Akeso is on a winning streak.

Following a positive readout for its closely watched PD-1xVEGF bispecific ivonescimab, Akeso has won the FDA’s go-ahead for its PD-1 inhibitor penpulimab co-developed with Sino Biopharmaceutical’s Chia Tai-Tianqing Pharmaceutical.

To be marked as Anniko, penpulimab is approved alongside chemotherapy for the first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma, or as a single agent in patients who have tried platinum-based chemo and at least one other prior line of therapy.

As Akeso noted Thursday, Anniko marks the company’s first innovative medicine to receive FDA approval. Previously, the drug has been approved in China for nasopharyngeal carcinoma, a rare cancer that develops in the nasopharynx, the upper part of the throat at the back of the nose. 

A separate application for Anniko in combination with Sino Biopharm’s VEGFR2 inhibitor anlotinib in first-line liver cancer is under review with Chinese authorities.

About 10 PD-1/L1 inhibitors have reached the U.S. market before Akeso. The FDA nod puts Anniko in direct competition with Coherus BioSciences and Junshi Biosciences’ fellow China-made PD-1 Loqtorzi, which became the first FDA-approved therapy for nasopharyngeal carcinoma in 2023.

The two Anniko indications are based on the international phase 3 AK105-304 trial and the pivotal AK105-202 study.

In the phase 3 trial, Anniko’s chemo combination reduced the risk of progression or death by 55% versus chemo alone in the first-line setting, according to the FDA. Patients in the Anniko arm lived without progression for a median 9.6 months, which is significantly longer than the 7 months recorded by the control arm.

Overall survival, a key secondary endpoint, was immature at the time of analysis, with 70% of prespecified deaths for the final analysis reported. According to the FDA, there was no sign of detriment to patients’ lives at this point. The full data from AK105-304 will be presented at the 2025 American Association for Cancer Research annual meeting in the following days.

Previously, Loqtorzi got its first-line nod after showing its cocktail with chemo could significantly reduce the risk of death by 37% versus chemo alone in a phase 3 trial.

As to the single-arm, China-only AK105-202 trial, Anniko triggered a 28% objective response rate in pretreated patients, and the median duration of response was not reached at the time of the analysis.

Recurrent or metastatic nasopharyngeal carcinoma is not a large business opportunity. Citing a WHO 2020 analysis, Akeso noted that 133,000 new nasopharyngeal cancer cases are diagnosed annually worldwide, with 70% at a locally advanced stage. After an official rollout in the U.S. at the beginning of 2024, Coherus recorded $19.1 million Loqtorzi sales last year.

According to the American Cancer Society, there is fewer than one case for every 100,000 people each year in the U.S., though it has higher rates in certain other countries, notably in South Asia. 

But the approval “highlights the quality of our innovation” and “underscores Akeso’s focus on delivering treatments for difficult-to-treat cancers for patients around the world,” Akeso CEO Michelle Xia, Ph.D., said in a statement.

Despite Anniko’s breakthrough for Akeso on the international market, investors’ focus remains on the company’s Summit Therapeutics-partnered PD-1xVEGF bispecific ivonescimab, which has shown potential to replace Merck & Co.’s PD-1 blockbuster Keytruda as the new immunotherapy king in non-small cell lung cancer.

Earlier this week, Akeso said the phase 3 HARMONi-6 trial in China found that ivonescimab and chemo did significantly better than BeiGene’s PD-1 inhibitor Tevimbra and chemo on progression-free survival for the first-line treatment of squamous NSCLC.

That latest positive trial proves that ivonescimab’s head-to-head win against Keytruda as NSCLC monotherapies in the HARMONi-2 study was not a “one hit wonder,” Citi analyst Yigal Nochomovitz, Ph.D., said in a note.