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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.

31 API products · Page 1 / 2
Cardiovascular / RenalAPI (Commercialized)To be assessed6 intermediates

Finerenone

Use · Indication

Chronic kidney disease (CKD) associated with type 2 diabetes; slows renal function decline and cardiovascular events

Why Listed

The first nonsteroidal mineralocorticoid receptor antagonist (nsMRA), filling an anti-inflammatory and anti-fibrotic gap in diabetic kidney disease and recommended by major guidelines, a clearly incremental new product.

CAS
1050477-31-0
Therapeutic Area
Cardio-Renal Metabolism
Target / Mechanism
NR3C2
Labeled Purity
99%+
Nonsteroidal MRACardio-Renal ProtectionGuideline-recommended
View 6 key intermediates and enquire →
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 →
Immunology / InflammationAPI (Commercialized)To be assessed8 intermediates

Upadacitinib

Use · Indication

Rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis and more

Why Listed

A leading oral targeted therapy in autoimmunity spanning rheumatology, dermatology and gastroenterology, with strong and definable volume upside.

CAS
1310726-60-3
Therapeutic Area
Autoimmune / Rheumatology
Target / Mechanism
JAK1·JAK2·JAK3·TYK2
Labeled Purity
98%+
Selective JAK1Oral TargetedMulti-indication
View 8 key intermediates and enquire →
Anti-infectivesAPI (Commercialized)To be assessed3 intermediates

Ozenoxacin

Use · Indication

Topical treatment of superficial skin bacterial infections such as impetigo

Why Listed

A topical non-fluoroquinolone quinolone targeting resistant Gram-positive bacteria; its pediatric and local-use profile offers differentiation in OTC and pediatric markets.

CAS
245765-41-7
Therapeutic Area
Anti-infective / Dermatology
Labeled Purity
98%+
Non-fluoroquinolone TopicalPediatric UseResistant Bacteria
View 3 key intermediates and enquire →
Gastroenterology / HepatologyAPI (Commercialized)To be assessed7 intermediates

Resmetirom

Use · Indication

Non-alcoholic steatohepatitis (MASH/NASH) with hepatic fibrosis

Why Listed

The world's first approved MASH therapy, opening a vast untreated blue-ocean; numerous follow-on pipelines will scale API demand alongside the entire class.

CAS
920509-32-6
Therapeutic Area
Metabolism / Hepatology
Target / Mechanism
THRB
Labeled Purity
99%+
First Approved MASH DrugTHR-beta AgonistBlue-ocean Market
View 7 key intermediates and enquire →
Gastroenterology / HepatologyAPI (Commercialized)To be assessed

Fexuprazan

Use · Indication

Gastroesophageal reflux disease (GERD) and erosive esophagitis

Why Listed

A next-generation potassium-competitive acid blocker (P-CAB) with faster onset and no food effect versus PPIs, the upgrade direction for acid-related disease.

CAS
1902954-60-2
Therapeutic Area
Gastroenterology / Acid-related
Target / Mechanism
ATP4A·ATP4B
Labeled Purity
99%+
P-CAB Novel MechanismFast OnsetAsia-first Launch
View profile & regulatory docs →
Urology / Women's HealthAPI (Commercialized)To be assessed6 intermediates

Fezolinetant

Use · Indication

Moderate-to-severe vasomotor symptoms (hot flashes) of menopause

Why Listed

The first approved non-hormonal therapy for menopausal hot flashes, with broad scope to replace hormone therapy, a large and long-unmet patient population.

CAS
1629229-37-3
Therapeutic Area
Women's Health
Target / Mechanism
TACR3
Labeled Purity
99%+
First NK3 AntagonistNon-hormonal TherapyMenopause Segment
View 6 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed5 intermediates

Fluralaner

Use · Indication

Long-acting eradication of fleas and ticks in dogs and cats

Why Listed

A mainstream pet parasiticide with single-dose long protection; rising global pet-care spending sustains growing animal-health API demand.

CAS
864731-61-3
Therapeutic Area
Animal Health
Labeled Purity
99%+
Isoxazoline ClassLong-acting Oral/TopicalPet Parasiticide
View 5 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed4 intermediates

Afoxolaner

Use · Indication

Prevention and treatment of flea, tick and certain mite infestations in dogs and cats

Why Listed

A core oral pet parasiticide with good palatability and monthly dosing, often combined with milbemycin oxime, enabling fixed-combination product lines.

CAS
1093861-60-9
Therapeutic Area
Animal Health
Labeled Purity
98%+
Isoxazoline ClassBroad-spectrum ParasiticideOral Chewable
View 4 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed3 intermediates

Lotilaner

Use · Indication

Ectoparasite control in dogs and cats; ophthalmic use for demodex blepharitis

Why Listed

The only isoxazoline expanded into human ophthalmology (demodex blepharitis), combining a steady animal-health base with a human-use upside option.

