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原料药 API

具备 GMP / DMF 注册就绪度的原料药(API)与候选药物 · 每条标明用途、适应症与为何值得上线

Related Intermediates →

Listing Logic · Why These Products

This category is not a mere directory listing—each product is selected against the four criteria below and comes with both its 'use' and 'why it is listed' so buyers can quickly assess fit. Products are drawn from Unibest's API & Candidates supply catalog and posted after dual qualification and demand screening.

Registration-ready

We prioritize APIs already GMP/DMF-ready that can directly support regulatory filing, avoiding the compliance cost of building from scratch.

Definable Demand

We target chronic long-term therapies, (WHO) public-health procurement and specialty must-have scenarios with low, predictable demand volatility.

Mechanistic Rarity

We include first-in-class mechanisms, first approvals or molecules addressing resistance/unmet need, offering differentiated pricing power.

Supply-chain Feasibility

We also tag the number of linked intermediates—deeper in-house intermediate coverage means higher feasibility for scale-up and cost reduction.

Browse by Indication

Pick a class to see only APIs for that disease area

Browse by Patent Expiry

The cliff decides when to act — filter by window first

Expiry years are compiled from public sources and estimated on compound patents in major markets (US / EU). They exclude polymorph, process and formulation patents, term extensions and paediatric exclusivity. Values marked indicative are directional; values marked to-verify are inferred from filing era. Actual generic entry timing depends on national patent offices and the Orange Book.

10 API products · Page 1 / 1
Oncology / HematologyAPI (Commercialized)To be assessed3 intermediates

Apalutamide

Use · Indication

Non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer

Why Listed

A core endocrine therapy for prostate cancer requiring continuous long-term dosing, ensuring stable annual API demand and well suited to long-term FSO supply arrangements.

CAS
956104-40-8
Therapeutic Area
Oncology / Urology
Target / Mechanism
AR
Labeled Purity
98%+
Androgen Receptor InhibitorProstate CancerLong-term Therapy
View 3 key intermediates and enquire →
Oncology / HematologyAPI (Commercialized)Off-patent · 2026 (indicative)

Ruxolitinib

Use · Indication

Myelofibrosis and polycythemia vera; topical formulations for vitiligo and atopic dermatitis

Why Listed

A foundational agent in myelofibrosis with continued dermatology indication expansion; long-marketed with rigid, predictable demand, a low-volatility steady product.

CAS
941678-49-5
Therapeutic Area
Oncology / Hematology
Target / Mechanism
JAK1·JAK2
Labeled Purity
98%+
Patent scope
US compound patent incl. term extension (timing differs by market)
JAK1/2 InhibitorRare Blood DisorderMulti-indication Extension
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Itacitinib

Use · Indication

Graft-versus-host disease (GVHD) and related hematologic malignancies

Why Listed

Addresses high-unmet need in post-transplant GVHD with a clear mechanism and limited competition, well suited to registration partnerships with transplant centers.

CAS
1334298-90-6
Therapeutic Area
Hematology / Transplant
Target / Mechanism
JAK1
Labeled Purity
98%+
Selective JAK1GVHDTransplant Complication
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Vactosertib

Use · Indication

Solid tumors and myelodysplastic syndromes; fibrosis indications in research

Why Listed

A TGF-beta pathway inhibitor valuable both as an immuno-oncology combination component and in fibrosis, a dual-track development asset.

CAS
1352608-82-2
Therapeutic Area
Oncology / Fibrosis
Target / Mechanism
TGFBR1
Labeled Purity
98%+
TGF-beta Receptor InhibitorImmuno-combinationDual Potential
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Ensartinib

Use · Indication

First- and later-line treatment of ALK-positive non-small cell lung cancer

Why Listed

A China-originated ALK inhibitor with globally competitive efficacy and safety, a mature asset for domestic innovative-drug export and licensing.

CAS
1370651-20-9
Therapeutic Area
Oncology / Lung Cancer
Target / Mechanism
ALK
Labeled Purity
98%+
ALK InhibitorNSCLCDomestic Innovation Going Global
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Berzosertib

Use · Indication

Advanced solid tumors (ovarian, NSCLC, etc.) with chemo/radiation sensitization

Why Listed

An ATR inhibitor targeting the DNA-damage-repair pathway, a hot combination strategy with chemo-radiotherapy and PARP inhibitors, strong pipeline extensibility.

CAS
1232416-25-9
Therapeutic Area
Oncology / Targeted Therapy
Target / Mechanism
ATR
Labeled Purity
98%+
ATR InhibitorDNA Damage RepairCombination Sensitization
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Eltanexor

Use · Indication

Myelodysplastic syndromes (MDS) and acute myeloid leukemia

Why Listed

A second-generation XPO1 inhibitor with improved tolerability over the first generation, offering a clear substitution opportunity in elderly AML/MDS.

CAS
1642300-52-4
Therapeutic Area
Oncology / Hematology
Labeled Purity
98%+
XPO1 InhibitorNuclear Export InhibitionHematologic Malignancy
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Vociprotafib

Use · Indication

Targeted therapy of solid tumors carrying MAPK-pathway aberrations

Why Listed

An SHP2 inhibitor confronting KRAS/EGFR resistance, a core combination partner with KRAS inhibitors and EGFR antibodies.

CAS
2172652-48-9
Therapeutic Area
Oncology / Targeted Therapy
Labeled Purity
98%+
SHP2 InhibitorOvercoming Resistance
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Vistusertib

Use · Indication

Advanced solid tumors with PI3K/mTOR pathway aberrations

Why Listed

The mTOR pathway is a core resistance mechanism in breast and gynecologic cancers; combination regimens with endocrine therapy continue to advance.

CAS
1009298-59-2
Therapeutic Area
Oncology / Targeted Therapy
Target / Mechanism
MTOR
Labeled Purity
98%+
mTOR InhibitorPI3K/AKT Pathway
View profile & regulatory docs →
Oncology / HematologyAPI (Commercialized)To be assessed

Afuresertib

Use · Indication

Targeted therapy of multiple myeloma and various solid tumors

Why Listed

An oral pan-AKT inhibitor explored in both hematologic and solid tumors, a common targeted candidate within diagnosis-to-treatment integrated pathways.

CAS
1047644-62-1
Therapeutic Area
Oncology / Hematology
Target / Mechanism
AKT2·AKT3·AKT1
Labeled Purity
99%+
AKT InhibitorPI3K/AKT Pathway
View profile & regulatory docs →

Supply source: Unibest API & Candidates supply catalog, sourced and delivered by Unibest. Therapeutic area, indication and selection rationale are qualitative summaries based on public drug knowledge for business reference; actual registration availability is subject to DMF/GMP documentation and the technical agreement confirmed at order.