{"schema_version":"1.0","type":"article","title":"愛滋預防針跌到40美元，中裕抗體搶治療端","url":"https://drugnews.com.tw/articles/2026-11-08-taimed-long-acting-hiv-lenacapavir-generic-40.html","markdown_url":"https://drugnews.com.tw/articles/2026-11-08-taimed-long-acting-hiv-lenacapavir-generic-40.md","lang":"zh-Hant","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":["中裕","愛滋","lenacapavir","長效療法","Gilead"],"summary":"FDA 11 月 2 日暫時核准印度 Dr. Reddy's 的 lenacapavir 學名藥，一年約 40 美元；吉立亞美國牌價 28,218 美元。預防端的價格分級已定，下一個大錢在穩定病人的長效維持療法，中裕 TMB-365/380 年底公布 2b 期中結果。","key_points":["FDA 於 2026-11-02 暫時核准 Dr. Reddy's 的 lenacapavir 學名藥，約每人每年 40 美元，供 120 個中低收入國家；Gilead 的 Yeztugo 美國牌價每年 28,218 美元。","Gilead 第三季愛滋營收 62 億美元、年增 18%，Yeztugo 單季 3.05 億美元；ViiV 的抗體 N6LS 每四個月一次，12 個月病毒抑制率靜脈組 94%、皮下組 82%、口服對照 88%。","中裕 11 月 3 日表示 TMB-365/380 的 2b 期關鍵期中結果今年底前出爐，並已與國際藥廠及 NIH 洽談授權與共同研發。"],"facts":[{"claim":"Yeztugo 美國牌價","value":28218,"unit":"美元/年","as_of":"2025-06","source":"Contagion Live"},{"claim":"Dr. Reddy's lenacapavir 學名藥價","value":40,"unit":"美元/人/年","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"學名藥適用國家數","value":120,"unit":"國","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"Yeztugo 核准到學名藥暫時核准","value":16,"unit":"月","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"非洲已開始使用 lenacapavir 人數","value":125000,"unit":"人（以上）","as_of":"2026-11-02","source":"Contagion Live"},{"claim":"Gilead 不賺錢供應計畫上限","value":3000000,"unit":"人（至2028）","as_of":"2026-09-16","source":"Gilead 2026-09-16 新聞稿"},{"claim":"Gilead Q3 愛滋營收","value":6.2,"unit":"十億美元","as_of":"2026-09-30","source":"Gilead Q3 2026 財報"},{"claim":"Gilead Q3 愛滋營收年增","value":18,"unit":"%","as_of":"2026-09-30","source":"Gilead Q3 2026 財報"},{"claim":"Biktarvy Q3 營收","value":4.1,"unit":"十億美元","as_of":"2026-09-30","source":"Gilead Q3 2026 財報"},{"claim":"Biktarvy 美國治療市占","value":53,"unit":"%","as_of":"2026-09-30","source":"Investing.com Q3 slides"},{"claim":"Descovy Q3 營收年增","value":49,"unit":"%","as_of":"2026-09-30","source":"Gilead Q3 2026 財報"},{"claim":"Yeztugo Q3 營收","value":305,"unit":"百萬美元","as_of":"2026-09-30","source":"Investing.com Q3 slides"},{"claim":"Yeztugo Q3 季增","value":31,"unit":"%","as_of":"2026-09-30","source":"Investing.com Q3 slides"},{"claim":"每週口服 Yeztugo PDUFA","value":"2027-02-02","unit":"日期","as_of":"2026-06-15","source":"Gilead 2026-06-15 新聞稿"},{"claim":"EMBRACE 12 個月抑制率：靜脈／皮下／口服","value":"94/82/88","unit":"%","as_of":"2026-02-25","source":"ViiV 新聞稿"},{"claim":"TMB-365 一期最大病毒量下降","value":1.57,"unit":"log10 copies/mL","as_of":"2026-10-21","source":"中裕 IDWeek 新聞稿"},{"claim":"TMB-380 敏感度下降株仍被 TMB-365 擋住","value":"19/20","unit":"株","as_of":"2026-10-21","source":"中裕 IDWeek 新聞稿"},{"claim":"TMB-365/380 二期a 受試者","value":20,"unit":"人","as_of":"2026-10-21","source":"中裕 IDWeek 新聞稿"},{"claim":"中裕 2b 期中結果時程","value":"2026 年底前","unit":"時程","as_of":"2026-11-03","source":"鉅亨網、經濟日報"},{"claim":"台灣 2025 新增感染","value":850,"unit":"例（估）","as_of":"2025-12-29","source":"中央社"},{"claim":"台灣公費 PrEP 名額 2026","value":9500,"unit":"人","as_of":"2025-12-29","source":"中央社"},{"claim":"台灣本國籍感染者","value":36494,"unit":"人","as_of":"2025-11","source":"中央社"},{"claim":"吉立亞 lenacapavir＋teropavimab＋zinlirvimab 