China's first original nuclear medicine approved, a domestic new force challenging multinational giants

Ask AI · How can domestic nuclear medicine drugs use SPECT technology to challenge PET’s diagnostic gold standard?

21st Century Business Herald reporter Ji Yuanyuan

On April 2, the domestic nuclear medicine drug sector saw a new breakthrough. The Class 1 innovative nuclear medicine drug “Technetium[99mTc] Pexeritide Peptide Injection” (brand name: Gilen Tai), filed by RuiDio (and its controlling shareholder Gilen Tai), an innovative nuclear medicine company incubated with investment by Baiyang Pharmaceutical Group, has officially received approval from the National Medical Products Administration (NMPA) for marketing.

This is not only China’s first Class 1 innovative nuclear medicine drug developed independently, but also a technological breakthrough that breaks nearly 30 years of the nuclear medicine tumor imaging diagnosis field’s single-path reliance on PET technology. In terms of the market, it marks that China’s homegrown innovation forces are starting to reshape the “blue ocean” layout of the nuclear medicine market, which has long been dominated by multinational giants such as Novartis, Bayer, and AstraZeneca.

Analysts from several securities firms told 21st Century Business Herald that this event signifies that China’s nuclear medicine drugs have officially stepped out of the comfort zone of “copying and following,” opening a new chapter of “leading with original innovation.” The nuclear medicine market is shifting from a “duopoly” monopoly to a “layered innovation” stage.

“For a long time, the domestic nuclear medicine market has shown a typical ‘duopoly’ pattern. China General Nuclear and Dongcheng Pharmaceutical, leveraging their upstream radionuclide production and distribution networks, together account for more than 70% of the market share. However, their business focus is largely on mature generic drugs such as 18F‑FDG and 99mTc. With the strong entry of players including Baiyang (Gilen Tai), Hengrui Medicine, Yuanda Medicine, and Xiantong Medical, the market logic is undergoing a fundamental qualitative change,” the analyst said.

It is not hard to see that in this “nuclear” race, China’s industrial capital and the spirit of scientists are trying to rewrite the rules of the game.

A technical revolution of “misaligned competition”

For a long time, there has been a clear “technical gap” in the global field of tumor imaging diagnosis.

PET/CT is considered the “gold standard” for tumor diagnosis—especially imaging agents represented by 18F‑FDG, which can capture tumor cells with high glucose metabolism. But this technology requires extremely high demands on equipment and infrastructure. One PET/CT system can cost tens of millions, and the supporting medical cyclotron and positron radionuclide production system require massive investment. As a result, its penetration in China is far lower than in developed countries.

By contrast, SPECT (single-photon emission computed tomography) has a much larger installed base in China. According to incomplete statistics, the domestic inventory of SPECT/CT is about 2-3 times that of PET/CT, with a higher adoption rate and more affordable examination fees. However, due to the lack of broad-spectrum, high-efficiency imaging agents, SPECT has long been “locked” to a limited range of applications such as bone scans and thyroid imaging. Clinically, it is viewed as a “low-end configuration,” making it difficult to handle complex tumor diagnosis.

The 99mTc-3PRGD2 approved this time by Gilen Tai is precisely a “targeted strike” at this pain point.

According to disclosures by Baiyang, as the world’s first integrin αvβ3-targeting “First-in-Class” radiopharmaceutical-coupled drug (RDC), 99mTc-3PRGD2 uses a unique RGD peptide molecular probe technology. Its Phase III clinical trial data show that for differentiating benign and malignant lung lesions, it has no statistical difference from 18F-FDG PET/CT. However, in evaluating lymph node metastasis in lung cancer, its SPECT/CT specificity and accuracy are even significantly higher than those of PET/CT.

This means that SPECT equipment, which makes up the vast majority of medical institutions in China, finally has a “universal key” to open the door to tumor diagnosis. Not only does it substantially reduce patients’ examination costs, but through precise lymph node metastasis assessment, it is also expected to change the current clinical pathway of tumor staging.

The aforementioned analyst pointed out that this implies that in the future, the nuclear medicine market will shift from purely “resource-monopoly” dynamics to “technology-driven” dynamics. Innovative companies with differential target layouts and integrated diagnosis-and-treatment capabilities will occupy the high-valuation positions.

In fact, during past waves of innovative drug development, China has mostly been a “follower.” Especially in the field of nuclear medicine—where there are crossovers among multiple disciplines and high technical barriers—few local companies have dared to challenge source innovation.

Gilen Tai’s breakthrough is powered by capital. According to information obtained by 21st Century Business Herald reporter, Baiyang Pharmaceutical Group plays a dual role behind the scenes as both an “investor” and an “industry organizer.”

