Tislelizumab

Some four months after the White House inked the last of its expected drug pricing deals with 17 of the industry’s top players, the U.S. government is back for round 2, this time lining up agreements with a host of medium-sized biopharmas under President Trump’s ‘most favored nation’ agenda. Up at the dealmaking table for this round are Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals and UCB, according to a White House fact sheet issued Monday afternoon. Notably, the new list includes companies from further afield than Europe and the U.S.—which dominated the first 17 MFN accords struck from last year through late April of 2026—with Sun based in India, Teva hailing from Israel, and Astellas and Kyowa Kirin headquartered in Japan, not to mention CSL in Australia. Under the terms laid out in the fact sheet, the agreements are set to curb Medicaid prices on drugs for conditions like hemophilia, Parkinson’s disease, macular degeneration, glaucoma, liver disease, skin conditions and multiple types of cancer. Details are mostly thin on which of the companies’ specific drugs are included in the pricing agreements and the precise discounts in the offering. The President’s MFN drug pricing campaign has broadly sought to realign prescription costs in the U.S. based on what certain high-income comparator countries pay. Specifically, the administration has worked toward MFN prices by utilizing net prices paid in Canada, Denmark, France, Germany, Italy, Japan, Switzerland and the U.K. While the administration has made big claims about the scope of savings its pricing measures could deliver, the fine details of the previous government-industry deals remain murky, with their true impact on medicine affordability for U.S. patients a continuing topic of debate. As with previous MFN deals, the midsized drugmakers lining up to sign have made financial commitments to their U.S. operations, too, boasting a collective investment pledge of at least $19.6 billion in American production in the near term, according to the fact sheet. Several of the firms have also agreed to donate active pharmaceutical ingredients (APIs) for certain products to the U.S. Strategy Active Pharmaceutical Ingredients Reserve (SAPIR), which the White House says will help curb reliance on foreign suppliers and bolster supplies in the event of a potential emergency. While many companies have agreed to onshore or expand certain portions of their manufacturing processes to the U.S. in recent years, the fundamental step of producing drug ingredients remains largely concentrated overseas in countries like China and India. Belgium’s UCB has agreed to contribute 163 tons of API for the seizure drug levetiracetam, while Sun will throw in 71.4 tons and 6.75 tons of the antibiotics clindamycin and doxycycline, respectively. For its part, Teva is pitching in 45 tons of the antibiotic metronidazole and 4.8 tons of the hypertensive drug amlodipine, while Astellas is adding 25 kg of the immunosuppressant tacrolimus to the SAPIR. While the White House release did not allude to tariffs on Monday, the cudgel of trade duties has been ever present in the deals struck so far. In the first round of agreements, of which Regeneron was the last to sign on in April, Big Pharma companies from Pfizer and AstraZeneca to Roche, Novartis and Johnson & Johnson made a combination of drug pricing commitments and domestic investment pledges to win temporary immunity from the Trump administration’s drug import tariffs . Midsized companies were not involved in the first round of dealmaking. Individual company press releases Monday, like UCB’s, suggest that tariff immunity is still very much part of the MFN equation. Oncology specialist BeOne also said it locked down an exemption from Section 232 pharmaceutical tariffs because of its investments in U.S. manufacturing. The company leaned on its participation in GENEROUS, an industry-government negotiation framework laid out early this year under which manufacturers provide rebates to participating states for certain drugs. Although the company sells multiple products in the U.S., currently only PD-1 inhibitor Tevimbra is subject to the Medicaid program. Meanwhile, BridgeBio will also expand state Medicaid access to Attruby under the GENEROUS model . The drug for transthyretin amyloid cardiomyopathy is the California company’s only commercial brand. Thanks to the new agreement, the company said Monday that it “does not expect to be subject to future pricing mandates.” Reporting $502.1 million in full-year revenues in 2025, BridgeBio is notably smaller than many of the other “mid-sized” pharmas who have lined up for this second round of deals. CSL, for its part, tied the agreement with the government to a recently disclosed plan for a $1.5 billion manufacturing plant expansion near Chicago. The company specified that under the deal, it will provide Medicaid access to its drugs at prices on par with other developed countries, alongside a pledge to similarly price any new therapies for all payers in the U.S. “These agreements provide a sustainable and stable access framework to important medicines for people living with rare diseases and serious conditions while strengthening the manufacturing capabilities, supply infrastructure and scientific innovation required to deliver those therapies reliably,” Diego Sacristan, CSL’s commercial chief, said in a statement. Recognizing the lack of similarly positioned firms at the table, 10 U.S. biotechs forged the Midsized Biotech Alliance of America (MBAA) back in February, taking aim at Trump’s MFN policy writ large. The group, whose original lineup included Alkermes, Alnylam, Ardelyx, BioMarin, Exelixis, Incyte and Neurocrine Biosciences, argued at the time that midsized companies are less well-positioned to weather MFN than resource-stocked Big Pharma, given that they’re often reliant on a single marketed product targeting more niche patient needs.

