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PELL BMT Investor Presentation 2026
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
Confidential
6949
沛爾生技醫藥股份有限公司
PALLBMT Ltd.沛爾生技醫藥股份有限公司
基本資料
- 設立時間：2017/3/30
- 登記資本額10億; 實收資本額6.49億
- 集團員工人數: 130人(博/碩士 61.5%)
- 市值：新台幣446億元
- 主要業務:
- ☑ 癌症之免疫基因工程療法
- ☑ 細胞治療相關技術與產品
- 總公司及分公司
- ☑ 台北總公司(內湖)
- ☑ 高雄分公司(左營)
- 子公司--台灣細胞製造股份有限公司 (tcmc) 竹北 PIC/S GMP廠
- 竹北生醫園區廠房面積 1,000坪
- CAR-T產能規劃 300例/年
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
2026/H1 Milestone
| 現金增資 | • 完成18.6億元現金增資 |
|---|---|
| PL001 | • 第二期臨床試驗，經IDMC通知，療效通過期中分析標準，達統計上顯著意義 |
| PP011 | • 提出IND申請 |
| 股票面額調整 | • 董事會通過面額調整為0.5元/股，待6/18股東會討論 |
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
集團架構
2026/3/31
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
癌細胞
T-CELL
一般T細胞
CAR-T細胞
癌細胞
CAR-T CELL
複合抗原受體T細胞療法CAR-T
(Chimeric Antigen Receptor T cell)
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
CAR-T
CAR-T 細胞治療具有下列 3 種治療特色
- Kymriah (Novartis) 為全球首例獲美國 FDA 核可上市，成為常規療法。
一劑價格 47.5 萬美元 - Kite Pharma 治療「瀰漫性大B細胞淋巴瘤」(Diffuse Large B Cell Lymphoma, 一劑價格 37.3 萬美元)
Global Data統計:
✓ 2024年全球細胞治療市場規模為73.1億美元，預計2033年為1,888.4億美元
https://www.polarismarketresearch.com/industry-analysis/car-t-cell-therapy-market
PALLBMT Ltd.
沛爾生特醫藥股份有限公司
核心競爭力
①acquire T cells from blood
②transduction of T cells with lentivirus
③expansion of CAR-T cell while maintaining stemness
insertion gene for CAR
④infusion into patient
⑤infection gene for CAR
傅病毒
⑥infusion into patient
CAR-T生產之門檻與困難
CAR平台具專利限制且效能仍需改善
LV 病毒製造不易且成本高昂
製程耗時長
CAR-T生產品質不佳
核心突破技術
新穎之次世代CAR-T平台
專利之新型慢病毒(LV)製造工藝
損案7天短天期製程
特殊製程產出高比例Tscm之CAR-T
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PALLBMT Ltd.沛爾生技醫藥股份有限公司
PELL核心技術
自主技術臨床應用
- CD19 CAR-T 和 BCMA CAR-T
-- B細胞淋巴癌、急性B細胞白血病、多發性骨髓瘤
- 淋巴癌的第2期臨床試驗，療效通過期中分析標準。
-
專利保護的 CAR-T 臨床生產製程，可產出超高 Tscm (stem central memory T cells) 比例，並僅需7日即可完成生產，為最先進之製程
-
多鏈 CAR-T 治療實體癌
-
In vivo CAR-T
PALLBMT Ltd.沛爾生技醫藥股份有限公司
Pipeline-CAR-T
| Pipeline | Indication | CAR engineering | Pre-Clinical | IND | Phase I | Phase II | Conditional approval/Phase III |
|---|---|---|---|---|---|---|---|
| PL001 | B-cell Lymphoma) | ||||||
| PL002 | Ovarian | ||||||
| PL003 | Multiple Myeloma | ||||||
| PL004 | In vivo |
PL001第二期臨床試驗，經獨立數據監測委員會(IDMC)通知，療效通過期中分析標準，達統計上顯著意義，將依第二期臨床試驗結果，併同台灣細胞製造股份有限公司(tcmc)採GMP標準之細胞生產數據，依「新藥查驗登記加速核准機制(accelerated approval；AA)」或「再生醫療製劑查驗登記及許可審查準則」，向衛生福利部食品藥物管理署遞交期中報告，並申請新藥查驗登記，提早上市。
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PALL BMT Ltd. 沛爾生技醫藥股份有限公司
PL001 - 優於競品之 CD19 CAR-T
| Product | Manufacturing period (days) | Turn-around time (days) |
|---|---|---|
| YESCARTA (Gilead/KITE) | 6-8 | 14 |
| KYMRIAH (Novartis) | 8-12 | 22 |
| BREYANZI (BMS) | NA | 24 |
| PL001 (PELL BioMed) | 7 | 10-14 |
Blood. 2014 Jun 12; 123(24): 3750-3759;
Oncotarget. 2016 Dec 13; 7(50): 82354-82368;
Cancer Immunology, Immunotherapy, 2018 doi.org/10.1007/s00262-018-2155-7;
Blood. 2016 Jul 28; 128(4): 519-528;
Front. Immunol. 2020: 11:482;
Nat Med. 2019 Sep;25(9):1408-1414;
J Clin Oncol 38: 2020 (suppl; abstr 3023)
P a L
BMT Ltd.
