ALTEOGEN Inc.

Merck's subcutaneous pembrolizumab with berahyaluronidase alfa demonstrated noninferior pharmacokinetics compared to intravenous KEYTRUDA in a pivotal Phase 3 trial for metastatic non-small cell lung cancer treatment.

AstraZeneca has secured worldwide rights to Alteogen's ALT-B4 hyaluronidase technology to develop subcutaneous formulations of several oncology drugs currently administered intravenously.

• Daiichi Sankyo has entered a $300 million partnership with Alteogen to develop a subcutaneous formulation of the cancer drug Enhertu, potentially making it the first injectable ADC. • The collaboration leverages Alteogen's Hybrozyme platform with ALT-B4 enzyme technology, receiving $20 million upfront with $280 million in potential milestone payments. • Enhertu's strong market performance, with $1.77 billion in sales during H1, could be further enhanced by this development, helping maintain its competitive edge against emerging oral therapies.

Merck's subcutaneous pembrolizumab, co-administered with berahyaluronidase alfa, met its dual primary pharmacokinetic endpoints in a Phase 3 trial for metastatic NSCLC.

Merck's subcutaneous Keytruda, combined with chemotherapy, demonstrated non-inferiority to intravenous Keytruda plus chemotherapy in treating metastatic non-small cell lung cancer (NSCLC).

Merck's subcutaneous formulation of Keytruda, combined with Alteogen's berahyaluronidase alfa, demonstrates comparable efficacy to intravenous Keytruda in treating first-line metastatic non-small cell lung cancer (NSCLC).

• Alteogen has applied for marketing authorization in Korea for ALT-L9, a biosimilar of aflibercept (Eylea®), marking a significant step in expanding treatment options for retinal diseases. • A Phase 3 study conducted across 12 countries demonstrated that ALT-L9 met its primary endpoint, establishing therapeutic equivalence to the reference product, Eylea®. • Alteogen's subsidiary, Altos Biologics, previously submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9, with potential approval expected in 2025.

• Altos Biologics, a subsidiary of South Korea's Alteogen, has completed patient enrollment in its Phase III clinical trial of ALT-L9, a biosimilar to Regeneron's Eylea (aflibercept) for wet age-related macular degeneration. • The randomized, double-masked, multicenter study has enrolled 431 patients with wet AMD, building on successful Phase I results that demonstrated similar safety and efficacy profiles to the originator product. • Alteogen plans to submit a biologics license application in early 2024, with European market launch anticipated in the first half of 2025, targeting a share of Eylea's $9.2 billion global market.