Jazz Pharmaceuticals has added a second overall survival win to Ziihera’s cap, bolstering the bispecific’s claim as the new HER2 agent of choice in stomach cancer. On the heels of a broad FDA approval for first-line HER2-positive gastroesophageal adenocarcinoma (GEA), the phase 3 trial supporting Ziihera’s recent nod reported meeting the overall survival endpoint in another comparison. This time, Ziihera plus chemo showed a statistically significant and clinically meaningful improvement in OS compared with trastuzumab (Herceptin) plus chemo during the second interim analysis of the Herizon-GEA-01 trial, Jazz announced Monday. Previously, Ziihera’s combination with BeOne Medicines’ PD-1 inhibitor Tevimbra and chemo delivered a positive OS readout at the first interim analysis with a 28% improvement over the trastuzumab-chemo duo. At that time, the Ziihera-chemo combo posted a favorable trend toward a 20% death-risk reduction, which didn’t pass the statistical significance threshold. Now, the magnitude of improvement has improved for both Ziihera regimens, either with or without Tevimbra, according to Jazz. “These results reinforce our confidence that Ziihera is the new HER2-targeted backbone therapy in first-line HER2+ advanced GEA, replacing trastuzumab and extending survival beyond the current standard of care,” Jazz’s R&D chief, Rob Iannone, M.D., said in an Aug. 31 statement. The FDA approved Ziihera to expand into HER2-positive GEA on Aug. 25. Following the approval, citing clinical data and potential to expand Ziihera’s development program, Jazz increased its peak sales projection of the HER2 bispecific antibody to a range between $3 billion and $5 billion, up from the previous $2 billion-plus target. The latest FDA nod came with an unexpected black box warning about diarrhea adverse events, including life-threatening cases. However, analysts mostly viewed the safety issue as manageable given the relatively low discontinuation rate in the Herizon-GEA-01 trial. The FDA label for the Ziihera-Tevimbra-chemo regimen covers tumors with HER2 expressions at IHC 3+ and IHC 2+/ISH+ , while the Ziihera-chemo doublet is limited to patients with IHC 3+ only. During a call with analysts on Aug. 25, Jazz’s chief commercial officer, Samantha Pearce, said that the company believes that Ziihera-Tevimbra-chemo is the “preferred choice” for all indicated patients, except those to whom Tevimbra may be contraindicated. While the second OS readout would be interesting to see, Jazz’s commercial focus will be on the Tevimbra-including triplet, she said on the call. Based on the FDA label, Jefferies analysts have put Ziihera’s peak sales potential in first-line GEA at more than $1.5 billion, while Leerink Partners analysts suggest the drug could reach $2.7 billion in the indication. GEA includes cancers of the stomach, gastroesophageal junction and esophagus and is the fifth most common cancer worldwide. About 20% of patients have HER2-positive disease, which translates into about 8,000 U.S. cases per year, according to Jazz. For Ziihera, the company said that about 3,000 to 4,000 patients in the U.S. are eligible to receive treatment in the first-line, unresectable disease setting and are tested for HER2.