HighTide Therapeutics

What HighTide Therapeutics does

HighTide Therapeutics is a global clinical-stage biopharmaceutical company headquartered in Shenzhen, China, founded in 2011 and listed on the Hong Kong Stock Exchange (2511.HK). The company focuses on developing first-in-class therapeutics for cardiovascular-kidney-metabolic (CKM) diseases, with its lead candidate HTD1801 (berberine ursodeoxycholate) representing a proprietary ionic salt that acts as an anti-inflammatory metabolic modulator targeting the AMPK-NLRP3 signaling axis. The mechanism addresses a shared inflammatory pathway across multiple metabolic and fibrotic conditions, enabling a single-asset, multi-indication development strategy.

HighTide's clinical pipeline spans type 2 diabetes (T2DM), non-alcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis (NASH/MASH), primary sclerosing cholangitis (PSC), dyslipidemia, obesity, and chronic kidney disease (CKD), with a second asset HTD4010 (Rimtoregtide) in development for pancreatitis. The lead asset has accumulated two FDA Fast Track designations, FDA Orphan Drug status, and inclusion in China's National Major Science & Technology Special Project, and has generated pivotal 52-week Phase III data with peer-reviewed publication in NEJM Evidence. The company accepted an NDA submission for T2DM with China NMPA in 2026.

The business model is a traditional clinical-stage biopharma model: HighTide develops therapeutics in-house, funds operations through equity financing (including a $107M Series C/C+ in 2023) and its HKEX listing, and plans to commercialize through direct sales and partnerships following regulatory approval. Leadership has been recruited from commercial-stage metabolic companies, notably Intercept Pharmaceuticals, and the company has supplemented its discovery capabilities through a strategic AI/ML partnership with Silexon Technology. The company is pre-revenue with its first commercial product launch pending China NMPA approval.

Name

HighTide Therapeutics

Legal name

HighTide Therapeutics, Inc.

Website

https://hightidetx.com

Company type

Public

Founded year

2011

Operating status

Operating

Headcount range

51–100 employees

Short description

HighTide Therapeutics is a global clinical-stage biopharmaceutical company developing first-in-class AMPK-NLRP3-targeting therapeutics for cardiovascular-kidney-metabolic diseases, led by HTD1801 for type 2 diabetes with an accepted China NDA.

Ownership category

akta.pro rank

Product category

Cardiometabolic Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAIAAAE

Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity)

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

SECONDARYHLAIAAAI

Gastroenterology & Hepatology Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

Keywords

• Clinical-stage biopharmaceutical
• Metabolic disease therapeutics
• Cardiometabolic drug development
• Inflammatory metabolic modulators
• Novel small molecule therapy

Headquarters

HQ city

Shenzhen

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical-stage company. Revenue will be generated through commercialization of HTD1801 and other pipeline candidates upon regulatory approval. The company is advancing multiple clinical programs across CKM diseases with NDA accepted for review by China's NMPA.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

HighTide Therapeutics develops and advances clinical-stage, multifunctional pharmaceutical therapies for cardiovascular-kidney-metabolic (CKM) diseases. Its lead product, HTD1801 (berberine ursodeoxycholate), is a first-in-class orally administered anti-inflammatory metabolic modulator targeting the AMPK-NLRP3 axis across Type 2 Diabetes, MASH, obesity, PSC, and CKD indications, with NDA accepted by China's NMPA. The pipeline also includes HTD4010 (Rimtoregtide) for pancreatitis. The company currently sells no commercial product and distributes investigational drug through its global clinical trial site network.

Product overview

HighTide Therapeutics is a biopharmaceutical company developing multifunctional, multi-targeted therapies for cardiovascular-kidney-metabolic (CKM) diseases. The company's core product is HTD1801 (berberine ursodeoxycholate), a first-in-class anti-inflammatory metabolic modulator with dual mechanism of action through AMPK activation and NLRP3 inflammasome inhibition. The pipeline also includes HTD4010 (Rimtoregtide) for pancreatitis. The company focuses on chronic metabolic diseases driven by insulin resistance and chronic inflammation, with clinical programs spanning Type 2 Diabetes, MASH (Metabolic dysfunction-Associated SteatoHepatitis), Obesity, PSC (Primary Sclerosing Cholangitis), and CKD (Chronic Kidney Disease). HTD1801 has received FDA Fast Track designations for both NASH and PSC, and Orphan Drug designation for PSC, with NDA accepted for review by China's NMPA.

