Hope Ignites: HLX22 Secures Key European Status in Gastric Cancer Fight!

• Lifeline Extended: HLX22, an anti-HER2 antibody, secures European Orphan Drug Designation for gastric cancer, a notoriously difficult-to-treat disease.
• Global Recognition: This critical European milestone follows a similar U.S. FDA designation, underscoring HLX22's global potential against HER2-positive gastric cancer.
• Strategic Victory: Originator Alligator Bioscience (STO:ATORX) is poised for significant returns, entitled to 35% of AbClon's revenue from the Henlius sublicense developing HLX22.

The air crackles with renewed hope for patients battling gastric cancer. The European Commission has just thrown its weight behind HLX22, granting it coveted Orphan Drug Designation (ODD) for this devastating illness^{2, 4}. This monumental step, announced May 26, 2025, signals a powerful endorsement for the anti-HER2 monoclonal antibody, originally developed by Alligator Bioscience.

This European recognition comes hot on the heels of a similar ODD from the U.S. Food and Drug Administration in March 2025¹, painting a clear picture: HLX22 is a serious contender in the fight against HER2-positive gastric and gastroesophageal junction (GEJ) cancer. Shanghai Henlius Biotech, Inc., which is developing HLX22 under sublicense from AbClon, Inc.^{1, 2, 3}, is already spearheading a global Phase 3 clinical trial (NCT06532006)^{1, 3}. This trial is evaluating HLX22 in a potent combination with trastuzumab and chemotherapy as a first-line defense for patients with metastatic forms of the disease across the U.S., China, Japan, and Australia^{1, 3}.

HLX22 isn't just another drug; it's a sophisticated humanized antibody designed to unleash the immune system against HER2-expressing tumor cells through mechanisms like antibody-dependent cell cytotoxicity (ADCC) and T lymphocyte stimulation³. Early trials have already showcased a good safety profile⁵. For Alligator Bioscience, the original innovators, this European ODD is more than just validation. They stand to receive 35% of AbClon's revenue from the Henlius sublicense^{1, 2, 4}, proving that pioneering science can yield critical advancements for patients and strategic success. This designation, granted for conditions affecting no more than five in 10,000 people in the EU, offers crucial incentives like protocol assistance, fee reductions, and a vital ten years of market exclusivity post-approval, fuelling the urgent drive to bring this potential lifeline to those who need it most.

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References

1. alligatorbioscience.se
2. alligatorbioscience.se
3. adisinsight.springer.com
4. www.marketscreener.com
5. alligatorbioscience.se
6. www.biospace.com
7. alligatorbioscience.se
8. alligatorbioscience.se