preface
Foreword
Original link:
Nuclear medicine is standing in the spotlight of the times, fearless of the so-called cold winter of the innovative drug industry. Since the beginning of this year,Xiantong PharmaceuticalTwo nuclear drug products have been approved for marketing, especially -PET imaging agent fluoro[18F]betabenzene injection, which fills the market gap of A-PET diagnostic imaging agent in the domestic AD field, and has also been completedMore than 1.1 billion yuan of financing, which has created the most financing of the year...;Hengrui PharmaceuticalIt also ushered in key progress, and lutetium [177lu] oxoctreotide injection was approved for clinical use. Internationally,Novartis, BayerThis year, it has reached a cooperation with bicycle therapeuticsDevelopment of bicyclic peptide-based RDCEli Lilly announced its $1.4 billion acquisition of Point Biopharma in early October, becoming another MNC that has entered the nuclear medicine track....Nuclear drug startup Rayzebio completed on September 14 with a total amount of 3$1.1 billion IPO, adding another explosion point to the nuclear medicine track. With the concerted efforts of all parties, nuclear medicine is on the rise. Novartis leads the way
The three domestic forces are accelerating the beach
According to a report by GlobalData, the amount of venture capital in the nuclear drug track this year is 40.8 billion US dollars, compared with 63 million US dollars in 2017, an increase of 550%. Nuclear drugs can buck the trend and turn red, and RDC (nuclide drug conjugates) is indispensable. Up to now, a total of 9 RDCs have been approved by the FDA, of which 2 are RDCs for ** and the remaining 7 are RDCs for diagnostics. The number of approved RDC drugs is gradually increasing, which promotes the drug development of the RDC track. And what is RDC?Because they are both drug conjugates, RDC is similar to ADC in terms of overall structure, and is also composed of "three major parts", targeting ligands, linking arms, chelates and nuclides. 
One of the biggest differences between the two sides is the drug loadRDC is no longer a small molecule but a nuclideThe difference in key groups is destined to have differences between RDC and ADC in terms of utility and drug cost. Radionuclides have two major functions: imaging and **, and some nuclides or even both, RDC can only change the nuclide part, so as to choose to achieve the integration of diagnosis and treatment, which is also a major trend in the development of RDC drugs, such as Grand Pharma has laid out three RDC drugs with integrated diagnosis and treatment. 
Grand Pharma's integrated diagnosis and treatment of RDC drugs, screenshot from its official website from the pipeline under development,Nuclide lutetium [177lu].Due to the advantages of high energy, short range, high stability and good druggabilityIt is the current mainstream of R&DNovel nuclides such as actinide [225AC] and gallium [68GA].It is one of the R&D concerns of many cutting-edge nuclide companies such as rayzebio and Nuoyu Biotech, and it is also worth looking forward to. However, there are strict requirements for the production and use of nuclides, and they can only be produced in specific equipment, which is also destined to keep the production cost of RDC at a relatively high level in the short term. In terms of the commercialization of RDC drugs, Novartis is currently far ahead, and among the 9 RDCs approved by the FDA, Novartis has 4 of them, including the only two ** RDCs. 
Two ** RDCs are from Novartis' Q3 2023 financial reportlutatheraIt is Novartis' first approved ** RDC drug, which was approved in 2018, and is also the first ** radiodrug approved by the FDA for gastroenteropancreatic neuroendocrine tumors, with sales of 4With a $7.5 billion answer, Lutathera will sell for $1 billion in 2022 for many industry organizations**. However, due to the limited market space for indications and the limitation of production capacity, Lutathera's sales in 2022 will decline instead of increasing. pluvictoIt is Novartis' second approved RDC drug for castration-resistant prostate cancer with a larger market space, and it has been achieved in the first year of marketing in 20222.$7.1 billion in sales. Novartis has also said on several occasions that Lutathera and Pluvicto are on the upscaling of salesAll of them have been shackled by production capacity to a certain extent. But this year, with Novartis' increasing production capacity investment, the dilemma has reversed. In the first three quarters of this year, Lutathera had sales of 4$5.8 billion, Pluvicto sales of $7$0.7 billion, Lutathera is finally on track to break the $600 million mark this year, and Pluvicto is running to a higher $1 billion. At the end of October, the FDA removed Pluvicto from the drug shortage list, signaling the release of nuclear drug capacity issues in the short termBut in the long run, capacity remains a major problem. To this end, Novartis continues to increase investment in production capacity, from the public information, Novartis currently has 6 nuclear drug production bases that have been built, and recently announced that it will invest more than 600 million yuan in China to build a nuclear drug production base to accelerate the layout in China. With production capacity guaranteed, Novartis has also raised Pluvicto's expectations, and at the recent 2023 R&D Day, Novartis raised Pluvicto's highest sales from$2 billion to $3 billion, which is enough to demonstrate