{
  "as_of": "2026-11-06",
  "title": "長效愛滋藥賽道",
  "title_en": "Long-Acting HIV Treatment and Prevention",
  "slug": "long-acting-hiv",
  "groups": {
    "tx": "治療",
    "tx_en": "Treatment",
    "prep": "預防（PrEP）",
    "prep_en": "Prevention (PrEP)"
  },
  "assets": [
    {
      "group": "tx",
      "section": "approved",
      "asset": "Trogarzo（ibalizumab）",
      "asset_en": "Trogarzo (ibalizumab)",
      "company": "中裕新藥（TaiMed，4147）",
      "company_en": "TaiMed Biologics (TPEx: 4147)",
      "country": "台灣",
      "country_en": "Taiwan",
      "mechanism": "單株抗體，結合人體 CD4 受體，讓病毒進不了細胞",
      "mechanism_en": "Monoclonal antibody that binds the human CD4 receptor so the virus cannot enter cells",
      "route": "靜脈注射",
      "interval": "每 2 週",
      "interval_en": "Every 2 weeks",
      "stage": "已核准",
      "stage_en": "Approved",
      "indication": "多重抗藥、多種療法失敗的成人感染者",
      "indication_en": "Heavily treatment-experienced adults with multidrug-resistant HIV",
      "trials": [],
      "deal": "北美：Theratechnologies；台灣：友華生技（4120）2024-05 獨家",
      "deal_en": "North America: Theratechnologies; Taiwan: exclusive commercialization agreement with Orient EuroPharma (4120) signed in May 2024",
      "latest": "2026-06 TFDA 核准函；2026-07-06 中裕宣布取得領證通知",
      "latest_en": "TFDA approval letter in June 2026; TaiMed announced receipt of the TFDA license-issuance notice on 2026-07-06",
      "date": "2026-07-06",
      "sources": [
        "https://www.taimedbiologics.com/article_d.php?id=3701&lang=tw&tb=5",
        "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000lbl.pdf",
        "https://wantrich.chinatimes.com/news/20260706900556-420101",
        "https://www.biospace.com/press-releases/taimed-biologics-4147-receives-tfda-drug-license-collection-notice-for-trogarzo-marking-the-final-step-toward-commercial-launch-in-taiwan"
      ],
      "asia": true
    },
    {
      "group": "tx",
      "section": "approved",
      "asset": "Cabenuva（cabotegravir＋rilpivirine）",
      "asset_en": "Cabenuva (cabotegravir + rilpivirine)",
      "company": "ViiV Healthcare／嬌生（Janssen）",
      "company_en": "ViiV Healthcare / Janssen",
      "country": "英國／美國",
      "country_en": "UK / US",
      "mechanism": "整合酶抑制劑＋非核苷反轉錄酶抑制劑，長效針劑",
      "mechanism_en": "Integrase inhibitor plus NNRTI, long-acting injection",
      "route": "肌肉注射",
      "interval": "每月或每 2 個月",
      "interval_en": "Monthly or every 2 months",
      "stage": "已核准",
      "stage_en": "Approved",
      "indication": "病毒已抑制的成人，及 12 歲以上、體重 ≥35 kg 青少年",
      "indication_en": "Virologically suppressed adults and adolescents aged 12 years or older weighing at least 35 kg",
      "trials": [],
      "deal": "—",
      "deal_en": "—",
      "latest": "2021-01-21 FDA 核准，第一個完整的長效注射治療",
      "latest_en": "FDA-approved on 2021-01-21, the first complete long-acting injectable regimen",
      "date": "2021-01-21",
      "sources": [
        "https://www.jnj.com/media-center/press-releases/janssen-announces-u-s-fda-approval-of-cabenuva-rilpivirine-and-cabotegravir-the-first-long-acting-regimen-for-the-treatment-of-hiv",
        "https://www.gsk.com/en-gb/media/press-releases/cabenuva-demonstrates-superiority-to-daily-oral-therapy-in-adolescents-living-with-hiv-as-viiv-healthcare-highlights-new-long-acting-injectable-data-at-aids-2026/"
