BioNTech与DualityBio公布trastuzumab pamirtecan治疗HR+/HER2-low转移性乳腺癌的3期试验顶线结果
6-K - BioNTech SE (0001776985) (Filer)
BioNTech与DualityBio宣布，评估trastuzumab pamirtecan治疗HR+/HER2-low转移性乳腺癌的全球3期DYNASTY-Breast02临床试验已公布顶线结果。相关新闻稿作为Exhibit 99.1附于BioNTech的6-K文件。
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 OCTOBER 2026
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(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 ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On October 26, 2026, BioNTech SE (Nasdaq: BNTX, “BioNTech”) and DualityBiologics (Suzhou) Co., Ltd. (“DualityBio”, HKEX: 9606.HK) announced topline results of the DYNASTY-Breast02 global Phase 3 clinical trial evaluating trastuzumab pamirtecan in HR+/HER2-low metastatic breast cancer. The press release is attached as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioNTech SE | ||||||||||||||
By: | /s/ Ramon Zapata-Gomez | By: | /s/ Dr. Sierk Poetting | |||||||||||
Name: Ramon Zapata-Gomez | Name: Dr. Sierk Poetting | |||||||||||||
Title: Chief Financial Officer | Title: Chief Operating Officer | |||||||||||||
Date: October 26, 2026
EXHIBIT INDEX
Exhibit | Description of Exhibit | ||||
99.1 | |||||
来源：SEC EDGAR · 本站存档