Dorzagliatin Overview - Dorzagliatin is a first-in-class drug with global rights, targeting the underlying cause of Type 2 Diabetes (T2D) by addressing impaired glucose homeostasis[13] - As of December 31, 2019, Hua Medicine had RMB 1.1 billion in cash[13] - The global T2D population is 453 million, with 120 million in China alone, representing a massive market opportunity[13] Clinical Trial Results - In a Phase III monotherapy trial, dorzagliatin achieved the primary endpoint, demonstrating a significant and sustainable reduction in HbA1c safely[13] - In the HMM0301 Phase III trial, the dorzagliatin-treated group showed a 1.07% HbA1c reduction from a baseline of 8.35%, compared to a 0.5% reduction from a baseline of 8.37% in the placebo group (p < 0.0001)[62] - 45.4% of patients treated with dorzagliatin achieved a target HbA1c level of 7.0% or less at 24 weeks, compared to 21.5% of patients treated with placebo (p < 0.0001)[62] - Patients treated with dorzagliatin achieved a homeostasis control rate of 45.0% compared with 21.5% in the placebo group (p < 0.0001)[62] Combination Therapy - A Phase I trial (HMM0111) showed that dorzagliatin combined with sitagliptin (DPP-4 inhibitor) resulted in a 33% reduction (p<0.01) in postprandial glucose level AUEC (0-4hr)[74] - A Phase I trial (HMM0112) showed that dorzagliatin combined with empagliflozin (SGLT-2 inhibitor) resulted in a 38% reduction (p<0.0001) in postprandial glucose level AUEC (0-4hr)[79] China Market - China has the largest diabetes population globally, with approximately 125 million T2D patients[232] - The diagnosis rate in China was 50.4% in 2018 and is expected to rise to 82.2% in 2028[235] - The China anti-diabetics market is projected to grow from RMB 57.3 billion in 2018 to RMB 135.6 billion in 2025, with an expected CAGR of 11.7% from 2018 to 2028[246]
Hua Medicine (02552) Earnings Call Presentation