{ "as_of": "2026-11-06", "title": "局部注射減脂新藥賽道", "title_en": "Injectable Fat Reduction Pipeline", "slug": "injectable-fat-reduction", "assets": [ { "section": "approved", "asset": "KYBELLA／BELKYRA（deoxycholic acid）", "asset_en": "KYBELLA / BELKYRA (deoxycholic acid)", "company": "艾伯維（AbbVie，原 Allergan）", "company_en": "AbbVie (formerly Allergan)", "country": "美國", "country_en": "US", "mechanism": "去氧膽酸，破壞脂肪細胞膜（細胞溶解，伴隨局部發炎腫脹）", "mechanism_en": "Deoxycholic acid; disrupts adipocyte membranes (cytolysis with local inflammation and swelling)", "route": "皮下注射", "stage": "已核准", "stage_en": "Approved", "indication": "中度至重度頦下脂肪（雙下巴）", "indication_en": "Moderate-to-severe submental fat", "trials": [], "deal": "—", "latest": "2015 年 FDA 核准，第一個獲 FDA 核准的注射溶脂藥", "latest_en": "FDA-approved in 2015; the first injectable fat-reduction drug approved by the FDA", "date": "2015-04-29", "sources": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf", "https://pubmed.ncbi.nlm.nih.gov/27785706/" ], "asia": false }, { "section": "approved", "asset": "VOILET（deoxycholic acid）", "asset_en": "VOILET (deoxycholic acid)", "company": "大熊製藥（Daewoong）", "company_en": "Daewoong Pharmaceutical", "country": "韓國", "country_en": "South Korea", "mechanism": "去氧膽酸，破壞脂肪細胞膜", "mechanism_en": "Deoxycholic acid; disrupts adipocyte membranes", "route": "皮下注射", "stage": "已核准（韓國）", "stage_en": "Approved (Korea)", "indication": "頦下脂肪；腋前脂肪研究者發起試驗獲准", "indication_en": "Submental fat; investigator-initiated trial in anterior axillary fat cleared", "trials": [], "deal": "—", "latest": "2021 年韓國核准；累計售出逾 20 萬瓶、供應逾 2,000 家醫療院所；2026-07 與首爾大學盆唐醫院、365mc 合作擴大到腋前脂肪，之後是腹部、手臂、大腿", "latest_en": "Approved in Korea in 2021; over 200,000 vials sold to 2,000+ clinics; July 2026 MOU with SNU Bundang Hospital and 365mc to expand to anterior axillary fat, then abdomen, arms and thighs", "date": "2026-07-16", "sources": [ "https://www.asiae.co.kr/en/article/2026071609305528497", "https://www.dailymedi.com/news/news_view.php?wr_id=911379" ], "asia": true }, { "section": "approved", "asset": "Newbeju（cholic acid，MT921）", "asset_en": "Newbeju (cholic acid, MT921)", "company": "Medytox", "company_en": "Medytox", "country": "韓國", "country_en": "South Korea", "mechanism": "膽酸（cholic acid），界面活性比去氧膽酸低", "mechanism_en": "Cholic acid; lower surfactant activity than deoxycholic acid", "route": "皮下注射", "stage": "已核准（韓國）", "stage_en": "Approved (Korea)", "indication": "中度至重度頦下脂肪", "indication_en": "Moderate-to-severe submental fat", "trials": [ "NCT05195112" ], "deal": "—", "latest": "2025-09-19 韓國食藥處核准；第三期 240 人（2023-02 完成），MRI 量到的脂肪體積下降顯著大於安慰劑", "latest_en": "Approved by Korea's MFDS on 2025-09-19; Phase 3 in 240 patients (completed Feb 2023) showed significantly greater MRI fat-volume reduction than placebo", "date": "2025-09-19", "sources": [ "https://www.asiae.co.kr/en/article/2025091917220932351", "https://www.asiae.co.kr/en/article/2023121815474699090", "https://clinicaltrials.gov/study/NCT05195112" ], "asia": true }, { "section": "clinical", "asset": "CBL-514", "asset_en": "CBL-514", "company": "康霈生技（Caliway，6919）", "company_en": "Caliway