Novartis' confidence and imagination on the nuclear drug track. As the benchmark of the RDC track, Novartis' success and continuous investment at this stage have made RDC one of the most certain branches in the innovative drug track, and it has also ignited domestic enthusiasm. Pulling the vision back to China, in the global RDC competition pattern, Chinese pharmaceutical companies are a force to be reckoned with. At present, domestic companies that develop RDC drugs can be basically divided into three forces. The first is to China Tongfu and Dongcheng PharmaceuticalAs the representative of the veteran nuclear drug companies, entering the RDC has an inherent advantage;The second is Hengrui Pharmaceutical, Grand Pharmaceutical, and Xiantong PharmaceuticalAs a representative, the traditional pharmaceutical companies have entered the RDC track with a forward-looking visionThe third is Full-Life Pharmaceutical, Hexin Pharmaceutical, WuXi Biologics, and Zhinu Biologicsand so on, as the representative of the new nuclear drug enterprises, capital favored, rapid layout of nuclear drug research and production. The three forces are competing with Novartis on the same stage and are constantly sparkling. The emergence of a new generation of nuclear medicine benchmarks
In 2021, the release of the first programmatic document for the application of nuclear technology in the field of medical and health care in China, the "Medium and Long-term Development Plan for Medical Isotopes (2021-2035)", pressed the acceleration button of the nuclear medicine industry. Since then, a number of nuclear drug start-ups, including Xiantong Pharmaceutical, Full-Life Pharmaceutical, WuXi Biologics, etc., have completed huge financing. According to the data of Arterial Network, in 2022, nuclear medicine will be the segment with the highest proportion of financing events of more than 100 million yuan in the field of innovative drugs, with an annual financing of nearly 900 million yuan. In 2023, the popularity of nuclear medicine in China will further increaseA new generation of benchmarks has also emerged. On July 3, Xiantong Pharmaceutical announced that it had completed a financing of more than 1.1 billion yuan, and investors includedSDIC Entrepreneurship, Goldstone Investment, National Survey, General Technology Venture Capital, etcMany national teams, industrial groups and well-known investment institutionsAnd the single amount has set a record for this year's pharmaceutical financing. According to public information, Xiantong Pharmaceutical entered the innovative nuclear drug track in 2014, and the nuclear drug track was still silent at that time. As of the end of 2022, Xiantong Pharma has more than 15 innovative projects under development, of which 2 are in the NDA review stage and 4 have entered the clinical trial stage. When the time comes to 2023, Xiantong Pharma will begin to enter the harvest period. Adenosine injection was approved for marketing at the beginning of the year for myocardial perfusion imaging and echocardio** drug stress test to assist in the diagnosis of coronary heart disease. Recently, there has been a lot of attentionA-PET imaging agent fluoro[18F]betabenzene injection was approved in ChinaIt fills the gap in the market of A-PET diagnostic imaging agent in the field of AD in China. While promoting the diagnosis of nuclear drugs, Xiantong Pharmaceutical is also accelerating the research and development of first-class nuclear drugs, and the first-class nuclear drugs currently under development are basically products with integrated diagnosis and treatment, which are in line with the future development trend. As a pioneer, the success of Xiantong Pharmaceutical in the financing side and the product side has brought more imagination space to the entire track. In addition to Xiantong Pharmaceutical, a number of nuclear medicine start-ups have announced the completion of a new round of financing this year. Hexin PharmaceuticalOn March 2, it completed a round of financing of over 100 million yuanNuoyu PharmaceuticalOn May 15, tens of millions of Series A financing was completedHua boron neutronsOn August 2, it completed an angel round of financing of over 100 million yuanNuclear Boat PharmaceuticalIt also recently announced the closing of a multi-million dollar seed round of funding. The continuous increase of capital and the outstanding achievements of the players are forming a virtuous circle of continuous upward movement, and nuclear medicine is coming out of the style of the next ADC. summary
Summary
In the case of nuclear medicine, it is not an exaggeration to say that mankind is "hesitating outside the gate of the temple of nuclear medicine". One could only speculate on what was going on in the temple from the occasional light from the temple window, and there were still too many special nuclear drug codes to be unlocked in the future. Fortunately, we now see hope. Note:The information is from the official websites of major companies and public information sources. The copyright belongs to the original author, only for readers to study, research or Xi, not for commercial use, if it involves the content of the work, copyright and other issues, please contact within 30 days to delete;This *** is neutral to the content, statements, and opinion judgments shared, and does not provide any express or implied guarantee for the authenticity, reliability or completeness of the content contained, and is only for readers' Xi and reference.