TaiMed Biologics (TPEX: 4147) 2026Q3 法說會簡報

Company Overview

• 公司名稱: 中裕新藥 · TaiMed Biologics
• 股票代號: TPEX: 4147
• 活動: 2026生技產業論壇
• 日期: July 2026
• 核心主題: CD4 標靶抗體平台 (CD4 Targeted Antibody Platform)
• 願景: 從 HIV 長效療法到精準免疫治療 (From HIV Long-Acting Therapy to Precision Immunotherapy)

公司概覽與投資亮點

• 01 CD4+ 細胞標靶抗體平台領導者 (Leader in CD4+-targeted antibody platform)
• 02 首創 (First-in-Class) 創新資產 (Differentiated assets across commercial, clinical & research)
• 03 自有 cGMP 生物製劑與 ADC 產能 (Fully integrated in-house cGMP manufacturing)
• 04 臨床與商業化雙重驗證 (Validated across clinical and commercial dimensions)
• 05 橫跨 HIV 與自體免疫的授權機會 (Differentiated licensing opportunity across HIV & autoimmune)

Products & Technologies

抗體平台三大核心價值資產

• Three core value assets — Products · Pipeline · Platform

THE FOUNDATION: 商業化產品 (Commercialized Products)

• 產品名稱: Trogarzo®
• 商業化能力: 2018年 FDA核准,台灣首例、全球首創 HIV 單抗 (2018 FDA approved, Taiwan's first, globally first HIV monoclonal antibody)
• 商業現金流: MDR HIV 標準療法,穩定營收支持管線 (MDR HIV standard therapy, stable revenue supports pipeline)
• 科學驗證: 真實世界數據證實 CD4 靶向安全有效 (Real-world data confirms CD4 targeting is safe and effective)

GROWTH ENGINE: 近期成長引擎 (Near-term Growth Engine)

• 產品名稱: TMB-365/380
• 市場定位: 瞄準數百億美元 HIV 市場中最快速的長效療法 (Targets the fastest growing long-acting therapy in the multi-billion dollar HIV market)
• 產品差異化: 全抗體、零 DDI、居家皮下自我注射潛力 (Full antibody, zero DDI, potential for home subcutaneous self-injection)
• 開發進度: Phase 2a 成功,推進 Phase 2b (Phase 2a successful, advancing to Phase 2b)

NEXT WAVE: 下一代引擎 (Next Generation Engine)

• 平台名稱: CD4-ADC Platform
• HIV 治癒: TMB-365 搭載藥物,精準清除潛伏病毒庫 (TMB-365 loaded with drugs, precisely clears latent viral reservoirs)
• 自體免疫: 開啟未被滿足的千億美元市場 (Unlocks an unmet multi-billion dollar market)
• 平台延展: 同一平台、多種載荷,多重授權機會 (Same platform, multiple payloads, multiple licensing opportunities)

多樣化的首創資產產品線 (A diversified portfolio of first-in-class assets)

• 備註: 植根於 CD4 · 橫跨多種模式 — Rooted in CD4. Expanded across modalities.

平台科學基礎 (Why CD4 · TMB-365 engineering · TMB-365/380 dual-antibody regimen)

為何 CD4+ T細胞是關鍵標靶 (Why CD4 matters — enabling treatment and cure strategies)

• 1. HIV 宿主標靶 (Host target): 更高的抗藥性屏障,不會因病毒突變而失效 (Higher barrier to resistance, not susceptible to viral mutation escape)
• 2. 臨床已驗證 (Clinically validated): 由 Trogarzo® 於人體臨床驗證安全有效 (Proven safe and effective in human clinical trials by Trogarzo®)
• 3. 病毒庫相關 (Reservoir-associated): CD4+ 細胞為潛伏病毒庫 → 治癒切入點 (CD4+ cells are latent reservoirs → entry point for cure)
• 4. 可內化 (Internalization): 使標靶化載荷 (payload) 遞送成為可能 (Enables delivery of targeted payload)
• 5. 平臺化應用 (Platform): 可切入多種 CD4+ T 細胞相關疾病的治療 (Applicable to treatment of various CD4+ T cell-related diseases)

