On November 17, Dupilumab's asthma indication was approved in China for the maintenance treatment of adolescents aged 12 years and above and adult asthma patients.*. As the "leading player" in Sanofi's immunology and inflammation field, Dupilumab has expanded rapidly in the Chinese market. This time, it has made its first mark in the respiratory field, achieving a horizontal leap from the dermatology field to the respiratory field.While market attention is focused on the performance of Dupilumab, it's easy to overlook Sanofi's recent frequent moves to lay out a broader innovative landscape. This innovative landscape aims at a diversified innovation path centered on immunology.Last month, Sanofi announced the launch of a new chapter in its "Play to Win" strategy, aiming to focus on key areas and projects to fully unlock the potential of its existing pipeline. "By 2030, Sanofi aims to achieve sales of over €22 billion in immunology and €10 billion in vaccines," declared Sanofi CEO Paul Hudson with bold confidence.According to a report released by the brokerage firm CITIC Securities, the proportion of immunological disease drugs in the Top 100 increased from 8% in 2009 to 27% in 2019, with their total sales increasing from $9.09 billion to $89.485 billion.[1]Undoubtedly, the entire industry's attention to immune diseases is now different from the past, which also means that future market competition will become even more intense. How can Sanofi achieve its ambitious journey centered on immunology?
Immunotherapy "Ace" Advances Rapidly, Expanding the Innovative LandscapeDupilumab, the "trump card" of immune inflammation, is indeed the source of Sanofi's confidence in expanding into a broader immunology field. From the current status of dupilumab’s approved indications in China, it has covered six indications: moderate-to-severe atopic dermatitis in infants aged 6 months and above through to adults, moderate-to-severe prurigo nodularis in adults, and asthma in adolescents aged 12 years and above as well as adults. It spans different age groups for atopic dermatitis, crosses various dermatological conditions, and extends across both respiratory and dermatological therapeutic areas.The market size of diseases targeted by Dupilumab is very impressive. In China, atopic dermatitis is known as the "No. 1 disease" in dermatology, with a large patient base. In the field of asthma, the prevalence rate among people aged 20 and above in China is 4.2%, with a total number reaching 45.7 million, and the prevalence rate is increasing year by year.[2]Globally, it is estimated that there are approximately 230 million cases of atopic dermatitis.[3], with approximately 262 million cases of asthma.[4]。The ability to capture such a large market is largely due to the IL-4Rα-mediated type 2 inflammation mechanism on which Dupilumab relies. IL-4 and IL-13 are common cytokines that induce type 2 inflammatory responses.[5]Therefore, dupilumab, as a monoclonal antibody targeting IL-4Rα, can precisely inhibit IL-4 and IL-13 mediated signaling.[5]Thereby blocking type 2 inflammation and the disease process, acting on type 2 inflammation-related conditions such as atopic dermatitis, prurigo nodularis, eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, and asthma.In May this year, Dupilumab achieved a breakthrough in the "valley of death for biologics" – the chronic obstructive pulmonary disease (COPD) indication. It became the first biologic for COPD to meet all primary endpoints in a Phase III study. COPD is the third leading cause of death globally and poses a serious threat to the health of at least 300 million people worldwide.[6], but due to its heterogeneity and intractability, there has been no breakthrough in biologic therapies in this field for over a decade. Statistics from some institutions show that the market size of COPD will approach 20 billion US dollars in 5 years.[7]. Just yesterday, the second Phase III clinical trial of Dupilumab for the treatment of moderate to severe COPD, the NOTUS study, met its primary and key secondary endpoints.[8], PhaseCompared with the control group, dupilumab further reduced the rate of moderate to severe acute exacerbations by 34%, further confirming the positive results of the first Phase III clinical trial, the BOREAS study. Sanofi and Regeneron plan to submit the marketing application for this indication to the FDA by the end of 2023.Sanofi has found a common "breakthrough" for many inflammatory diseases through the mechanism of type 2 inflammation, paving the way for its next-generation broad-spectrum immunological product and marking a solid first step on its path to becoming an "immunology giant."