CAS
1369852-71-0
Therapeutic Area
Animal Health / Ophthalmology
Labeled Purity
98%+
Isoxazoline ClassCross-speciesHuman Ophthalmic Expansion
View 3 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed2 intermediates

Sarolaner

Use · Indication

Prevention and treatment of flea, tick and other ectoparasite infestations in dogs and cats

Why Listed

One of several same-class agents, suitable as a combination supply within an animal-health portfolio to meet customers' generic and differentiated sourcing needs.

CAS
1398609-39-6
Therapeutic Area
Animal Health
Labeled Purity
98%+
Isoxazoline ClassPet Parasiticide
View 2 key intermediates and enquire →
Cardiovascular / RenalAPI (Commercialized)To be assessed

Iptacopan

Use · Indication

Paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy and C3 glomerulopathy

Why Listed

The first oral complement-factor-B inhibitor, converting PNH from infusion to oral therapy and expanding into nephrology, a high-value rare-disease molecule.

CAS
1644670-37-0
Therapeutic Area
Rare Disease / Nephrology
Target / Mechanism
CFB
Labeled Purity
98%+
Complement Factor B InhibitorFirst OralRare Disease
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 →
Anti-infectivesAPI (Commercialized)To be assessed

Zoliflodacin

Use · Indication

Uncomplicated gonorrhea, especially resistant Neisseria gonorrhoeae

Why Listed

An oral single-dose agent with a wholly new mechanism against antimicrobial-resistant gonorrhea, a WHO-priority AMR direction with clear public-health procurement demand.

CAS
1620458-09-4
Therapeutic Area
Anti-infective / Resistant Bacteria
Labeled Purity
98%+
Novel Topoisomerase InhibitorResistant Gonorrhea单剂口服
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)To be assessed

Vapendavir

Use · Indication

Rhinovirus infection, to reduce acute exacerbations in asthma/COPD patients

Why Listed

A capsid-binding inhibitor of rhinovirus that can reduce hospitalizations from COPD/asthma exacerbations, a scarce causal-therapy attempt in respiratory care.

CAS
439085-51-5
Therapeutic Area
Anti-infective / Respiratory
Labeled Purity
98%+
Capsid InhibitorRhinovirusRespiratory Indication
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 →
Anti-infectivesAPI (Commercialized)To be assessed

Itarnafloxin

Use · Indication

Antibacterial treatment of bacterial infectious diseases

Why Listed

A broad-spectrum fluoroquinolone with extensive clinical experience and controllable cost, suited as a mature generic supply for regional markets.

CAS
865311-47-3
Therapeutic Area
Anti-infective
Labeled Purity
98%+
Fluoroquinolone ClassOral Antibacterial
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)To be assessed

Islatravir

Use · Indication

Treatment of HIV-1 infection and long-acting pre-exposure prophylaxis (PrEP)

Why Listed

A novel nucleoside reverse-transcriptase translocation inhibitor (NRTTI) with long-acting dosing, the core evolution of HIV treatment and prevention, high strategic value.

CAS
865363-93-5
Therapeutic Area
Anti-infective / HIV
Labeled Purity
98%+
Long-acting NRTTIHIV Treatment/PreventionLow-frequency Dosing
View profile & regulatory docs →
RespiratoryAPI (Commercialized)To be assessed6 intermediates

Ensifentrine

Use · Indication

Maintenance treatment of chronic obstructive pulmonary disease (COPD)

Why Listed

The first novel-mechanism inhaled COPD maintenance therapy in over a decade, combining bronchodilation and anti-inflammation, filling the gap after triple therapy.

CAS
298680-25-8
Therapeutic Area
Respiratory / COPD
Target / Mechanism
PDE3A·PDE3B·PDE4A·PDE4D·PDE4B·+more
Labeled Purity
99%+
PDE3/4 Dual InhibitorInhaled DeliveryNovel Mechanism
View 6 key intermediates and enquire →
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 →
Anti-infectivesCandidate (In-research)To be assessed

Bemnifosbuvir Sulfate

Use · Indication

Treatment of hepatitis C virus (HCV) infection

Why Listed

An NS5B nucleotide analog with pangenotypic activity and a high resistance barrier, an important component of HCV combination and retreatment regimens.

CAS
2241337-84-6
Therapeutic Area
Antiviral / Hepatitis
Labeled Purity
98%+
NS5B Polymerase InhibitorPangenotypicCombination Regimen
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 →
CNS / PsychiatryAPI (Commercialized)To be assessed

Elpetrigine

Use · Indication

Anticonvulsant treatment of epileptiform and other neuronal hyperexcitability disorders

Why Listed

A voltage-gated sodium-channel modulator for epilepsy; antiepileptic demand is stable in emerging markets, suited as a long-term mature product reserve.

CAS
212778-82-0
Therapeutic Area
Neurology
Target / Mechanism
SCN2A·SCN3A·CACNA1C·CACNA1S·CACNA1D·+more
Labeled Purity
99%+
Sodium Channel BlockerAntiepileptic
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.