Merck Wins CHMP Backing for Keytruda-Padcev Combo in Bladder Cancer

AstraZeneca and Daiichi Sankyo's Enhertu has been cleared for use by England's National Health Service for patients with HER2-low metastatic breast cancer, reversing an earlier NICE decision that rejected funding on cost-effectiveness grounds. NICE's revised recommendation follows changes to drug valuation methods and a U.S.-UK agreement aimed at aligning medicine prices, and around 1,000 women in England are expected to benefit annually. Enhertu carries a list price of £1,455 per 100 mg vial, although the financial terms agreed with NICE were not disclosed, and NICE cited clinical evidence showing a six-month survival benefit for some patients. The decision expands access in one of Europe's largest healthcare markets and comes as Enhertu is already a significant growth driver: combined sales reported by AstraZeneca and Daiichi Sankyo reached $2.96 billion in the first half of 2026, up 29% from $2.29 billion a year earlier, while AstraZeneca's own H1 alliance revenue from Enhertu rose to $1.06 billion from $834 million. In Europe, AstraZeneca reported $401 million of Enhertu revenue, up 28%, and combined global sales increased 36% in FY2025 to $4.98 billion, with AstraZeneca's alliance revenue reaching $1.80 billion versus $1.44 billion in 2024. The direct financial contribution from England may remain relatively limited given the roughly 1,000 patients expected annually and the undisclosed commercial terms, making the incremental revenue, margin, or cash-flow benefit difficult to quantify.

Beijing has unveiled a five-year plan aimed at making China a global leader in drug innovation, with a target of developing 25% of the world's first-in-class drugs by 2030. The plan, issued in a joint notice from multiple government ministries, lays out 25 priority tasks spanning innovation capacity, research and technology, including expanded R&D, the use of AI and quantum computing in drug discovery, and the building of pharmaceutical ecosystems beyond pipelines. The government aims for the industry to reach 3.5tn yuan, or $520bn, in annual revenue by 2030, with 50 companies exceeding $1.5bn in annual revenue, and at least five Chinese drugs achieving global annual sales above $1bn. The notice singled out next-generation therapies including antibody-drug conjugates, cell and gene therapies, and CAR-T, along with vaccines and newer platforms such as mRNA, and included a section on industrialising traditional Chinese medicine. Citi analysts said the plan signals a shift from scale-driven growth toward innovation-driven, quality-oriented development, with a broad whole-value-chain policy push covering innovative drugs, medical devices, AI-driven drug discovery, and CDMO/CRO. The biomedical plan was released alongside counterparts for other strategic sectors, including integrated circuits, aerospace, the low-altitude economy, new energy storage and intelligent robotics.