Akeso's Ivonesimab Data Shakes Bispecific Market, AstraZeneca Faces China Probe

Akeso's Ivonesimab Trial Results Cause Market Turbulence

Akeso's first overall survival readout for its PD-1xVEGF bispecific antibody, ivonesimab, has sent shockwaves through the pharmaceutical industry. In the HARMONi-2 trial, a head-to-head comparison with Merck's Keytruda in first-line PD-L1-positive non-small cell lung cancer, ivonesimab demonstrated a 22.3% reduction in the risk of death at an unplanned interim analysis. However, this result did not meet statistical significance, leading to a violent market reaction.

The news caused significant stock price declines for Akeso, its partner Summit Therapeutics, and BioNTech. Akeso's CEO, Michelle Xia, Ph.D., attempted to reset expectations, stating that the market's interpretation of the data "deviated from the core of the issue." Despite the market turmoil, the company remains optimistic about ivonesimab's potential.

In a separate development, Akeso and Sino Biopharmaceutical received FDA approval for their PD-1 inhibitor, penpulimab, marketed as Anniko. The drug is approved for nasopharyngeal carcinoma and will compete with Coherus BioSciences and Junshi Biosciences' Loqtorzi in the U.S. market.

AstraZeneca's China Challenges and Daiichi Sankyo Partnership

AstraZeneca disclosed potential legal troubles in China, facing a possible fine of up to $8 million over the alleged illegal importation of the antibody-drug conjugate Enhertu. The company also addressed a separate case involving suspected unlawful collection of personal information, stating that authorities found no illegal gain to the firm from the alleged conduct.

Despite these challenges, AstraZeneca reported a 5% revenue growth at constant exchange rates in China for the first quarter, generating $1.8 billion in sales.

On a more positive note, AstraZeneca's partnership with Daiichi Sankyo continues to bear fruit. Their jointly developed antibody-drug conjugate, Datroway (datopotamab deruxtecan), has seen a "smooth market launch" according to Daiichi Sankyo CEO Hiroyuki Okuzawa. Following approvals in Japan and the United States, Datroway generated 1.4 billion Japanese yen ($10 million) in sales for Daiichi as of March 2025.

Industry Reshuffling: Layoffs and New Partnerships

The pharmaceutical landscape continues to evolve, with companies adjusting their workforce and forging new alliances. Ono Pharma announced a significant layoff of 83 staffers at its Cambridge, Massachusetts site, which houses the Japanese company's U.S. headquarters. This move comes in the wake of Ono's acquisition of Waltham, Massachusetts-based Deciphera Pharmaceuticals, which recently secured FDA approval for the tenosynovial giant cell tumor drug Romvimza.

In the contract development and manufacturing organization (CDMO) sector, Samsung Biologics has inked a $518 million production contract with an unnamed U.S. pharmaceutical company, extending its streak of major deals.

Sandoz, meanwhile, has licensed a biosimilar candidate targeting Bristol Myers Squibb's Yervoy from Henlius, further expanding its biosimilar portfolio.

These developments underscore the ongoing realignment of resources and partnerships within the pharmaceutical industry as companies seek to optimize their operations and product pipelines.