Baloxavir Marboxil

The Xofluza license deal between Roche and the Medicines Patent Pool comes as ongoing hantavirus and Ebola outbreaks have once again thrust pandemic preparedness into the spotlight. (Roche/Genentech) Roche has signed a voluntary license agreement providing its popular influenza antiviral drug Xofluza (baloxavir marboxil) for generic drugmakers to copy in 129 developing countries. The deal with the Medicines Patent Pool will enable generic supply of baloxavir in 129 low- and middle-income countries, “both supporting seasonal flu and broader pandemic preparedness and response efforts,” MPP said in a May 18 release. The deal will create “additional supply pathways for equitable access, which is particularly important during a pandemic, when demand is the highest,” MPP, a United Nations-backed organization, said in the release. As part of the Roche deal, MPP is seeking applications from qualified generic manufacturers with the required capacity to support the development and supply of generic Xofluza. Once the generic makers are identified, Roche will provide access to a data package, reference Xofluza product for bioequivalence studies and necessary regulatory waivers. Each sublicensee will still be responsible for independently developing and producing its generic versions. Ongoing outbreaks of hantavirus and Ebola have once again thrust pandemic preparedness into the spotlight. As much as the Xofluza deal is about improving access to influenza treatment in low- and middle-income nations, it also “reflects a shared commitment to pandemic prevention, preparedness and response […] ensuring that the necessary tools and manufacturing capacity are in place before the next health emergency,” Charles Gore, executive director of MPP, said in a statement. Roche CEO Thomas Schinecker added that the license is “an important step towards strengthening global health resilience, particularly in LMICs.” Roche has first-hand experience with what a health crisis could look like for Xofluza demand. A surge in influenza cases in China in early 2025 sparked fears of a shortage as antiviral medications became difficult to find. In response, Roche redirected its Xofluza supply to the country to ensure stability. China is not one of the 129 countries included in the latest Roche-MPP deal because the Swiss pharma “already has a strong presence in the country, including dedicated manufacturing and distribution capabilities for Xofluza,” a Roche spokesperson told Fierce. “Our selection of countries for this voluntary license with MPP was a deliberate, strategic decision to prioritize regions where access challenges are the highest and populations are most vulnerable in the event of a potential outbreak,” the spokesperson added. The unpredictability of each flu season has caused major fluctuations in Roche’s Xofluza sales. In the first quarter of 2026, Xofluza sales of 19 million Swiss francs hit 83% below analysts’ expectations, the biggest gap in the company’s earnings for the three months. Roche cited a weaker flu season and, consequently, a year-over-year decline in China as the reason for the drug’s sales decline. As a follow-up to Roche’s Tamiflu, Xofluza was first approved in the U.S. in 2018 as a treatment for acute uncomplicated influenza and was later cleared for the prevention of the flu following contact with an infected person. Through a “most favored nation” drug pricing deal recently signed with the Trump administration, Roche is offering Xofluza on the direct-to-consumer platform TrumpRx for $50 rather than the regular $168. This isn’t the first time Roche has partnered with MPP, which pools intellectual property to facilitate generic supplies for underserved regions. Back in 2013, Roche agreed with MPP to provide Valcyte, a drug used to prevent and manage cytomegalovirus infections, at lower costs for people living with HIV in 138 developing countries. Antivirals represent a big component of MPP’s licensing partnerships with the industry. The Unitaid-funded organization has made HIV medication deals with GSK and Gilead Sciences, and it also struck agreements for oral COVID-19 drugs from Pfizer and Merck & Co. during the pandemic. The content above comes from the network. if any infringement, please contact us to modify.

