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Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer

Lund, Sweden – 9 Dec 2025 – Alligator Bioscience (Nasdaq Stockholm: ATORX) today comments on the announcement by Shanghai Henlius Biotech, Inc. that applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (an antibody-drug conjugate targeting HER2) have been approved by China’s National Medical Products Administration (NMPA). The trials are intended for first-line treatment of HER2-positive breast cancer and for neoadjuvant treatment of HER2-positive breast cancer.

HLX22 is an anti-HER2 monoclonal antibody being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

“Shanghai Henlius regulatory approvals to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer represent continued progress for this programme and broaden its clinical development,” said Søren Bregenholt, CEO of Alligator Bioscience. ”While Alligator is not directly involved in the development, we follow HLX22 closely as it represents an opportunity for future revenue streams from milestones and royalties upon potential approval.”

Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius. For further information and the latest updates on HLX22’s clinical development, please refer to Henlius’ announcement available on HKEXnews.

For further information, please contact:

Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00

The information was submitted for publication, through the agency of the contact person set out above, at 12:00 p.m. CET on 9 December 2025.

About Alligator Bioscience

Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company’s lead drug candidate mitazalimab is currently ready for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1.

Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.

For more information, please visit alligatorbioscience.com.

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Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer

Datum 2025-12-09, kl 12:00
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Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer
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