Biopharmaceuticals (TWSE: 6919)", "country": "台灣", "country_en": "Taiwan", "mechanism": "小分子，誘導脂肪細胞凋亡", "mechanism_en": "Small molecule that induces adipocyte apoptosis", "route": "皮下注射", "stage": "第三期", "stage_en": "Phase 3", "indication": "腹部皮下脂肪（大面積）；另有橘皮組織、Dercum 氏病（CBL-514D）", "indication_en": "Abdominal subcutaneous fat (large area); also cellulite and Dercum's disease (CBL-514D)", "trials": [ "NCT07140939", "NCT07526974", "NCT07733947", "NCT07608770", "NCT06005441" ], "deal": "—", "latest": "兩個全球樞紐第三期：SUPREME-01（CBL-0301，約 320 人，美加 13 個試驗點，2026-08 宣布開始收案）與 SUPREME-02（CBL-0302，約 320 人，美加澳），結果預計 2027；第二期 CBL-0205（173 人）脂肪體積減少 ≥20% 的比例 54.2% 對安慰劑 0%，平均減少 166.6 mL（22.4%）；與 tirzepatide 併用的第二期已獲 FDA 同意；亞太第二期 CBL-0206（約 250 人）已獲台灣、澳洲核准、澳洲收案中；中國第三期 CBL-0304 規劃 2026 下半年申請", "latest_en": "Two global pivotal Phase 3 trials: SUPREME-01 (CBL-0301, ~320 participants, 13 US/Canada sites, enrollment announced Aug 2026) and SUPREME-02 (CBL-0302, ~320, US/Canada/Australia), results expected in 2027. Phase 2b CBL-0205 (n=173): 54.2% reached ≥20% fat-volume reduction vs 0% on placebo; mean reduction 166.6 mL (22.4%). FDA cleared a Phase 2 with tirzepatide. Asia-Pacific Phase 2 CBL-0206 (~250) approved in Taiwan and Australia, enrolling in Australia. China Phase 3 (CBL-0304) application planned for 2H 2026", "date": "2026-08-25", "sources": [ "https://clinicaltrials.gov/study/NCT07140939", "https://clinicaltrials.gov/study/NCT07526974", "https://www.biospace.com/press-releases/caliway-announces-cbl-514-second-phase-2b-study-results-cbl-0205-met-endpoints", "https://www.biospace.com/press-releases/caliway-announces-u-s-fda-ind-clearance-for-cbl-0302-its-second-global-pivotal-phase-3-study-of-cbl-514", "https://www.placera.se/pressmeddelanden/caliway-s-cbl-514-combination-therapy-cleared-by-u-s-fda-for-phase-2-trial-pivotal-phase-3-trial-supreme-01-initiates-enrollment-20260826" ], "asia": true, "client": true }, { "section": "clinical", "asset": "RZL-012", "asset_en": "RZL-012", "company": "Raziel Therapeutics（中國權利：復星醫藥旗下 JuveStar）", "company_en": "Raziel Therapeutics (China rights: Fosun Pharma affiliate JuveStar)", "country": "以色列／中國", "country_en": "Israel / China", "mechanism": "注射型溶脂分子，破壞目標脂肪細胞", "mechanism_en": "Injectable lipolytic molecule that destroys targeted fat cells", "route": "皮下注射", "stage": "第三期完成（中國）", "stage_en": "Phase 3 completed (China)", "indication": "頦下脂肪；復星規劃身體塑形試驗", "indication_en": "Submental fat; Fosun planning a body-contouring trial", "trials": [ "NCT05763160" ], "deal": "2020 年授權中港澳台，里程碑最高 7,400 萬美元（上市前 2,700 萬、銷售 4,700 萬）加分級權利金", "deal_en": "2020 license for mainland China, Hong Kong, Macau and Taiwan: up to US$74M in milestones (US$27M pre-approval, US$47M sales) plus tiered royalties", "latest": "2026-09-02 中國第三期（480 人）主要反應率比安慰劑高 30 個百分點；計畫 2026 年底前向中國藥監局送新藥上市申請", "latest_en": "On 2026-09-02, the China Phase 3 (n=480) showed a 30-percentage-point responder-rate advantage over placebo; NDA to China's regulator planned by end of 2026", "date": "2026-09-02", "sources": [ "https://www.prnewswire.com/il/news-releases/raziel-therapeutics-and-fosun-pharma-announce-positive-phase-3-results-for-rzl-012-in-submental-fat-reduction-clearing-the-path-to-a-china-nda-filing-302867570.html", "https://www.calcalistech.com/ctech/articles/0,7340,L-3850958,00.html" ], "asia": true, "trials_display": "中國第三期未在 ClinicalTrials.gov 登錄；NCT05763160 為美國第二期開放標籤試驗（15 人，2023 完成）", "trials_display_en": "China Phase 3 is not registered on ClinicalTrials.gov; NCT05763160 is a US Phase 2 open-label trial (15 participants, completed 2023)" }, { "section": "clinical", "asset": "AYP-101（polyene phosphatidylcholine）", "asset_en": "AYP-101 (polyene phosphatidylcholine)", "company": "AMI Pharm", "company_en": "AMI Pharm", "country": "韓國", "country_en": "South Korea", "mechanism": "多烯磷脂醯膽鹼，誘導脂肪細胞凋亡、不引發發炎", "mechanism_en": "Polyene phosphatidylcholine; induces adipocyte apoptosis without an inflammatory response", "route": "皮下注射", "stage": "第三期完成", "stage_en": "Phase 3 completed", "indication": "頦下脂肪", "indication_en": "Submental fat", "trials": [ "NCT06256445" ], "deal": "—", "latest": "韓國第三期 252 人已完成，結果未公布；第二期逾 70% 受試者頦下脂肪改善至少 1 級", "latest_en": "Korean Phase 3 (n=252) completed, results not yet published; in Phase 2, over 70% improved by at least one grade", "date": "2025-08-11", "sources": [ "https://clinicaltrials.gov/study/NCT06256445", "https://modernaesthetics.com/news/ami-pharm-advances-ayp-101-to-phase-3-testing-for-noninflammatory-fat-reduction/2476093/" ], "asia": true }, { "section": "clinical", "asset": "CU-20401（重組突變膠原酶）", "asset_en": "CU-20401 (recombinant mutant collagenase)", "company": "科笛（Cutia Therapeutics，2487.HK）", "company_en": "Cutia Therapeutics (HKEX: 2487)", "country": "中國", "country_en": "China", "mechanism": "作用在包覆脂肪組織的細胞外基質", "mechanism_en": "Acts on the extracellular matrix surrounding fat tissue", "route": "皮下注射", "stage": "第二期完成", "stage_en": "Phase 2 completed", "indication": "頦下脂肪", "indication_en": "Submental fat", "trials": [ "NCT06194188" ], "deal": "—", "latest": "2024-11-29 中國第二期（108 人）高低劑量組反應率都顯著高於安慰劑，未見嚴重不良事件", "latest_en": "On 2024-11-29, the China Phase 2 (n=108) showed significantly higher response rates than placebo at both doses, with no serious adverse events", "date": "2024-11-29", "sources": [ "https://clinicaltrials.gov/study/NCT06194188", "https://www.itiger.com/news/2487376028" ], "asia": true }, { "section": "clinical", "asset": "STP705（siRNA）", "asset_en": "STP705 (siRNA)", "company": "聖諾醫藥（Sirnaomics，2257.HK）", "company_en": "Sirnaomics (HKEX: 2257)", "country": "美國／中國", "country_en": "US / China", "mechanism": "siRNA，同時壓低 TGF-β1 與 COX-2", "mechanism_en": "siRNA that silences TGF-β1 and COX-2", "route": "皮下注射", "stage": "第二期", "stage_en": "Phase 2", "indication": "頦下脂肪", "indication_en": "Submental fat", "trials": [ "NCT07677683" ], "deal": "—", "latest": "澳洲第二期 30 人，2026-07-28 開始收案", "latest_en": "Australian Phase 2 (n=30) began enrolling on 2026-07-28", "date": "2026-07-28", "sources": [ "https://clinicaltrials.gov/study/NCT07677683" ], "asia": false }, { "section": "clinical", "asset": "10XB-101", "asset_en": "10XB-101", "company": "10xBio", "company_en": "10xBio", "country": "美國", "country_en": "US", "mechanism": "公司未公開", "mechanism_en": "Not