TMB-365: 臨床驗證的 CD4 抗體 (Engineered from ibalizumab · Humanized IgG1 · Post-attachment inhibitor)

• 1. 增強廣度與效價 (Enhanced breadth): 透過 N-glycan 工程,較 ibalizumab 更廣的 HIV-1 覆蓋 (Broader HIV-1 coverage than ibalizumab via N-glycan engineering)
• 2. 延長半衰期 (Extended half-life): FcRn 與 pH 依賴性結合工程,支持長效暴露 (FcRn and pH-dependent binding engineering supports long-acting exposure)
• 3. 臨床驗證 (Clinical validation): 已建立安全性檔案,Phase 1/2 概念驗證完成 (Safety profile established, Phase 1/2 proof-of-concept completed)
• 藥物動力學 (PK) : 克服傳統 CD4 抗體的限制 (Pharmacokinetics (PK): Overcoming limitations of traditional CD4 antibodies)
  • pH 依賴性 CD4 結合 + FcRn 循環工程 → 實現長效暴露 (pH-dependent CD4 binding + FcRn recycling engineering → achieves long-acting exposure)
  • 相較 IBALIZUMAB 更高廣度與效價 (Higher breadth and potency compared to IBALIZUMAB)
  • PK 模型支持給藥間隔延長至 Q12W,契合新興長效 HIV 療法 (PK model supports dosing interval extension to Q12W, aligns with emerging long-acting HIV therapies)

TMB-365 對多重抗藥性 HIV 具廣泛活性 (Broad activity across diverse and multi-drug-resistant HIV)

• 總體活性: 98-100% MPI 橫跨多種 HIV 亞型 (MPI across various HIV subtypes)
• 廣泛的抗病毒覆蓋支持維持療法開發。 (Broad antiviral coverage supports maintenance therapy development.)

TMB-365/380 雙機制全抗體 HIV 療法 (Dual mechanism of action — host target + viral target)

• TMB-365 (第二代 CD4 抗體)
  • 角色: 宿主導向附著抑制劑 (Host-directed attachment inhibitor)
  • 作用: 結合 CD4 受體,阻斷病毒進入大門,不影響細胞功能。(Binds to CD4 receptor, blocks viral entry, does not affect cell function.)
• TMB-380 (廣效中和抗體 (bNAb))
  • 角色: 病毒導向中和劑 (Virus-directed neutralizing agent)
  • 作用: 直接結合並中和病毒 (gp120),阻止感染新細胞。(Directly binds and neutralizes virus (gp120), prevents infection of new cells.)
• 創新「雙機制全抗體」維持療法: 同時靶向宿主細胞 (TMB-365) 與病毒本身 (TMB-380),形成互補的雙重進入阻斷。(Simultaneously targets host cells (TMB-365) and the virus itself (TMB-380), forming a complementary dual entry blockade.)
• 策略性優勢 · Strategic Advantages
  • 極高抗藥性屏障: 「一鎖門、一拆彈」互補設計,病毒難同時突變逃避。(Complementary "lock the door, defuse the bomb" design, making it difficult for viruses to simultaneously mutate and escape.)
  • 完全避免 DDI: 大分子蛋白不經肝臟 CYP450 代謝,契合高齡共病。(Large molecule protein not metabolized by liver CYP450, suitable for elderly with comorbidities.)
  • 無 INSTI 副作用: 非整合酶方案,避免體重增加與代謝副作用。(Non-integrase regimen, avoids weight gain and metabolic side effects.)

TMB-365/380 三大差異化優勢 (Three commercial differentiators for broad, durable adoption)

• 01 雙標靶 - 宿主細胞及病毒 (Dual Target - Host Cell & Virus)
  • No screening
  • 廣效病毒覆蓋 (Broad viral coverage)
  • 極低的抗藥性風險 (Extremely low resistance risk)
  • 擴大可治療人口 (Expands treatable population)
• 02 避免藥物交互作用 (Avoids Drug-Drug Interactions)
  • Zero DDI
  • 純抗體不經 CYP450 代謝 (Pure antibody not metabolized by CYP450)
  • 降低換藥風險,減少共病患者的換藥負擔 (Reduces risk of switching drugs, less burden for patients with comorbidities)
  • 無小分子藥物相關毒性 (No small molecule drug-related toxicity)
• 03 給藥「甜蜜點」 (Dosing "Sweet Spot")
  • Dosing sweet spot
  • Q2M IV 契合既有回診節奏 (Q2M IV fits existing follow-up rhythm)
  • Q1M 皮下自我注射潛力 (Potential for Q1M subcutaneous self-injection)
  • 降低治療失敗與病毒傳播風險 (Reduces risk of treatment failure and viral transmission)

