On October 28th, Science and Technology Innovation Board Daily (Reporter Xu Hong): "Even chronic obstructive pulmonary disease can be overcome! Dabitol will probably be the strongest self immune drug." In March of this year, when Sanofi and Shengsheng Yuan announced that Dabitol had successfully achieved Phase III clinical application for indications of chronic obstructive pulmonary disease, someone wrote this lament.
Self immunity (autoimmune diseases) has always been an important disease field among the top generation. According to statistical data, among the top 100 global drug sales, self immunity drugs account for over 20%. The legend of Dabitol lies in its global sales of nearly 20 billion euros in just 5 years after its launch.
Having a good background is one reason. Dabitou not only has a brand new target, but also has a high ceiling due to its large patient base on the self free track. At the same time, self immune drugs usually have broad-spectrum properties, so multiple indications can often be developed, and dabitol is no exception.
In addition, it is also inseparable from the importance and layout of the large market. I can tell everyone that our global CEO will also be present at the Expo this year, which will be his third visit to China this year, "a staff member from Sanofi China told reporters during a recent media exchange event.
By taking the opportunity to enter Bo, Dabitou is accelerating its entry into China.
Da Bi Tu: a self free top stream popular model that is ready to go on sale
On March 28, 2017, dabitol was approved for its first indication in the United States for the treatment of moderate to severe atopic dermatitis in adults. Subsequently, multiple other indications such as asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), and nodular prurigo were successively approved.
Perhaps some people may ask why these different diseases can be treated with the same biological agent. If you have some understanding of traditional Chinese medicine, you may have heard that different diseases may be homologous and can be treated together. The same principle is that these diseases are actually chronic type 2 inflammatory diseases, which come from chronic inflammation caused by immune network disorders Huang Yuanyuan, the head of respiratory medicine at the Medical Department of Sanofit China, said.
Dabitol (chemical name: Duprizumab injection) is a targeted biological agent that plays an important role in inhibiting the signaling pathways of key cytokines such as interleukin-4 (IL-4) and interleukin-13 (IL-13) in type 2 inflammation. It can help patients achieve targeted treatment, effectively alleviate disease symptoms, and ultimately achieve the important goal of long-term effective disease control and improving patient quality of life.
In the past, type 2 inflammatory diseases were generally treated symptomatically through oral antihistamines, topical hormones, etc., but they often failed to achieve good efficacy and had little effect on disease progression. Dabitol is considered to have ushered in a new era of anti-inflammatory treatment, and all precise targeted therapies for type 2 inflammation have so far originated from the launch of dabitol.
Due to its combination of safety and efficacy, dabitol has been selling well since its launch. In February of this year, Sanofi's 2022 financial report showed that the company's total annual revenue reached 42.7 billion euros, of which Dabitol sold 8.293 billion euros globally, accounting for nearly 20% of the company's total revenue.
Entering 2023, Dabitou continues to perform strongly, with sales of $5.35 billion in the first half of the year and is expected to hit the $10 billion mark throughout the year, becoming a well-deserved flagship product for Sanofi.
If the indication for chronic obstructive pulmonary disease is obtained, there is no doubt that Dabitol will go further in the future. Huang Yuanyuan told Sci Tech Innovation Board Daily that patients with chronic obstructive pulmonary disease have always relied on triple inhalation preparations and other drugs for treatment. On the basis of triple inhalation therapy, Dabitol can further reduce the incidence of moderate to severe acute exacerbation by 30%, improve lung function, quality of life, and respiratory symptoms.
At present, Dabitol is the first and only biological agent that can achieve significant benefits in COPD, achieving a breakthrough of "zero" in a decade of innovative biological therapy for COPD.
Take the opportunity to enter China quickly by taking the opportunity to enter the Expo
As the countdown to the 6th China International Import Expo (referred to as the "CIIE") begins, a reporter from the Science and Technology Innovation Board Daily learned that this year, Dabitou will make an appointment to participate in the CIIE six times, bringing the world's debut for indications for chronic obstructive pulmonary disease and the Chinese debut for indications for asthma.
After more than 40 years of deep cultivation in the Chinese market, Sanofi has actively seized the opportunity to enter the Expo. Several innovative products have been transformed from exhibits into commodities, among which Dabitol is a strong 'spillover effect' of the Expo and a beneficiary of China's medical reform. "Xie Lijuan, General Manager of Sanofi Specialty Medicine in China, said that the Expo can be seen as the growth process of Dabitol in China from approval, listing, entering medical insurance, to expanding indications:
In November 2018, Dabitou made its first appearance at the Shanghai CIIE; In May of the following year, it was included in the second batch of clinical urgently needed overseas new drugs list, accelerating the approval process for listing; In June 2020, it was officially approved as the first indication for the treatment of adult moderate to severe atopic dermatitis, two years ahead of the planned time, achieving approval and drug supply in only 25 days, breaking a new record for the new speed of the release of biological agents in China; In December 2020, it was successfully included in medical insurance again, and it only took 5 months from listing to being included in medical insurance
As of now, Dabitol has been successively approved as one of the top 5 indications in China, covering all age groups including adults, adolescents, children, and infants with moderate to severe atopic dermatitis, as well as moderate to severe adult nodular prurigo, which was just approved on the eve of this year's doctoral program.
From dermatology to respiratory surgery, Dabitou took advantage of this year's entry stage to announce two new indications for chronic obstructive pulmonary disease and asthma, demonstrating Sanofi's determination to accelerate the implementation of new indications in China.
It is reported that the asthma indications of Dabitol have been submitted for CDE application, and the indications for chronic obstructive pulmonary disease are still in the global clinical trial stage. But no matter when it is approved, we hope to have a comprehensive and in-depth cooperation with our respiratory team in medical education around these two diseases from at least 2024 onwards, "said He Yabin, the head of Dabitol business in Sanofit China.
Chinese patients should be the same as patients from other countries around the world. As long as this product can bring effective treatment benefits to their diseases, we have the responsibility to accelerate the implementation of phase III clinical research, accelerate the speed of registration applications, and ultimately make more patients with type 2 inflammation-related diseases in China have a different life, "He Yabin said.
The huge patient population also means that the Chinese market may become the next lucky spot for Dabitol. According to relevant statistics, the total number of asthma patients in China's population aged 20 and above has reached 45.7 million, and 55% -70% of them are in a state of poor control. If poorly controlled, prolonged airway inflammation may lead to recurrent acute asthma attacks, and 90% of uncontrolled asthma patients are mainly driven by type 2 inflammation. Prevention and treatment still face huge unmet medical needs.
Chronic obstructive pulmonary disease is another common chronic respiratory disease in China, with estimated patient data of nearly 100 million. Chronic obstructive pulmonary disease (COPD) can cause persistent coughing and breathing difficulties in patients, thereby damaging lung function. However, the improvement brought about by existing treatment plans is very limited and the effect is slow, and new treatment methods are also urgently needed.
More importantly, driven by various policies, these Chinese demands are still being released: in specialized dermatology hospitals, we see that atopic dermatitis has generally become a specialized outpatient clinic, and the entire medical industry is paying increasing attention to atopic dermatitis; The process of COPD being included in the national basic public health service project is also accelerating. In the future, we are expected to manage COPD like diabetes and hypertension.
The successful effect of Dabitol has attracted a large number of domestic and foreign enterprises to follow, and the future of Dabitol in China is even more worth looking forward to.