June 4, 2025
Source: drugdu
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In May, the Hong Kong-listed innovative drug sector was extremely lively.
Rongchang Biopharma raised nearly 800 million yuan through allotment financing, Hengrui Medicine and Paige Biopharma were listed one after another, and Xiantong Pharmaceutical also submitted an application for listing.
Xiantong Pharmaceutical is a new generation leading enterprise in the field of nuclear medicine. Its prospectus shows that its pre-IPO valuation has reached 5.188 billion yuan, and its cumulative financing has exceeded 2.9 billion yuan. With this IPO, Xiantong Pharmaceutical is expected to broaden its financing channels and accelerate the research and development and commercialization of its nuclear medicine products, which also marks a key step in the capitalization process of China's nuclear medicine industry.
Four core pipelines
In the past two years, Xiantong Pharmaceutical's operating income was RMB 10.232 million and RMB 44.064 million respectively, and the corresponding net losses were RMB 309 million and RMB 156 million respectively.
Although it is currently in the red, Xiantong Pharmaceutical has established a complete industrial chain from the development and production of radionuclides, the research and development of radioactive drugs to the manufacturing and commercialization of radioactive drugs, laying the foundation for future profitability.
In terms of R&D, Xiantong Pharmaceutical focuses on three major areas: oncology, neurodegenerative diseases, and cardiovascular diseases, including 15 drug candidates, two of which are already on the market, and four products (namely XTR008, XTR006, XTR004 and XTR003) have the potential to be first-in-class or best-in-class.
XTR008 is China's potential first therapeutic radioligand targeting SSTR and is currently in the registration stage.
The drug is a 177Lu-labeled somatostatin receptor (SSTR)-targeted radioligand, the same target as Novartis' best-selling drug Lutathera. Lutathera is the only radioligand therapy approved in the world for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NENs). Since its launch in 2018, its sales have grown to $724 million in 2024, and it is expected to exceed $1 billion in the near future.
Phase III clinical trials of XTR008 showed that its PFS and efficacy indicators were comparable to or better than those observed in Lutathera's Phase III NETTER-1 trial, and it has BIC potential.
XTR006 is a potential best-in-class 18F-labeled tubulin-associated unit (tau)-targeted PET diagnostic radioligand.
The drug uses an innovative molecular design to effectively overcome the off-target binding problem observed in approved PET tracers, thereby greatly improving specificity and signal-to-noise ratio, and improving imaging quality and diagnostic accuracy. Currently, XTR006 is undergoing a Phase III clinical trial and is expected to be completed in 2027.
It is worth noting that XTR005 of Xintong Pharmaceutical is the only pathological targeted PET tracer approved for AD diagnosis in China. If XTR006 is also approved, Xintong Pharmaceutical will have both Aβ and tau targeted PET tracers, establishing market advantages in the field of AD diagnosis.
XTR004 is the first and only PET-MPI tracer under clinical development in China.
The drug is a 18F-labeled diagnostic radioligand targeting mitochondrial complex I. The completed Phase I and Phase II clinical trials have demonstrated the excellent safety and diagnostic efficacy of XTR004. Xiantong Pharmaceuticals plans to launch Phase III trials in the fourth quarter of 2025.
XTR003 is the world's first and only PET tracer for imaging myocardial fatty acid metabolism.
The drug is an 18F-labeled radioligand for PET diagnosis. It has completed Phase I and Phase II clinical trials in healthy subjects using XTR003/18F-deoxyglucose ("FDG") combined imaging, and plans to launch a Phase IIb clinical trial in 2025.
In terms of production, Xiantong Pharmaceutical has built two major production bases in Wuxi and Zhongshan, with a total construction area of over 20,000 square meters and a total of 12 commercial-scale production lines. In addition, Xiantong Pharmaceutical's production base in Mianyang City, Sichuan Province is expected to start production this year.
Hundred billion blue ocean market
Xiantong Pharmaceutical's IPO in Hong Kong at this time not only reflects the Hong Kong stock market's support for innovative drugs, but also reflects the hotness of the nuclear medicine track.
Nuclear medicine spans two major areas: diagnosis and treatment. Its core advantage lies in achieving precise diagnosis and treatment through targeted molecules labeled with radionuclides.
