On February 1, 2024 (Beijing Time), Sanofi announced its financial report for 2023. The total sales revenue for the full year of 2023 reached 43.07 billion euros (46.52 billion US dollars, calculated at the current exchange rate of 1 euro = 1.08 US dollars, the same below), increasing by 5.3% year-on-year. The total revenue in the fourth quarter was 10.9 billion euros (11.77 billion US dollars), increasing by 9.3% year-on-year (all data in this article are calculated at constant exchange rates).

Pharmaceuticals business revenue was 30.4 billion euros (32.83 billion USD), vaccines business revenue was 7.5 billion euros (8.1 billion USD, +8.3%), and consumer healthcare business revenue was 5.2 billion euros (5.62 billion USD, +6.3%).

The pharmaceutical sector is divided into specialty drugs and general drugs. Specialty drug sales reached 18 billion euros (19.44 billion USD), a year-on-year increase of 14.2%; general drug sales amounted to 12.4 billion euros (13.39 billion USD), a year-on-year decrease of 7.1%. Core assets revenue was 6.3 billion euros (6.8 billion USD), a year-on-year increase of 3.3%.

Dupilumab Takes the Lead

Dupilumab is Sanofi's leading product,Has achieved great success in the autoimmune field, especially in the indication of atopic dermatitis.Propping up half of the specialty drug sector,Sales in the fourth quarter were €2.99 billion ($3.23 billion), with full-year 2023 sales reaching €10.715 billion ($11.57 billion, Figure 1).[1]。See details:Autoimmune Field: Which MNC Pipeline is the Strongest?

2023Year,Dupilumab has also made significant progress, including for the treatment of chronic obstructive pulmonary disease (COPD) of3PeriodBOREAS、NOTUSThe success of clinical trials andFDA Approved as the first and only one for use in1 Years and older with eosinophilic esophagitis (EoE) Treatment Methods for Childrenetc.

COPDIs a chronic pulmonary disease with high disability rates andCase Fatality RateVery high, it is the third leading cause of death globally,Expected to2030will reach by the year278Billion-dollar market size, with many unmet needs。

2023Year3Month23Recently, Sanofi announced a3Periodic assessment of Dupilumab in patients currently receiving maximum standard-of-care inhalation therapy (triple therapy) with uncontrolled symptoms.COPDAnd2Type inflammation patients trial (BOREAS）Results: Compared with placebo, the dupilumab group achieved the primary endpoint and all key secondary endpoints.[2]。

This trial demonstratesDupilumab is the first and only one inCOPDModerate or severe acute exacerbation (rapid and acute worsening of respiratory symptoms) (30%) with clinical significance and a highly significant reduction in biologics,At the same time, it also showed lung function, quality of life, andCOPDSignificant improvement in respiratory symptoms.

2023Year11Month27Recently, Sanofi announced the second indication for Dupilumab.3 Period TreatmentCOPDTest (NOTUS) Results:NOTUSThe trial achieved its primary endpoint with overwhelming efficacy., compared with placebo, dupilumab in2Type inflammation evidence (i.e., blood eosinophils≥300Cell/μL) Moderate to SevereCOPD Among the patients,Acute exacerbations significantly reduced34%`, confirming the milestone` BOREAS Results of the Key Trials[3]。

The NOTUS trial also confirmed that Dupixent treatment led to rapid and significant improvement in lung function at 12 weeks, with sustained improvement at 52 weeks. These results come from an interim analysis and will be considered the primary analysis of the trial given the overwhelming positive efficacy of the primary endpoint.

On January 26, 2024, Sanofi announced that the FDA had approved dupilumab for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE) [4].

Currently, Dupilumab isThe first and only drug approved in the United States specifically for the treatment of these pediatric patients. This approval expandsFDAIn2022Year5Monthly Usage12Years old and above, weighing at least40KilogramEoEThe patient's preliminary approval.

This approval is based on3PeriodEoE KIDSTest Results:Compared with placebo, takingDupilumabA higher proportion of children achieved histological remission.。

Dupilumab in2020 Year6 Approved for the first time in China this month, as of now, has been approved in China for the treatment of moderate to severe atopic dermatitis (the population has been expanded to include6months to adults), prurigo nodularis, and asthma indications, etc. Recently, the new indication of Dupilumab Injection has been submitted for marketing in China (acceptance number:JXSS2400002), Indications have not been disclosed yet.