與夥伴長效產品組合的互補策略 (A complementary host-targeted mechanism for LA franchises)

• 作為宿主導向 (CD4) 機轉,TMB-365 與所有病毒導向的抗病毒藥物類別正交 (orthogonal),可與整合酶 (INSTI)、衣殼 (Capsid)、套膜抑制劑 (Envelope) 組成全新長效組合。(As a host-targeted (CD4) mechanism, TMB-365 is orthogonal to all virus-directed antiviral drug classes, and can form new long-acting combinations with Integrase (INSTI), Capsid, and Envelope inhibitors.)
• 整合酶抑制劑 (INSTI): ✓ Integrase + CD4
• 衣殼抑制劑 (Capsid, 如 LEN): ✓ Capsid + CD4
• 套膜抑制劑 (Envelope): ✓ Envelope + CD4
• 病毒庫標靶 ADC (Reservoir Targeted ADC): ✓ Reservoir ADC
• TMB-365 為何改變格局 (Why TMB-365 Changes the Landscape)
  • 宿主導向 Host-targeted: 作用獨立於病毒突變路徑,具獨特抗藥性檔案 (Mechanism independent of viral mutation pathways, unique resistance profile)
  • 正交機轉 Orthogonal mechanism: 與病毒導向療法互補,無交叉抗藥性 (Complementary to virus-directed therapies, no cross-resistance)
  • 產品組合多元化 Diversified product combinations: 賦能全新長效組合,對抗集中化抗藥性風險 (Enables new long-acting combinations, combats concentrated resistance risk)

CD4-ADC 平台與 HIV 治癒 (The CD4-ADC Platform and HIV Cure)

• 核心概念: Reservoir biology · Reveal & Reduce · Preclinical PoC · Autoimmune expansion

HIV 治癒: 製藥業的聖杯,而中裕握有關鍵 (HIV cure — the industry's holy grail, and TaiMed holds the key)

• 功能性治癒是 HIV 領域四十年來未竟的終極目標 - 各大藥廠競相投入的聖杯。(Functional cure is the ultimate goal in HIV for forty years - the holy grail that major pharmaceutical companies are vying for.)
• The barrier is the latent reservoir in CD4+ cells — reaching it requires a validated CD4-targeting key.
• 業界研發中策略 | 主要限制
  • Reveal & Reduce | 全身性毒性 (Systemic toxicity)
  • 基因編輯 (Gene Editing) | 體內遞送困難 (In vivo delivery difficulties)
  • CAR-T / 細胞治療 (CAR-T / Cell Therapy) | 個人化製程複雜、成本高 (Complex personalized manufacturing, high cost)
  • 廣效中和抗體 (bNAb) | 難以有效清除潛伏病毒儲存庫 (Difficult to effectively clear latent viral reservoirs)

為何 HIV 治癒如此困難,而中裕握有關鍵 (Why HIV Cure is So Difficult, and TaiMed Holds the Key)

