Per reporter: Lin Zichen Per editor: Liang Qi
The nuclear drug sector is taking financing by storm. According to incomplete statistics, since the beginning of this year, a total of 18 financing events have occurred in the global nuclear drug field, with a total financing amount exceeding US$1.3 billion. Among them, there were 4 cases in mainland China, with a total financing amount of more than 1.3 billion yuan, of which Xiantong Pharmaceutical led the way with a financing amount of more than 1.1 billion yuan.
Recently, Xiantong Pharmaceutical held a press conference on the nuclear drug "Euvenin" fluorine [18F]bethabene injection in Beijing. On September 15, the product was approved by NMPA, becoming the first Aβ (β amyloid)-PET (positron emission tomography) imaging agent approved for the diagnosis of Alzheimer's disease (AD) in China, and the first approved PET imaging agent in China in the past two decades. The company said that it expects to achieve the commercial launch of the product in the first half of next year at the earliest.
Compared with traditional drugs, this is a different path to commercialization. Due to the particularity of radionuclear drugs, the number of nuclear drugs that can be used in clinical practice in China is small and the utilization rate is low, and there is a lack of a sufficiently powerful technology transformation and clinical platform. How to do a good job in clinical promotion and production and distribution is a question that Xiantong Medicine needs to answer.
Alzheimer's disease is expected to be diagnosed 15 to 20 years in advance
As a neurodegenerative disease, Alzheimer's disease is considered to be the main cause of Alzheimer's disease, but due to the complex pathogenic mechanism, it faces the dilemma of difficult treatment and few drugs available. According to the 2022 World Alzheimer's Disease Report, more than 55 million people worldwide are currently diagnosed with AD, and it is expected that by 2050, this number may exceed 130 million.
From the perspective of clinical pathology, Aβ deposition is the earliest characteristic pathological change of AD, which takes a long time until the patient actually appears clinical symptoms, and if early screening, early intervention and dynamic monitoring are used, the age of onset of AD can be delayed by more than 10 years.
At present, the most authoritative means for diagnosing AD are cerebrospinal fluid index detection and PET scanning, of which PET scanning can achieve non-invasive early accurate diagnosis, but domestic AD detection-related PET imaging agents are in the blank stage, until Ovenin breaks this situation. As the first domestic Aβ-PET imaging agent applied to AD, it can be used to qualitatively interpret and quantitatively determine the level of amyloid β in the brain of adult patients by PET/CT (positron emission tomography (positron emission tomography system) equipment, which can be used to qualitatively interpret and quantitatively determine the level of amyloid in adult patients to assess the cause of AD or other cognitive decline.
Globally, Aβ-PET imaging agents have been approved for marketing in the European Union, the United States, Japan, South Korea and other places in 2014, and a large number of real-world studies have been carried out, and their effectiveness and clinical value have been well verified. Foreign studies have shown that abnormal deposition of Aβ can be detected by Aβ-PET 15 to 20 years before the onset of clinical dementia symptoms.
However, in China, this radiopharmaceutical called "nuclear drug" is not well-known, and it is even easy to be confused with radiotherapy for cancer, but there is an essential difference between the two. Yu Wenbin, vice president and secretary of the board of directors of Xiantong Pharmaceutical, made a figurative analogy: if radiation therapy is a cannonball, which can destroy cell responses, prevent cancer cells from dividing and eventually cause their death, then nuclear drugs are a "cruise missile", more accurate, composed of carriers (ordinary drugs) and radionuclides, of which the carrier is the projectile body, which can automatically navigate into specific cells in the human body; Radionuclides are "warheads" that, when specific cells have accumulated, emitted radiation that can destroy or identify diseased tissue.
Yu Wenbin, Vice President and Secretary of the Board of Directors of Xiantong Pharmaceutical
Image source: Courtesy of the company
According to the functional differentiation, nuclear drugs can be divided into diagnostic nuclear drugs and therapeutic nuclear drugs. The reporter of "Daily Economic News" learned at the meeting that the current product pipeline of Xiantong Pharma covers the main application fields of global nuclear drugs such as nerve, cardiovascular, and oncology.
Xiantong Pharmaceutical Product Pipeline Source: Provided by respondents
It will be commercially launched in the first half of next year at the earliest
As the first approved PET imaging agent in China in the past two decades, although Ovenin has a first-mover advantage, it also faces commercialization challenges. In recent years, multinational pharmaceutical companies such as Novartis, Bayer, and Boston Scientific have entered the nuclear drug track, which has pushed up the heat of this high-barrier scarcity track. However, due to the particularity of radionuclear drugs, the number of nuclear drugs that can be used in clinical practice in China is small and the utilization rate is low, and there is a lack of a sufficiently powerful technology transformation and clinical platform.
At the press conference, Wang Xin, director of medical marketing of Xiantong Pharmaceutical, told the "Daily Economic News" reporter that the company plans to focus on Alzheimer's disease-related departments such as neurology, psychiatry, and geriatrics to understand the overall needs of clinical practice and build an intelligent diagnosis platform for AD.
At the same time, the company will assist the association to establish a standardized Aβ-PET operation process, build an Aβ-PET demonstration center in the hospital system, carry out local science education through various public welfare undertakings, engage in more AD diagnosis academic activities, participate in national large-scale AD scientific research projects in a timely manner, and better promote the improvement of domestic AD diagnosis rate and medical treatment rate.
In addition, nuclear pharmacies, which integrate production, management, distribution and service, are also an important part of the commercialization of Auvenin. Different from traditional drugs, the validity period of nuclear drugs is shorter, the half-life of diagnostic nuclear drugs is about 6~8 hours, and the half-life of therapeutic nuclear drugs is about 3~5 days, generally ordered on the same day, produced at night, and transported to the hospital the next day for patient use, so nuclear drug enterprises are generally sold first, then produced. Dongcheng Pharmaceutical (002675. SZ, stock price 16.71 yuan, market value 13.779 billion yuan) for example, its long-half-life nuclear drug products adopt the production mode of sales and production, combined with inventory and overall market conditions to determine the output; short half-life nuclear drug products adopt customized production mode because of their half-life characteristics.
This puts forward extremely high requirements for the production, storage and distribution of nuclear drugs. At the press conference, Zhao Lihui, sales director of Xiantong Pharmaceutical, said that the company is ready for production and commercialization, with three nuclear drug production bases in Zhongshan, Guangdong, Wuxi, Jiangsu and Mianyang, Sichuan, and built its own commercialization team, and established cooperative relations with about 200 hospitals across the country. The product is expected to be commercially available in the first half of next year at the earliest. Specifically, the first covered cities are gathered in Beijing-Tianjin-Hebei, Yangtze River Delta and Guangdong, and other cities will start supplying in the second half of 2024.
Cover image source: Visual China - VCG21gic6332800
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