In the first few days of April 2026, two "spring thunderclaps" echoed successively across China’s radiopharmaceutical industry.

On April 2, an official approval document on the National Medical Products Administration website announced that China’s first domestically developed Class 1 innovative radiopharmaceutical—Rediopharma’s Technetium [⁹⁹ᵐTc] Pexiretatide Injection (brand name: Jiluntai) and its 配套 kit had officially been approved for launch.

This represents not only an original breakthrough from 0 to 1 for China’s nuclear medicine drugs, but also breaks the nearly 30-year-long monopoly of PET/CT in tumor imaging diagnosis, giving the world a "Chinese solution" for broad-spectrum SPECT tumor imaging.

Just 24 hours later, another "nuclear bomb" detonated the capital market—emerging radiopharma star Neurite Medical announced the completion of a 1-billion-yuan Series E financing. Capital cast a vote of confidence in the commercial prospects of China’s radiopharmaceuticals with real money.

On one side, technological ice-breaking for original drugs; on the other, capital fueling through blockbuster financing. Within two days, China’s radiopharmaceutical industry achieved a critical leap from scientific research breakthroughs to industrial acceleration.

The two pieces of news shone brightly side by side, sending a clear signal: China’s radiopharmaceutical industry is transitioning from "catching up" to "leading the race", advancing from isolated breakthroughs to a full-scale outbreak.

2026 is regarded as the first year of "systematic competition" in radiopharmaceuticals—and this "China storm" in the radiopharma sector has only just begun.

01、A "Nuclear Bomb"-Scale Detonation

In nuclear medical imaging, PET/CT is considered the "gold standard" for tumor diagnosis, especially imaging agents represented by 18F-FDG, which can detect tumor cells with high glucose metabolism. Yet this "gold standard" is far from perfect.

First, there are mechanistic flaws. 18F-FDG relies on glucose metabolism: both tumor cells and inflammatory cells avidly take up glucose, appearing as high-uptake foci on images, leading to a high false-positive rate and insufficient specificity in differentiating benign and malignant lesions and assessing lymph node metastasis. Meanwhile, patients’ blood glucose levels can also interfere with imaging quality.

Second, there is the accessibility dilemma. PET/CT equipment is expensive and mainly concentrated in top tertiary hospitals; a single scan costs 5,000–7,000 yuan and is mostly self-funded in most regions. 18F-FDG depends on centralized production via cyclotrons, with complex drug preparation and extremely strict logistics timelines.

Jiluntai, which has just been approved, delivers a "precision strike" against all these pain points.

As the world’s first-in-class radiotheranostic drug (RDC) targeting integrin αvβ3, Jiluntai employs a unique RGD peptide molecular probe technology.

Phase III clinical trial data show that in differentiating benign and malignant pulmonary lesions, it has no statistically significant difference from 18F-FDG PET/CT. However, in evaluating lymph node metastasis in lung cancer, the specificity and accuracy of its SPECT/CT imaging are significantly higher than those of PET/CT.

More crucially, it offers superior accessibility. Jiluntai uses SPECT imaging, a technology widely available across China. A single scan costs only 300–800 yuan and is covered under Class B medical insurance in most regions, greatly improving patient access.

This means SPECT equipment, which accounts for the vast majority of medical imaging devices in China, finally has a "master key" to unlock tumor diagnosis. It not only drastically reduces patients’ testing costs but also, through precise lymph node metastasis assessment, is poised to reshape the current clinical pathway for tumor staging.

Radiopharmaceuticals inherently possess the "theranostic integration" trait: the same targeting ligand and linker can be conjugated to diagnostic radionuclides for precision imaging, or to therapeutic radionuclides for targeted radiotherapy, forming a closed loop of diagnosis, treatment, and monitoring. RDCs are a typical embodiment of this model.

Integrin αvβ3, targeted by Jiluntai, is a transmembrane glycoprotein critical to angiogenesis and cancer cell metastasis across multiple tumor types. It is highly expressed on the surface of lung cancer, glioblastoma, breast cancer, and other tumor cells, as well as tumor neovascular endothelial cells, making it broadly applicable. Therapeutic radiopharmaceuticals targeting the same receptor are expected to cover multiple cancer types.

The company has built a rich R&D pipeline covering highly targeted and effective therapeutic and diagnostic radiopharmaceuticals for pan-tumor indications. Its diagnostic radiopharmaceutical 99mTc-HP-Ark2 for HER2-positive breast cancer has received IND approval, and the αvβ3-targeting therapeutic radiopharmaceutical 177Lu-AB-3PRGD2 has initiated Class 1 new drug application.

