Behind Neweast Medical's Yttrium-90 CarboSphere Injection Clinical Approval: China's Radiopharmaceutical Industry Gains Momentum

Yesterday afternoon, Chengdu New Radiomedicine Technology Co., Ltd. (hereinafter referred to as “New Radiomedicine”) announced that its independently developed yttrium [⁹⁰[Y] Carbon Microsphere Injection Approved by the National Medical Products Administration (NMPA) for Clinical Trials, with Metastatic Liver Cancer as the First Indication.

Yttrium [⁹⁰Y] Carbon Microsphere Injection product is the successor to Boston Scientific's Yttrium-[⁹⁰Y] glass microspheres, Australia's Sirtex Medical Company's yttrium [⁹⁰Y] resin microspheres, the third-generation yttrium [⁹⁰Y] Microspheres.

Yttrium [⁹⁰Y]ttrium microspheres for injection were independently developed over four years by the research and development team at New Radiomedicine. As radioactive microspheres for selective internal radiation therapy (SIRT), yttrium [⁹⁰Y] Carbon Microsphere Injection is a carrier-based formulation loaded with high-activity radioactive yttrium [⁹⁰Y] obtained by transarterial infusion via DSA-guided interventional procedure into the tumor-feeding arteries. Yttrium [⁹⁰Y] microspheres distribute with the blood flow and become lodged in the small arteries and capillaries of tumor tissue, yttrium[⁹⁰Y] emits pure beta particles with an average energy of 0.9367 MeV, a maximum tissue penetration depth of 11 mm, and an average tissue penetration depth of 2.5 mm, ultimately achieving therapeutic objectives by destroying tumor cells through selective internal radiation therapy.

According to reports, Yttrium [⁹⁰Y] The outstanding advantages of the carbon microsphere injection product include: enabling 24/7 production and supply; high specific activity, long shelf life (8 days), and low risk of reflux; appropriate specific gravity for easy perfusion, with all core metrics meeting or exceeding those of international counterparts.

New Radiomedicine plans to complete the enrollment of the first patient in its clinical trials in 2022, striving to finalize the trials at the earliest possible date so as to ensure access to medication for liver cancer patients in China, thereby treating diseases, saving lives, and benefiting society.

New Radiomedicine, established in 2016, is an enterprise integrating the research and development, innovation, and industrialization of radiopharmaceuticals. It is primarily engaged in the development, production, and sales of diagnostic and therapeutic drugs based on medical isotopes. Currently, New Radiomedicine has built three major technical platforms: a radiopharmaceutical testing and research platform, a radiopharmaceutical pharmacology and toxicology research platform, and a radiopharmaceutical industrialization platform. The company holds qualifications including a GMP quality management system, a “Radiation Safety License,” and an “Laboratory Animal Use License.”

In addition to yttrium [⁹⁰Y] Carbon Microsphere Injection Product: The IND for NT003 (NRT6003 Injection), a carbon microsphere candidate in the company’s R&D pipeline, has been accepted by the Center for Drug Evaluation of the National Medical Products Administration.

In April 2022, New Radiomedicine completed a new round of financing (Series C1) amounting to hundreds of millions of yuan. Based on firm confidence in the company’s development, this round was fully subscribed by existing shareholders, with a significant increase in valuation compared to the previous round.

In March this year, VCBeat’s New Medicine invited Ge Qiang, Deputy General Manager of New Radiomedicine, to participate in the offline salon event “VB Thought Share,” to discuss the current practical challenges and future prospects of the radiopharmaceutical industry (for details, please see“A Nuclear Entrepreneur’s Narrative: Industry Rules Apply, and Entry Is Not Easy”). Previously, this company had encountered nearly all conceivable difficulties in the development of therapeutic radiopharmaceuticals. They made some beneficial attempts and accumulated valuable experience.

According to Ge Qiang, the barrier to entry in the field of radiopharmaceuticals is very high. During its first six years of operation, New Radiomedicine focused on infrastructure development in the initial three years (2016–2018), obtaining a Class A Radiation Safety License required for the research and development and production of radiopharmaceuticals.

He cautioned that the qualification requirements for the development of therapeutic radiopharmaceuticals in China are exceptionally stringent. Prior to project initiation, developers must already determine the intended clinical dosage and identify the appropriate facilities for conducting trials. “When entering this field, you must also secure a reliable source of radionuclides and obtain the technical documentation for radionuclide separation processes; failure to meet these prerequisites will result in rejection by the Center for Drug Evaluation (CDE). If accelerator-based radionuclide production is planned, careful consideration must be given to the selection of accelerator suppliers, the acquisition of the appropriate level of Radiation Safety License, and the establishment of an operations and maintenance team.”

Currently, New Radiomedicine has obtained approval from the Ministry of Ecology and Environment for one Class A facility, two Class B facilities, and one Class C facility. The company plans to further expand its qualifications and product portfolio in the future. Ge Qiang also stated that in the second half of this year, New Radiomedicine will achieve commercial supply of Yttrium-90 (Y-90) in China, serving not only the domestic market but also exporting Chinese-made Y-90 to the entire Asia-Pacific region.

In addition to New Radiomedicine, two other domestic pharmaceutical companies have made significant progress with their radiopharmaceutical products this year.

Last week, VCBeat disclosed that SNA002, a radioactive imaging agent independently developed by the Chinese nuclear medicine company SmartNuclide, became the first radiopharmaceutical imaging drug in China to receive dual Investigational New Drug (IND) approvals from both China and the United States.

In February this year, Grand Pharmaceutical introduced SIR-Spheres Yttrium-90 from Sirtex⁹⁰Yttrium-90 (⁹⁰Y) Microsphere Injection Receives Drug Registration Certificate from the National Medical Products Administration, with Its First Approved Indication Being the Treatment of Unresectable Colorectal Cancer Liver Metastases in Patients Who Have Failed Standard Therapy. On May 5, Grand Pharmaceutical’s Yttrium-90 (⁹⁰Y) Resin Microspheres Were Officially Launched at Zhongda Hospital Affiliated to Southeast University, Completing the Transition from Approval to Clinical Implementation Within Three Months and Sending a Positive Signal to the Industry.

Furthermore, innovative pharmaceutical companies establishing a presence in the domestic radiopharmaceutical sector are emerging in large numbers. In addition to the two major industry giants, Dongcheng Pharmaceutical and China Isotope & Radiation Corporation, there are companies such as Hexin Medicine, which is dedicated to the R&D of dual-target integrated radiodiagnostic and radiotherapeutic agents; Xiantong Medicine, which focuses primarily on myocardial perfusion imaging, protein tracers for Alzheimer’s disease, and radiopharmaceuticals for the treatment of metastatic castration-resistant prostate cancer; and Faber New Tian, which is gradually transitioning from a nuclear medicine CRO to a radiopharmaceutical R&D enterprise.

It is foreseeable that in the near future, these domestic radiopharmaceutical companies will intensively advance their product pipelines. From R&D and clinical application to regulatory breakthroughs, the radiopharmaceutical industry is gathering momentum.