(Yicai) Aug. 26 -- Akeso’s shares climbed after the Chinese drugmaker said results from the Phase III clinical trial of its innovative drug ivonescimab in combination with chemotherapy showed it outperformed other global first‑line treatments for advanced biliary tract cancer.

Akeso [HKG: 9926] closed up 6 percent at HKD94.20 (USD12.02) a share in Hong Kong today, after earlier surging by as much as 9 percent. The stock is still down nearly 17 percent since the end of last year.

The Phase III registrational study of ivonescimab, a programmed cell death protein 1/vascular endothelial growth factor bispecific antibody, plus chemotherapy for advanced BTC returned positive topline results with statistical significance and meaningful clinical benefit, the Zhongshan-based company announced today.

The study’s control arm used AstraZeneca’s programmed death-ligand 1 monoclonal antibody durvalumab combined with chemotherapy, the current preferred first‑line immunotherapy regimen for BTC recommended by Chinese and foreign clinical guidelines, Akeso noted. Global sales of durvalumab jumped 29 percent to USD6.1 billion last year.

This was ivonescimab’s first positive Phase III outcome in gastrointestinal oncology, following four positive Phase III readouts in lung cancer indications, said Dr. Xia Yu, founder, chairman, president, and chief executive of Akeso. The result shows that the drug’s groundbreaking clinical value is expanding from lung cancer to a broader range of solid tumors, he added.

Ivonescimab captured global market attention when it became the world’s first innovative drug to beat Keytruda in a head‑to‑head Phase III efficacy trial. Developed by Merck, which is known as Merck Sharp & Dohme outside of the United States and Canada, Keytruda is the world’s best-selling PD‑1 monoclonal antibody.

Ivonescimab has secured Chinese regulatory approval for lung cancer indications, while its US marketing application remains under regulatory review.

PD-L1 agents have secured their cornerstone status in immuno‑oncology thanks to broad-spectrum and durable anti‑tumor activity. However, they cannot fully meet unmet clinical needs because of constraints from tumor microenvironment complexity and drug resistance.

PD‑1/VEGF bispecific antibodies, exemplified by ivonescimab, are expected to challenge the market position of PD‑L1 monoclonal antibodies epitomized by the so‑called “drug king” pembrolizumab, driven by efficacy advantages in treating some tumors.

Editors: Tang Shihua, Martin Kadiev