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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

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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.

5 API products · Page 1 / 1
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 →
Gastroenterology / HepatologyAPI (Commercialized)Off-patent · 2026 (indicative)

Vonoprazan

Use · Indication

Reflux esophagitis, gastric ulcer; eradication of Helicobacter pylori with antibiotics

Why Listed

The first marketed P-CAB with stronger, more durable acid suppression and markedly higher H. pylori eradication; especially sizable demand in high-H. pylori Asian markets.

CAS
881681-00-1
Therapeutic Area
Gastroenterology / H. pylori
Target / Mechanism
ATP4A·ATP4B
Labeled Purity
99%+
Patent scope
Japan compound patent; US later
First-marketed P-CABPotent Acid SuppressionH. pylori Eradication
View profile & regulatory docs →
Gastroenterology / HepatologyAPI (Commercialized)Off-patent · 2020 (to verify)

Devazepide

Use · Indication

Exploratory indications related to gastrointestinal motility and appetite regulation

Why Listed

A classic cholecystokinin-receptor antagonist research molecule, commonly used in basic studies of digestion physiology and appetite regulation.

CAS
103420-77-5
Therapeutic Area
Gastroenterology / Metabolism
Labeled Purity
99+%
Patent scope
1990s compound patent; expired per 20-yr term estimate — to be verified
CCK-B AntagonistGI/Appetite
View profile & regulatory docs →
Gastroenterology / HepatologyAPI (Commercialized)Off-patent · 2015 (indicative)

Dexecadotril

Use · Indication

Symptomatic treatment of acute diarrhea

Why Listed

An anti-secretory antidiarrheal that does not inhibit intestinal motility and pairs with rehydration, widely used in pediatric acute diarrhea.

CAS
112573-72-5
Therapeutic Area
Gastroenterology
Labeled Purity
98%+
Patent scope
Cadotril-class older product; compound patent expired
Enkephalinase InhibitorAnti-secretory AntidiarrhealCommonly Used in Pediatrics
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.