With Multiple Potential "Blockbusters," Advancing on Multiple Fronts to Ensure Continuous Growth"Oracle of Omaha" Buffett does not bet all his funds on a single stock, and similarly, multinational pharmaceutical companies do not overly rely on a single flagship product to support their performance, avoiding the predicament of leaning on one leg.While fully exploring the potential of Dupilumab, Sanofi is also focusing on developing follow-up products, adopting a multi-pronged growth model centered around the immunology field.Public information shows that Sanofi's current pipeline layout in the immunology field mainly includes three major categories: systemic disease pathways such as asthma and atopic dermatitis; peripheral inflammatory diseases such as rheumatoid arthritis, as well as autoimmune challenges in type 1 diabetes and cancer; combined with Sanofi's strengths in the vaccine field, these form an innovative pillar for the company’s future with immunology as a key component.According to the Q3 financial report, several mid-to-late-stage immunology products currently in Sanofi's pipeline are under development, each with peak sales projected at 2-5 billion euros. Among them, Amlitelimab has recently made progress. Data from the Phase IIb STREAM-AD study, presented at the European Academy of Dermatology and Venereology Annual Meeting, shows that Amlitelimab has the potential to become a best-in-class treatment for atopic dermatitis.[9], and Sanofi is also exploring its potential in the respiratory field. It can be seen that, based on Type 2 inflammation, Sanofi is actively developing a pipeline that goes "beyond Type 2 inflammation."In addressing autoimmune challenges,Teplizumab-mzwv（Tilizumab (Proposed）) It was approved by the FDA last year, as the world's first and only innovative drug to delay the onset of type 1 diabetes, and was just named one of TIME Magazine's Best Inventions of 2023 this October.In the advantageous field of immunoprevention, Sanofi has also been delivering good news. In July this year, the US FDA approved Nirsevimab from Sanofi, the world's first and only long-acting preventive measure against respiratory syncytial virus infection for all infant populations.Jointly developed by Sanofi and AstraZeneca）The marketing authorization application has been submitted and it has been included in the vaccine management of the Centers for Disease Control and Prevention (CDC), making nirsevimab the first long-acting monoclonal antibody to be incorporated into the CDC’s vaccine management in the United States. In May this year, the product was granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China, entering the fast track for approval. With nirsevimab and two RSV pipeline candidates targeting children and the elderly, Sanofi has already become a major player in the billion-dollar RSV market.Notably, Sanofi is committed to building an immunization R&D pipeline portfolio more focused on "first-in-class" and "best-in-class" innovations. The company plans to advance at least 10 innovative products into clinical trials by 2025, six of which will come from the mRNA technology platform.[10]In addition, Sanofi expects that by 2025, at least five immunoprophylactic products with first-in-class or best-in-class potential will enter Phase III clinical trials.[11]Recently, Sanofi also reached a development and commercialization agreement with Johnson & Johnson for a potential first-in-class vaccine project targeting extraintestinal pathogenic Escherichia coli (ExPEC).At the recently concluded 6th CIIE, Sanofi showcased six groundbreaking innovative achievements, including dupilumab, tilizumab (tentative), and nirsevimab, which are leading representatives in the immunology field. Wang Shi, President of Sanofi Greater China, stated: "Innovation is the driving force behind Sanofi's continuous development and the foundation of our service to the vast patient population in the Chinese market. Currently, China, as a necessary participant in global synchronized R&D, has joined over 90% of global R&D projects, enabling us to accelerate the implementation of R&D outcomes and introduce innovative global medicines and vaccines to the Chinese market more quickly, truly helping Chinese patients regain their vitality."Sanofi's innovative layout in the Chinese market is gradually entering the harvest period. This year, Sanofi has achieved approval in China for 10 innovative drugs and vaccines as well as new indications. This number is expected to increase further, as on November 22, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that Sanofi’s monoclonal antibody SAR445088 (BIVV020), targeting complement C1s protein, was officially included in the list of breakthrough therapies for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). As more innovative products are designated as breakthrough therapies, this will further accelerate their approval process in China."China's innovative vitality will bring a new look to global pharmaceutical R&D, and China will also become one of the global innovation engines," Schwabe added. "The huge unmet needs in the field of immunology are undoubtedly one of our key focuses in Sanofi's innovation landscape. So far this year, Sanofi has received approval for 10 innovative drugs and vaccine products and indications in China, indicating that we are advancing the launch of innovative products at an unprecedented speed to meet the health needs of the Chinese people. In the future, we will continue to connect China and the world with accelerated innovation, exploring more scientific miracles in core disease areas."Sanofi's series of moves to double down on the broader immunology field atop Dupilumab demonstrate its determination to deeply cultivate this area.A new strategy of multi-pronged approach also opens up more possibilities for future innovation.As the global innovation landscape expands, China's importance in Sanofi's launch of the "Win with All Our Might" new chapter continues to grow.We will wait and see how Sanofi, with immunology as the breakthrough point, continues to inject new vitality into innovation from prevention to treatment.- Scroll up and down to view references -
* Can be used for the maintenance treatment of adolescents aged 12 years and above and adult asthma patients, including those with poorly controlled asthma characterized by type 2 inflammation (indicated by increased eosinophils and/or elevated fractional exhaled nitric oxide) despite treatment with medium- to high-dose inhaled corticosteroids (ICS) combined with other asthma control medications, as well as oral corticosteroid-dependent asthma patients.
[1] CITIC Securities《In-depth Report on Immunology Drugs: Soaring High Like a Peng Bird Riding the Wind》
[2] Huang K, Yang T, Xu J, et al. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study[J]. Lancet, 2019, 394(10196): 407-418.
[3] Atopic dermatitis. The Lancet. 2020. 396(10247):345-360.
[4] Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet. 2020. 396(10258):1204-1222.
[5] Dual blockade of IL-4 and IL-13 with dupilumab, an IL-4Rα antibody, is required to broadly inhibit type 2 inflammation. Allergy. 2020. 75(5):1188-1204.
[6] World Health Organization.The top 10 causes of death.2020.[7] Research and Markets report:Insights on the Worldwide COPD Market to 2028.[8] https://www.sanofi.com/en/media-room/press-releases/2023/2023-11-27-06-30-00-2785836[9] Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis.https://www.sanofi.com/en/media-room/press-releases/2023/2023-10-13-14-00-00-2760021[10] Harnessing the potential of mRNA to overcome major healthcare challenges (sanofi.com)[11] Présentation PowerPoint (sanofi.com)Copyright © 2023 PHARMCUBE. All Rights Reserved.
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