      ],
      "asia": false
    },
    {
      "group": "tx",
      "section": "approved",
      "asset": "Sunlenca（lenacapavir）",
      "asset_en": "Sunlenca (lenacapavir)",
      "company": "吉立亞（Gilead）",
      "company_en": "Gilead Sciences",
      "country": "美國",
      "country_en": "US",
      "mechanism": "衣殼抑制劑",
      "mechanism_en": "Capsid inhibitor",
      "route": "皮下注射",
      "interval": "每 6 個月",
      "interval_en": "Every 6 months",
      "stage": "已核准",
      "stage_en": "Approved",
      "indication": "多重抗藥成人感染者（搭配其他藥）",
      "indication_en": "Multidrug-resistant HIV in adults (with other drugs)",
      "trials": [],
      "deal": "—",
      "deal_en": "—",
      "latest": "2022-12-22 FDA 核准，第一個一年兩次的愛滋治療",
      "latest_en": "FDA-approved on 2022-12-22, the first twice-yearly HIV treatment",
      "date": "2022-12-22",
      "sources": [
        "https://www.gilead.com/news/news-details/2022/sunlenca-lenacapavir-receives-fda-approval-as-a-first-in-class-twice-yearly-treatment-option-for-people-living-with-multi-drug-resistant-hiv"
      ],
      "asia": false
    },
    {
      "group": "tx",
      "section": "approved",
      "asset": "艾博韋泰（albuvirtide）",
      "asset_en": "Albuvirtide (Aikening)",
      "company": "前沿生物（Frontier Biotechnologies）",
      "company_en": "Frontier Biotechnologies",
      "country": "中國",
      "country_en": "China",
      "mechanism": "長效融合抑制劑",
      "mechanism_en": "Long-acting HIV-1 fusion inhibitor",
      "route": "靜脈注射",
      "interval": "每週",
      "interval_en": "Weekly",
      "stage": "已核准（中國）",
      "stage_en": "Approved (China)",
      "indication": "曾接受治療的感染者（併用其他抗病毒藥）",
      "indication_en": "Treatment-experienced HIV-1 (with other antiretrovirals)",
      "trials": [
        "NCT02369965"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "2018-05 中國核准",
      "latest_en": "Approved in China in May 2018",
      "date": "2018-05-01",
      "sources": [
        "https://clinicaltrials.gov/study/NCT02369965",
        "https://en.frontierbiotech.com/info.html"
      ],
      "asia": true
    },
    {
      "group": "prep",
      "section": "approved",
      "asset": "Apretude（cabotegravir）",
      "asset_en": "Apretude (cabotegravir)",
      "company": "ViiV Healthcare",
      "company_en": "ViiV Healthcare",
      "country": "英國",
      "country_en": "UK",
      "mechanism": "整合酶抑制劑，長效針劑",
      "mechanism_en": "Integrase inhibitor, long-acting injection",
      "route": "肌肉注射",
      "interval": "每 2 個月",
      "interval_en": "Every 2 months",
      "stage": "已核准",
      "stage_en": "Approved",
      "indication": "暴露前預防（PrEP）",
      "indication_en": "Pre-exposure prophylaxis (PrEP)",
      "trials": [],
      "deal": "2022-07-28 與 MPP 簽自願授權，涵蓋 90 國",
      "deal_en": "Voluntary license signed with MPP on 2022-07-28, covering 90 countries",
      "latest": "2021-12-20 FDA 核准，第一個長效注射預防藥",
      "latest_en": "FDA-approved on 2021-12-20, the first long-acting injectable PrEP",
      "date": "2021-12-20",
      "sources": [
        "https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2021/december/viiv-healthcare-announces-fda-approval-of-apretude/",
