Baloxavir Marboxil

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)

iStock, Wirestock By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries. Roche has signed off on generic production of its antiviral influenza treatment baloxavir marboxil, inking a voluntary license agreement to expand access to the drug. The Swiss company’s agreement with the Medicines Patent Pool (MPP), a United Nations–backed public health body, will allow generic manufacturers to develop, produce and supply baloxavir in 129 low- and middle-income countries. MPP has asked companies that want to supply the product in the countries to send details of their capacity, capabilities and track record for manufacturing quality-assured medicines. Roche’s Genentech charges U.S. cash-pay patients $50 for the antiviral, which it sells as Xofluza, under the terms of a direct-to-patient initiative introduced last year. The cash-pay rate is 70% lower than the list price, Genentech said. Allowing generic companies to manufacture and supply the drug could support lower prices outside the U.S. and other advanced economies. The model adopted by MPP, which struck its first deal in 2011, has cut the annual cost of an HIV drug to $70 in Africa, compared to $10,000 in Europe, Marisol Touraine, chair of the executive board at MPP-backer Unitaid, said in a statement. Most of MPP’s agreements cover HIV, but the organization also has licenses for treatments of conditions including hepatitis C, tuberculosis and cancer. Baloxavir is a long-standing target for MPP, with the body including the single-dose oral antiviral treatment on the priority licensing list in its 2024 annual report. In 2023, MPP said baloxavir is available in a small number of low- and middle-income countries at prices that are generally higher than for oseltamivir, another antiviral that Roche sells as Tamiflu. Clinical trials have shown that the time to the alleviation of influenza signs and symptoms is similar for baloxavir and oseltamivir. Baloxavir is administered once, compared to twice daily for five days on oseltamivir. FDA FDA Approves Flu Treatment for Preventative Use After Exposure Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency. November 24, 2020 · 3 min read · Brandon May Read more Manufacturing informed MPP’s decision to prioritize securing a license for baloxavir. Production involves a standard manufacturing process for tablets, MPP said, and there are no challenges related to excipients or final packaging. Roche will give generic manufacturers access to a foundational data package, reference products for bioequivalence studies and necessary regulatory waivers. Securing rights to baloxavir will support seasonal flu and broader pandemic preparedness and response efforts, MPP said. The deal contains specific provisions for pandemics, with Roche and MPP agreeing to collaborate to remove access barriers such as “supply constraints, territory restrictions and royalties” in the event of a global flu outbreak.