GSK, Roche and Novartis continued Big Pharma's dealmaking spree with Asian companies. Three midsized Asian biopharmas reached “most favored nation” deals with the White House. Akeso and Summit Therapeutics' ivonescimab delivered a head-to-head overall survival win against Keytruda. And more.
1. GSK pens $1.3B Hutchmed deal for early-stage KRAS-EGFR cancer asset
In a deal potentially worth nearly $1.3 billion, GSK is paying Hutchmed $110 million up front to license an antibody-targeted therapy conjugate. The preclinical candidate, coded HMPL-A830, attaches a KRAS inhibitor payload to an anti-EGFR antibody. Clinical development will initially focus on colorectal, pancreatic and lung cancers, with a phase 1 expected to start this year.
2. Roche inks $1.53B deal for Simcere’s B-cell-targeting antibody
Roche will gain exclusive global rights to a preclinical trispecific antibody targeting CD79a, CD19 and CD3 from Simcere Zaiming. The up to $1.53 billion deal features a $75 million upfront payment. The drug’s mechanism holds potential across B-cell-mediated diseases, including in patients pretreated with CD20- or CD19-directed therapies, according to Simcere.
3. Genentech doubles down on ADC-resistant cancers with $1B DualityBio pact
Roche’s Genentech has signed a platform deal to utilize DualityBio’s Dupac antibody-drug conjugate platform. The platform has produced multiple payloads, which are designed to retain efficacy in tumors that progress on topoisomerase-based ADCs. The deal includes $45 million in upfront payment and could be worth more than $1 billion in milestones.
4. White House unveils next round of MFN pricing deals with 9 midsized drugmakers
Astellas, Kyowa Kirin and Sun Pharma are among nine midsized biopharmas to have signed “most favored nation” drug pricing deals with the Trump administration this week. Besides lowering prices for Medicaid, Astellas will donate 25 kg of tacrolimus active pharmaceutical ingredient to the U.S. strategic reserve. Kyowa highlighted that its agreement includes the deferral of Section 232 tariffs.
5. Akeso, Summit’s ivonescimab extends lives in Keytruda head-to-head trial. What now?
The Chinese Harmoni-2 trial, which first sparked hopes that Akeso’s ivonescimab—and the PD-1xVEGF class by extension—could replace Keytruda, has met its overall survival endpoint in first-line PD-L1-positive non-small cell lung cancer. However, with attention circling Summit Therapeutics’ global Harmoni-3 trial, reception to the new topline readout was tepid.
6. Novartis inks $3.2B subcutaneous drug delivery deal with Alteogen
Novartis has struck a potential $3.2 billion option and license deal to develop subcutaneous products utilizing Alteogen’s ALT-B4, the same recombinant human hyaluronidase that Merck & Co. uses for its subcutaneous version of Keytruda. AstraZeneca, Biogen and GSK are also among the South Korean company’s customers.
7. Takeda bolsters blood cancer portfolio with FDA nod for Mimrylo in polycythemia vera
Takeda won FDA approval for Mimrylo, or rusfertide, for the rare blood cancer polycythemia vera. It’s the first drug for PV that mimics hepcidin, a hormone that regulates iron in the body, to control overproduction of red blood cells, a hallmark of the disorder. Mimrylo is among three launches that Takeda’s new CEO, Julie Kim, is counting on to drive future growth.
Other News of Note:
8. Why Roche is 'really excited' about a UCN2 analog for obesity after seeing preclinical data
9. FDA leaders telegraph tightened foreign clinical data oversight (FDA Voices)
10. AZ, Hutchmed combo hits ph.3 goal in first-line lung cancer subtype (release)
11. Alumis crushed by midstage lupus flop but plots path to phase 3 for TYK2 inhibitor
12. FDA dings Alar over ‘extremely concerning’ ketamine claims