In recent years, radioligand therapy for integrated diagnosis and treatment has grown rapidly. Novartis acquired Advanced Accelerator Applications in 2017 and Endocyte in 2018, and subsequently launched two radioligand therapies, Lutathera and Pluvicto, in the US market. According to Novartis' financial report, the revenue of these two nuclear drugs will reach US$2.116 billion in 2024, of which Pluvicto's sales will reach US$1.392 billion, becoming a blockbuster less than three years after its launch.
Therapeutic radioligands are designed to deliver targeted radiation directly to cancer cells or other diseased sites. They are similar in structure to ADCs and consist of a targeting ligand that binds to a specific receptor or antigen on the target cell and is coupled to a radionuclide that releases cytotoxic radiation.
Diagnostic radioligands emit a signal detectable by imaging techniques such as PET or SPECT.
Integrated diagnosis and treatment uses targeting ligands with the same or similar structures, and carries both diagnostic and therapeutic (such as α/β-ray emitters used in treatment) radionuclides. Diagnostic radioligands can be used to image tumors or lesions first, and then therapeutic radioligands with the same or similar structural targeting ligands are used as carriers to accurately deliver therapeutic radiation to the target area.
In this mode, seamless connection from diagnosis to precise treatment and real-time monitoring of treatment effects can be achieved, and the plan can be adjusted accordingly to improve the overall tumor management effect.
In addition, since radioligand therapy is very different from other treatment methods in terms of mechanism, cross-resistance can be avoided and it can be used in combination with other treatment methods such as nuclear therapy, immunotherapy, and chemotherapy.
Therefore, the market has high hopes for radioligand therapy, and a wave of global mergers and acquisitions has emerged. Multinational pharmaceutical companies are accelerating the layout of nuclear medicine assets. Novartis, BMS, AstraZeneca and others have seized the opportunity through large-scale mergers and acquisitions. For example, Bristol-Myers Squibb acquired RayzeBio, which has no marketed products, for US$4.1 billion, highlighting the market's high recognition of the potential of nuclear medicine.
According to the prospectus of Xiantong Pharmaceutical, the global market size of nuclear medicines has increased from US$5 billion in 2018 to US$9.7 billion in 2024, with a compound annual growth rate of 11.7%. It is estimated that it will climb to US$57.3 billion by 2035, with a compound annual growth rate of 17.5% between 2024 and 2035.
In the Chinese market, policies continue to increase the development of nuclear medicine. In 2021, eight ministries and commissions jointly issued the document "Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)". With the progress of science, technological breakthroughs, and policy support, my country's nuclear medicine field is expected to usher in an explosive period.
China's nuclear medicine industry is entering a period of explosive growth
At present, China's nuclear medicine market has formed a duopoly competition pattern led by China Nuclear Power Technology and Dongcheng Pharmaceutical. With the rise of radioligand therapy integrating diagnosis and treatment, new companies such as Xiantong Pharmaceutical and Yuanda Pharmaceutical have begun to emerge.
Yuanda Pharmaceutical's innovative nuclear medicine yttrium [90Y] microsphere injection (trade name: Yigantai) was launched in China in 2022, opening up a new direction for the treatment of liver malignant tumors. From 2022 to 2024, Yigantai achieved sales of more than HK$60 million, HK$200 million and HK$490 million, respectively, showing rapid growth.
In addition, established pharmaceutical companies such as Hengrui Medicine, Kelun Pharmaceutical, and Yunnan Baiyao have also made breakthroughs in the field of nuclear medicine. For example, Hengrui Medicine's Lutetium [177Lu] Oxyoctreotide Injection, HRS-4357 Injection, and HRS-9815 Injection have been approved for clinical trials. Kelun Pharmaceutical's Kelun Biotech's radionuclide-coupled drug SKB107 has been approved by NMPA for clinical trials of bone metastases in advanced solid tumors. Yunnan Baiyao's innovative therapeutic nuclear medicine INR102's clinical trial application has been approved by NMPA, and it has agreed to conduct clinical trials for prostate cancer.
The launch of the IPO process by Xiantong Pharmaceutical may inject strong momentum into the high-quality development of China's nuclear medicine industry. If it successfully enters the capital market, the funds raised will be used to accelerate the clinical advancement and global layout of therapeutic nuclear medicines. In the long run, with policy support, capital investment and technological breakthroughs, China's nuclear medicine market is expected to usher in a golden period of development.
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