By Fineline Cube 
Hengrui Medicine (SHA: 600276, HKG: 1276) today announced the commercial launch of its first independently developed oral triple‑combination hypoglycemic formulation: Henagliflozin/Retagliptin/Metformin Extended‑Release Tablets (I & II). The product is approved for adults with type 2 diabetes mellitus (T2DM) whose glycaemic control remains inadequate on metformin hydrochloride alone, when combined with diet and exercise.
Product Profile
| Component | Class | Key Mechanism | Clinical Benefit |
|---|---|---|---|
| Henagliflozin | SGLT2 inhibitor | Inhibits renal SGLT2 → ↑ urinary glucose excretion | ↓ fasting glucose, weight loss |
| Retagliptin | DPP‑4 inhibitor | Blocks DPP‑4 → ↑ GLP‑1 → ↑ insulin, ↓ glucagon | Post‑prandial glucose control |
| Metformin | Biguanide | Reduces hepatic gluconeogenesis | Baseline glycaemic control |
- First‑in‑China: Henagliflozin is China’s first independently developed SGLT2i; Retagliptin is the first domestic DPP‑4i.
- Extended‑Release: Tablets (I & II) provide sustained drug release, improving adherence.
- Fixed‑Dose Combination: One pill replaces multiple tablets, simplifying therapy for patients.
Clinical Evidence
- Phase III Trial (SHR3824‑SP2086‑MET‑301)
- 1,540 participants; 12‑week double‑blind crossover.
- HbA1c reduction: 1.54 % (baseline → 7.00 %).
- Responder rate: 57.4 % achieved HbA1c ≤ 7 %.
- Additional benefits: 0.52‑0.65 % greater HbA1c lowering versus dual‑combination; modest weight loss and systolic BP reduction.
- Safety: Low hypoglycaemia risk, tolerable GI profile.
- Bioequivalence (HR20031‑101) & Food‑Effect PK (HR20031‑102)
- Demonstrated comparable absorption across formulations and with or without food.
Regulatory & Market Impact
- Approval: Granted by the China Food and Drug Administration (CFDA) under the “Class 1 Chemical Novel Drug” pathway.
- Market Position: Addresses a critical unmet need—patients who cannot achieve target HbA1c on metformin monotherapy.
- Commercial Strategy: Hengrui will partner with leading hospitals for early‑adoption programs and is preparing for reimbursement negotiations with Chinese payers.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech