Nuoyu Pharma Accelerates Clinical Validation and Commercialization Through Bedside-Bench-Bedside Innovation Model

At the end of 2021, Nuoyu Pharma, a radiopharmaceutical company, secured tens of millions of RMB in angel-round investment led by Wu Yuding, founder of Xinghua Dingli.Prior to this, the founding team of Nuoyu Pharma had met Wu Yuding only twice.

Wu Yuding has invested in the early-stage financing rounds of promising ventures such as Obio Technology (688238), Jinyi Shengshi, LC-Bio, Huadao Biology, and Shangjian Biotech. He has also served as a director or supervisor for more than 20 companies, including Obio Technology (688238), and has achieved notable investment success in the biopharmaceutical and semiconductor sectors.

Nuoyu Pharma is one of the key projects closely monitored by Xinghua Dingli. “Prior to the investment, Mr. Wu had conducted due diligence on the vast majority of domestic radiopharmaceutical companies. Nuoyu’s founding philosophy aligned perfectly with Mr. Wu’s vision, leading to a swift closure of the angel round.”Co-Founder & General ManagerYan Chenglong candidly stated that investors have great confidence in Nuoyu.

It was not until May this year that angel investors, including Wu Yuding, visited Wuxi Nuoyu Pharmaceutical for the first time. Following in-depth discussions, Xinghua Dingli led the investment round again in June, with Zhuhai Bairui Hengsheng making additional investments. As a result, Nuoyu Pharmaceutical swiftly completed its Pre-A financing round, raising tens of millions of RMB.

Since its angel round of financing last September, the Nuoyu team has rapidly expanded from just six members to nearly 50.It includes experts from both domestic and international communities, has preliminarily established a research and development system for original radiopharmaceuticals and innovative drugs, and has completedPreclinical proof-of-concept for nearly 20 targets, and clinical validation in nearly 200 research patients across 7 targets and more than 10 molecules.

Nuoyu Pharma has established a third-generation antibody-conjugated radiopharmaceutical platform with fully independent intellectual property rights, the world’s first “Visualizable XDC” platform, and the “Mortise-and-Tenon” radiopharmaceutical equipment platform. Its self-operated GMP-compliant radiopharmaceutical facility has received environmental impact assessment approval from the Jiangsu Provincial Department of Ecology and Environment and is scheduled to commence trial operations by the end of the year.

Meanwhile,Nuoyu has also established close collaborations with numerous medical institutions and well-known innovative pharmaceutical companies in China., and jointly established a Joint Laboratory for Clinical Translation in Nuclear Medicine with renowned Grade A tertiary hospitals such as the Affiliated Hospital of Jiangnan University.

How Did the Typically Low-Profile Nuoyu Pharma Achieve Rapid Growth?

The founding team of Nuoyu Pharma has over a decade of experience in the field of radiopharmaceuticals,The founders previously worked at China’s earliest commercial CRO company to leverage isotope labeling and molecular imaging technologies for the evaluation of traditional innovative drugs, and also participated inParticipated in the domestic registration and commercialization of innovative radiopharmaceuticals from major international pharmaceutical companies, and established Nuoyu Pharma in 2018 to conduct R&D and industrialization of innovative radiopharmaceuticals.Such a team background is truly rare in the field of nuclear medicine.

“While industry insiders are familiar with our team members, they remain unaware of Nuoyu Company’s existence..” Yan Chenglong said with a smile.

With the addition of Professor Jiang Ji, Director of the Phase I Clinical Research Unit at the Clinical Pharmacology Research Center of Peking Union Medical College Hospital, Nuoyu Pharma has achieved greater efficiency in the clinical development of innovative drugs. Professor Jiang has served as Principal Investigator or Investigator in over 200 Phase I clinical trials across various therapeutic areas.

The addition of Dr. Wu Weisi, Merck’s first radiopharmaceutical engineer, has further strengthened NovoRay Pharmaceuticals’ capabilities in innovative drug R&D. Dr. Wu previously participated in establishing the pharmaceutical industry’s first molecular imaging R&D team globally and brings over 30 years of experience in medical molecular imaging and its applications in drug development. He has helped design more than a thousand animal molecular imaging studies to accelerate drug discovery and development.

For years, the founding team of Nuoyu has been focused on the radiopharmaceutical industry.Since 2008, no innovative radiopharmaceuticals have been approved for market launch in China, with only one agent, 18F-FDG, currently approved in the domestic market. In contrast, the United States has approved 20 diagnostic PET tracers to date. Notably, since 2018, the U.S. FDA has approved two breakthrough therapeutic radiopharmaceuticals labeled with 177Lu, which are poised to become blockbuster drugs. This progress has accelerated the strategic expansion of major international pharmaceutical companies (such as Novartis, Bayer, and Johnson & Johnson) in the radiopharmaceutical sector. Meanwhile, numerous prominent international venture capital firms have made significant investments in radiopharmaceutical startups, propelling the field into a period of explosive growth.

It is precisely the significant gap observed between the development of radiopharmaceuticals domestically and internationally, combined with the unmet demand for radiopharmaceuticals in China, thatNuoyu Founding TeamIt is believed that developing original innovative radiopharmaceuticals in China is an urgent priority.

In May 2018, Nuoyu Pharma was established in Anhui Province and was renamed Wuxi Nuoyu Pharmaceutical Technology Co., Ltd. in 2021. At its inception, the company consisted of only two individuals, Yan Chenglong and Fang Peng. To refine their technological platform and systems, they collaborated with institutions such as the Affiliated Hospital of Jiangnan University, dedicating over three years to clinical and grassroots-level work.

It was not until the second half of 2021, when Nuoyu Pharma secured angel-round financing from Wu Yuding of Xinghua Dingli, that the team expanded rapidly and the company entered a fast-growth trajectory.They have gradually identified viable pathways for “rapid product validation” and “accelerated time-to-market.”

Radiopharmaceuticals are widely recognized within the industry as a high-barrier sector, with equipment and licensing constituting the initial hurdles. Many companies adopt a development model of building relevant facilities first and then proceeding to product R&D, which is time-consuming, capital-intensive, and high-risk. Meanwhile, if they follow the traditional “drug R&D – clinical trials – commercialization” pathway, it will be extremely difficult for small-scale startups pursuing “innovation” and “speed” to gain a competitive edge. Every step presents significant challenges.

Fortunately,Leveraging the networks and resources they have accumulated over many years in the radiopharmaceutical industry, the two founders have pioneered a path characterized by low-cost trial-and-error and efficient validation.

The Department of Nuclear Medicine at the Affiliated Hospital of Jiangnan University boasts state-of-the-art equipment and laboratories. As the first formally established nuclear medicine department in the Wuxi region, it is designated as a Key Clinical Specialty of Jiangsu Province.

Across China, the Nuclear Medicine Department Laboratory at the Affiliated Hospital of Jiangsu University ranks among the top in terms of hardware facilities, with an investment nearing tens of millions of yuan. The laboratory is equipped with comprehensive cell and molecular biology instruments, an animal facility, small-animal PET-CT, a cyclotron, as well as nuclear medicine imaging systems such as PET-CT and SPECT-CT. Most importantly, it holds a Class IV license for radiopharmaceuticals and features therapeutic wards. With a laboratory space of nearly 1,000 square meters, it can comfortably accommodate Nuoyu’s R&D team of more than 20 members.

The Affiliated Hospital of Jiangnan University attaches great importance to the development of its nuclear medicine department and highly recognizes Nuoyu Pharmaceutical’s scientific research and innovation capabilities.The two parties quickly reached a consensus and successfully established a collaboration in the form of a joint laboratory, resolving challenges related to equipment and laboratory infrastructure. This partnership marked the beginning of the “Nuoyu Speed” in new drug development and clinical translation.Currently, Nuoyu’s self-operated GMP facilities and office areas cover a total of over 3,600 square meters, equipped with more than 100 R&D devices.

In recent years, intense competition within the industry has arisen largely because many pharmaceutical companies lack pathways for early clinical validation of innovative targets, forcing them to follow mature targets already validated abroad.Nuoyu possesses resource advantages in "rapid clinical proof-of-concept for molecular imaging,"Can be achievedFocusing on Two Dimensions: First-in-Class for Novel Targets and Best-in-Class for Established TargetsImplement strategic layout.

Nuoyu has successively completed the validation of clinical concepts and development strategies for over a dozen targets across major disease areas, including pancreatic cancer, renal cell carcinoma, gastric cancer, ovarian cancer, prostate cancer, and multiple myeloma. Furthermore, it has conducted investigator-initiated clinical studies involving hundreds of patients, with certain products already adopted as routine new diagnostic and therapeutic technologies in clinical practice.