沛爾生技醫藥股份有限公司
沛爾核心技術：多鏈平台
- 專利保護多鏈 CAR-T平台優於傳統單鏈
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
PL002 間皮素多鏈 CAR-T
新世代
NKp30-based CAR-T
毒殺固態腫瘤
- NKp30平台具有極佳腫瘤毒殺能力，勝過所有已知之41BB.zeta平台，包含毒殺癌細胞之速度、深度，以及耗竭速度
- 強化實體癌毒殺能力
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PALLBMT Ltd.沛爾生技醫藥股份有限公司
間皮素多鏈CAR-T可有效治療卵巢癌
為方便顯示，亦在不影響評估療效趨勢的情況下，此圖沒有呈現D24,D38,D52之影像數據
腫瘤完全消失
13
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
間皮素多鏈CAR-T可治療多種癌症
圖. 間皮素蛋白於不同類型癌症，於病患中出現的百分比
- 除卵巢癌外，間皮素高表現的癌症包括胰臟癌、胃癌、肺癌、肝癌及大腸癌，皆為常見且高死亡率的惡性腫瘤
- 胰臟癌與卵巢癌表現率高達70%以上
- 開發抗間皮素多鏈CAR-T用於治療其它實體癌症，可望縮短研發時程、降低研發成本、加速進入臨床試驗階段
資料來源：Protein Atlas, https://www.proteinatlas.org/ENSG00000102854-MSLN/pathology
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
PLO03 BCMA CAR-T 治療多發性骨髓瘤
BCMA CAR-T 已在美國和中國上市，為目前CAR-T臨床試驗主要靶點之一
clinical trials
N=87
N=94
全球已上市 BCMA CAR-T 療法
| 地區 | 產品名稱 | 公司 | 上市日期 | 價格(參考) |
|---|---|---|---|---|
| 美國 | Abecma | BMS | 2021年 | 52.4萬美元 |
| Carvykti | J&J/南京傳奇 | 2022年 | 46.5萬美元 | |
| 中國 | 賽愷澤 | 科濟生物 | 2024年 | 115萬人民幣 |
| 卡衛荻 | J&J/南京傳奇 | 2024年 | -- |
資料來源：Nat Rev Drug Discov. 2024 Oct;23(10):736-737
科濟藥業2024年9月公司介紹簡報
PALLBMT Ltd.沛爾生技醫藥股份有限公司
CAR-T 相較其他 BCMA 療法更具優越療效
- 統計2018-2023 年多發性骨髓瘤患者研究 (n=339) 顯示：
CAR-T 相較 TCE 和 ADC 療效更佳，具更好疾病無惡化存活期 (PFS) 和整體存活期 (OS)，是多發性骨髓瘤患者首選 BCMA 靶向治療 (BDT)
| 使用不同 BCMA 靶向療法的臨床結果 | ||
|---|---|---|
| PFS | OS | |
| ADC | 1.9個月 | 5.6個月 |
| TCE | 4.6個月 | 18個月 |
| CAR-T | 13.4個月 | 33.4個月 |
ADC: antibody drug-conjugate; TCE: T-cell engager
PALLBMT Ltd.沛爾生技醫藥股份有限公司
BCMA CAR-T 體外效果等同國際藥廠
多發性骨髓瘤細胞株毒殺效果比較
- 目前FDA僅核准兩款 BCMA CAR-T 產品 (ide-cel, cilta-cel) 上市
- 體外實驗證實 PL003 於低劑量具強烈毒殺效果，與 Commercial BCMA 無顯著差異
- PL003 動物實驗已啟動
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
18
PML BMT Ltd. 沛爾生技醫藥股份有限公司
火熱的醫藥市場－還會再燙20+年
2024/03
波士頓麻省總醫院和賓州大學醫學院使用嵌合抗原受體T細胞(CAR-T)
-- 對抗難以治療的腦瘤膠質母細胞癌 (Glioblastoma)
打CAR-T的前一天
打完CAR-T的第二天
PALLBMT Ltd.沛爾生技醫藥股份有限公司
自體轉向in vivo
自體細胞治療 (autologous)
- 客製化生產，耗時
- 高成本
- 起始細胞變異大，品質不穩定
? 異體細胞治療 (allogeneic)
- 細胞來源→可篩選合適捐贈者
- off-the-shelf → 無需費時等待培養
- 大量生產→可負擔的醫療費用
- 標準化製程→提升製備成功率、彈性生產時程
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
Novel in vivo CAR-T PL004
- Quicker
- Simpler
-
cheaper
-
效果等同自體CAR-T
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
Short peptide PP011 & PP021
| Pipeline | Indication | Pre-Clinical | IND | Phase I | Phase II | Accelerated Approval / Phase III |
|---|---|---|---|---|---|---|
| PP011 | RA | |||||
| PP021 | Parkinson | 2026/06 |
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
PP011
2030年全球類風濕性關節炎病例總數預計超過2000萬人
類風濕性關節炎(Rheumatoid Arthritis: RA)全球藥物市場
| Study Period | 2020-2032 | CAGR | 4.9% |
|---|---|---|---|
| Historical Period | 2020-2022 | Forecast Period | 2024-2032 |
| Base Year | 2023 | Base Year Market Size | USD 67.9 billion |
