IASO 经营分析
2025 · 12

研发管线 · 10 个在研/已上市资产 · BCMA CAR-T 商业化 + 体内 in-vivo CAR-T 平台

IASO Bio is a commercial-stage ATMP (advanced therapy medicinal products) company founded 2017, focused on cell therapies and biologics for hematologic malignancies and autoimmune disease. Its core commercial product is the fully-human BCMA-targeted autologous CAR-T equecabtagene autoleucel (eque-cel, brand 福可苏®/Fucaso®, internal code CT103A), approved in China (NMPA, Jun 2023) for r/r MM after >=3 prior lines and now expanding to earlier lines and autoimmune indications. The company runs an integrated platform spanning a >240-billion fully-human antibody library, high-throughput CAR-T screening, an in-vivo CAR-T platform (engineered lentiviral vectors + T-cell-specific promoters delivering CAR genes directly inside the patient, no ex-vivo manufacturing), and advanced CMC/manufacturing. The portfolio comprises 1 commercialized product plus 9 pipeline candidates: 3 ex-vivo (autologous) CAR-T, 5 in-vivo CAR-T, and 1 antibody.

01

管线相位图 Pipeline

按最advanced适应症相位填充;点击展开各适应症 · 颜色=modality(体内平台为核心)

临床前
IND
I 期
II 期
III 期
上市申请
已上市
体内 in-vivo CAR-T(平台核心) 体外 ex-vivo CAR-T 抗体
02

催化剂日历 × 现金跑道

前瞻申报/读出 + 近期里程碑,叠加现金跑道覆盖范围(IR 核心:现金能否撑到下一个价值拐点)

前瞻催化剂 Catalysts

现金跑道覆盖至 ≈ 2029 年中

按当前烧钱速度,近 1–2 年内的注册申报与数据读出催化剂落在现金跑道覆盖范围内。

Oct 2025
NMPA full sales-license (BLA) application submitted for eque-cel r/r MM (>=3L) based on 109-pt FUMANBA-1 data
eque-cel / 福可苏® · regulatory filing
Oct 2025
IASO206, IASO207, IASO208 (in-vivo CAR-T) entered IIT stage
in-vivo CAR-T platform · trial start
Oct 2025
eque-cel PMDA (Japan) IND approval for pivotal r/r MM trial
eque-cel · regulatory filing / approval
Nov 2025
eque-cel Hong Kong BLA approval (launch)
eque-cel · approval
Oct 2025
GC Cell (Korea) exclusive out-license signed for eque-cel MM in Korea
eque-cel · partnership
Q4 2025
eque-cel autoimmune-basket IIT (MS/SLE/IIM) to be completed
eque-cel · data readout / trial completion
Q4 2025
eque-cel NDMM (high-risk 1L) IIT to be completed
eque-cel · trial completion
Q4 2025
IASO140 (BCMA/GPRC5D) IIT enrollment to be completed
IASO140 · trial completion
Q4 2025
IASO207 & IASO208 in-vivo CAR-T IIT patient enrollment to initiate
IASO207 / IASO208 · trial start
1H 2026
eque-cel MG Phase I patient enrollment to initiate (China + USA)
eque-cel · trial start
1H 2026
IASO206 in-vivo BCMA CAR-T IIT enrollment to initiate
IASO206 · trial start
2026 (planned)
Planned BLA submissions for 福可苏® in Korea, UAE, Mexico, Australia, Brazil, Canada
eque-cel / 福可苏® · regulatory filing
2H 2026
eque-cel earlier-line MM (2L/3L) Phase III registrational enrollment to be completed
eque-cel · trial completion
2H 2026
eque-cel MS Phase I patient enrollment to initiate (USA)
eque-cel · trial start
2H 2026
IASO118 (GPRC5D) Phase I patient enrollment to initiate
IASO118 · trial start
2H 2026
IASO120 (CD19/CD22) Phase II registrational enrollment to initiate (r/r B-NHL 3L)
IASO120 · trial start
2H 2026
IASO782 Phase Ia patient enrollment to be completed (ITP/wAIHA)
IASO782 · trial completion
2H 2026
IASO207 & IASO208 in-vivo CAR-T IND applications to US FDA & NMPA
IASO207 / IASO208 · regulatory filing
2027
eque-cel SLE/LN Phase I patient enrollment to initiate (USA)
eque-cel · trial start
1H 2027
IASO206 in-vivo BCMA CAR-T IND applications to US FDA & NMPA
IASO206 · regulatory filing
1H 2027
IASO782 SLE Phase Ib patient enrollment to initiate
IASO782 · trial start

近期里程碑 Recent

Jun 2023
eque-cel NMPA BLA approval — first launch (r/r MM >=3L)
eque-cel · approval
Jun 2023
IASO782 NMPA + US FDA IND approval (ITP/wAIHA)
IASO782 · regulatory filing
Jan 2024
eque-cel MG NMPA IND approval
eque-cel · regulatory filing
Mar 2024
eque-cel 2L-3L MM NMPA IND approval
eque-cel · regulatory filing
Apr 2024
eque-cel MG US FDA IND approval
eque-cel · regulatory filing
Jun 2024
IASO118 r/r MM NMPA IND approval
IASO118 · regulatory filing
Jul 2024
eque-cel MS US FDA IND approval
eque-cel · regulatory filing
Jul 2024
IASO782 SLE NMPA IND approval
IASO782 · regulatory filing
Aug 2024
eque-cel SLE & LN US FDA IND approval
eque-cel · regulatory filing
Mar 2025
eque-cel Macau SAR BLA approval
eque-cel · approval
May 2025
eque-cel Saudi Arabia orphan drug designation
eque-cel · regulatory designation
Jul 2025
eque-cel Korea (MFDS) orphan drug designation
eque-cel · regulatory designation

数据口径:PRIMARY SOURCE = 招股书.pdf (HK prospectus, Traditional Chinese) pipeline table + 'Recent developments' (近期发展) + program-detail sections; this is the most authoritative and current pipeline source. Fully…

管线/临床数据来源:HK 招股书 + Cure deck(公开 IR 材料,as of Latest Practicable Date in prospectus (FY data cutoff 2025-06-30; pipeline status reflects events through 2025-10))。