R&D strategy

Focusing science to transform lives

Recent breakthroughs in science and technology have revealed new opportunities in our areas of priority and expertise: vaccines and specialty care. Novel biologics are enabling our teams to address seemingly intractable problems in drug and vaccine design, while digital and data systems are bolstering our patient-centric R&D approach.

In 2020 we expanded our means to do extraordinary science, developing and acquiring innovative technologies to access previously unimaginable pharmacology and building knowledge to deliver the future of medicine.

  • The acquisition of Principia brought revolutionary chemistry to Sanofi drug discovery with its TAILORED COVALENCY® platform, which offers greater control over how small molecules bond–reversibly or irreversibly–to their protein targets.
  • The launch of our new, cross-functional Genomic Medicine Unit opened the door to developing therapeutics that address the root causes of disease.
  • A new collaboration forged with immunotherapy company Kiadis1 presented new possibilities for developing cell-based therapeutics for cancers and other diseases.

1 Sanofi’s offer to acquire Kiadis was announced in November 2020.

Supporting patients

The global pandemic stress-tested our new Play to Win strategy and culture. In early 2020 our teams acted swiftly, leveraging digital technologies to maintain continuity of clinical trials, keeping patients in studies, and increasing both efficiency and productivity. At the same time, we advanced new treatments for patients with allergic and inflammatory diseases, breast cancer, blood cancers, multiple sclerosis, hemophilia, and many other conditions.

Partnering for healthy societies

In 2020 the world saw the true value of pulling together to advance science for healthier societies. A new collaboration with GSK enabled the development of a recombinant protein vaccine against COVID-19, and our long-standing collaboration with Translate Bio produced a candidate mRNA vaccine against COVID-19, prompting co-development of mRNA vaccines across other infectious diseases. Sanofi acquired six companies in 2020, bringing with them talented people, pipeline products, and research-enabling technologies that inspire frontier science and strengthen our capacity to deliver practice-changing medicines.

Key figures: R&D in 20202

  1. 522
    Clinical studies continued
  2. 89
    Additional studies launched
  3. 98%
    Patients maintained in studies
  1. 120,978
    Patients participating globally
  2. 37,536
    Patients treated

2 Clinical development figures include pharmaceutical, medical, and vaccine studies. Study participants are considered “active” from first treatment to last visit. “Treated” refers to a person having a first treatment in 2020.

COVID-19: Maintaining critical clinical trials during the pandemic

As clinical trials for our COVID-19 vaccine candidates were launched with unprecedented speed, Sanofi worked in parallel to maintain, where possible, the continuity of critical clinical trials for other diseases. Find out how, together with clinical study sites, investigators and health authorities, our teams have created patient-focused solutions to overcome obstacles caused by the pandemic.

Find out more about: Supporting Scientific Progress Through Clinical Trials

Voices from the Lab:
Overcoming obstacles

Sanofi scientist Iris Valtingojer talks about her passion for discovery, and her commitment to changing long-term treatments for cancer.

This section is intended for investors and media.

2020 key R&D pipeline highlights3

Vaccines

  • COVID-19 vaccine candidate developed jointly with GSK advances to clinical trials.
  • Results of mRNA vaccine candidate against COVID-19 in preclinical studies prompts Translate Bio collaboration to co-develop mRNA vaccines across other infectious diseases.
  • Respiratory Syncytial Virus (RSV) infections requiring medical care were reduced in healthy, premature infants immunized with nirsevimab, an investigational monoclonal antibody co-developed with AstraZeneca in phase 2 clinical trials.

Immunology & Inflammation

  • Dupixent®4 is designated a Breakthrough Therapy for eosinophilic esophagitis, and achieves milestones for atopic dermatitis and asthma in the US, EU, and China.
  • Itepekimab, an investigational antibody, progresses to phase 3 studies in former smokers with Chronic Obstructive Pulmonary Disease (COPD).
  • Rilzabrutinib, an oral, reversible-covalent Bruton’s tyrosine kinase (BTK) inhibitor, is granted FDA Fast Track Designation for treatment of immune thrombocytopenia and enters phase 3 trials.

Cancer

  • Amcenestrant, an investigational, oral drug for metastatic breast cancer, advances to a pivotal phase 3 clinical trial as a first-line combination treatment.
  • FDA and European Commission approve Sarclisa®, a treatment for adult patients with relapsed refractory multiple myeloma.
  • Cemiplimab monotherapy was shown to increase overall survival in first-line advanced non-small cell lung cancer in phase 3 trial.

Neurology

  • Tolebrutinib, an investigational, brain-penetrant BTK inhibitor that showed reduced disease activity in people with relapsing multiple sclerosis in a phase 2 trial, entered multiple phase 3 clinical trials.

Rare Diseases & Rare Blood Disorders

  • Olipudase alfa, the first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency, demonstrated positive top-line results.
  • Phase 3 trials of avalglucosidase alfa, an investigational enzyme replacement therapy for Pompe disease, showed improvements in respiratory muscle strength and mobility.
  • Rilzabrutinib is granted FDA Fast Track Designation for treatment of immune thrombocytopenia.
  • Efanesoctocog alfa (BIVV001), an investigational factor-replacement therapy for people with severe hemophilia, showed positive results in phase 1/2a clinical study.
  • Fitusiran, a potentially transformative siRNA therapy for people with hemophilia A or B with or without inhibitors, is granted Fast Track Designation by the US FDA for all indications.

3 See Capital Markets Day presentation for 2020 updates on late-stage strategic assets.
4 Dupixent® (dupilumab) is a product in collaboration with Regeneron. Dupixent® is approved for different patient populations with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps. It might not be approved in markets where you live, please check locally.