China Sets 2030 Goal to Develop 25% of Global First-in-Class Drugs

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.

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Keytruda in combination with Pfizer's Padcev for an expanded bladder cancer indication. The CHMP recommended Keytruda and its subcutaneous formulation, Keytruda Qlex, each in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment in adult patients with resectable muscle-invasive bladder cancer. The opinion was based on data from the phase III KEYNOTE-B15 study, conducted in collaboration with Pfizer and Astellas, and will now be reviewed by the European Commission, with a final decision expected in the fourth quarter of 2026. If approved, the regimen would become the first and only PD-1 inhibitor plus antibody-drug conjugate combination approved for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility in Europe. The same regimen was approved by the FDA for the same indication in July 2026, while a separate cisplatin-ineligible MIBC approval was granted by the European Commission in June 2026 based on the phase III KEYNOTE-905 study. Keytruda generated $16.40 billion in sales in the first half of 2026, up 4.2% year over year, while Padcev, added from the December 2023 Seagen acquisition, generated $1.26 billion in the first half of 2026, up 30% year over year.