        "https://medicinespatentpool.org/news-publications-post/viiv-healthcare-and-the-medicines-patent-pool-sign-new-voluntary-licensing-agreement-to-expand-access-to-innovative-long-acting-hiv-prevention-medicine"
      ],
      "asia": false
    },
    {
      "group": "prep",
      "section": "approved",
      "asset": "Yeztugo（lenacapavir）",
      "asset_en": "Yeztugo (lenacapavir)",
      "company": "吉立亞（Gilead）",
      "company_en": "Gilead Sciences",
      "country": "美國",
      "country_en": "US",
      "mechanism": "衣殼抑制劑",
      "mechanism_en": "Capsid inhibitor",
      "route": "皮下注射",
      "interval": "每 6 個月",
      "interval_en": "Every 6 months",
      "stage": "已核准",
      "stage_en": "Approved",
      "indication": "暴露前預防（PrEP）",
      "indication_en": "Pre-exposure prophylaxis (PrEP)",
      "trials": [],
      "deal": "—",
      "deal_en": "—",
      "latest": "2025-06-18 FDA 核准；2026-06-29 美國牌價：年度維持注射 29,036.32 美元，起始口服藥另計；2026 年第三季營收 3.05 億美元",
      "latest_en": "FDA-approved on 2025-06-18; US annual maintenance injection list price US$29,036.32 as of 2026-06-29, with initiation tablets priced separately; Q3 2026 sales US$305M",
      "date": "2026-10-29",
      "sources": [
        "https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection",
        "https://www.gileadpriceinfo.com/yeztugo",
        "https://investors.gilead.com/news/news-details/2026/Gilead-Sciences-Announces-Third-Quarter-2026-Financial-Results/default.aspx"
      ],
      "asia": false
    },
    {
      "group": "prep",
      "section": "tentative",
      "asset": "lenacapavir 學名藥",
      "asset_en": "Generic lenacapavir",
      "company": "Dr. Reddy's（吉立亞自願授權）",
      "company_en": "Dr. Reddy's (Gilead voluntary license)",
      "country": "印度",
      "country_en": "India",
      "mechanism": "衣殼抑制劑",
      "mechanism_en": "Capsid inhibitor",
      "route": "皮下注射",
      "interval": "每 6 個月",
      "interval_en": "Every 6 months",
      "stage": "暫時核准（學名藥）",
      "stage_en": "Tentative approval (generic)",
      "indication": "120 個中低收入國家的暴露前預防",
      "indication_en": "PrEP in 120 low- and middle-income countries",
      "trials": [],
      "deal": "2024-10 吉立亞授權 6 家學名藥廠、免權利金；2025-09 與 Unitaid、CHAI、Wits RHI 談定約 40 美元一年",
      "deal_en": "Oct 2024 royalty-free voluntary licenses to six generic makers; Sept 2025 price of about US$40 a year agreed with Unitaid, CHAI and Wits RHI",
      "latest": "2026-11-02 FDA 暫時核准（不能在美國賣，可供美國國際援助採購），2026 年底前供貨",
      "latest_en": "FDA tentative approval on 2026-11-02 (not sold in the US, eligible for US aid purchasing); first supplies by end of 2026",
      "date": "2026-11-02",
      "sources": [
        "https://www.drreddys.com/cms/sites/default/files/2026-11/20261102_Lenacapavir_Generic_FDA_Approval_PressRelease_Final.pdf",
        "https://www.fda.gov/international-programs/presidents-emergency-plan-aids-relief-pepfar/pepfar-database-frequently-asked-questions",
        "https://www.clintonhealthaccess.org/wp-content/uploads/2025/11/2025-CHAI-HIV-Market-Report-Executive-Summary.pdf",
        "https://www.clintonhealthaccess.org/news/us-fda-approves-first-generic-injectable-lenacapavir-for-hiv-prevention/",
        "https://www.gilead.com/news/news-details/2024/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries"
      ],
      "asia": true
    },
    {
      "group": "tx",