• 抑制 ≠ 清除。ART 可抑制病毒複製,卻無法清除已整合、潛伏於 CD4+ 細胞中的病毒庫 - 這是治癒的根本難題。(Suppression ≠ Clearance. ART can inhibit viral replication but cannot clear integrated, latent viral reservoirs in CD4+ cells - this is the fundamental challenge to a cure.)
• 1. 潛伏病毒庫 (Latent reservoir): 具複製能力的病毒潛藏於 CD4+ T細胞,將病毒基因整合進宿主基因體,並進入休眠狀態,免疫系統與藥物皆難以辨識。(Replication-competent viruses hide in CD4+ T cells, integrating viral genes into the host genome, entering a dormant state, making them difficult for the immune system and drugs to recognize.)
• 2. 病毒庫自我更新 (Reservoir persistence): 長壽命記憶細胞與同步增殖使病毒庫自我更新,可存續數十年。(Long-lived memory cells and concomitant proliferation allow the reservoir to self-renew, persisting for decades.)
• 3. 停藥即反彈 (Rapid viral rebound): 即使極少量病毒庫,一旦停止 ART,病毒負荷數週內即反彈。(Even with minimal viral reservoirs, viral load rebounds within weeks of ART cessation.)
• 抗 CD4 標靶提供解方 (Anti-CD4 Target Provides Solution)
  • 治癒必須「觸及並清除」病毒庫細胞 - 正是 CD4 標靶 ADC 平台的切入點。(Cure requires "reaching and clearing" reservoir cells - this is the entry point for the CD4-targeted ADC platform.)
  • CD4 標靶 TMB-365 ADC 使多樣化藥物遞送至病毒庫細胞成為可能 - 高胞內濃度、實現漸進式病毒庫削減 (erosion)。(CD4-targeted TMB-365 ADC enables delivery of diverse drugs to reservoir cells - high intracellular concentration, achieving gradual reservoir reduction (erosion).)

TMB-365 ADC 實現兩種互補的 HIV 病毒庫削減策略

• 單一 CD4 標靶平台可將「病毒庫再活化」與「病毒庫清除」兩類載荷精準遞送,支持 HIV 功能性治癒。(A single CD4-targeted platform can precisely deliver two types of payloads, "viral reservoir reactivation" and "viral reservoir clearance," supporting functional HIV cure.)
• LRA 載荷 (潛伏反轉劑) (LRA Payload (Latency Reversing Agent))
  • 目標: 暴露潛伏的病毒庫細胞 (Expose latent reservoir cells)
  • 機制: 誘導 HIV 轉錄 (Induces HIV transcription)
  • 載荷: 例: Romidepsin (e.g., Romidepsin)
• TACK 載荷 (標靶細胞殺傷激活劑) (TACK Payload (Targeted Apoptotic Cell Killer))
  • 目標: 清除表達 HIV 的細胞 (Clear HIV-expressing cells)
  • 機制: 觸發選擇性細胞死亡 (Triggers selective cell death)
  • 載荷: 具 TACK 活性的 NNRTIs (NNRTIs with TACK activity)

CD4-ADC 臨床前概念驗證 (Preclinical proof-of-concept — four validated milestones)

• 01 高標靶專一性 (High Target Specificity): 結合並內化至 CD4+ 細胞 (Binds and internalizes into CD4+ cells)
• 02 選擇性胞內釋放 (Selective Intracellular Release): 選擇性標靶藥物在 CD4+ 細胞 (Selective targeting drug in CD4+ cells)
• 03 有效藥物釋放 (Effective Drug Release): 載荷於標靶細胞內釋放 (Payload released inside target cells)
• 04 體外抗病毒活性 (In Vitro Antiviral Activity): 確認 TMB-365-ADC 抗病毒活性 (Confirms TMB-365-ADC antiviral activity)
• 備註: 於 IDWeek 2025 發表 · 全球首個 HIV 專用 ADC,目標 2028 進入 IND 階段。(Presented at IDWeek 2025 · World's first HIV-specific ADC, targeting IND entry in 2028.)

CD4-ADC 平台的自體免疫應用 (Extending the platform to CD4-driven autoimmune diseases)

• TMB-365-ADC 解決方案 (TMB-365-ADC Solution)
  • 精準鎖定 CD4 細胞,在目標處局部釋放藥物 (Precisely targets CD4 cells, locally releases drugs at target site)
  • 大幅提升療效,同時降低全身劑量與毒性 (Significantly enhances efficacy while reducing systemic dose and toxicity)
  • 避免 JAK/TNF 抑制劑的黑框風險 (感染、血栓) (Avoids black box risks of JAK/TNF inhibitors (infection, thrombosis))
  • 有望成為下一代免疫治療模式 (Expected to become a next-generation immunotherapy model)
• CD4 主導型自體免疫可及市場: $80B (CD4-driven autoimmune addressable market)

