China’s First-in-Class GKA Antidiabetic Drug Dorzagliatin Accelerates Global Reach

Author: DengYueMed International Business Department

In October 2022, China’s first-in-class innovative drug, Dorzagliatin tablets (Huātángníng®), (INN, sometimes also called Dorzagidn) was approved by the National Medical Products Administration (NMPA) and included in the national reimbursement list in 2024.

As the world’s first oral Glucokinase Activator (GKA) for diabetes, Dorzagliatin represents a major mechanistic breakthrough, regulating insulin secretion, glucagon, incretins, and hepatic glycogen storage.

In September 2025, Hong Kong’s Department of Health accepted its new drug application (75 mg, MYHOMSIS®), marking a key step in HuaLing Pharma’s global expansion and positioning Hong Kong as a gateway to Southeast Asia and beyond.

The company is also advancing combination therapy research with GLP1 receptor agonists and SGLT2 inhibitors, laying the groundwork for future international indications and market growth.

Global Disease Context: Rising Diabetes Burden Highlights Need for Mechanism-Driven Drugs

According to the latest data from the International Diabetes Federation (IDF), the global number of diabetes patients is projected to reach:

l 2021: 537 million

l 2030: 643 million

l 2045: 783 million

Over 90% of cases are type 2 diabetes (T2DM). Despite rapid growth of therapies such as GLP-1RA and SGLT2 inhibitors, many patients still face:

1. Inadequate postprandial glucose control

2. Progressive β-cell dysfunction

3. Long-term drug tolerance decline

4. Adherence challenges from multi-drug regimens

Against this backdrop, drugs that enhance the body’s sensitivity to glucose via new mechanisms are a global R&D priority.

Dorzagliatin: Redefining Glycemic Control Through “High-Sensitivity Glucokinase”

Dorzagliatin’s mechanism can be summarized in four synergistic layers:

1. Activating glucokinase (GK) – making the pancreas “smarter”
Enhances GK glucose-sensing, allowing β-cells to detect rising glucose earlier and release insulin precisely—effectively equipping the system with a high-sensitivity “detector.”

2. Inhibiting glucagon – blocking “blood glucose rise signals”
Suppresses α-cell glucagon secretion, preventing abnormal fasting and postprandial glucose spikes.

3. Promoting endogenous GLP-1 secretion – multi-metabolic benefits
Aligns with physiological rhythms to:

l Stimulate insulin secretion

l Suppress glucagon

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l Delay gastric emptying

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l Reduce appetite

l Protect cardiovascular function

4. Enhancing hepatic glycogen storage – stabilizing blood glucose reserves
Improves liver glycogen storage, smoothing glucose fluctuations and reducing hypoglycemia risk.

This multi-target, physiologically aligned mechanism is seen internationally as a promising direction for next-generation oral antidiabetic therapies.

Safety and Metabolism：

Dorzagliatin is primarily metabolized via hepatic CYP450 enzymes. Clinically, attention is needed for interactions with:

l CYP3A4 inhibitors (e.g., fluconazole)

l Broad CYP450 inducers (e.g., rifampicin)

Common multi-target antiepileptics, overall, Dorzagliatin demonstrates a favorable safety profile, supporting its potential for long-term T2DM management.

Commercial Potential: First GKA Drug Reaching Market

GKA development worldwide has faced long-term challenges, including safety and hypoglycemia risk. HuaLing Pharma’s successful launch makes it the first global entrant in this field. Market potential arises from:

Large unmet needs

1. Oral administration

2. Multi-target mechanism

3. Low hypoglycemia risk

4. Complements existing therapies

Complementary with GLP-1RA / SGLT2i rather than competitive
Optimal for:

l Poor postprandial glucose control

l Declining β-cell function

l GLP-1RA intolerance (nausea, vomiting)

l Elderly or low-adherence patients requiring oral therapy

Enhanced market penetration via domestic reimbursement
Insurance coverage increases accessibility, supports real-world studies, and boosts international registration interest.

Countries with Highest Need for GKA Drugs

Based on IDF data, insurance policies, drug accessibility, and supply chain capability, Dengyuemed categorizes global need into three tiers:

Tier 1: India, Indonesia, Bangladesh – high diabetes burden & limited access

l India: ~77 million diabetics, GLP-1RA largely unaffordable, policies favor low-cost oral drugs → Dorzagliatin offers oral, mechanism-driven, relatively cost-effective therapy.

l Indonesia & Bangladesh: Rapidly rising prevalence, price-sensitive national procurement, reliance on generics

→ GKA mechanism offers affordable innovation.

Tier 2: Middle East & North Africa (Saudi Arabia, Egypt, UAE) – obesity epidemic & reliance on imports

High obesity rates, fast T2DM growth, dependence on imported innovative drugs

→ Dorzagliatin provides a non-injectable innovation to fill structural gaps.

Tier 3: Latin America (Brazil, Mexico) – large markets

Over 50 million diabetics, government procurement emphasizes cost-effectiveness, local pharma lacks mechanism-driven oral drugs

→ GKA drugs could enter public or commercial insurance systems.

Why these countries need GKA Dorzagliatin

1. Large demand for non-injectable options (avoiding GLP-1RA costs and GI side effects)

2. Postprandial glucose control critical in Asian populations

3. Limited healthcare budgets → oral GKA offers cost advantage

4. Stable supply chain from China:

l High-quality API production

l China as largest chemical pharma raw material producer

l Export policies support international registration and tech transfer (MAH, multi-center trials)

Policy Perspective: Global Registration Window

1. WHO prequalification (PQP) opens access for metabolic drugs to Africa, Middle East, South Asia

2. RCEP recognition of Chinese approvals facilitates faster registration in Indonesia, Thailand, Vietnam

3. Multi-center trial data can be recognized across countries, lowering overseas launch costs

Conclusion: Dorzagliatin – From Domestic Breakthrough to Global Standard

From first-in-class mechanistic innovation to domestic reimbursement and clear international demand, Dorzagliatin represents a flagship of China’s global drug innovation.

As international registrations advance, China medicine exporter Dengyuemed can distribute Dorzagliatin worldwide, allowing hundreds of millions of diabetes patients to access safer, physiologically aligned, and more convenient treatments, while providing reliable, traceable supply channels to healthcare institutions globally.