      "section": "clinical",
      "asset": "islatravir＋lenacapavir（每週口服）",
      "asset_en": "Islatravir + lenacapavir (weekly oral)",
      "company": "吉立亞／默沙東（Gilead／MSD）",
      "company_en": "Gilead / MSD",
      "country": "美國",
      "country_en": "US",
      "mechanism": "核苷反轉錄酶轉位抑制劑＋衣殼抑制劑",
      "mechanism_en": "NRTTI plus capsid inhibitor",
      "route": "口服",
      "interval": "每週",
      "interval_en": "Weekly",
      "stage": "第三期（第 48 週主要終點達成）",
      "stage_en": "Phase 3 (week-48 primary endpoint met)",
      "indication": "病毒已抑制的成人感染者",
      "indication_en": "Virologically suppressed adults",
      "trials": [
        "NCT06630286",
        "NCT06630299"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "ISLEND-1（607 人，對 Biktarvy）與 ISLEND-2（626 人）第 48 週均達不劣性；ISLEND-1 刊於 NEJM，ISLEND-2 於 AIDS 2026 發表；Merck 2026-11-02 仍列為研究中療法",
      "latest_en": "ISLEND-1 (607 participants, versus Biktarvy) and ISLEND-2 (626) met non-inferiority at week 48; ISLEND-1 published in NEJM, ISLEND-2 presented at AIDS 2026; still described as investigational by Merck on 2026-11-02",
      "date": "2026-11-02",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06630286",
        "https://clinicaltrials.gov/study/NCT06630299",
        "https://www.merck.com/news/merck-to-present-new-data-from-its-broad-oral-hiv-portfolio-and-pipeline-at-hiv-glasgow-2026/",
        "https://www.nejm.org/doi/full/10.1056/NEJMoa2607973",
        "https://www.merck.com/wp-content/uploads/sites/124/2026/08/AIDS-2026-Investor-Event-Presentation.pdf"
      ],
      "asia": false
    },
    {
      "group": "tx",
      "section": "clinical",
      "asset": "lenacapavir＋teropavimab＋zinlirvimab",
      "asset_en": "Lenacapavir + teropavimab + zinlirvimab",
      "company": "吉立亞（Gilead）",
      "company_en": "Gilead Sciences",
      "country": "美國",
      "country_en": "US",
      "mechanism": "衣殼抑制劑＋兩支廣效中和抗體（瞄準病毒外殼）",
      "mechanism_en": "Capsid inhibitor plus two broadly neutralizing antibodies targeting the viral envelope",
      "route": "皮下（lenacapavir）＋靜脈輸注（兩支抗體）",
      "interval": "每 26 週",
      "interval_en": "Every 26 weeks",
      "stage": "第三期",
      "stage_en": "Phase 3",
      "indication": "病毒已抑制的成人感染者（對抗體敏感者）",
      "indication_en": "Virologically suppressed adults (antibody-sensitive virus)",
      "trials": [
        "NCT07683000",
        "NCT07682961"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "兩個第三期各預計 590 人，2026-07 開始收案，其中一個對照 Cabenuva",
      "latest_en": "Two Phase 3 trials, each with an estimated 590 participants, began in July 2026; one compares the regimen with Cabenuva",
      "date": "2026-07-14",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07683000",
        "https://clinicaltrials.gov/study/NCT07682961"
      ],
      "asia": false
    },
    {
      "group": "tx",
      "section": "clinical",
      "asset": "lepetegravir＋lenacapavir pacfosacil（每週口服）",
      "asset_en": "Lepetegravir + lenacapavir pacfosacil (weekly oral)",
      "company": "吉立亞（Gilead）",
      "company_en": "Gilead Sciences",
      "country": "美國",
      "country_en": "US",
      "mechanism": "整合酶抑制劑＋衣殼抑制劑前驅藥",
      "mechanism_en": "Integrase inhibitor plus capsid inhibitor prodrug",
      "route": "口服",
      "interval": "每週",
      "interval_en": "Weekly",