多層次競爭保護 (Why TMB-365 is Difficult to Replicate)

• 一個平台,打造多元產品管線 (One platform, building a diversified product pipeline)
• 1. 抗體工程 (Antibody Engineering)
  • 專有抗體序列 (Proprietary antibody sequence)
  • N-醣鏈工程 (N-glycan engineering)
  • pH 依賴性結合 (pH-dependent binding)
  • FcRn 結合優化 (FcRn binding optimization)
• 2. 臨床驗證 (Clinical Validation)
  • 人體安全性已建立 (Human safety established)
  • Phase II
  • 長效 PK 已驗證 (Long-acting PK validated)
  • 抗病毒活性已證實 (Antiviral activity confirmed)
• 3. 智慧財產布局 (Intellectual Property Layout)
  • 核心抗體專利 (Core antibody patent)
  • 抗體工程專利 (Antibody engineering patent)
  • ADC 平台專利 (ADC platform patent)
  • Payload 組合專利 (Payload combination patent)

Recent Performance and Results

Phase 2a 臨床概念驗證 (CROI 2025 late-breaker — durable suppression, clean safety)

• Week 24 病毒量 <50 copies/mL: 94%
• 確認之病毒學失敗 (VF): 0
• Grade ≥3 治療相關 AE: 0
• 注射部位反應 (ISR): 0
• 關鍵發現 · Key findings
  • 24 週維持療法:每8週單次 IV 輸注 (各 4800 mg),維持病毒抑制、CD4 穩定 (24-week maintenance therapy: single IV infusion every 8 weeks (4800 mg each), sustained viral suppression, stable CD4)
  • 無需事前敏感性篩檢即完成收案 - 廣度與效價涵蓋多重抗藥性病毒株 (No pre-screening for sensitivity required for enrollment - breadth and potency cover multi-drug resistant viral strains)
  • 無 SAE、無 Grade 3/4 事件、無急性輸注反應;抗藥性風險低 (No SAEs, no Grade 3/4 events, no acute infusion reactions; low resistance risk)
  • Phase 2b 已於 2025/12 收案首例,主要療效數據預計 2027 上半年 (Phase 2b enrolled first patient in 2025/12, primary efficacy data expected H1 2027)

TMB-365 + TMB-380 Phase 2b

• Phase 2b 進行中 (收案已完成) (Phase 2b ongoing (enrollment completed))
  • Participants: 88 (2:1 randomized)
  • IV Dosing: Q8W
  • Treatment: 48 Weeks
  • Population: Virologically Suppressed
  • 備註: 收案前無需基線敏感性篩檢 (No baseline sensitivity screening required before enrollment)

Outlook & Strategy

潛在市場規模 (Market opportunity — HIV + autoimmune > US$470B by 2033)

• HIV 藥物 (2033)
  • 成長穩定 · 整體市場約 US$58B (Stable growth · Total market approx. US$58B)
  • 長效型市場 (20%): US$12B (Long-acting market (20%): US$12B)
• 自體免疫藥物 (2033)
  • 成長快速 · 整體市場約 US$410B (Rapid growth · Total market approx. US$410B)
  • CD4 主導市場 (20%): US$80B (CD4-driven market (20%): US$80B)
• 綜合市場 Total: $470B
• 可及市場 Addressable: $92B

三階段成長: 打造國際級藥廠 (A staged growth roadmap, mirroring Gilead's value trajectory)

• 中裕的策略路線圖直接呼應 Gilead 經過驗證的三階段估值成長。(TaiMed's strategic roadmap directly mirrors Gilead's validated three-stage valuation growth.)
• 01 基礎創新 (Foundational Innovation)
  • Gilead: Tenofovir → $4B (2001)
  • 產品: Trogarzo®
  • 策略: 首創 CD4 導向抗體,驗證核心平台與藥證開發能力。(First-in-class CD4-directed antibody, validating core platform and regulatory development capabilities.)
  • 狀態: 市場進入完成 (Market entry completed)
• 02 策略多元化 (Strategic Diversification)
  • Gilead: 單顆藥丸組合 → $40B (2007)
  • 產品: TMB-365/380
  • 策略: 首個長效 HIV 抗體組合,將 TaiMed 擴展至前線用藥。(First long-acting HIV antibody combination, expanding TaiMed into frontline therapy.)
  • 狀態: 下一任估值驅動 (Next valuation driver)
• 03 平台主導 (Platform Leadership)
  • Gilead: HCV/腫瘤 → 巔峰 $144B (2015)
  • 平台: CD4-ADC 平台 (CD4-ADC Platform)
  • 策略: HIV 治癒與自體免疫,開啟可觀的長期成長潛力。(HIV cure and autoimmune, unlocking significant long-term growth potential.)
  • 狀態: 未來潛力 (Future potential)