Sac-TMT's three positive phase 3 trials, strategies in striking China biotech deals, and Takeda's first-of-its-kind pay-for-delay verdict made our news this week. Merck & Co. and Kelun-Biotech's sac-TMT is on fire this week with details or first reports of three positive phase 3 trials. Local know-how, proper due diligence and AI are helpful in striking licensing deals in China, experts say. For the first time, a federal jury has found a drugmaker liable in a pay-for-delay case. And more.1. ASCO: Merck, Kelun's sac-TMT ADC combo beats Keytruda by 65% on progression in first-line lung cancerMerck, Kelun score with sac-TMT in endometrial cancer trialCombining Merck & Co. and Kelun-Biotech’s TROP2 antibody-drug conjugate sac-TMT with Keytruda cut the risk of progression or death by 65% versus Keytruda alone in first-line, PD-L1-positive non-small cell lung cancer, according to an ASCO 2026 abstract detailing results from the OptiTROP-Lung05 study in China. The data look competitive compared with Akeso and Summit Therapeutics’ PD-1xVEGF bispecific ivonescimab as a monotherapy.Meanwhile, sac-TMT just had its first global phase 3 win, as Merck’s TroFuse-005 trial met both its progression-free survival and overall survival endpoints at an interim analysis. The study pitted sac-TMT against chemo in previously treated endometrial cancer. Then, Kelun announced that its OptiTROP-Breast03 trial in China also showed a “statistically significant and clinically meaningful improvement” in PFS and a “positive trend” regarding OS for sac-TMT versus chemotherapy at an interim analysis. The first-line triple-negative breast cancer study enrolled patients with PD-L1-negative tumors, as well as those with PD-L1-positive expression who had received prior anti-PD-(L)1 inhibitor therapy in early-stage disease.2. Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep upWhen doing biotech deals in China, Geoff Meyerson, founder and CEO of Locust Walk, stressed the importance of having people on the ground. Sidley Austin lawyer Adam Welland highlighted the importance of due diligence, including around development strategies. And Mwyngil Therapeutics CEO Luba Greenwood said the explosion of data and candidates in China makes AI a powerful sourcing tool.3. Takeda slapped with $885M verdict in pay-for-delay antitrust caseA federal jury in Boston has found that Takeda conspired with a competitor to delay the entry of a generic version of its constipation drug Amitiza as part of a class-action lawsuit filed by purchasers of the drug. The jury ordered the company to pay $885 million in damages, which will be tripled upon final decision under antitrust law.  4. Daiichi, AstraZeneca’s Enhertu breaks into early breast cancer with dual FDA approvalsDaiichi Sankyo and AstraZeneca’s Enhertu got two simultaneous FDA go-aheads in early breast cancer, making the HER2 ADC both a neoadjuvant and an adjuvant treatment. However, the adjuvant label excludes the possibility of continued use of Enhertu in patients who already received it in the neoadjuvant setting.5. Eisai's slow push toward blockbuster Leqembi sales gains steam with $900M forecastBiogen-shared Alzheimer’s disease drug Lemqebi generated 88 billion ($555 million) Japanese yen of sales in Eisai’s 2025 fiscal year. As the use of blood-based tests increases and more convenient formulations attract new patients, Eisai hopes the anti-amyloid antibody will reach 143.5 billion yen ($905 million) in fiscal 2026 sales. 6. Amgen's Tavneos, facing liver injury scrutiny, gets label update in Japan as patient starts resumeAfter Kissei Pharmaceutical paused new patient starts of Amgen-partnered rare disease med Tavneos in Japan, the company has worked with the local authority to revise the drug’s label, and doctors can now resume prescriptions. The move followed reports of 20 fatal cases of serious liver injury among Tavneos takers in the country, and it came as the same problem has drawn regulatory concerns in both EU and the U.S.Other News of Note:7. Novartis terminates plant contract with Chinese CDMO Porton, threatens $64M in legal claims8. Gilead inks another deal with Korean API manufacturer Yuhan, this time worth $140M9. Vincentage sees 12.4% weight loss for oral GLP-1, will chase Lilly to Chinese regulators10. GHO Capital, CBC Group plan to merge, forming $21B healthcare investment firm11. Roche signs generic Xofluza licensing deal with Medicines Patent Pool for 129 countries12. Otsuka can’t reverse generic’s win over kidney drug patents (Bloomberg Law)13. Singapore court keeps injunction against KBP as Novo fraud case plays out in arbitration (release)