{"schema_version":"1.0","type":"article","title":"TaiMed Bets on HIV Treatment as PrEP Hits $40","url":"https://drugnews.com.tw/articles/2026-11-08-taimed-long-acting-hiv-lenacapavir-generic-40-en.html","markdown_url":"https://drugnews.com.tw/articles/2026-11-08-taimed-long-acting-hiv-lenacapavir-generic-40-en.md","lang":"en","date":"2026-11-08","publish_at":"2026-11-08T08:00:00+08:00","updated_at":"2026-11-08","category":"商業分析系列","topic":"公司研究","tags":["TaiMed","HIV","lenacapavir","long-acting","Gilead"],"summary":"FDA tentatively approved Dr. Reddy's generic lenacapavir at about $40 a year versus Gilead's $28,218 US price. Prevention pricing is settled; the next prize is long-acting maintenance treatment, where TaiMed's TMB-365/380 Phase 2b reads out by year-end.","key_points":["On 2026-11-02 the FDA tentatively approved Dr. Reddy's generic lenacapavir at about $40 per person per year for 120 low- and middle-income countries; Gilead's Yeztugo lists at $28,218 a year in the US.","Gilead's Q3 HIV sales rose 18% to $6.2 billion and Yeztugo sold $305 million; ViiV's every-four-month antibody N6LS showed 94% (IV) and 82% (SC) suppression at 12 months versus 88% on oral therapy.","On 2026-11-03 TaiMed said Phase 2b interim results for TMB-365/380 are due by year-end and that it is in licensing and co-development talks with global drugmakers and the NIH."],"facts":[{"claim":"Yeztugo US list price","value":28218,"unit":"USD/year","as_of":"2025-06","source":"Contagion Live"},{"claim":"Generic lenacapavir price","value":40,"unit":"USD/person/year","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"Countries covered by licenses","value":120,"unit":"countries","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"People in Africa started on lenacapavir","value":125000,"unit":"people (more than)","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"Gilead no-profit supply ceiling","value":3000000,"unit":"people through 2028","as_of":"2026-09-16","source":"Gilead"},{"claim":"Gilead Q3 HIV sales","value":6.2,"unit":"USD billion","as_of":"2026-09-30","source":"Gilead Q3 2026"},{"claim":"Gilead Q3 HIV growth","value":18,"unit":"%","as_of":"2026-09-30","source":"Gilead Q3 2026"},{"claim":"Biktarvy Q3 sales","value":4.1,"unit":"USD billion","as_of":"2026-09-30","source":"Gilead Q3 2026"},{"claim":"Biktarvy US treatment share","value":53,"unit":"%","as_of":"2026-09-30","source":"Investing.com"},{"claim":"Yeztugo Q3 sales","value":305,"unit":"USD million","as_of":"2026-09-30","source":"Investing.com"},{"claim":"Weekly oral Yeztugo PDUFA","value":"2027-02-02","unit":"date","as_of":"2026-06-15","source":"Gilead"},{"claim":"EMBRACE month-12 suppression IV/SC/oral","value":"94/82/88","unit":"%","as_of":"2026-02-25","source":"ViiV"},{"claim":"TMB-365 max viral load drop","value":1.57,"unit":"log10 copies/mL","as_of":"2026-10-21","source":"TaiMed"},{"claim":"TMB-380-reduced variants neutralized by TMB-365","value":"19/20","unit":"variants","as_of":"2026-10-21","source":"TaiMed"},{"claim":"TMB-365/380 Phase 2a participants","value":20,"unit":"people","as_of":"2026-10-21","source":"TaiMed"},{"claim":"Taiwan new HIV cases 2025","value":850,"unit":"cases (est.)","as_of":"2025-12-29","source":"CNA"},{"claim":"Taiwan PrEP quota 2026","value":9500,"unit":"people","as_of":"2025-12-29","source":"CNA"},{"claim":"Taiwanese nationals living with HIV","value":36494,"unit":"people","as_of":"2025-11","source":"CNA"}],"sections":["01 | From a US price to an Indian price in 16 months","02 | Cheap abroad, profitable at home","03 | Winners and losers","04 | The real fight: freeing stable patients from daily pills","05 | Both giants bet on antibodies, and both hit the same wall","06 | TaiMed's card: guard the host's door","07 | Why the big companies need an outside antibody","08 | Taiwan: record-low infections, rising long-term costs","09 | What to read in the interim data","10 | Where this call could fail","References"],"references":[{"title":"FDA Tentatively Approves First Generic Lenacapavir PrEP for 120 LMICs","source":"Contagion Live","date":"2026-11-03","url":"https://www.contagionlive.com/view/fda-tentatively-approves-first-generic-lenacapavir-prep-for-120-lmics"},{"title":"FDA approves generic version of HIV prevention shot lenacapavir","source":"STAT","date":"2026-11-02","url":"https://statnews.com/pharmalot/2026/11/02/lenacapavir-generic-version-approved-fda-hiv-prevention-dr-reddys"},{"title":"Gilead Sciences Announces Third Quarter 2026 Financial Results","source":"Gilead Sciences","date":"2026-10-29","url":"https://investors.gilead.com/news/news-details/2026/Gilead-Sciences-Announces-Third-Quarter-2026-Financial-Results/default.aspx"},{"title":"Gilead