disclosed", "route": "皮下注射", "stage": "第二期完成", "stage_en": "Phase 2 completed", "indication": "頦下脂肪", "indication_en": "Submental fat", "trials": [ "NCT05154955" ], "deal": "—", "latest": "美國第二期 51 人，2024-03 完成", "latest_en": "US Phase 2 (n=51) completed in March 2024", "date": "2024-03-19", "sources": [ "https://clinicaltrials.gov/study/NCT05154955" ], "asia": false }, { "section": "clinical", "asset": "HY-2003（脂質體包覆去氧膽酸）", "asset_en": "HY-2003 (liposomal deoxycholic acid)", "company": "四川匯宇製藥", "company_en": "Sichuan Huiyu Pharmaceutical", "country": "中國", "country_en": "China", "mechanism": "脂質體包覆去氧膽酸", "mechanism_en": "Liposome-encapsulated deoxycholic acid", "route": "皮下注射", "stage": "第一期", "stage_en": "Phase 1", "indication": "頦下脂肪", "indication_en": "Submental fat", "trials": [ "NCT06756490" ], "deal": "—", "latest": "中國第一期 30 人，與 BELKYRA、安慰劑對照，主要完成日 2026-12", "latest_en": "China Phase 1 (n=30) versus BELKYRA and placebo; primary completion December 2026", "date": "2024-12-26", "sources": [ "https://clinicaltrials.gov/study/NCT06756490" ], "asia": true }, { "section": "clinical", "asset": "Ronkyla Plus（去氧膽酸鈉新劑型）", "asset_en": "Ronkyla Plus (new sodium deoxycholate formulation)", "company": "Glonova Pharma", "company_en": "Glonova Pharma", "country": "台灣", "country_en": "Taiwan", "mechanism": "去氧膽酸鈉，打進皮下形成水凝膠", "mechanism_en": "Sodium deoxycholate that forms a hydrogel at the injection site", "route": "病灶內注射", "stage": "第一期", "stage_en": "Phase 1", "indication": "淺層脂肪瘤、頦下脂肪", "indication_en": "Superficial lipoma; submental fullness", "trials": [ "NCT07237425" ], "deal": "—", "latest": "台灣第一期 56 人（3 個試驗點），2025-11 開始收案", "latest_en": "Taiwan Phase 1 (n=56, 3 sites) enrolling since November 2025", "date": "2025-11-14", "sources": [ "https://clinicaltrials.gov/study/NCT07237425" ], "asia": true }, { "section": "discontinued", "asset": "Qwo（collagenase clostridium histolyticum-aaes）", "asset_en": "Qwo (collagenase clostridium histolyticum-aaes)", "company": "Endo", "company_en": "Endo", "country": "美國", "country_en": "US", "mechanism": "膠原酶，切斷造成凹凸的纖維束", "mechanism_en": "Collagenase that releases the fibrous septae behind dimpling", "route": "皮下注射", "stage": "已停產", "stage_en": "Discontinued", "indication": "成年女性臀部橘皮組織", "indication_en": "Cellulite of the buttocks in adult women", "trials": [], "deal": "—", "latest": "2020 年 FDA 核准，2022-12 因瘀青範圍大且難預測、可能長期色素沉澱而停產停售", "latest_en": "FDA-approved in 2020; production and sales ended in December 2022 over the extent and variability of bruising and possible prolonged skin discoloration", "date": "2022-12-12", "sources": [ "https://practicaldermatology.com/news/endo-removes-qwo-from-market-due-to-concerns-about-injection-site-bruising-skin-discoloration/2461467/", "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761146s000lbl.pdf" ], "asia": false } ], "summary_expected": { "total": 12, "approved": 3, "clinical": 8, "phase3_including_completed": 3, "discontinued": 1, "asia_company_or_partner_in_clinical": 6, "large_area_phase3": 1 } }