| Forecast Year | 2032 | Forecast Year Market Size | USD 104.5 billion |
| Largest Market | Asia-Pacific | Fastest Growing Market | North America |
2023年全球類風濕性關節炎藥物市場規模約為$679億美元
2023-2032年複合年增長率為 4.9% 。
市場規模預計於2032年將達1,045億美元
資料來源：
1. https://straitsresearch.com/report/rheumatoid-arthritis-market
2. Lancet Rheumatol 2023; 5: e594-610
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
類風溼性關節炎兩大暢銷藥物全球收入 (2020 – 2024)
| 藥物名稱 | Humira (adalimumab)
(復選注射劑) | Xeljanz (Tofacitinib)
(捷抑炎膜衣錠) |
| --- | --- | --- |
| 藥廠名稱 | 美商艾伯維 (AbbVie) | 美商輝瑞 (Pfizer) |
| 專利到期 | 2023 | 2025 |
| 收入急遽下降 | 專利到期，學名藥 (生物相似藥)
於2023 年上市 | ● FDA (2021): 增加心臟疾病與癌症的副作用發生率
● 同類型機轉多項藥物已上市
● 專利即期 (2025)，學名藥競爭激烈 |
復選 全球收入
捷抑炎 全球收入
復選 2002-2022營業額 2,080億美元
資料來源：AbbVie, Pfizer 歷年財報 (2020-2024)
3M
BMT Ltd. 公司
BMT Ltd.
沪昆生技醫藥股份有限公司
Effect 1: reducing RA Severity
- PP011 reduces RA severity, as measured by RA score*, and the effect was comparable to that of tofacitinib.
(A)
(B)
*RA score: The arthritis score for collagen-induced arthritis (CIA) in mice is calculated by adding up the scores of 4 feet. Each Foot (including toes, sole and ankle) has a maximum of 15 Points. For individual toe (0 or 1 point): 0 point = no swelling, and 1 point = swelling, and the maximum of 5 toes of each foot is 5 points. For each sole (0, 1, 3, or 5 points): 0 = normal, 1 = redness and mild swelling, 3 = moderate redness and swelling, 5 = severe redness and swelling, and the maximum is 5 points for each sole. For each ankle (0, 1, 3, or 5 points): 0 = normal, 1 = redness and mild swelling, 3 = moderate redness and swelling, 5 = severe redness and swelling, and the maximum is 5 points for each ankle. Therefore, the maximal score from 4 feet (20 toes, 4 soles and 4 ankles) is 60 Points. RA Score: (Total score of four feet / 60) × 100%.
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3.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2
Effect 2: protecting bone from erosion in RA mice
PP011 -- the medium (3 mg/kg) and high-doses (10 mg/kg) reduces bone erosion after 2 weeks' treatment
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Effect 2:
10 mg/kg PP011 for 2 weeks protects bone from erosion in RA
PP011, rather than tofacitinib, improves the unevenness and disrupted surfaces of the calcaneus bones in CFA-induced arthritis mice
01 RA causes Bone Erosion
CFA-induced arthritis mice exhibited unevenness and disturbed surface integrity of calcaneus bone visualized by $\mu$CT scan
02 PP011 Improves Bone Contour and Integrity
Once daily oral 10 mg/kg PP011 for 2 weeks restored the roughness to much smoother surfaces with fewer spikes
03 Tofacitinib Fails to Protect Bones in RA
Tofacitinib treatment, on the other hand, did not rescue the bone contour and the bone destruction progressed further
3
BMT Ltd. 公司
通信技術研究院
BMT Ltd.