Q3 2026 slides: HIV sales surge drives decade-best growth","source":"Investing.com","date":"2026-10-29","url":"https://www.investing.com/news/company-news/gilead-q3-2026-slides-hiv-sales-surge-drives-decadebest-growth-93CH-4985434"},{"title":"Gilead Accelerates Global Access Planning for Investigational Once-Yearly Lenacapavir","source":"Gilead Sciences","date":"2026-09-16","url":"https://investors.gilead.com/news/news-details/2026/Gilead-Accelerates-Global-Access-Planning-for-Investigational-Once-Yearly-Lenacapavir-for-HIV-Prevention/default.aspx"},{"title":"U.S. FDA Accepts Gilead's Application for Investigational Once Weekly Oral Yeztugo","source":"Gilead Sciences","date":"2026-06-15","url":"https://www.gilead.com/news/news-details/2026/u-s--fda-accepts-gileads-application-for-investigational-once-weekly-oral-yeztugo-potentially-the-first-long-acting-pill-for-hiv-prevention"},{"title":"FDA Approves First Twice-a-Year HIV Prevention Shot, Yeztugo","source":"Drugs.com","date":"2025-06-20","url":"https://www.drugs.com/news/fda-approves-first-twice-year-hiv-prevention-shot-125459.html"},{"title":"bNAb lotivibart (N6LS) maintains high levels of viral suppression","source":"ViiV Healthcare","date":"2026-02-25","url":"https://viivhealthcare.com/en-us/media-center/news/press-releases/2026/february/bnab-lotivibart-n6ls-maintains-high-levels-of-viral-suppression/"},{"title":"Gilead HIV research at CROI 2026","source":"Business Wire","date":"2026-02-17","url":"https://www.businesswire.com/news/home/20260217423823/en"},{"title":"TaiMed Biologics Reports IDWeek 2026 Data Highlighting TMB-365","source":"GlobeNewswire","date":"2026-10-21","url":"https://www.globenewswire.com/news-release/2026/10/21/3385515/0/en/taimed-biologics-reports-idweek-2026-data-highlighting-tmb-365-and-its-potential-across-long-acting-hiv-combinations.html"},{"title":"TaiMed advances long-acting HIV dual-antibody Phase 2b, interim results by year-end","source":"Anue (cnyes","date":"2026-11-03","url":"https://news.cnyes.com/news/id/6645221"},{"title":"TaiMed targets year-end interim data, overseas partnerships progress","source":"Economic Daily News","date":"2026-11-03","url":"https://udn.com/news/story/7241/9854710"},{"title":"TaiMed Phase 2b enrollment passes 80%","source":"uAnalyze","date":"2026-04-07","url":"https://uanalyze.com.tw/articles/7636350164"},{"title":"Taiwan's new HIV cases hit record low; PrEP quota to rise to 9,500","source":"OCAC News (CNA","date":"2025-12-30","url":"https://ocacnews.net/article/416432"},{"title":"U.S. FDA Approves Gilead's Bixlenvo, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV","source":"Gilead Sciences","date":"2026-08-27","url":"https://gilead.com/news/news-details/2026/u-s--fda-approves-gileads-bixlenvo-a-new-once-daily-single-tablet-option-for-virologically-suppressed-adults-with-hiv-including-those-on-complex-regimens"},{"title":"4 key takeaways from the third round of drugs selected for Medicare drug price negotiation","source":"Milliman","date":"2026-02-20","url":"https://www.milliman.com/en/insight/key-takeaways-third-medicare-drug-price-negotiation"},{"title":"A Phase 2b Study of the Safety, Pharmacokinetics, and Efficacy of the Combination of TMB-365 and TMB-380 as Maintenance Therapy in HIV-1 Infected Individuals Suppressed With Combination Antiretroviral Therapy (NCT07215468","source":"ClinicalTrials.gov","date":"2026-11-05","url":"https://clinicaltrials.gov/study/NCT07215468"},{"title":"Broadly neutralising antibodies may be partners for long-acting antiretrovirals","source":"aidsmap (CROI 2024 report","date":"2024-03","url":"https://www.aidsmap.com/news/mar-2024/broadly-neutralising-antibodies-may-be-partners-long-acting-antiretrovirals"}],"images":[{"alt":"Fig. 1 | One shot, two prices","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40-en/figure-01.png"},{"alt":"Fig. 2 | Gilead's HIV engine, third quarter 2026","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40-en/figure-02.png"},{"alt":"Fig. 3 | Two ways to block HIV entry","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40-en/figure-03.png"},{"alt":"Fig. 4 | Three long-acting maintenance contenders","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40-en/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40-en/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-11-08）。TaiMed Bets on HIV Treatment as PrEP Hits $40。https://drugnews.com.tw/articles/2026-11-08-taimed-long-acting-hiv-lenacapavir-generic-40-en.html","disclaimer":"This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/","ai_question":"What changed for On 2026-11-02 the FDA tentatively approved Dr?"}