Vaccine Segment Beyfortus Is Highly Anticipated

Vaccines are Sanofi's second largest source of revenue after pharmaceuticals.，In 2023, the revenues of influenza, Polio/Pertussis/Hib, and Meningitis vaccines were €2.669 billion ($2.88 billion), €2.165 billion ($2.34 billion), and €1.17 billion ($1.26 billion), respectively, representing year-over-year decreases of 5.5%, 0.1%, and 0.5% (Figure 2).

Figure 2. Sales of Sanofi's main vaccines

Sanofi urgently needs new growth momentum in the vaccine field,Fortunately,Long-acting Respiratory Syncytial Virus (RSV）Monoclonal AntibodyBeyfortusLiving up to expectations,Reached in the second quarter of launch4.1Billion euros（4.4Billion USD).

Beyfortus, a long-acting RSV monoclonal antibody jointly developed by Sanofi and AstraZeneca, was approved in the EU and the UK in October and November 2022, respectively.

2023Year7Month,BeyfortusByFDAApproved for marketing,Used for prevention in the firstRSVBorn in the season or entering the firstRSVRespiratory Syncytial Virus (RSV) in Newborns and Infants by SeasonRSV) Lower respiratory tract diseases (LRTD), and24Months below in the secondRSVSeasons are still prone to severeRSVSecondary Infections in Children with Diseases[5]。

RSVIt is a virus that can cause acute respiratory infections in all age groups. Although most infants and young children will experience mild cold-like symptoms,But some infants, especially those with first-time infections, may develop lower respiratory tract illnesses, such as pneumonia and bronchiolitis (swelling in the small airway passages of the lungs), which often leads to visits to the emergency department or the doctor.。

Premature infants, infants with chronic lung disease of prematurity, or severe congenital heart disease are at the highest risk for severe RSV disease. According to the American Academy of Pediatrics, approximately 1% to 3% of children under 12 months of age in the United States are hospitalized each year due to RSV.

This FDA approval was based on the support of three clinical trials (Trials 03, 04, and 05). The key efficacy endpoint was the incidence of medically attended RSV lower respiratory tract infections (MA RSV LRTI) assessed within 150 days after Beyfortus administration.

Trials 03The test results showed that: upon receivingBeyfortusAmong the treated infants,25Name (2.6%) infants experiencedMA RSV LRTI, while the infants receiving the placebo were46Name (9.5%). Compared with placebo,BeyfortusWillMA RSV LRTIThe risk was reduced by approximately70%。

Trials 04The test results showed that: upon receivingBeyfortusAmong the treated infants,12Name (1.2%) infants experiencedMA RSV LRTI, while infants receiving placebo had25Name (5.0%). Compared with placebo，Beyfortus WillMA RSV LRTI The risk was reduced by approximately75%。

Trials 05 supports the use of Beyfortus in children under 24 months of age who remain at risk for severe RSV disease during their second RSV season.

2024Year1Early this month,BeyfortusApproved in China for the prevention of neonatal and infant entryRSVSeasonal or PeriodRSVLower Respiratory Tract Infection (LRTI）。

China is also one of the countries with a high prevalence of Respiratory Syncytial Virus (RSV) globally. RSV is a common and highly contagious respiratory virus, and it is the leading cause of hospitalization for lower respiratory tract infections (such as bronchiolitis and pneumonia) in infants under 1 year old [6].

Since Beyfortus was launched globally in the autumn of 2023, there has been a peak in vaccinations. Its recent approval in China not only provides protection for Chinese babies but also is expected to help reduce the burden on China's healthcare system during the high-incidence season of respiratory diseases caused by RSV infections.

Benefiting from the huge market demand in China, Beyfortus is expected to increase its supply soon, which might reverse the initial downturn in the vaccine sector.

In the vaccine sector, Sanofi reached a cooperation agreement with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, in November 2023 to develop and commercialize the extraintestinal pathogenic Escherichia coli (9-valent) (ExPEC9V) candidate vaccine [7].

$2.9 Billion for Tzield, Expanding Diabetes Pipeline

Once, Sanofi held a significant position in the diabetes field with Lantus and Toujeo. However, due to a lack of follow-up strategies and missing key diabetes targets such as GLP-1 and SGLT-2, it has fallen far behind Eli Lilly and Novo Nordisk in the diabetes sector.

However, Sanofi has not abandoned the diabetes field,2023Year3Month,Sanofi at a high29Acquisition of Diabetes Company for $ BillionProvention Bio, its core productTzieldPocketed for treatment1Type 2 Diabetes Patients。

Over the past century, patients with type 1 diabetes have primarily relied on insulin injections or insulin pumps to sustain life.