沖關生技醫藥股份有限公司
Effect 3: Recovering bone mineral density in RA
CFA-induced arthritis mice exhibited reduced bone mineral density (measured from $\mu$CT scan images).
Once daily oral $10\mathrm{mg/kg}$ PP011 for 2 weeks improved the bone mineral density.
Tofacitinib, on the other hand, did not affect the bone mineral density.
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P a L BMT Ltd.沛爾生技醫藥股份有限公司
Collagen-Induced Arthritis (CIA) model in rat
- CIA induction: 14 days
- Oral
- 5, 10, 20 mg/kg (TID x 14)
Effect 1: Amelioration of RA-induced paw pathology severity in rats
(Note: green arrow indicates synovial hyperplasia; blue arrow indicates synovial inflammation; black arrow indicates pannus formation; red arrow indicates cartilage damage; yellow arrow indicates bone erosion)
Representative images (x4)
PALLBMT Ltd. 沛爾生技醫藥股份有限公司
Effect 2: Amelioration of RA-induced paw pathology severity in rats
Histopathological score of hind ankles
Histopathological score of hind paws
Pathological evaluation items included five parameters: synovial inflammation, synovial hyperplasia, pannus formation, bone erosion, and cartilage damage. Each parameter was graded according to severity as follows: normal = 0; mild = 1; moderate = 2; marked = 3; and severe = 4. The histological score of each hind paw calculated as the sum of these grades (normal = 0; maximum score = 20).
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PALLBMT Ltd.
沛爾生技醫藥股份有限公司
PP021
One platform of NF-kB-NLRP-3-iNOS inhibition for multiple neurodegenerative diseases
Parkinson's Disease
tremor
dapamine
Deprimed
Diminished substantia nigra
Neuron affected by Parkinson's
PP021 (10 mg/Kg, p.o., 30 min) in Mouse Brain Homogenate Samples – crossing BBB
RT: 13.86 AV: 1 NL: 4.07E6 T: FTMS = p NSI Full ms [100.00-2000.00]
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
Control-Blank
5 min
10 min
15 min
20 min
IVIS: Cy5.5-PP021 (20 ug/mouse, i.v.)
Cy5.5-PP021 (30 min) TISSUE DISTRIBUTION
PAL BMT Ltc
本期生技醫藥股份有限公司
Mean Brain and CSF Concentration of PP021 in Rat after Single PO at 1000 mg/kg
| Study Number | Analyte | Subject | Time | Group | Dose Level mg/kg | Sample Type | Mean Concentration ng/g; ng/mL | SD |
|---|---|---|---|---|---|---|---|---|
| 8568474 | PP021 | Rat | 0.333 | 3 | 1000 | Brain | 3.21 | 5.42 |
| PP021 | Rat | 1.00 | 3 | 1000 | Brain | 6.49 | 8.32 | |
| PP021 | Rat | 1.5 | 3 | 1000 | Brain | 5.62 | 12.4 | |
| PP021 | Rat | 4 | 3 | 1000 | Brain | 7.29 | 16.9 | |
| 8568474 | PP021 | Rat | 0.333 | 3 | 1000 | CSF | 0.533 | 0.487 |
| PP021 | Rat | 1.00 | 3 | 1000 | CSF | 0.152 | 0.172 | |
| PP021 | Rat | 1.5 | 3 | 1000 | CSF | 0.163 | 0.130 | |
| PP021 | Rat | 4 | 3 | 1000 | CSF | 0.00 | NA |
Brain
CSF
PALLBMT Ltd. 沛爾生技醫藥股份有限公司
MPTP-induced PD model
PP021 RESEARCH RATIONALE: INTERCEPTING THE iNOS PATHOGENIC CASCADE
PAL BMT Ltd. 沛爾生技醫藥股份有限公司
Parkinson's disease (subacute)
Dosing (10 days; Day 1 ~ Day 10):
- Madopar: 100 mg/kg (PO; QD)
- PP021: 1, 10, 50 mg/kg (PO; BID)
Induction of Parkinson's disease
- MPTP (i.p., 25 mg/kg, 5 mL/kg); 1 time/day for 10 days (Day 1 ~ Day 10)
Motor function (Day 10):
- Pole test (Pole test time; Pole test gait score)
- Grip strength test (Grip strength value)
- Rotarod test (Latency to first fall; Number of falls)
Tyrosine Hydroxylase (TH)
