{ "as_of": "2026-11-06", "title": "寵物基因與細胞治療新藥賽道", "title_en": "Companion-Animal Gene and Cell Therapy Pipeline", "slug": "companion-animal-gene-cell-therapy", "assets": [ { "section": "approved", "asset": "Vetmedin（pimobendan）B2 期適應症", "asset_en": "Vetmedin (pimobendan), Stage B2 indication", "company": "百靈佳殷格翰動物保健（Boehringer Ingelheim Animal Health）", "company_en": "Boehringer Ingelheim Animal Health", "country": "德國／美國", "country_en": "Germany / US", "species": "狗", "species_en": "Dog", "modality": "小分子", "modality_en": "Small molecule", "mechanism": "強心與擴張血管", "mechanism_en": "Inodilator", "regulator": "美國 FDA 獸醫中心（CVM）", "regulator_en": "US FDA CVM", "stage": "已核准（由條件式轉完整核准）", "stage_en": "Approved (conditional converted to full)", "indication": "延緩 B2 期（尚無症狀）二尖瓣黏液樣退化（MMVD）犬隻進入鬱血性心衰", "indication_en": "Delaying onset of congestive heart failure in dogs with Stage B2 preclinical MMVD", "deal": "—", "latest": "2022-06-16 先以 Vetmedin-CA1 條件式核准；EPIC 研究到心衰、死亡或安樂死的中位時間 1,228 天，對照組 761 天，多 467 天；2026-01 百靈佳殷格翰公告 Vetmedin 咀嚼錠與口服液取得 B2 期完整核准，是 FDA 第一次把條件式核准的動物藥適應症轉為完整核准", "latest_en": "Conditionally approved as Vetmedin-CA1 on 2022-06-16; in EPIC, median time to heart failure, cardiac death or euthanasia was 1,228 days vs 761 days (467 days longer). In January 2026 Boehringer Ingelheim announced full approval of the Stage B2 indication for Vetmedin chewable tablets and solution, the first time FDA converted a conditionally approved animal-drug indication to full approval", "date": "2026-01-01", "sources": [ "https://www.fda.gov/animal-veterinary/cvm-updates/fda-conditionally-approves-first-drug-delay-onset-congestive-heart-failure-dogs", "https://animalhealth.boehringer-ingelheim.com/pets/vetmedin-announcements" ], "asia": false }, { "section": "approved", "asset": "ELIAS Cancer Immunotherapy", "asset_en": "ELIAS Cancer Immunotherapy", "company": "ELIAS Animal Health", "company_en": "ELIAS Animal Health", "country": "美國", "country_en": "US", "species": "狗", "species_en": "Dog", "modality": "自體免疫治療", "modality_en": "Autologous immunotherapy", "mechanism": "以病犬自身腫瘤製作的個人化免疫治療", "mechanism_en": "Patient-specific immunotherapy made from the dog's own tumor", "regulator": "美國農業部獸醫生物製劑中心（USDA CVB）", "regulator_en": "USDA Center for Veterinary Biologics", "stage": "已授權（完整）", "stage_en": "Fully licensed", "indication": "犬骨肉瘤", "indication_en": "Canine osteosarcoma", "deal": "—", "latest": "2025-03 取得美國農業部完整授權，第一個用於犬骨肉瘤的自體處方產品", "latest_en": "Received full USDA approval in March 2025, the first autologous prescription product for canine osteosarcoma", "date": "2025-03-18", "sources": [ "https://animalhealthdigest.com/elias-animal-health-receives-full-approval-from-usda-for-first-in-class-canine-osteosarcoma-treatment" ], "asia": false }, { "section": "approved", "asset": "Librela（bedinvetmab）", "asset_en": "Librela (bedinvetmab)", "company": "碩騰（Zoetis）", "company_en": "Zoetis", "country": "美國", "country_en": "US", "species": "狗", "species_en": "Dog", "modality": "單株抗體", "modality_en": "Monoclonal antibody", "mechanism": "抗神經生長因子（NGF）", "mechanism_en": "Anti-nerve growth factor (NGF)", "regulator": "美國 FDA 獸醫中心（CVM）", "regulator_en": "US FDA CVM", "stage": "已核准", "stage_en": "Approved", "indication": "控制狗退化性關節炎疼痛，每月皮下注射一次", "indication_en": "Control of osteoarthritis pain in dogs; monthly subcutaneous injection", "deal": "—", "latest": "2023-05-05 FDA 核准；2022-01-13 FDA 核准第一個動物用單株抗體（貓退化性關節炎疼痛）", "latest_en": "FDA-approved on 2023-05-05; the first animal monoclonal antibody (for cat osteoarthritis pain) was approved on 2022-01-13", "date": "2023-05-05", "sources": [ "https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-monoclonal-antibody-dogs-osteoarthritis-pain" ], "asia": false }, { "section": "approved", "asset": "Oncept（犬黑色素瘤 DNA 疫苗）", "asset_en": "Oncept (canine melanoma DNA vaccine)", "company": "Merial（現屬百靈佳殷格翰）", "company_en": "Merial (now Boehringer