TMB-365/380 資產估值拐點 (Value inflection — a staged valuation trajectory)

• 巔峰銷售潛力估計 $3–4B。 (Peak sales potential estimated $3–4B.)
• 現況資產估值 · today: ~$1.0B
• Phase 2b 正面數據後: ~$2.3B
• 預期 2030 BLA 核准後: $9-12B

關鍵臨床與商業催化劑 (Milestones & catalysts, 2025-2030)

• 2025/12: Phase 2b 首例收案 (FPI) (Phase 2b First Patient In (FPI))
• 2026末-27初: Phase 2b 6M 期中分析 (Phase 2b 6M Interim Analysis)
• 2027 H2: Phase 2b 臨床試驗完成 (Phase 2b Clinical Trial Completion)
• ~2028: 預期 CD4-ADC HIV Cure 進入 IND (Expected CD4-ADC HIV Cure IND entry)
• ~2029: 預期 CD4-ADC Autoimmune 進入 IND (Expected CD4-ADC Autoimmune IND entry)
• 2030: 預期 TMB-365/380 BLA 核准上市 (Expected TMB-365/380 BLA approval and launch)

授權與合作機會 (From market expansion to early innovation — multiple entry points)

• COMMERCIAL: Trogarzo®
  • 現況 / STATUS: 積極拓展至中東、北非及亞洲市場,具成熟商業化基礎。(Actively expanding into Middle East, North Africa, and Asian markets, with a mature commercialization foundation.)
  • 合作機會 / OPPORTUNITY: 開放特定新興市場的區域性商業授權,最大化產品價值。(Open for regional commercial licensing in specific emerging markets, maximizing product value.)
• LATE-STAGE: TMB-365/380
  • 現況 / STATUS: 2026末-2027初期中數據,2027 完整臨床數據。(Interim data late 2026 - early 2027, full clinical data 2027.)
  • 合作機會 / OPPORTUNITY: 進入授權階段 - 尋求全球或區域性授權及共同開發夥伴。(Entering licensing phase - seeking global or regional licensing and co-development partners.)
• PLATFORM: CD4-ADC Platform
  • 現況 / STATUS: 已完成臨床前概念驗證,目標兩年內進入 IND。(Preclinical proof-of-concept completed, targeting IND entry within two years.)
  • 合作機會 / OPPORTUNITY: 多元合作:愛滋病治癒,自體免疫兩大平台共同開發及技術授權。(Diverse collaborations: HIV cure, autoimmune two major platforms for co-development and technology licensing.)

Additional Data

中裕引領愛滋治療變革,開創精準免疫未來 (Three strategic reasons to invest in the CD4 platform)

• 1. 去風險的 CD4 平台 (De-risked CD4 platform): Trogarzo® 成功上市,已驗證 CD4 靶點、法規能力與商業化生產實力。(Trogarzo® successfully launched, validating CD4 target, regulatory capabilities, and commercial production strength.)
• 2. 近期成長引擎 (Near-term growth engine): TMB-365/380:全抗體、長效、零 DDI、無需篩檢、可居家自打,切入數十億至百億美元 HIV 市場。(TMB-365/380: full antibody, long-acting, zero DDI, no screening required, potential for home self-injection, entering multi-billion dollar HIV market.)
• 3. 平台化未來成長 (Platform-driven upside): 從 HIV 維持治療延伸至 CD4-ADC (HIV 治癒、自體免疫),打開長期估值上行空間。(Extending from HIV maintenance therapy to CD4-ADC (HIV cure, autoimmune), unlocking long-term valuation upside.)

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