Immunohistochemistry in the Substantia Nigra pars compacta (SNpc) of the Brain (Day 10)
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
Parkinson's disease (subacute)
Role test
Time of climbing pole
Gait scores of climbing pole
Rotarod test
Latency of the first fall
Frequency of the fall
PALLBMT Ltd.沛爾生技醫藥股份有限公司
Parkinson's disease (subacute)
Grip Strength
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
Tyrosin hydroxylase staining for dopaminergic neurons
PALLBMT Ltd. 沛爾生技醫藥股份有限公司
TH(+) cells in substantia nigra
| Group | N | TH+ cells | |
|---|---|---|---|
| Mean ± SD | P value | ||
| G1: Normal mice | 9 | 251.11 ± 58.01 | |
| G2: Diseased mice | 10 | 45.5 ± 29.53### | <0.0001 |
| G3: Madopar (100mg/kg) | 10 | 134.2 ± 44.21*** | 0.0001 |
| G4: PP021 (50mg/kg) | 9 | 151.56 ± 92.11** | 0.003 |
| G5: PP021 (10mg/kg) | 9 | 139.89 ± 42.36*** | <0.0001 |
| G6: PP021 (1mg/kg) | 8 | 90.75 ± 46.4* | 0.0227 |
P < 0.001 vs Sham group; * P < 0.05 ** P < 0.01 *** P < 0.001 vs model mice.
Note: ### P < 0.001 vs control; P < 0.05, P < 0.01, **P < 0.001 vs control
♣ substantia nigra pars compacta (SNpc) TH⁺ cells
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PALLBMT Ltd. 沛爾生技醫藥股份有限公司
How about chronic? -- Chronic MPTP + Probenecid-Induced PD
MPTP twice a week for consecutive 5 weeks
From d8, starting Madopar or PP021 bid x 20 days
Time of Climbing Pole
Note: $^{}P < 0.001$ vs Control, $^{}P < 0.01$ , $^{**}P < 0.001$ vs. Model.
Pole test
Gait scores of climbing pole
Note: $^{}P < 0.001$ vs Control, $^ P < 0.05$ $^{**}P < 0.01$ $^{}P < 0.001$ vs. Model.
P a L
BMT Ltd.
沛爾生技醫藥股份有限公司
Parkinson's disease animal models (Chronic)
Rotarod test
Latency of the first fall
Note: ##P<0.01, ###P<0.001 vs Control, P<0.05, P<0.01, **P<0.001 vs. Model.
Frequency of the fall
Note: #P<0.05, ##P<0.01, ###P<0.001 vs Control, P<0.05, *P<0.01 vs. Model.
PALLBMT Ltd. 沖繩生技醫藥股份有限公司
Parkinson's disease animal models (Chronic)
Grip Strength
Note: ###P<0.001 vs Control, ***P<0.001 vs. Model.
Tremor Score
Note: ##P<0.01, ###P<0.001 vs Control; P<0.05, *P<0.01 vs. Model.
42
P a L BMT Ltd. 沛爾生技醫藥股份有限公司
Parkinson's disease animal models (Chronic)
Number of TH+ cells
Note: ###P<0.001 vs Control, P<0.05, *P<0.001 vs. Model.
Body weight
PALL BMT Ltd.沛爾生技醫藥股份有限公司
Conclusion: Novel Molecules PP011 and PP021
PP011 targets multiple pathways (incl. iNOS inhibition) potentially for treating Rheumatoid Arthritis (RA) and Parkinsons Disease
| Pipeline | Indication | Discovery | Pre-Clinical | Phase 1 | Phase 2 | Phase 3/4 |
|---|---|---|---|---|---|---|
| PP011 | Rheumatoid Arthritis | |||||
| PP021 | Parkinson’s Disease | Phase 1 trial starts in June 2026 |
Clinical Implication for Rheumatoid Arthritis
Rescues bone erosion and inhibits the decline of RA-induced bone mineral density, which tofacitinib cannot achieve
No significant adverse events in rats and dogs
Clinical Implication for Parkinson Disease
- No effective treatment (apart from deep brain stimulation) once the first-line drug (dopamine precursor) fails
Our Solution:
- Ability to penetrate the blood-brain barrier (BBB) for excellent neuro-protection and symptomatic improvement
PELL BIO-MED TECHNOLOGY CO., LTD. | www.pellbmt.com 27-May-26
PALLBMT Ltd.
沛爾生技醫藥股份有限公司
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