Our country's first independently developed innovative nuclear medicine has been approved for market launch

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Reporter: Liu Zhao

On April 2, according to the National Medical Products Administration website, the radioactive drug application submitted by Foshan Radio Pharma Co., Ltd. for “technetium [99mTc] pexidertide injection and its accompanying drug kit” (hereinafter referred to as “technetium pexidertide”) has been approved for marketing through the priority review and approval program. The technetium [99mTc] pexidertide injection is used for auxiliary examinations for suspected lung cancer patients’ regional lymph node metastasis.

The reporter learned that this is the first domestically developed innovative nuclear medicine radiodiagnostic Class 1 new drug approved for marketing in China. For China’s domestic nuclear medicine industry, the significance of this development is not only the addition of another product, but also the shift of our nuclear medicine drug R&D from long-term following to original breakthroughs, beginning to open up a new situation on sub-sectors.

An interviewee told the reporter that the approved product uses SPECT/CT imaging. While maintaining a high detection capability, it is expected to provide more accessible diagnostic tools for more medical institutions. Especially against the backdrop of uneven distribution of primary healthcare resources and patients being more sensitive to examination costs, the launch of this product provides a new foothold for expanding the use of nuclear medicine imaging technologies.

Filling application gaps

From a clinical value perspective, the most attention-grabbing aspect of this product is that it is expected to change the technological perception that SPECT/CT has long had difficulty being effectively used for tumor diagnosis, staging, and treatment response evaluation. Technetium pexidertide is mainly used for imaging chest tumors, including the diagnosis, differentiation, and assessment of primary lung tumors and metastases. Compared with traditional imaging approaches that rely on metabolic activity, this drug achieves targeted imaging by binding to tumor-related receptors, demonstrating stronger targeting in auxiliary judgment of lymph node metastasis in lung cancer.

More importantly, clinical data provides strong support for its approval. It is understood that in a prospective, multicenter, self-controlled Phase III clinical trial, the product was compared “head-to-head” with 18F-FDG PET/CT. The results show that there is no significant difference between the two in detection rates for differentiating benign from malignant lung tumors, but the SPECT/CT of technetium pexidertide is clearly superior to 18F-FDG PET/CT in specificity and accuracy for diagnosing lymph node metastasis in lung cancer. Its practical significance lies in reducing false positives and improving clinical judgment efficiency.

From this perspective, this approval is both the outcome of a single product’s successful R&D and a reflection of a change in domestic nuclear medicine R&D thinking. In the past, domestic nuclear medicine drugs relied more on importing or following. Now, as improvements continue in target selection, conjugation processes, and clinical translation capabilities, domestic companies have begun to achieve breakthroughs from 0 to 1 in original diagnostic nuclear drugs. This means that the nuclear drug sector is no longer operating under the old logic of overseas giants defining the market and domestic companies waiting to catch up; instead, it has the possibility that Chinese companies will proactively open up new paths.

The industrialization test is only just beginning

However, approval of the product is only the first step. Whether it can proceed smoothly to complete market education and clinical adoption will still determine the industrial value of this innovative nuclear drug. Unlike therapeutic nuclear drugs, diagnostic nuclear drugs rely more on hospitals’ acceptance of new technical routes, and also depend more on equipment infrastructure, doctor training, and channel reach capability.

It is understood that as early as November 2023, Qingdao Baiyang Pharmaceutical Co., Ltd. (hereinafter referred to as “Baiyang Pharmaceutical”) had already obtained the exclusive commercialization rights in mainland China for the Radio Pharma series of radiopharmaceuticals, responsible for subsequent promotion and sales. This means that commercialization preparations around this product have been laid out in advance.

A relevant executive from Baiyang Pharmaceutical told the reporter of The Securities Daily that compared with PET/CT, SPECT/CT has a broader domestic installed base, and the costs for drug preparation and examinations are relatively lower, providing practical conditions for penetration into more hospitals. This also means that once clinical awareness is gradually established, the promotion radius of products of this kind is expected to be larger, driving nuclear medicine diagnosis to extend from a small number of major hospitals to a wider range of medical endpoints. For patients, lower examination barriers and broader accessibility may also allow precise imaging diagnosis to benefit more people.

Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., told the reporter of The Securities Daily that the nuclear drug industry naturally has high barriers to entry. Whether it is isotope preparation and transportation and distribution, or hospital usage qualifications and nuclear pharmacy layout, these factors determine that this track cannot simply replicate the expansion and volume increase paths of traditional chemical drugs or biologics. Precisely for this reason, the approval of China’s first self-developed innovative nuclear drug is both a milestone in industrial breakthroughs and also the starting point of a bigger test. Next, as more original products move out of the laboratory and into hospitals, whether China’s nuclear medicine industry can form a complete closed loop from R&D to application will likely become an important window for observing the quality of China’s innovative drugs as “hard technology.”

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