Akeso's PD-1 Inhibitor Anniko Wins FDA Approval, Enters Competitive Market

Akeso, in collaboration with Sino Biopharmaceutical's Chia Tai-Tianqing Pharmaceutical, has secured FDA approval for its PD-1 inhibitor penpulimab, to be marketed as Anniko. This milestone marks Akeso's first innovative medicine to receive FDA approval, signaling a significant step forward for the company in the competitive immunotherapy landscape.

Anniko's Approved Indications and Clinical Data

Anniko has been approved for two key indications:

1. First-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma, in combination with chemotherapy.
2. Single-agent therapy for patients who have previously tried platinum-based chemotherapy and at least one other line of treatment.

The approval is based on data from two pivotal studies:

• The international phase 3 AK105-304 trial demonstrated that Anniko's combination with chemotherapy reduced the risk of progression or death by 55% compared to chemotherapy alone in the first-line setting. Median progression-free survival was 9.6 months for the Anniko arm versus 7 months for the control arm.

• The single-arm, China-only AK105-202 trial showed a 28% objective response rate in pretreated patients, with the median duration of response not reached at the time of analysis.

Market Positioning and Competition

Anniko enters a crowded field, becoming the 11th PD-1/L1 inhibitor to reach the U.S. market. Its primary competitor in the nasopharyngeal carcinoma space is Coherus BioSciences and Junshi Biosciences' Loqtorzi, which became the first FDA-approved therapy for this indication in 2023.

While the market for recurrent or metastatic nasopharyngeal carcinoma is relatively small, with an estimated 133,000 new cases diagnosed annually worldwide, Akeso CEO Michelle Xia emphasized that the approval "highlights the quality of our innovation" and underscores the company's focus on addressing difficult-to-treat cancers.

Akeso's Pipeline and Future Prospects

Beyond Anniko, investors are closely watching Akeso's PD-1xVEGF bispecific antibody, ivonescimab, which has shown promising results in non-small cell lung cancer (NSCLC) trials:

• The phase 3 HARMONi-6 trial in China found that ivonescimab combined with chemotherapy significantly outperformed BeiGene's PD-1 inhibitor Tevimbra plus chemotherapy in progression-free survival for first-line treatment of squamous NSCLC.

• This success follows the earlier HARMONi-2 study, where ivonescimab demonstrated superiority over Merck & Co.'s Keytruda as monotherapy in NSCLC.

These results have sparked speculation about ivonescimab's potential to challenge Keytruda's dominance in the lucrative NSCLC market. Citi analyst Yigal Nochomovitz noted that the latest trial proves ivonescimab's success is not a "one hit wonder," further elevating expectations for this promising bispecific antibody.