Sanofi Completes $600 Million Acquisition of DR-0201 to Enhance Immunology Pipeline and Advance Autoimmune Disease Treatments

Sanofi Completes $600 Million Acquisition of DR-0201 to Enhance Immunology Pipeline and Advance Autoimmune Disease Treatments

(IN BRIEF) Sanofi has completed the acquisition of DR-0201 from Dren Bio, now renamed SAR448501, to enhance its immunology pipeline. This bispecific myeloid cell engager, which has shown promising results in B-cell depletion, may offer potential breakthroughs in autoimmune diseases, including lupus. The deal, worth $600 million upfront with additional milestone payments of up to $1.3 billion, strengthens Sanofi’s position in the immunology sector. Dren Bio will maintain its operations independently to further its development of antibody therapeutics targeting pathogenic cells.

(PRESS RELEASE) PARIS, 28-May-2025 — /EuropaWire/ — Sanofi has successfully finalized its acquisition of DR-0201, a promising bispecific myeloid cell engager, from Dren Bio, Inc., a private, clinical-stage biopharmaceutical enterprise. This strategic acquisition strengthens Sanofi’s goal of becoming the leader in immunology and expands its already prominent immunology portfolio.

Now designated as SAR448501, DR-0201 has demonstrated significant B-cell depletion in both pre-clinical and early clinical trials. This innovative, first-in-class bispecific myeloid cell engager targets specific tissue-resident and circulating myeloid cells to trigger substantial B-cell depletion via selective phagocytosis.

Initial findings from pre-clinical and early clinical studies in autoimmune disorders suggest that profound B-cell depletion may be capable of resetting the adaptive immune system, which could result in long-lasting treatment-free remission in patients suffering from refractory B-cell mediated autoimmune diseases like lupus, a condition with substantial unmet medical needs.

The acquisition of DR-0201 was completed through the purchase of Dren Bio’s affiliate, Dren 0201, Inc., for an upfront payment of $600 million, with the potential for an additional $1.3 billion in milestone-based payments tied to future development and launch progress. Dren Bio will remain independent, continuing its mission to advance its portfolio of antibody therapeutics targeting pathogenic cells and other disease-related agents.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. 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.

Media Contacts:

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@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

Dren Bio
Jeff Macfarland, EVP, Finance | ir@drenbio.com

SOURCE: Sanofi

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