Hua Medicine (2552) BIO International 2024 San Diego Presentation summary

Market overview and unmet need

• Over 537 million adults globally have diabetes, with more than 120 million in China and 38 million in the US; diabetes-related health expenditure is projected to reach $825 billion by 2030.

• Current diabetes drugs manage symptoms but do not address the underlying cause or modify disease progression.

• Nine classes of diabetes drugs are available, yet none restore glucose homeostasis or induce remission.

• Poor glycemic control leads to severe complications, including cardiovascular, kidney, nerve, and eye diseases.

• Maintaining glucose Time In Range (TIR) is critical for reducing mortality and complications in T2D.

Scientific innovation and mechanism

• Glucokinase acts as the body's glucose sensor; its dysfunction leads to loss of glucose homeostasis and T2D.

• Dorzagliatin, a first-in-class glucokinase activator, restores glucose homeostasis by repairing early-phase insulin and GLP-1 secretion, reducing insulin resistance, and improving TIR.

• Dorzagliatin serves as a cornerstone therapy, synergizing with other T2D drugs to enhance glucose control.

• Clinical trials show dorzagliatin improves GLP-1 secretion in obese T2D patients, normalizing insulin response.

• Animal studies indicate dorzagliatin may protect against cognitive decline by stabilizing glucose metabolism in the brain.

Clinical evidence and real-world impact

• The DREAM study showed 65.2% diabetes remission at 52 weeks in drug-naïve T2D patients treated with dorzagliatin.

• Long-term dorzagliatin use significantly improves TIR and gradually restores islet function, with potential benefits for patients with diabetic kidney disease.

• No drug interactions were observed with sitagliptin or empagliflozin; combination therapy further improved glycemic control and beta cell function.

• Dorzagliatin is approved and reimbursed in China for drug-naïve and metformin-tolerant T2D, with broad allowances for use in DKD and in combination therapies.

• Bayer Healthcare is the exclusive commercial partner in China, with significant upfront payments and wide distribution channels.