      "stage": "第二／三期",
      "stage_en": "Phase 2/3",
      "indication": "病毒已抑制的成人感染者",
      "indication_en": "Virologically suppressed adults",
      "trials": [
        "NCT06544733",
        "NCT06613685"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "WONDERS-1（預計 675 人）進行中；未治療族群的 WONDERS-2 於 2026-03 由公司決定終止",
      "latest_en": "WONDERS-1 (estimated 675 participants) ongoing; WONDERS-2 in treatment-naive people terminated by the sponsor in March 2026",
      "date": "2026-03-16",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06544733",
        "https://clinicaltrials.gov/study/NCT06613685"
      ],
      "asia": false
    },
    {
      "group": "tx",
      "section": "clinical",
      "asset": "lotivibart（N6LS）＋cabotegravir",
      "asset_en": "Lotivibart (N6LS) + cabotegravir",
      "company": "ViiV Healthcare",
      "company_en": "ViiV Healthcare",
      "country": "英國",
      "country_en": "UK",
      "mechanism": "廣效中和抗體（每 4 個月）＋整合酶抑制劑（每月）",
      "mechanism_en": "Broadly neutralizing antibody (every 4 months) plus monthly cabotegravir",
      "route": "靜脈或皮下＋肌肉注射",
      "interval": "抗體每 4 個月",
      "interval_en": "Antibody every 4 months",
      "stage": "第二期 b",
      "stage_en": "Phase 2b",
      "indication": "病毒已抑制的成人感染者",
      "indication_en": "Virologically suppressed adults",
      "trials": [
        "NCT05996471"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "EMBRACE 12 個月：靜脈組病毒抑制率 94%、皮下組 82%、續用口服藥對照組 88%",
      "latest_en": "EMBRACE at 12 months: viral suppression 94% (IV), 82% (subcutaneous) vs 88% for continued oral therapy",
      "date": "2026-02-25",
      "sources": [
        "https://viivhealthcare.com/en-us/media-center/news/press-releases/2026/february/bnab-lotivibart-n6ls-maintains-high-levels-of-viral-suppression/",
        "https://clinicaltrials.gov/study/NCT05996471"
      ],
      "asia": false
    },
    {
      "group": "tx",
      "section": "clinical",
      "asset": "TMB-365／TMB-380",
      "asset_en": "TMB-365 / TMB-380",
      "company": "中裕新藥（TaiMed，4147）",
      "company_en": "TaiMed Biologics (TPEx: 4147)",
      "country": "台灣",
      "country_en": "Taiwan",
      "mechanism": "雙抗體：TMB-365 結合人體 CD4 受體第二區；TMB-380 瞄準病毒外殼的 CD4 結合位",
      "mechanism_en": "Dual antibodies: TMB-365 binds domain 2 of the human CD4 receptor; TMB-380 targets the viral envelope's CD4-binding site",
      "route": "靜脈注射",
      "interval": "每 8 週",
      "interval_en": "Every 8 weeks",
      "stage": "第二期 b",
      "stage_en": "Phase 2b",
      "indication": "病毒已抑制的成人感染者（維持治療）",
      "indication_en": "Virologically suppressed adults (maintenance)",
      "trials": [
        "NCT07215468",
        "NCT05275998",
        "NCT04027387"
      ],
      "deal": "—（尚無已簽授權）",
      "deal_en": "— (no signed license announced)",
      "latest": "第二期 b 已收滿 88 人（對照續用口服藥），期中結果預計 2026 年底，主要完成日（CT.gov 預估）2027-05；第二期 a：核心組 20 人每 8 週靜脈給藥、停用口服藥 24 週；有第 24 週數據的 17 人中 16 人（94%）維持病毒量 <50 copies/mL，完成治療者無試驗定義的病毒學失敗；2024-02-07 FDA 快速審查認定；公司表示與 NIH 及國際藥廠洽談技術授權、策略合作與共同研發（鉅亨網 2026-11-03）",