TzieldIs a targetedTCellCD3Humanized monoclonal antibody, has been2022Year11Month ObtainedFDAApproved for Delay8 Years or older preclinical (stage 2) Clinical in patients with the disease1 Type diabetes (stage 3) episodes,Become the first-ever disease-modifying therapy capable of slowing the progression of this condition.Of great significance. 

At the 49th ISPAD Annual Meeting in 2023, Sanofi presented new data from the PROTECT Phase 3 trial of Tzield. The PROTECT study investigated the efficacy and safety of Tzield in slowing β-cell loss and preserving β-cell function (measured by C-peptide) compared to placebo, in children and adolescents aged 8-17 who were diagnosed with Stage 3 autoimmune Type 1 Diabetes (T1D) within the past 6 weeks. The specific results were published in the New England Journal of Medicine [8,9].

The study results showed that, compared with placebo,TzieldReached the primary endpoint of the study, through significantSlowdown AverageCPeptide Level (4Area Under the Curve After Hourly Mixed Meal Tolerance Test[AUC]) The decrease shows excellentβCell Preservation Capability。CPeptides areβBiomarkers of cell function. This significant difference indicatesTZIELD It is possible to slow down in this population3Period1Progression of Type Diabetes (Figure3）。

$2.2 Billion to Strengthen Rare Disease Pipeline

2024Year1Month23Day,SanofiAnnounced that it has reached an agreement withInhibrxReach a final agreement. According to the agreement,SanofiSubsidiaryAventisWill Acquire andINBRX-101All related assets and liabilities[10]。

For each share of Inhibrx stock, Inhibrx shareholders will receive $30 in cash, a $5 contingent value right (CVR), and 0.25 shares of the newly listed company, which will retain Inhibrx's non-INBRX-101 assets ("New Inhibrx").

This acquisition supports Sanofi's product portfolio growth strategy and complements Sanofi's 30-year legacy in the rare disease field as well as its proven industry leadership in immunology and inflammation.

INBRX-101 Is a precisely engineered recombinant humanAAT-Fc Fusion Protein (Figure4), is expected to α-1 Alpha-1 Antitrypsin Deficiency (AATD) Patients achieve serum with less frequent dosingα-1 Antitrypsin (AAT) Normalization of levels。

AATD is a hereditary rare disease characterized by low levels of AAT protein, primarily affecting the lungs with progressive tissue deterioration. INBRX-101 may help reduce inflammation and prevent further deterioration of lung function in affected individuals. 

The current status and standard of care for AATD patients are not ideal. Weekly infusions of plasma-derived AAT cannot maintain normal serum AAT levels. AAT has proven difficult to develop through recombinant methods, often showing loss of activity and undergoing accelerated degradation.

INBRX-101Has the following potential: to expand the drug delivery range fromOnce a week expanded to once every three to four weeks, while keeping the patient in a normal stateAATWithin the exposure range (Fig.5); overcome in maintaining recombinantAATThe challenge of simultaneous functionality and commercial-scale production; meticulously designed to maximizeAAT Functional activity, especially in the lungs; supplementRNAi Method, but applicable to allAATD Patient.

Previously,INBRX-101The1Phase clinical trials also achieved positive results:In severe shortageAATTheAATD Patients receive intravenous injections every three weeks.40、80 And120 mg/kg INBRX-101, can makeAAT Horizontal accumulation and achieving full normal functionalityAAT Horizontal capability. According to PK The model is expected to continue accumulating after subsequent doses and reach a steady state after approximately five to six consecutive doses administered every three to four weeks.

Inhibrx has initiated a Phase 2 registrational clinical trial using AAT levels as the primary endpoint for regulatory approval. Preliminary results are expected to be announced by the end of 2024.

INBRX-101Is also exploring new indications, such as for the treatment ofAcute Graft-Versus-Host Disease(aGVHD)It has the potential to enable more sustainable dosing regimens and may offer superior safety benefits and enhanced efficacy.

The autoimmune and vaccine fields are Sanofi's strong sectors. As a precaution, Sanofi is also actively exploring new growth points in the autoimmune and vaccine fields, such as the subsequent pipeline in the autoimmune field.itepekimab、amlitelimab、frexalimabAndSAR441566, The vaccine pipeline includes vaccines targeting acne, extraintestinal pathogenic E. coli, and respiratory syncytial virus in the elderly.。

Sanofi has also actively expanded into other fields, such as acquiring the Type 1 diabetes drug Tzield and the rare disease AATD treatment INBRX-101.

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