Drugnews

Asia Anti-infective medicines

Anti-infectives: drugs against viruses, bacteria and fungi.

8Tracked assets
8Approved

How this track works

Anti-infective drugs target viruses, bacteria and fungi. Japanese companies have led several firsts, including baloxavir, a single-dose flu drug with a new mechanism, and cefiderocol, an antibiotic that slips into resistant bacteria by hijacking their iron uptake. China built a domestic antiviral industry during COVID-19 and has its own once-weekly HIV injection, albuvirtide. Drug-resistant bacteria remain a major unmet need, but antibiotics earn little, so new ones often depend on public funding and access partnerships.

Development stage

Approved88

Origin country / region

Japan44
China44

Assets

RankAssetINNOriginatorCountryTargetsMechanismHighest stageIndicationTrial IDsOverseas rights holderDeal dateUpfrontTotal ceilingLatest eventLatest event dateSourcesSource date
1Favipiravir (Avigan)favipiravirToyama Chemical (now FUJIFILM Toyama Chemical)JapanViral RNA polymeraseRNA polymerase inhibitorApproved — Japan (2014-03; restricted influenza use)Novel/re-emerging influenza (restricted indication); SFTS (Japan approval 2024-06)jRCT2061240089Dr. Reddy's Laboratories / Global Response Aid (2020 overseas development/commercialisation alliance; current status not fully verified)2020-06 (agreement month; announced 2020-07-01)Not disclosedNot disclosedCompany pipeline records Japan approval for SFTS in June 20242024-061 2 3 4 5 2024-06
2Baloxavir marboxil (Xofluza; S-033188)baloxavir marboxilShionogi & Co., Ltd.JapanInfluenza cap-dependent endonucleaseCap-dependent endonuclease inhibitorApproved — Japan (2018-02)Treatment of influenza; post-exposure prophylaxis (jurisdiction-specific labels)NCT02954354 | NCT07827599Roche / Genentech (worldwide excluding Japan and Taiwan)2016-02-29Not disclosedNot disclosedNew baloxavir post-exposure prophylaxis Phase 3 study registry updated; recruiting2026-10-221 2 3 4 5 6 2026-10-22
3Albuvirtide (Aikening; ABT)albuvirtideFrontier Biotechnologies Inc.ChinaHIV-1 fusionLong-acting HIV-1 fusion inhibitorApproved — China (2018-05)HIV-1 infection with other antiretrovirals in treatment-experienced patientsNCT02369965None reported———TALENT albuvirtide Phase 3 registry updated; completed2021-10-061 2 3 2021-10-06
4Cefiderocol (Fetroja / Fetcroja; S-649266)cefiderocolShionogi & Co., Ltd.JapanBacterial cell-wall synthesisSiderophore cephalosporin antibacterialApproved — United States (2019-11)Complicated urinary tract infections; hospital/ventilator-associated bacterial pneumonia (jurisdiction-specific labels)NCT02714595GARDP / sublicensees (135-country access licence); Shionogi group retains other markets2022-06-15Not disclosedNot disclosedShionogi announced China NMPA approval for complicated urinary tract infections2026-01-081 2 3 4 5 2026-01-08
5AzvudineazvudineHenan Genuine Biotech Co., Ltd.ChinaHIV-1 reverse transcriptase / VifNucleoside reverse-transcriptase and Vif inhibitor (HIV indication)Approved — China (2021-07; conditional)HIV-1 infection (combination therapy); COVID-19 (China conditional approval 2022-07)NCT04303598None reported———Company history records April 2026 application to convert HIV conditional approval to regular approval2026-041 2 3 2026-04
6Ensitrelvir (Xocova; S-217622)ensitrelvirShionogi & Co., Ltd. / Hokkaido UniversityJapanSARS-CoV-2 3CL protease3CL protease inhibitorApproved — Japan (2022-11; emergency; standard 2024-03)COVID-19 treatment (Japan); post-exposure prophylaxis (United States approval 2026)NCT05897541Medicines Patent Pool (117-country voluntary licence); Juniper Therapeutics / Therapeutix (Singapore; via Shionogi Hong Kong, formerly Ping An-Shionogi)2022-10-04 (MPP); 2023-12-06 (Juniper normal-approval/sales rights; disclosed 2023-12-19)Not disclosedNot disclosedSCORPIO-PEP Phase 3 registry updated; completed, after US post-exposure prophylaxis approval2026-10-071 2 3 4 5 6 7 8 2026-10-07
7Simnotrelvir / ritonavir (Xiannuoxin; SIM0417)simnotrelvir / ritonavirSimcere Pharmaceutical / Shanghai Institute of Materia Medica / Wuhan Institute of VirologyChinaSARS-CoV-2 3CL protease3CL protease inhibitor co-packaged with ritonavirApproved — China (2023-01; conditional; regular 2024-07)Mild to moderate COVID-19 in adultsNCT05506176None reported———Company announced conversion to regular China approval (announcement refers to July 11, 2024)2024-07-231 2 3 2024-07-23
8Leritrelvir (RAY1216; Leruiling)leritrelvirGuangdong Raynovent BiotechChinaSARS-CoV-2 3CL proteaseOral 3CL protease inhibitorApproved — China (2023-03; conditional)Mild to moderate COVID-19 in adultsNCT05620160None reported———Company year-end review records December 2023 national reimbursement-list inclusion2023-12-131 2 3 4 2024-01-03

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