早期試驗篩檢人數與合格比例","value":"124 人／44%","unit":"人／%","as_of":"2024-03","source":"aidsmap（CROI 2024）"},{"claim":"中裕 TMB-365/380 2b 期收案人數","value":88,"unit":"人","as_of":"2026-11-05","source":"ClinicalTrials.gov NCT07215468"},{"claim":"中裕 2b 期給藥方式","value":"每 8 週靜脈輸注","unit":"","as_of":"2026-11-05","source":"ClinicalTrials.gov NCT07215468"},{"claim":"中裕 2b 期主要分析預計完成","value":"2027-05","unit":"日期","as_of":"2026-11-05","source":"ClinicalTrials.gov NCT07215468"},{"claim":"Biktarvy Medicare 議價價格生效日","value":"2028-01-01","unit":"日期","as_of":"2026-02-20","source":"Milliman 2026-02-20"},{"claim":"FDA 核准 Bixlenvo","value":"2026-08-27","unit":"日期","as_of":"2026-08-27","source":"Gilead Sciences 2026-08-27"}],"sections":["01｜七百倍價差，是吉立亞自己切出來的","02｜下一戰：穩定病人不用天天吃藥","03｜中裕的牌：守住人體細胞的門","04｜大廠缺的，是一支不挑病毒的抗體","05｜年底只看一件事：抗體組有沒有追平口服","台股連結","參考資料"],"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（官方","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（官方","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（官方","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（官方","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（Gilead 官方新聞稿","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（中裕官方新聞稿","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":"中裕全力推進長效愛滋雙抗體新藥臨床2b試驗 今年底前取得期中結果","source":"鉅亨網","date":"2026-11-03","url":"https://news.cnyes.com/news/id/6645221"},{"title":"中裕長效愛滋雙抗體拚年底取得期中數據 海外合作布局取得進展","source":"經濟日報","date":"2026-11-03","url":"https://udn.com/news/story/7241/9854710"},{"title":"中裕愛滋新藥臨床2b試驗收案突破8成 可望提前完成收案","source":"優分析（轉載鉅亨網","date":"2026-04-07","url":"https://uanalyze.com.tw/articles/7636350164"},{"title":"台灣愛滋新增感染創新低 PrEP名額明年增至9500人","source":"宏觀新聞（中央社","date":"2025-12-30","url":"https://ocacnews.net/article/416432"},{"title":"HIV 新藥很好賺呀...吉利德財報披露","source":"藥時事","date":"2026-05-19","url":"https://drugnews.com.tw/articles/2026-05-19-gilead-hiv-yeztugo-prep-growth.html"},{"title":"Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries","source":"Gilead Sciences（官方","date":"2014-09-15","url":"https://www.gilead.com/news/news-details/2014/gilead-announces-generic-licensing-agreements-to-increase-access-to-hepatitis-c-treatments-in-developing-countries"},{"title":"U.S. FDA Approves Gilead's Bixlenvo, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV","source":"Gilead Sciences（官方","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 報導","date":"2024-03","url":"https://www.aidsmap.com/news/mar-2024/broadly-neutralising-antibodies-may-be-partners-long-acting-antiretrovirals"}],"images":[{"alt":"圖1｜同一支預防針，兩個世界的價格","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40/figure-01.png"},{"alt":"圖2｜吉立亞第三季：愛滋仍是印鈔機","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40/figure-02.png"},{"alt":"圖3｜兩種抗體，兩種擋法","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40/figure-03.png"},{"alt":"圖4｜長效維持療法三強，同一把尺","url":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/taimed-long-acting-hiv-lenacapavir-generic-40/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）。愛滋預防針跌到40美元，中裕抗體搶治療端。https://drugnews.com.tw/articles/2026-11-08-taimed-long-acting-hiv-lenacapavir-generic-40.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}