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the first domestically produced innovative nuclear drug is included in priority review! sorting out listed companies that benefited

2024-10-03

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financial news agency, october 2 (editor xuan lin)recently,my country’s first domestically produced innovative nuclear drug is included in priority review. according to public information from the drug evaluation center of the state drug administration, technetium [99mtc] hydrazinonicotinamide polyethylene glycol bicyclic rgd peptide injection (abbreviated as“99mTc-3PRGD2”) and sodium tosylate nicotinamide hydrazone polyethylene glycol bicyclic rgd peptide for injectionincluded in the priority review list of the center for drug evaluation (cde) of the state food and drug administration of china

99mtc-3prgd2 is a radionuclide conjugated drug (rdc) independently developed by radiopharmaceuticals., is our countrythe first class 1 new drug for nuclear medicine radiodiagnosis, and it is also the world’s first broad-spectrum tumor imaging agent for spect imaging. zhao haichun and others from guojin securities stated in a research report on september 25 that compared with ordinary antibody drug conjugates (adcs) without radioactivity,nuclear drugs (rdc) can reduce the resistance of tumor cells, improve efficacy and increase the treatment window., in addition, rdc also has the specific advantage of targeted therapy, which can effectively avoid the toxic side effects of traditional radiotherapy on healthy cells.

in addition to its amazing therapeutic effects,the potential of large-scale nuclear medicines is also emerging. novartis' prostate cancer nuclear drug pluvicto was approved by the fda in march 2022.two years after listing, sales approached us$1 billion(according to novartis’ financial report, the drug’s global sales will be us$980 million and us$500 million in 2023 and 1h24 respectively). in addition, factors such as nuclear drug radioactivity make upstream raw materials scarce, and there are fewer midstream r&d and manufacturing companies and downstream logistics and pharmacies.the competitive landscape is good amid high industry barriers. zhao haichun and others said that the upstream, midstream and downstream companies in the domestic nuclear medicine industry chain are all in the early stages of development.significant first-mover advantage, is a good opportunity for forward-looking layout.it is recommended to pay attention to the scarce targets in china that have the advantage of integrating the nuclear medicine industry chain.

according to nature (nature magazine), the global nuclear medicine market has expanded rapidly since 2013.the cagr over the past ten years is about 6%, and the global nuclear medicine market is expected to reach us$12 billion in 2026. data from the china nuclear safety administration shows that the domestic radiopharmaceutical market size is expected to reach 9.3 billion yuan in 2025.by 2030, the market size will further increase to rmb 26 billion

the upstream of the nuclear medicine industry chain isproduction and supply of radionuclide raw materials such as medical isotopes; midstream isnuclear drug r&d and production enterprise, and the enterprise uses special preparation and distribution to deliver the nuclear medicine to the nuclear pharmacy; finallyreach end patients through medical institutions in nuclear pharmaciesupstream medical isotope production is highly concentrated and in short supply, china currently relies on imports for most of its medical isotopes. there are two main types of midstream market participants:one is a company focusing on traditional radiopharmaceuticals, such as siemens, general motors, etc.;another is a company developing innovative radiopharmaceuticals, such as novartis, eli lilly, etc. compared with traditional nuclear medicine treatments, innovative nuclear medicine treatments rely less on large and complex external equipment assets, and therefore are moreemerging players can leverage their technological advantages to carve out a niche for innovative treatments in nuclear medicines such as radioligand therapy (rlt)

downstream,subject to the half-life of the nuclide itself and transportation safety considerations, how to quickly deliver nuclear medicine to the hands of end patients is crucial. nuclear drug distribution requires strict consideration of transportation distance and complete upstream and downstream industry supporting facilities.nuclear pharmacy is one of the important core assets of nuclear medicine enterprises. according to arterial network data,my country's nuclear pharmacy resources are basically concentrated in two companies, china tongfang and dongcheng pharmaceutical., among which dongcheng pharmaceutical currently builds more than 30 nuclear pharmacies.basically meet the nuclear medicine needs of 94% of domestic patients. compared with ordinary pharmacies, nuclear pharmaciesthe construction period and investment capital of the former are about 3 times and 40 times that of the latter respectively.in addition, the space occupation effect of nuclear pharmacies is obvious. the radiation range of a single nuclear pharmacy is 150-200 kilometers, which is about a 4-hour drive. therefore,those who move first will have a first-mover advantage and will form a greater barrier to latecomers.

regarding a-share listed companies,dongcheng pharmaceuticalfive major platforms have been initially formed: a stable nuclide supply platform, a drug incubation platform, a transformation service platform, a production and distribution platform, and a diagnosis and treatment marketing platform.basically completed the layout of the entire nuclear medical industry chain and built a complete nuclear medical ecosystem.tianjin hengrui, a subsidiary of hengrui pharmaceuticals, mainly develops radionuclide drugs related to the integration of tumor diagnosis and treatment., obtain the first radioactive pharmaceutical production license at the end of 2023,currently, four nuclear drug products have been approved for clinical trialskelun botai, a holding subsidiary of kelun pharmaceutical, entered into an exclusive license agreement with the affiliated hospital of southwest medical university on september 14, 2023 for the rdc drug tbm-001, this drug is intended to be used for early diagnosis and precise targeted therapy of tumor bone metastasis.

(xuanlin, financial associated press)
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