      "latest_en": "Phase 2b fully enrolled at 88 participants versus continued oral therapy; interim results expected by end-2026 and estimated primary completion in May 2027 (CT.gov). Phase 2a: In the 20-participant core cohort, IV dosing every 8 weeks replaced oral therapy for 24 weeks; 16 of 17 participants with week-24 data (94%) maintained HIV-1 RNA <50 copies/mL, with no protocol-defined virologic failures among treatment completers. FDA Fast Track designation announced on 2024-02-07. The company reports discussions with NIH and international drugmakers on licensing, strategic collaboration and joint R&D (cnyes, 2026-11-03)",
      "date": "2026-11-03",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07215468",
        "https://clinicaltrials.gov/study/NCT05275998",
        "https://www.taimedbiologics.com/article_d.php?id=3824&lang=en&tb=5",
        "https://www.taimedbiologics.com/article_d.php?id=1910&lang=en&tb=2",
        "https://www.taimedbiologics.com/article_d.php?id=3858&lang=tw&tb=5",
        "https://www.cna.com.tw/news/afe/202402070088.aspx",
        "https://news.cnyes.com/news/id/6645221",
        "https://www.taimedbiologics.com/article_d.php?id=3843&lang=tw&tb=5"
      ],
      "asia": true
    },
    {
      "group": "prep",
      "section": "clinical",
      "asset": "口服每週 Yeztugo（lenacapavir）",
      "asset_en": "Weekly oral Yeztugo (lenacapavir)",
      "company": "吉立亞（Gilead）",
      "company_en": "Gilead Sciences",
      "country": "美國",
      "country_en": "US",
      "mechanism": "衣殼抑制劑",
      "mechanism_en": "Capsid inhibitor",
      "route": "口服",
      "interval": "每週",
      "interval_en": "Weekly",
      "stage": "FDA 審查中",
      "stage_en": "Under FDA review",
      "indication": "暴露前預防（PrEP）",
      "indication_en": "PrEP",
      "trials": [
        "NCT04994509",
        "NCT04925752"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "2026-06-15 FDA 受理，預定 2027-02-02 做決定；sNDA 依據：PURPOSE 1、PURPOSE 2",
      "latest_en": "FDA accepted the application on 2026-06-15; decision date 2027-02-02; sNDA based on PURPOSE 1 and PURPOSE 2",
      "date": "2026-06-15",
      "sources": [
        "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"
      ],
      "asia": false
    },
    {
      "group": "prep",
      "section": "clinical",
      "asset": "lenacapavir 一年一次",
      "asset_en": "Once-yearly lenacapavir",
      "company": "吉立亞（Gilead）",
      "company_en": "Gilead Sciences",
      "country": "美國",
      "country_en": "US",
      "mechanism": "衣殼抑制劑",
      "mechanism_en": "Capsid inhibitor",
      "route": "肌肉注射",
      "interval": "每年",
      "interval_en": "Once a year",
      "stage": "第三期",
      "stage_en": "Phase 3",
      "indication": "暴露前預防（PrEP）",
      "indication_en": "PrEP",
      "trials": [
        "NCT07047716"
      ],
      "deal": "自願授權範圍已先擴大到一年一次的版本",
      "deal_en": "Voluntary licensing already extended to the once-yearly version",
      "latest": "第三期 PURPOSE 365：開放標籤藥動學試驗，339 人，收案結束；2026-09 宣布加速全球可近性規劃",
      "latest_en": "Phase 3 PURPOSE 365: open-label pharmacokinetic trial, 339 participants, enrollment closed; accelerated global access planning announced in September 2026",
      "date": "2026-09-16",
      "sources": [
        "https://investors.gilead.com/news/news-details/2026/Gilead-Accelerates-Global-Access-Planning-for-Investigational-Once-Yearly-Lenacapavir-for-HIV-Prevention/default.aspx",
        "https://clinicaltrials.gov/study/NCT07047716"
      ],
      "asia": false
    },
    {
      "group": "prep",
