Akeso's first overall survival readout for its Keytruda challenger caused a violent market reaction. AstraZeneca disclosed another potential fine in China. Ono unveiled layoffs in a notice filed in Massachusetts. And more.
Akeso’s initial overall survival data for its Summit Therapeutics-partnered ivonesimab rocked the PD-1xVEGF bispecific field. In the closely watched HARMONi-2 Keytruda head-to-head trial in first-line PD-L1-positive non-small cell lung cancer, ivonesimab cut the risk of death by 22.3% at an unplanned interim analysis, which did not meet statistical significance. Akeso, Summit and BioNTech all saw their share prices plummet following the news, although Akeso CEO Michelle Xia, Ph.D., said the market’s interpretation of the data “deviated from the core of the issue.”
2. AstraZeneca telegraphs new fine in China over Enhertu (release)
AstraZeneca said it could face a fine of up to $8 million in China over the alleged illegal importation of the antibody-drug conjugate Enhertu. In a separate case around suspected unlawful collection of personal information, AZ said it has been informed by authorities that there was no illegal gain to the firm from the alleged conduct. The company recorded 5% revenue growth at constant exchange rates in China in the first quarter, generating $1.8 billion in sales in the country.
3. Ono Pharma lays off 83 staffers at Cambridge, Massachusetts, site
Ono Pharma disclosed an 83-person layoff round in Cambridge, Massachusetts, where the Japanese company’s U.S. headquarters are located. Ono last year acquired Waltham, Massachusetts-based Deciphera Pharmaceuticals, which in February produced an FDA approval for the tenosynovial giant cell tumor drug Romvimza.
4. Daiichi Sankyo, AstraZeneca's highly touted ADC Datroway off to 'smooth market launch'
Daiichi Sankyo CEO Hiroyuki Okuzawa described the initial launch of AstraZeneca-partnered Datroway as “smooth.” After a Japanese nod in December and an FDA approval in January, the TROP2-directed antibody-drug conjugate has generated 1.4 billion Japanese yen ($10 million) in sales for Daiichi as of March 2025.
In another milestone for Akeso, the Chinese biotech has received its very first FDA approval. The drug, a PD-1 inhibitor called penpulimab and co-developed with Sino Biopharmaceutical, has been approved in nasopharyngeal carcinoma. To be marketed under the brand name Anniko, the drug will compete with Coherus BioSciences and Junshi Biosciences’ fellow China-made PD-1 Loqtorzi.
6. Samsung Biologics inks $518M production contract with US pharma, extending CDMO's dealmaking streak
7. Tariffs push GE HealthCare to cut 2025 guidance, despite strong quarterly sales
8. Sandoz licenses Henlius’ biosimilar candidate targeting BMS’ Yervoy (release)