FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2)
(aflibercept-mrbb)

EQS-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2)
(aflibercept-mrbb)

28-Jun-2024 / 23:50 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation
(EU) No 596/2014, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Disclosure of inside information according to Article 17 of the Regulation
(EU) No 596/2014

FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2)
(aflibercept-mrbb)

Planegg-Martinsried, Germany, 28. June 2024 - Formycon AG (FSE: FYB,
"Formycon") and its licensing partner Klinge Biopharma GmbH ("Klinge")
announce that the U.S. Food and Drug Administration ("FDA") today approved
FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®.

FYB203/AHZANTIVE® obtained FDA approval for the treatment of patients with
neovascular Age-Related (wet) Macular Degeneration (nAMD) and other serious
retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy
(DR) and Macular Edema following Retinal Vein Occlusion (RVO).

The approval for FYB203/AHZANTIVE® is based on a thorough evaluation of a
comprehensive data package including analytical, pre-clinical, clinical and
manufacturing data. FYB203/AHZANTIVE® demonstrated comparable efficacy,
safety, pharmacokinetics and immunogenicity to the reference drug Eylea® in
patients with neovascular Age-Related (wet) Macular Degeneration (nAMD).

1) Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.
2) AHZANTIVE® is a registered Trademark of Klinge Biopharma GmbH

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

phone +49 (0) 89 - 86 46 67 149 | fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

Disclaimer
Certain statements contained in this release may constitute "forward-looking
statements" that involve a number of risks and uncertainties.
Forward-looking statements can generally be identified by the use of the
words "may," "will," "should," "plan," "expect," "anticipate," "estimate,"
"believe," "intend," "project," or "aim," or the negative of these words or
other variations of these words or comparable terminology. Forward-looking
statements are based on assumptions, forecasts, estimates, projections,
opinions or plans that, by their nature, are subject to significant risks
and uncertainties and contingencies that are subject to change.

Formycon does not and will not give any assurance that any forward-looking
statement will be achieved or prove to be accurate. Actual future business,
financial condition, results of operations and prospects may differ
materially from those projected or anticipated in the forward-looking
statements. Subject to applicable legal requirements, neither Formycon nor
any other person intends to update, review, revise or revise any
forward-looking statements in this release to reflect actual events or
developments, whether as a result of new information becoming available, new
developments occurring in the future or otherwise, nor does it undertake any
such obligation.


End of Inside Information

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   Language:       English
   Company:        Formycon AG
                   Fraunhoferstraße 15
                   82152 Planegg-Martinsried
                   Germany
   Phone:          089 864667 100
   Fax:            089 864667 110
   Internet:       www.formycon.com
   ISIN:           DE000A1EWVY8
   WKN:            A1EWVY
   Indices:        Scale 30
   Listed:         Regulated Unofficial Market in Berlin, Dusseldorf,
                   Frankfurt (Scale), Hamburg, Munich, Stuttgart,
                   Tradegate Exchange
   EQS News ID:    1936195

End of Announcement EQS News Service
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1936195 28-Jun-2024 CET/CEST