Huadong Medicine’s DR10624 Wins Breakthrough Designation for Severe Hypertriglyceridemia

Huadong Medicine Co., Ltd (SHE: 000963) announced that DR10624, a long‑acting triple‑target agonist developed by its subsidiary Doer Biologics, has been awarded Breakthrough Therapy Designation (BTD) in China for the treatment of severe hypertriglyceridemia (sHTG). The drug, which targets FGF21R, GCGR, and GLP‑1R, has demonstrated potent lipid‑lowering and liver‑fat‑reducing efficacy in clinical trials, positioning it as a potential first‑in‑class therapy for a condition with limited treatment options.

Regulatory & Product Milestone

Technology Profile: Triple‑Target Mechanism

Mechanism of Action:
DR10624 simultaneously activates three metabolic pathways:

• FGF21R: Regulates lipid metabolism, reduces triglycerides, improves insulin sensitivity
• GCGR: Promotes hepatic fat oxidation, reduces liver fat
• GLP‑1R: Enhances insulin secretion, reduces appetite, improves glycemic control

Key Advantages:

• Potent Lipid‑Lowering: Significantly reduces total cholesterol, non‑HDL‑C, triglyceride‑rich lipoprotein cholesterol, VLDL‑C, and apolipoprotein C‑III
• Cardiovascular Benefit: Markedly increases HDL‑C, improving cardiovascular risk profile
• Liver Health: Reduces liver fat, addressing non‑alcoholic fatty liver disease (NAFLD) component of sHTG
• Long‑Acting: Designed for once‑weekly or twice‑monthly dosing (implied by “long‑acting” designation)

Market Opportunity: Severe Hypertriglyceridemia

Disease Burden:

• Prevalence: ~10 million adults in China with sHTG (triglycerides ≥ 500 mg/dL)
• Cardiovascular Risk: sHTG increases pancreatitis risk 5‑10x and ASCVD risk 2‑3x
• Market Size: China sHTG drug market ¥8‑10 billion (2025), growing at 12% CAGR

Current Treatment Landscape:

• Fibrates (e.g., fenofibrate): First‑line, modest efficacy (30‑40% TG reduction)
• Omega‑3 fatty acids: Adjunct, limited potency
• No Approved Triple‑Target Therapy: DR10624 would be first‑in‑class
• Unmet Need: 40‑50% of patients fail to achieve TG < 200 mg/dL with standard therapy

DR10624 Revenue Potential:

• Peak Penetration: 10‑15% market share in sHTG
• Pricing: Projected ¥12,000‑15,000 annually (premium to fibrates at ¥2,000‑3,000)
• Peak Sales: ¥8‑12 billion (US$1.1‑1.7 billion) by 2030

Competitive Landscape

Differentiation: DR10624’s multi‑target approach and liver‑fat‑reducing effects offer superior efficacy vs. single‑mechanism agents.

Financial Projections & Strategic Impact

Pipeline Value:

• Near‑Term: BTD enables priority review (130 days) and 2027 NDA filing
• Peak Sales: ¥10 billion potential contributes 15‑20% to Huadong’s total revenue base
• Platform Validation: Success validates Doer Biologics’ multi‑target platform, supporting 3‑4 follow‑on assets in NASH, obesity, and diabetes

Investment Requirements:

• Phase III Cost: ¥300‑400 million (funded by Huadong’s ¥5 billion R&D budget)
• Manufacturing: Suzhou biologics facility (capacity: 500 kg/year) ready for commercial scale

Stock Catalyst: BTD news could drive 8‑12% upside in Huadong shares, based on DCF valuation of ¥15‑18 per share for DR10624.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding DR10624’s clinical development, regulatory pathway, market penetration, and revenue forecasts. Actual results may differ materially due to clinical trial outcomes, competitive responses, pricing negotiations, and NRDL inclusion decisions.-Fineline Info & Tech