Belumosudil Mesilate

EU regulators have refused to greenlight Eli Lilly’s weight loss drug Mounjaro as a treatment for a type of heart failure, while giving the go-ahead for Novo Nordisk’s semaglutide in liver disease. Lilly failed to get support from the European Medicines Agency’s human medicines committee, or CHMP, on Friday for Mounjaro to treat chronic heart failure with preserved ejection fraction in adults with obesity. HFpEF is when the heart becomes too stiff to pump enough blood around the body. The committee said Mounjaro didn’t reduce the number of patient deaths due to heart problems in patients with obesity and HFpEF. While the drug did reduce the number of heart failure-related hospitalizations, it’s unclear whether that was due to the weight loss-independent effect of Mounjaro, CHMP said. Lilly had also been angling after the heart failure label expansion in the US, but withdrew the application for Mounjaro — marketed as Zepbound for weight loss — from the FDA in May. Despite declining to expand Mounjaro’s label for heart failure, the committee said it would include the data from Lilly’s Phase 3 SUMMIT study in the drug’s product information. Meanwhile, Novo Nordisk won the panel’s go-ahead for semaglutide, branded as Kayshild, to be used as a treatment for patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis stages F2 to F3. Semaglutide is already available in the US to treat patients with MASH, after securing FDA approval in August. CHMP also gave positive opinions for four other new therapies: The agency also gave recommendations to extend the labels of nine therapies:

Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease Recommendation supported by safety and efficacy results from several clinical studies and real-world evidenceIf approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in the EU for the treatment of adults and in children aged 12 years and older with a body weight of at least 40 kg, with chronic graft-versus-host disease (GVHD). The medicine is to be used when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted. This positive recommendation comes after Sanofi requested a re-examination of the prior negative opinion adopted by the CHMP in October 2025. The final European Commission decision is expected in the coming weeks. “Chronic GVHD can involve multiple organs and profoundly affect patients’ daily lives, limiting everyday activities and taking a substantial emotional toll,” said Prof Mohamad Mohty, Professor of Haematology, Head of the Haematology and Cellular Therapy Department at Hôpital Saint-Antoine and Sorbonne University, Paris, France. “For patients who have exhausted available treatment options, this positive opinion marks an important step forward in our ability to better manage this challenging disease.” “We sought a re-examination of the CHMP opinion, and made the commitment to conduct a new post-approval confirmatory study, given the limited late-line treatment options available for EU patients living with chronic GVHD and the body of Rezurock clinical evidence generated including data from patients in Europe,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “We remain committed to supporting the GVHD community and welcome this positive CHMP opinion, which brings us closer to delivering a new approved treatment in the EU for adult and adolescent GVHD patients who are waiting.” This CHMP recommendation is based on safety and efficacy results from several clinical studies and real-world evidence. This includes the randomised, multicentre ROCKstar phase 2 study, which demonstrated clinically meaningful and durable responses with Rezurock for patients living with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy. Treatment was generally well tolerated. Under the CHMP positive opinion for conditional marketing authorisation, Sanofi will also conduct a confirmatory randomised controlled study. Rezurock is approved in 20 countries, including the US, UK, and Canada for the treatment of patients 12 years and older with chronic GVHD after failure of at least two prior lines of systemic therapy and in China after failure of one prior line of systemic therapy. More than 17,000 patients living with chronic GVHD have been treated with Rezurock in approved countries since its first approval in the US in July 2021. About RezurockRezurock (belumosudil) is Sanofi's first-in-class selective ROCK2 (Rho-associated coiled-coil kinase 2) inhibitor (ROCK2i). It has been shown to help many different types of people with chronic GVHD after failure of any two other types of treatment. Sanofi is committed to investigating the safety and efficacy of Rezurock in other age groups and indications, including through ongoing studies for paediatric patients with chronic GVHD from one year old who have been treated with at least two prior lines of systemic therapy and for patients with chronic lung allograft dysfunction. These additional indications are currently under investigation and have not been approved by regulatory authorities. About the ROCKstar studyROCKstar was a pivotal phase 2, open label, non-controlled, randomised, multicentre study that evaluated the efficacy and safety of Rezurock in patients with chronic GVHD after receiving 2 to 5 prior lines of systemic therapy. A 3-year, open-label, follow-up analysis of the ROCKstar study evaluated the long-term efficacy of Rezurock. Treatment consisted of Rezurock 200 mg and was administered continuously until clinically significant progression of chronic GvHD or unacceptable toxicity. The primary endpoint was best overall response rate (ORR) at any time. Study results demonstrated clinically meaningful and statistically significant best ORR of 74% on treatment with Rezurock (n=77, 95% CI, 63-83). The most common adverse reactions were fatigue (46%), diarrhoea (35%), nausea (35%), dyspnoea (32%), cough (30%) and upper respiratory tract infections (26%). About chronic graft-versus-host diseaseGVHD is a life-threatening complication that can occur following stem cell transplant (or allogeneic hematopoietic stem cell transplant) where the donor’s (graft) cells attack the host’s cells, leading to inflammation and fibrosis (scarring or thickening) that can damage multiple tissues and organs. Chronic GVHD devastates the lives of up to 50% of patients who undergo an allogeneic hematopoietic stem cell transplant. GVHD is considered one of the main causes of morbidity (poor health) and late non-relapse mortality after stem cell transplant. The consequences are far-reaching, both in terms of the burden it can place on the individual’s physical and emotional well-being, as well as the broader socio-economic impact. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.comLéo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@sanofi.comVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Investor RelationsThomas Kudsk Larsen | + 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 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The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this media update are the property of the Sanofi group. Attachment Press release