In past waves of innovative drug development, China has largely been a "follower", especially in high-barrier, multidisciplinary fields like radiopharmaceuticals, where few domestic companies dared to pursue pioneering innovation.

The birth of Jiluntai marks a historic leap for China from "catching up" to "leading" in this high-barrier radiopharma race.

02、Capital Reassesses the Radiopharma Track

One day after Jiluntai’s approval, Neurite Medical announced the completion of a 1-billion-yuan Series E financing—the largest financing in China’s radiopharmaceutical sector this year, and another domestic record after its 800-million-yuan Series D financing in late 2025.

This round was co-led by Shanghai Science and Technology Innovation Group, Shanghai Guoxin, and Nanjing Hi-Tech Xinjun, with participation from more than a dozen well-known institutions. Proceeds will mainly support clinical development of core radiopharmaceutical pipelines, R&D and production of medical isotopes, and market construction.

Behind heavy capital investment lies a breakthrough in a core pain point of China’s radiopharmaceutical industry: independent control of radionuclides.

For a long time, over 90% of clinically critical radionuclides in China have relied on imports, with high costs often exceeding 300,000 yuan per treatment course, and supply highly vulnerable to global geopolitics and logistics disruptions.

Founded in 2016 by senior scientists from the nuclear industry, Neurite Medical is committed to building a complete industrial chain from radionuclide raw materials to end drugs, directly addressing this "bottleneck" challenge.

In January 2026, the world’s second and China’s first Cyclone IKON 30MeV cyclotron was officially put into operation at Neurite Medical, with a total investment of 250 million yuan and a construction period of more than three years. This national key equipment stably produces four clinically urgently needed radionuclides—Germanium-68, Iodine-123, Zirconium-89, and Actinium-225—and supports the production of F-18, Copper-64, and other isotopes.

After commissioning, domestic supply of clinical radionuclides will be initially realized within 1–2 years. Upon full capacity, annual output value will exceed 1 billion yuan, forming a closed industrial chain from "radionuclide raw materials to end drugs".

Meanwhile, Neurite’s clinical pipeline is accelerating: NRT6003 Injection for liver cancer has entered Phase III clinical trials, and NRT6008 Injection for pancreatic cancer has completed Phase I/II patient enrollment, with launch application expected in 2027.

Among them, the globally innovative Yttrium [90Y] Carbon Microsphere Injection is the first radiopharmaceutical to conduct Phase I clinical trials for pancreatic cancer in China, enabling precision targeted therapy for liver and pancreatic cancers.

In terms of competitive barriers, Neurite Medical has established three core advantages:

China’s first commercial 30MeV cyclotron achieves stable radionuclide production, with a single unit meeting 30% of domestic market demand;

Layout of high-profile therapeutic radionuclides such as Radium-226 and Lead-212;

15% market share of germanium-gallium generators in Southeast Asia, with strong overseas advantages.

Enterprises that master both radionuclide supply and drug R&D capabilities will gain significantly enhanced bargaining power in the industrial chain—this is the underlying logic why major global radiopharma companies simultaneously deploy reactor resources, radiochemistry platforms, and drug pipelines.

Neurite Medical has conquered multiple "bottleneck" technologies, pioneered a complete radiopharmaceutical industrial chain, completed two consecutive financings totaling nearly 2 billion yuan, and is preparing for a STAR Market IPO—clear proof of capital’s high recognition of its full "radionuclide + drug" industrial chain capabilities.

The value of China’s radiopharmaceutical assets is undergoing a systematic reassessment.

03、China’s Radiopharma "Beachhead Campaign"

Over the past two years, radiopharmaceuticals have stood out as one of the few golden tracks in biomedicine untouched by the "capital winter". Novartis’ Pluvicto neared $2 billion in sales in 2025, growing by over 40% for two consecutive years, validating the market potential of targeted radiotherapy.

In China, research and production of medical radioisotopes and radiopharmaceuticals began in the 1950s. Entering the 21st century, the regulatory system for such drugs has steadily improved. Especially since the 14th Five-Year Plan, the state has prioritized supporting the radiopharmaceutical sector, issuing multiple supportive policies intensively over the past three years.