      "section": "clinical",
      "asset": "alimatravir（MK-8527）",
      "asset_en": "Alimatravir (MK-8527)",
      "company": "默沙東（MSD）",
      "company_en": "MSD",
      "country": "美國",
      "country_en": "US",
      "mechanism": "核苷反轉錄酶轉位抑制劑",
      "mechanism_en": "NRTTI",
      "route": "口服",
      "interval": "每月",
      "interval_en": "Monthly",
      "stage": "第三期",
      "stage_en": "Phase 3",
      "indication": "暴露前預防（PrEP）",
      "indication_en": "PrEP",
      "trials": [
        "NCT07044297",
        "NCT07071623"
      ],
      "deal": "2026-07-24 與 7 家學名藥廠簽免權利金自願授權，涵蓋 129 個中低收入國家",
      "deal_en": "Royalty-free voluntary licenses signed with seven generic manufacturers on 2026-07-24, covering 129 low- and middle-income countries",
      "latest": "兩個第三期：4,390 人、預估 4,580 人；主要完成日預估 2027 年；Merck 2026-11-02 表示兩案成人收案已完成",
      "latest_en": "Two Phase 3 trials: 4,390 participants and an estimated 4,580; estimated primary completion in 2027; Merck stated on 2026-11-02 that adult enrollment in both trials was complete",
      "date": "2026-11-02",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07044297",
        "https://clinicaltrials.gov/study/NCT07071623",
        "https://www.merck.com/news/merck-announces-initial-access-plans-for-alimatravir-an-investigational-once-monthly-oral-hiv-pre-exposure-prophylaxis-in-phase-3-development/",
        "https://www.merck.com/news/merck-to-present-new-data-from-its-broad-oral-hiv-portfolio-and-pipeline-at-hiv-glasgow-2026/"
      ],
      "asia": false
    },
    {
      "group": "prep",
      "section": "clinical",
      "asset": "cabotegravir 每 4 個月（CAB ULA Q4M）",
      "asset_en": "Cabotegravir every 4 months (CAB ULA Q4M)",
      "company": "ViiV Healthcare",
      "company_en": "ViiV Healthcare",
      "country": "英國",
      "country_en": "UK",
      "mechanism": "整合酶抑制劑",
      "mechanism_en": "Integrase inhibitor",
      "route": "肌肉注射",
      "interval": "每 4 個月",
      "interval_en": "Every 4 months",
      "stage": "第二期 b（註冊用）",
      "stage_en": "Phase 2b (registrational)",
      "indication": "暴露前預防（PrEP）",
      "indication_en": "Pre-exposure prophylaxis (PrEP)",
      "trials": [
        "NCT06741397"
      ],
      "deal": "—",
      "deal_en": "—",
      "latest": "EXTEND 4M：229 人；主要完成日 2026-09-09；評估藥動學、安全性與耐受性",
      "latest_en": "EXTEND 4M: 229 participants; primary completion 2026-09-09; evaluates pharmacokinetics, safety and tolerability",
      "date": "2026-09-09",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06741397",
        "https://www.gsk.com/en-gb/media/press-releases/cabenuva-demonstrates-superiority-to-daily-oral-therapy-in-adolescents-living-with-hiv-as-viiv-healthcare-highlights-new-long-acting-injectable-data-at-aids-2026/"
      ],
      "asia": false
    }
  ],
  "summary_expected": {
    "total": 16,
    "approved": 6,
    "tentative": 1,
    "clinical": 9,
    "phase3_or_review": 5,
    "treatment": 9,
    "prevention": 7,
    "asia": 4,
    "taiwan": 2
  },
  "scope": "本頁收錄第二期以上長效治療與預防藥物；VH-184、VH-499、GS-3242 等第一期長效藥未列，dapivirine 陰道環不列入本頁。",
  "scope_en": "This page covers long-acting treatment and prevention assets from Phase 2 onward. Phase 1 assets including VH-184, VH-499 and GS-3242, and the dapivirine vaginal ring, are excluded."
}