Tzield China approval, SAR402663 fast track, brivekimig positive Phase 2a

Rhea-AI Filing Summary

Sanofi reported three corporate press developments in September 2025 affecting its late-stage pipeline. On September 10, 2025, Tzield was approved in China as the first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes, marking a regulatory milestone for that indication in China. On September 11, 2025, Sanofi announced that SAR402663 received fast track designation in the U.S. for neovascular age-related macular degeneration, which can accelerate development and review. On September 17, 2025, Sanofi reported positive phase 2a results for brivekimig in hidradenitis suppurativa. The report is signed by Alexandra Roger, Head of Legal Corporate & Finance.

Positive

• Tzield approved in China as the first disease-modifying therapy for adult and pediatric stage 2 type 1 diabetes, a clear regulatory milestone
• SAR402663 received fast track designation in the U.S. for neovascular age-related macular degeneration, potentially accelerating development and review
• Brivekimig showed positive phase 2a results in hidradenitis suppurativa, indicating early clinical efficacy signal

Negative

• None.

Insights

Biopharma Regulatory Analyst

TL;DR: Three regulatory and clinical milestones improve Sanofi's pipeline positioning across diabetes, ophthalmology, and dermatology.

Each announcement signals progress at different development and regulatory stages. The China approval of Tzield as the first disease-modifying therapy for stage 2 type 1 diabetes is a clear market-access milestone within that jurisdiction and patient population. Fast track designation for SAR402663 in the U.S. may shorten development timelines and facilitate earlier interactions with regulators for neovascular AMD. Positive phase 2a data for brivekimig suggest proof-of-concept in hidradenitis suppurativa but will require larger studies to confirm efficacy and safety. Together, these items indicate diversified clinical momentum across therapeutic areas.

Clinical Development Specialist

TL;DR: Clinical signals and regulatory support are favorable but differ in immediacy and evidentiary weight.

The China approval represents an immediate regulatory outcome enabling potential commercialization locally. Fast track designation is procedural support that can expedite development but is not an approval. Positive phase 2a results are an encouraging early efficacy signal; however, phase 2a is exploratory and requires confirmatory trials. These distinctions affect near-term commercial impact versus longer-term value creation.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of September 2025

Commission File Number: 001-31368

SANOFI

(Translation of registrant’s name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒   Form 40-F ☐

1

In September 2025, Sanofi published the press releases attached hereto as Exhibits 99.1, and 99.2 and 99.3 which are incorporated herein by reference.

Exhibit Index

Exhibit No.		Description
Exhibit 99.1		Press Release dated September 10, 2025: Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes
Exhibit 99.2		Press Release dated September 11, 2025: Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
Exhibit 99.3		Press Release dated September 17, 2025: EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: September 17, 2025				SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

3

FAQ

What regulatory milestone did Sanofi report for Tzield (SNYNF) in September 2025?

On September 10, 2025 Sanofi reported that Tzield was approved in China as the first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes.

What is the significance of fast track designation for SAR402663 announced by Sanofi?

On September 11, 2025 Sanofi said SAR402663 earned U.S. fast track designation for neovascular age-related macular degeneration, which can facilitate expedited development and more frequent FDA interactions.

What clinical data did Sanofi disclose about brivekimig in September 2025?

On September 17, 2025 Sanofi reported that brivekimig achieved positive phase 2a results in hidradenitis suppurativa.

Who signed the Sanofi 6-K report summarizing these announcements?

The report is signed by Alexandra Roger, listed as Head of Legal Corporate & Finance.

Do these disclosures include financial results or transaction details?

No. The filing contains press release headlines and dates about regulatory and clinical events but does not include financial results or transaction details.