Ingelheim)", "country": "美國", "country_en": "US", "species": "狗", "species_en": "Dog", "modality": "DNA 質體疫苗", "modality_en": "DNA plasmid vaccine", "mechanism": "質體表現人類酪胺酸酶，誘發免疫攻擊黑色素瘤", "mechanism_en": "Plasmid encoding human tyrosinase that triggers an immune response against melanoma", "regulator": "美國農業部獸醫生物製劑中心（USDA CVB）", "regulator_en": "USDA Center for Veterinary Biologics", "stage": "已授權（完整）", "stage_en": "Fully licensed", "indication": "手術局部控制後的第 II、III 期口腔黑色素瘤，延長存活", "indication_en": "Stage II–III oral melanoma after local surgical control, to prolong survival", "deal": "與紀念斯隆凱特琳癌症中心、紐約動物醫學中心共同開發", "deal_en": "Developed with Memorial Sloan Kettering Cancer Center and the Animal Medical Center of New York", "latest": "2010 年取得美國農業部完整授權", "latest_en": "Received full USDA licensure in 2010", "date": "2010-02-16", "sources": [ "https://www.avma.org/News/JAVMANews/Pages/100301f.aspx", "https://www.biospace.com/vical-incorporated-announces-licensee-s-approval-of-oncept-tm-therapeutic-melanoma-vaccine-for-dogs" ], "asia": false }, { "section": "development", "asset": "PT401", "asset_en": "PT401", "company": "寶泰生醫（7850）", "company_en": "Baotai Biomedical (TPEx Emerging: 7850)", "country": "台灣", "country_en": "Taiwan", "species": "狗", "species_en": "Dog", "modality": "AAV 雙基因治療", "modality_en": "Dual-gene AAV gene therapy", "mechanism": "抑制心臟纖維化、調節能量代謝，延緩疾病進展", "mechanism_en": "Inhibits cardiac fibrosis and regulates energy metabolism to slow progression", "regulator": "泰國、台灣動物用藥主管機關", "regulator_en": "Thai and Taiwanese veterinary regulators", "stage": "田間試驗", "stage_en": "Field trials", "indication": "犬二尖瓣黏液樣退化（MMVD）", "indication_en": "Canine myxomatous mitral valve disease (MMVD)", "deal": "2024 年底自 Rejuvenate Bio 取得亞太獨家權利；2026-06-09 與 Rejuvenate Bio、默沙東動物保健三方合作臨床開發與全球商業化", "deal_en": "Exclusive Asia-Pacific rights from Rejuvenate Bio in late 2024; on 2026-06-09, three-way alliance with Rejuvenate Bio and Merck Animal Health for clinical development and global commercialization", "latest": "泰國主管機關核准啟動臨床；2026-05 取得朱拉隆功大學動物實驗倫理委員會核准，在泰國啟動 B1 期早期介入先導田間試驗；台灣推進樞紐田間試驗；獲第 22 屆國家新創獎", "latest_en": "Thailand approved the start of clinical testing; Chulalongkorn University ethics approval in May 2026 for a Stage B1 early-intervention pilot field trial; pivotal field trial advancing in Taiwan; won Taiwan's 22nd National Innovation Award", "date": "2026-06-09", "sources": [ "https://udn.com/news/story/7241/9554342", "https://www.ctee.com.tw/news/20260506702144-430504", "https://www.ctee.com.tw/news/20260609700534-430504" ], "asia": true, "client": true }, { "section": "development", "asset": "RJB-01", "asset_en": "RJB-01", "company": "Rejuvenate Bio", "company_en": "Rejuvenate Bio", "country": "美國", "country_en": "US", "species": "狗", "species_en": "Dog", "modality": "AAV 雙基因治療", "modality_en": "Dual-gene AAV gene therapy", "mechanism": "表現 FGF21 與可溶性 TGF-β 第二型受體（sTGFβR2），壓低 TGF-β1", "mechanism_en": "Expresses FGF21 and soluble TGF-β receptor 2 (sTGFβR2) to dampen TGF-β1", "regulator": "—", "regulator_en": "—", "stage": "先導研究", "stage_en": "Pilot study", "indication": "犬二尖瓣黏液樣退化（MMVD）", "indication_en": "Canine MMVD", "deal": "2026-06-11 完成 600 萬美元募資，默沙東動物保健參與投資並簽研發合作", "deal_en": "Closed a US$6M financing on 2026-06-11 with Merck Animal Health investing and signing an R&D collaboration", "latest": "先導研究 17 隻狗；12 隻騎士查理王小獵犬併用 pimobendan，到疾病進展的時間比歷史 pimobendan 對照多約 600 天，左心房縮小", "latest_en": "Pilot study in 17 dogs; in 12 Cavalier King Charles Spaniels on pimobendan, time to progression was about 600 days longer than historical pimobendan controls, and left atrial size decreased", "date": "2026-06-11", "sources": [ "https://dvm360.com/view/gene-therapy-demonstrates-benefit-to-dogs-with-myxomatous-mitral-valve-disease", "https://aap.com.au/aapreleases/cision20260611ae81674/" ], "asia": false }, { "section": "development", "asset": "sonruvetcel", "asset_en": "sonruvetcel", "company": "Gallant", "company_en": "Gallant", "country": "美國", "country_en": "US", "species": "貓", "species_en": "Cat", "modality": "異體間質幹細胞（現成可用）", "modality_en": "Allogeneic mesenchymal stromal cells (off-the-shelf)", "mechanism": "子宮組織來源的間質幹細胞，調節免疫", "mechanism_en": "Uterine-derived mesenchymal stromal cells that modulate immunity", "regulator": "美國 FDA 獸醫中心（CVM）", "regulator_en": "US FDA CVM", "stage": "條件式核准審查中", "stage_en": "Under review for conditional approval", "indication": "難治型貓慢性齒齦口炎（FCGS）；另有貓狗關節炎、狗異位性皮膚炎、貓慢性腎病", "indication_en": "Refractory feline chronic gingivostomatitis (FCGS); also feline and canine osteoarthritis, canine atopic dermatitis, feline chronic kidney disease", "deal": "2025-06 完成 1,800 萬美元 B 輪", "deal_en": "US$18M Series B in June 2025", "latest": "2025-09 FDA 認可「合理有效預期」章節、2025-11 認可目標動物安全性章節（365 天）；2026-04 報導仍在等條件式核准，另一項貓關節炎產品取得擴大條件式核准途徑資格", "latest_en": "FDA-CVM accepted the Reasonable Expectation of Effectiveness section in Sept 2025 and the Target Animal Safety section (365 days) in Nov 2025; as of April 2026 conditional approval was still pending, and a separate feline osteoarthritis product gained eligibility for the expanded conditional approval pathway", "date": "2026-04-16", "sources": [ "https://www.gallant.com/news/gallant-achieves-fda-technical-section-complete-for-reasonable-expectation-of-effectiveness-advancing-first-ready-to-use-stem-cell-therapy/", "https://www.prnewswire.com/news-releases/fda-completes-safety-for-gallants-first-ready-to-use-stem-cell-therapy-for-refractory-fcgs-302610213.html", "https://www.theunderbite.co/news/gallant-feline-oa-stem-cell" ], "asia": false }, { "section": "development", "asset": "ElenaVet", "asset_en": "ElenaVet", "company": "CureLab Veterinary", "company_en": "CureLab Veterinary", "country": "美國", "country_en": "US", "species": "狗", "species_en": "Dog", "modality": "DNA 質體", "modality_en": "DNA plasmid", "mechanism": "表現 SQSTM1/p62 蛋白，提高體內抗發炎物質", "mechanism_en": "Encodes SQSTM1/p62 to raise the body's own anti-inflammatory mediators", "regulator": "美國農業部獸醫生物製劑中心（USDA CVB）", "regulator_en": "USDA Center for Veterinary Biologics", "stage": "先導研究", "stage_en": "Pilot study", "indication": "狗慢性退化性關節炎疼痛", "indication_en": "Chronic osteoarthritis pain in dogs", "deal": "—", "latest": "先導研究 17 隻狗，每週肌肉注射 1 mg、共 10 週，90% 達預設治療成功標準；已與美國農業部討論樞紐試驗，預計 2–3 年內送件（視資金而定）", "latest_en": "Pilot in 17 dogs, 1 mg IM weekly for 10 weeks; 90% met predefined treatment success; pivotal protocol talks with USDA CVB, licensing application expected in 2–3 years depending on funding", "date": "2025-06-13", "sources": [ "https://www.finanzen.net/nachricht/aktien/curelab-veterinary-s-elenavet-gene-therapy-delivers-90-success-in-pet-dog-osteoarthritis-study-14561679" ], "asia": false }, { "section": "development", "asset": "PT001", "asset_en": "PT001", "company": "寶泰生醫（7850）", "company_en": "Baotai Biomedical (TPEx Emerging: 7850)", "country": "台灣", "country_en": "Taiwan", "species": "狗", "species_en": "Dog", "modality": "免疫治療疫苗（生物藥）", "modality_en": "Immunotherapy vaccine (biologic)", "mechanism": "免疫治療疫苗", "mechanism_en": "Therapeutic vaccine", "regulator": "台灣動物用藥主管機關", "regulator_en": "Taiwanese veterinary regulator", "stage": "田間試驗收案中", "stage_en": "Field trial enrolling", "indication": "犬黑色素瘤", "indication_en": "Canine melanoma", "deal": "—", "latest": "在台灣北、中、南多家動物醫院同步收案與田間試驗；2024 年獲傑出新創獎", "latest_en": "Enrolling in field trials at partner veterinary hospitals in northern, central and southern Taiwan; won an outstanding innovation award in 2024", "date": "2025-12-18", "sources": [ "https://wantrich.chinatimes.com/news/20251218900269-420101" ], "asia": true, "client": true } ], "summary_expected": { "total": 9, "approved_or_licensed": 4, "development": 5, "gene_therapy_aav": 2, "taiwan": 2, "dog": 8, "cat": 1 }, "summary": { "total": 9, "approved_or_licensed": 4, "development": 5, "gene_therapy_aav": 2, "taiwan": 2, "dog": 8, "cat": 1 }, "language": "zh" }