging agents and two novel neuro-PET imaging agents.

GaoKe Xinjun was established in 2015, led by Nanjing Gaoke (600064) as the limited partner. Its management team hails from top-tier domestic investment and investment banking institutions, possessing visionary insight and abundant resources in venture capital and capital markets. Xinjun focuses on equity investments in growth-stage enterprises, with primary investment directions in big health and high technology. By leveraging an international investment perspective and management model, Xinjun helps companies build a resource ecosystem for growth. Selected investment cases in the medical and big health sectors include: ACROBiosystems, Shuoshi Biotech, Allist, Hualan Shares, Rendu Biology, Chengdu Newreat, Yimai Yangguang, Dakang Medical, and Zhengya Dental.

Mido (Nanjing) Biotechnology Co., Ltd. was established in 2012. As a domestic Molecular Imaging Contract Research Organization (MI-CRO), Mido Biotech leverages radiolabeling and molecular imaging technologies to provide comprehensive new drug development solutions and outsourced technical services to clients both in China and abroad. These services include drug screening, biodistribution studies, pharmacokinetic research, and pharmacodynamic evaluation. The company’s business encompasses translational studies ranging from nude mice, rats, and non-human primates to humans, with a particular focus on major diseases such as cancer, cardiovascular and cerebrovascular disorders, Alzheimer’s disease, Parkinson’s disease, epilepsy, rheumatic and immune diseases, diabetes, and non-alcoholic steatohepatitis (NASH), as well as frontier research areas including receptors, genes, and stem cells. Through these efforts, Mido Biotech aims to explore disease mechanisms, develop diagnostic and therapeutic agents, and evaluate treatment efficacy. Furthermore, Mido Biotech offers one-stop services for radiopharmaceuticals, covering early-stage development, chemistry, manufacturing, and controls (CMC), preclinical studies, clinical trials, and regulatory submissions, and has successfully obtained clinical trial approvals in China for multiple projects.

Beijing Sinotau International Pharmaceutical Technology Co., Ltd. is a leading innovative radiopharmaceutical company rooted in China with a global development outlook. The company officially commenced research and development of next-generation radiopharmaceuticals in 2014. Headquartered in Beijing, the capital of China, it operates modern intelligent manufacturing bases for radiopharmaceuticals in Jiangsu, Guangdong, and Sichuan provinces, maintains a branch in the United States, and has established business collaborations with more than ten multinational pharmaceutical companies. Leveraging globally leading R&D resources for precision theranostics in radiopharmaceuticals, Sinotau has pioneered the development of multiple targeted therapeutic and precision diagnostic radiopharmaceuticals in the fields of oncology, neurodegenerative diseases, and cardiovascular conditions. These products are either undergoing or have completed clinical trials and are scheduled for sequential market launch in the coming years. Since April 2020, Sinotau has successfully raised nearly RMB 1 billion, garnering favor from major institutional investors, and plans to list on major capital markets in the near future.

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