In 2022, Baiyang Pharmaceutical Group chose to invest in Gilen Tai, and its listed company, Baiyang Pharmaceutical, subsequently obtained commercialization rights for a series of radiopharmaceutical products, including 99mTc-3PRGD2.

The commercialization barriers for nuclear medicine drugs are extremely high. Because the half-life of radionuclides is limited (for example, the commonly used technetium-[99mTc] has a half-life of only 6 hours), from production to injection into patients, the drug must be controlled with precision down to the hour. This not only requires the manufacturing company to have extremely strong logistics and dispatch capabilities, but also requires it to have strong control over the end-terminal network of nuclear medicine departments in hospitals.

“Baiyang Pharmaceutical saw this. Relying on its nationwide commercialization team and pharmaceutical distribution network, it is trying to build a bridge connecting scientific research and the market for this innovative nuclear medicine drug,” the aforementioned analyst believed. This division of labor—scientists focusing on R&D while industry capital handles the transformation of outcomes—is becoming an efficient model for drug innovation in China.

Reshaping the market landscape

Gilen Tai’s approval could not have come at a more intense moment in the global nuclear medicine track.

In the past two years, nuclear medicine has been one of the very few sectors in biopharma that did not face a “capital winter.” Novartis’s Pluvicto is projected to bring sales close to 2 billion USD in 2025, with growth rates exceeding 40% for two consecutive years, validating the billion-dollar market potential of targeted radiotherapies.

This massive cake has attracted the attention of top global pharmaceutical companies. Bayer and Novartis have been deeply involved for years, while AstraZeneca announced a major decision in March 2026: to build a radiopharmaceutical (RDC) production and supply base in the Huangpu District of Guangzhou, betting on China’s nuclear medicine market. BMS (Bristol Myers Squibb) is also moving into the next generation of nuclear drugs through acquisitions such as RayzeBio, including planning for actinium-225.

The influx of multinational giants creates a “double-edged sword” effect for China’s local market.

On the one hand, they bring advanced concepts and supply-chain standards, accelerating the popularization of nuclear medicine departments in China. On the other hand, if local innovation cannot keep up, China’s large population of cancer patients (over 4.5 million new cases each year) will have to continue relying on imported drugs, paying expensive prices.

Based on publicly available information, the competitive focus among multinational giants is currently highly concentrated in therapeutic areas (such as PSMA prostate cancer and SSTR neuroendocrine tumors). In the diagnostic field, especially in broad-spectrum SPECT imaging, 99mTc-3PRGD2 has established a technical barrier thanks to its “broad-spectrum” and “high accessibility.”

This is not only filling a gap, but also delivering a “dimensionality-reduction attack” on the existing market landscape. “If primary hospitals can use SPECT to complete lung cancer staging that previously required PET-CT, then 99mTc-3PRGD2 will quickly release a huge incremental market for primary healthcare. This will create strong market pressure against imported imaging agents that depend on high-end PET-CT equipment,” the analyst said.

However, although the outlook is bright, for China’s nuclear medicine sector to truly achieve “leading,” it still faces serious challenges. These challenges mainly lie at the very top of the industrial chain—the radionuclide raw materials.

According to data from industry institutions, currently, whether it is molybdenum-99 (the parent of technetium-99m) used for diagnosis, or lutetium-177 and actinium-225 used for therapy, their supply has long been controlled by only a few research reactors.

AstraZeneca’s choice to implement its operation in Guangzhou—besides market considerations—also reflects a core factor: the China Spallation Neutron Source located near Dongguan. This major scientific facility is breaking through the domestically-produced supply of actinium-225, trying to resolve the dilemma of “no materials to cook with.”

For Baiyang and Gilen Tai, the future focus points will also be here. With the commercialization scale-up of 99mTc-3PRGD2, its demand for a stable supply chain of technetium-[99mTc] and its supporting drug kits will grow exponentially. How to leverage China’s potential in reactors (such as nuclear power institute facilities in Sichuan and Zhejiang) and accelerators to build an independent and controllable radionuclide supply chain is key to determining whether it can become an industry leader.

In addition, “integrated diagnosis and treatment” is the ultimate narrative for nuclear medicine. Gilen Tai has already taken this step. According to disclosures from Baiyang, at the same time as the diagnostic-side approval of 99mTc-3PRGD2, the therapeutic nuclear medicine in its pipeline, 177Lu-AB-3PRGD2, has also initiated its application.

This is exactly the unique appeal of RDC drugs: using the same target—use the diagnostic radionuclide to see “where the enemy is,” and use the therapeutic radionuclide to “precisely eliminate the enemy.”

This also means that in the future, the nuclear medicine track will no longer be just a competition of drug R&D. Instead, it will be an ecosystem-wide competition across the entire industrial chain: “radionuclide raw materials + logistics and distribution + hospital networks + data services.”