Nuoyu currently has one global first-in-class innovative radiopharmaceutical and one best-in-class innovative radiopharmaceutical in the data preparation stage for Investigational New Drug (IND) applications for registrational clinical trials, and plans to complete dual IND submissions in China and the United States for 3–4 registrational clinical trials in 2023. Going forward, Nuoyu plans to submit 2–3 new molecular entity IND applications annually to continuously expand its clinical pipeline.

In drug development, the traditional approach has almost exclusively followed a “bench-to-bedside” model: molecular R&D is conducted in the laboratory first, followed by animal studies; if the results are favorable, preparation and submission of an Investigational New Drug (IND) application ensue. In reality, however, there is a substantial discrepancy between outcomes in animal experiments and those observed in clinical trials with patients. Often, companies do not identify critical issues until Phase II clinical trials, after having invested hundreds of millions of yuan. Coupled with the pressure from valuation adjustment mechanisms (VAMs) between companies and investors, clinical programs cannot be halted, resulting in low clinical success rates. Leveraging its extensive clinical resources, Nuoyu can boldly explore solutions during the preclinical stage and significantly enhance the success rate of drug development through early-phase clinical proof-of-concept studies—namely, their“Bedside-Bench-Bedside” Model。

At the outset, through close collaboration with oncologists and nuclear medicine physicians, Nuoyu was better positioned to directly assess the clinical application scenarios of drug candidates and identify products with genuine clinical value during project initiation.

“During the R&D process, we repeatedly conduct preclinical and clinical trials to continuously refine drug molecules. ‘After our molecular design is completed, we will promptly proceed with scientific and clinical validation to assess clinical developability, expand indications, adjust dosages, and more. If any shortcomings are identified, we will return to optimize the molecular design and then re-conduct scientific and clinical validation. Only candidate molecules that meet expected outcomes will be advanced to IND preparation and submission,’ introduced Yan Chenglong.”

During the preclinical research phase, Nuoyu has already obtained early-stage clinical pharmacokinetic parameters, such as drug distribution in tumor target organs and non-target organs, as well as systemic pharmacokinetic parameters, thereby determining the drug’s indications and its interactions with other medications. This approach is akin to repeatedly conducting “mock exams,” enabling faster progress and a significantly higher success rate in R&D when advancing to formal clinical trials compared to other companies.

From the perspective of the entire industry, Nuoyu has significant resource advantages.We have established collaborations with many renowned nuclear medicine diagnosis and treatment centers both domestically and internationally. This not only provides a solid foundation for drug development and clinical trials but also enables us to reach the end-user stage of drug application, thereby laying the groundwork in advance for the commercialization of pharmaceuticals and nuclear medicine equipment.

“It is crucial to consider the application scenarios of innovative drugs; we had commercialization in mind from the outset.“Moreover, the commercialization of nuclear medicine products will inevitably be driven by the nuclear medicine sector. As we have already entered hospitals at this stage, the likelihood of their adopting our products in the later stages is very high,” said Yan Chenglong, General Manager of Nuoyu.

Nuoyu Pharma targets the entire nuclear medicine industry chain, starting with the establishment of infrastructure and R&D systems,Established the “Mortise-and-Tenon” Intelligent Radiopharmaceutical Equipment Platform,We aim to enhance the overall standardization of radiopharmaceutical use.

The radiopharmaceutical module is related to product manufacturing processes,Nuoyu believes that it is most appropriate for radiopharmaceutical companies to develop radiopharmaceutical equipment.“Sunmao” Intelligent Radiopharmaceutical Equipment ZM001 integrates multiple functions, including purification of metallic radionuclides, radiolabeling of small molecules/peptides, and radiolabeling of macromolecules. It features autonomous drug process editing, user/permission management, database audit trails, process parameter recording, and production report generation. Reportedly, this commercial model was successfully rolled off the production line at the Wuxi factory recently and is poised for delivery to customers.

Nuoyu Pharma’s commercially available models of its independently developed M2–M5 series modules, featuring mortise-and-tenon design for radiopharmaceutical dispensing and multifunctional FDG/fluorine applications, will be rolled out in the near future. These solutions provide the nuclear medicine industry with fully automated, end-to-end capabilities spanning radionuclide purification, radiopharmaceutical development and production, dispensing, and injection.

Investment institutions represented by Xinghua Dingli place significant emphasis on Nuoyu’s commercialization potential. Nuoyu Pharmaceuticals remains committed to the research and development of original innovative drugs, conducts rigorous scientific and clinical validation, and has a clear path to commercialization.

Nuoyu Team plans to launch a new round of financing in the fourth quarter to support the R&D of new drug projects and the commercialization of nuclear medicine equipment.