Driven by policy and technology, China’s radiopharmaceutical market is experiencing explosive growth. According to Frost & Sullivan, China’s radiopharmaceutical market will expand from 5 billion yuan in 2023 to 26 billion yuan by 2030, with a compound annual growth rate (CAGR) of 22.7%.

Globally, the CAGR of new drug pipelines for both therapeutic and diagnostic radiopharmaceuticals exceeds 20%, with RDCs reaching 28.4%. As of November 2025, per Insight Database, China accounted for nearly half (49%) of new global RDC pipeline additions.

Domestically, the market has long been a "duopoly": China National Nuclear Corporation and Dongcheng Pharmaceutical, relying on upstream radionuclide production and distribution networks, hold over 70% of the market share, yet focus mostly on mature generics such as 18F-FDG and 99mTc.

With the strong entry of emerging players, the market logic is undergoing a fundamental shift.

In addition to Rediopharma and Neurite Medical mentioned above, innovative firms such as Tongrui Medical and Fulian Technology, traditional pharma companies Yunnan Baiyao and By-Health, and ADC leaders Kelun-Biotech, Hengrui, and Baili Tianheng have all joined the race. More than 120 domestic enterprises and institutions are now engaged in RDC R&D.

Tongrui Bio, founded in 2021, has built a R&D and production base of over 28,000 square meters in Chengdu Medical City, holding a Class A Radiation Safety License and China’s first fully automated radiopharmaceutical production line.

Leveraging self-developed radionuclide production processes and customized automated facilities, Tongrui Bio solves industrial chain challenges while advancing its own pipeline. In January this year, its Class 1 therapeutic radiopharmaceutical TRC003 Injection received clinical approval—its fourth radiopharmaceutical and second PSMA-targeted therapeutic candidate. Its first clinical-stage therapeutic radiopharmaceutical, 177Lu-TR0471 Injection, has entered Phase I trials.

Fulian Technology aims to build a full-chain radiopharmaceutical enterprise covering R&D, production, and commercialization, with its UniRDCTM RDC discovery platform and 14 pipeline candidates.

In July 2024, it completed China’s first radiopharmaceutical License-out deal, granting SK Biopharmaceuticals exclusive global rights to develop, manufacture, and commercialize FL-091 for NTSR1-positive cancers, with a total transaction value of $571.5 million (over 4 billion yuan).

Yunnan Baiyao identified radiopharmaceuticals as a key innovative track as early as 2022.

In March 2025, it launched Phase III trials for its PSMA-targeted diagnostic radiopharmaceutical INR101 (for prostate cancer), enrolling 240 patients and expected to complete in May 2026. Its PSMA-targeted therapeutic radiopharmaceutical INR102 is in Phase I trials, with the first patient dosed in July 2025.

By-Health acted as an investor and industrial organizer behind Jiluntai’s launch. In 2022, By-Health Group invested in Jiluntai, and its listed subsidiary obtained commercialization rights for a series of radiopharmaceuticals including 99mTc-3PRGD2.

Hengrui Pharmaceutical is among China’s first large pharma firms to 布局 radiopharmaceuticals. It established a fully owned subsidiary, Tianjin Hengrui, in November 2020. Its first RDC candidate HRS-4357 entered clinical trials in 2023; it now has 5 RDCs in its pipeline, with Lutetium [177Lu] Oxodotreotide in Phase III.

Since 2025, leading ADC biotechs including Kelun-Biotech and Baili Tianheng have also disclosed RDC pipelines:

In March 2025, SKB107, an RDC jointly developed by Kelun-Biotech and Professor Chen Yue’s team at the Affiliated Hospital of Southwest Medical University, received clinical approval for advanced solid tumor bone metastases.
In September 2025, Baili Tianheng’s Lutetium [177Lu]-BL-ARC001 Injection received clinical approval for locally advanced or metastatic solid tumors, marking the clinical translation of its HIRE-ARC platform.

From traditional giants to innovative biotechs, from TCM enterprises to ADC leaders, backed by capital and boosted by cross-border BD deals, China’s radiopharmaceutical "beachhead campaign" is unfolding with diverse players and multi-dimensional strategies.

Forces from all sides are converging to lift China’s radiopharmaceutical industry from "isolated breakthroughs" to "systemic rise". The charge of this campaign has just sounded.

References：
1.阿基米德Biotech，新一代「世纪分子」？首个国产创新核药获批
2.21世纪经济报道，重大突破！中国首个原创核药获批
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4.器械之家，中国首台“大国重器”，IPO前融资18亿
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