Dear Shareholders and Investors,

 

We are pleased to share that Daiichi Sankyo has initiated a Phase 1 clinical trial for the subcutaneous (SC) formulation of Enhertu, utilizing ALT-B4, Alteogen’s proprietary recombinant human hyaluronidase.

 

Daiichi Sankyo, a global pharmaceutical company, entered into a license agreement with Alteogen in November 2024 to incorporate ALT-B4 into the SC development of its blockbuster ADC therapy, Enhertu. Following the U.S. FDA’s Investigational New Drug (IND) clearance, the company has commenced preparations for patient enrollment in a Phase 1 study.

 

The clinical trial is now listed on ClinicalTrials.gov:
https://clinicaltrials.gov/study/NCT07015697?intr=nct07015697&rank=1#contacts-and-locations

 

As previously announced, the agreement with Daiichi Sankyo includes license payments of up to USD 300 million (excluding royalties) for the use of ALT-B4, reflecting the growing recognition of Alteogen’s SC platform technology in the global biopharmaceutical industry.

We remain committed to delivering innovative solutions through Hybrozyme™, and will continue to provide timely updates as development progresses.

 

Thank you for your continued support.

Alteogen.