Differentiator

Problem solved

Functional benefit

Products and services

• HTD1801 (Berberine Ursodeoxycholate) First-in-class oral anti-inflammatory metabolic modulator (AIMM) and ionic salt of berberine and ursodeoxycholic acid; activates AMP Kinase and inhibits the NLRP3 inflammasome to address chronic metabolic and inflammatory pathways underlying T2DM, MASH, PSC, obesity, and CKD. NDA under review by China's NMPA; global Phase III clinical program ongoing.
• HTD4010 (Rimtoregtide) Drug candidate in clinical development for the treatment of pancreatitis; completed Phase I clinical trials in Australia and intended to advance to Phase II in the United States.

Quantifiable outcome

• Phase III SYMPHONY-2: HbA1c reduction of -1.2% at 24 weeks and -1.1% at 52 weeks when combined with metformin
• +4 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core and supporting.

• Silexon TechcoreStrategic or Co-development Partner · 10 October 2019Long-term strategic partnership for new drug research and development combining HighTide's drug research and clinical development experience with Silexon's AI/machine learning algorithm tools. The partnership aims to accelerate and optimize drug development through AI technology, diversify HighTide's pipeline, and reduce R&D costs.
• JLABS @ ShanghaisupportingStrategic or Co-development Partner · 10 July 2019HighTide became a resident company at Johnson & Johnson Innovation - JLABS @ Shanghai, the first JLABS site in Asia-Pacific and largest in the global JLABS network. The 4,400 square-meter incubator is located in Shanghai's Zhangjiang Hi-Tech Park.
• PSC Partners Seeking a CuresupportingStrategic or Co-development PartnerHighTide sponsors the annual PSC patient advocacy conference organized by PSC Partners Seeking a Cure, demonstrating commitment to patient advocacy and rare disease community engagement.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Terns Pharmaceuticals: Terns is a clinical-stage China-US biotech developing oral therapies for metabolic diseases including MASH and obesity. As a fellow Asia-headquartered cardiometabolic company with global development, Terns is a comparable peer in geographic positioning and therapeutic focus.
• Intercept Pharmaceuticals: Intercept developed obeticholic acid for NASH and PSC, the same rare liver indications HighTide is pursuing with HTD1801. Intercept's late-stage clinical journey, FDA interactions, and eventual commercial challenges provide the closest analog for HighTide's regulatory and launch trajectory in liver disease.
• Madrigal Pharmaceuticals: Madrigal commercialized Rezdiffra, the first FDA-approved MASH therapy, validating the MASH/NASH market opportunity that HTD1801 is also pursuing via the AMPK-NLRP3 mechanism. Both companies are addressing insulin resistance-driven liver disease with oral therapies.
• Akero Therapeutics: Akero is developing efruxifermin (FGF21 analog) for MASH with T2DM comorbidity, overlapping with HighTide's T2DM/NASH combination focus. Both target the metabolic dysfunction underlying CKM diseases through distinct but complementary mechanisms.
• Viking Therapeutics: Viking is a clinical-stage cardiometabolic company developing therapies for obesity and metabolic disease, directly comparable to HighTide's obesity and T2DM development focus. Both are pre-commercial biotechs advancing novel mechanisms against entrenched incumbents.
• Mirum Pharmaceuticals: Mirum commercializes therapies for rare liver diseases including Alagille syndrome and PFIC, with PSC pipeline assets. Both companies pursue rare cholestatic liver diseases where unmet need is high and orphan designation provides regulatory leverage.
• Inventiva Pharma: Inventiva is developing lanifibranor for MASH and has overlapping cardiometabolic liver disease focus with HighTide. Both are late-stage clinical companies targeting the CKM/MASH axis with novel oral mechanisms.
• CymaBay Therapeutics: CymaBay developed seladelpar for primary biliary cholangitis (PBC), a cholestatic liver disease adjacent to PSC that HighTide is pursuing. Both companies target rare inflammatory liver diseases with novel mechanisms.

Broad incumbents

• Gilead Sciences: Gilead is a large biopharmaceutical company with significant MASH and HIV-related metabolic disease programs, providing a benchmark for what scaled commercialization of liver/metabolic therapies looks like. As a potential partner or acquirer, Gilead represents the strategic exit pathway for HighTide.

Emerging players

• Zealand Pharma: Zealand is developing novel peptide therapeutics for metabolic disease and obesity with global clinical programs. Comparable as a clinical-stage metabolic-focused biotech advancing differentiated mechanisms, though based in Denmark rather than Asia.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/HighTideThera

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about HighTide Therapeutics