China’s Hua Medicine has spent over a decade on one medicine—a diabetes candidate in-licensed from Roche. Now under a partnership with Bayer, the drug has snagged a global first-in-class nod in China.
Bayer and Hua Medicine, a leading innovative drug development company, have announced a commercialization agreement and strategic partnership for dorzagliatin, a novel diabetes treatment, in China.
SHANGHAI, CHINA, July 1, 2020 - (ACN Newswire) - Hua Medicine today announced the positive 24-week top-line results from HMM0302, a Phase III registration trial in China of its global first-in-class glucokinase activator dorzagliatin add-on to metformin, a first line oral antidiabetic therapy in Type 2 diabetes. All subjects are treated with metformin (Glucophage) at 1500mg/day as basic therapy throughout the entire 52-week treatment period. These patients are also given either twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. The clinical study evaluates the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period when all patients will receive dorzagliatin 75mg twice daily. The primary efficacy endpoint is evaluated at the conclusion of the first 24 weeks. The subsequent 28-week treatment period is ongoing.
On April 30th, the two-year anniversary passed of the Stock Exchange of Hong Kong’s (HKEX) implementation of its new biotech chapter. As we reflect on it two years later, this pivotal decision has aged well with time and is delivering on its promise in a big way. While casual observers might recall that the new biotech era in Hong Kong started off with some growing pains, listings have strengthened over time to the extent that Hong Kong is right up there with New York and is arguably even the stronger market for biotech listings in early 2020. The timing couldn’t have been better. Just as current events illustrate how vital our industry is to the world, biotech is starting to bloom in Asia. This wouldn’t be possible without the public markets.
HMM0112 is a Phase I trial conducted in the United States in Type 2 Diabetes (T2D) patients with insufficiently controlled blood glucose levels while on metformin, DPP-4 inhibitors or SGLT-2 inhibitors, alone or in combination treatment. The principal purpose of HMM0112 is to investigate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of dorzagliatin and empagliflozin (a SGLT-2 inhibitor) as either monotherapy or combination therapy. The PK results demonstrated no impact of dorzagliatin (75 mg BID) and empagliflozin (25 mg QD) on their respective PK properties under co-administration, supporting their combination use in the clinical setting, while the PD results demonstrated a clear synergistic effect in efficacy under combination therapy. Following OGTT, the combination treatment achieved significantly enhanced glucose lowering effect (AUEC: 279 h•mg/dL) over empagliflozin (AUEC: 452 h•mg/dL, P<0.01) or dorzagliatin (AUEC: 364 h•mg/dL, P<0.05) monotherapy. Moreover, significantly increased C-peptide secretion was also observed for the combination treatment over empagliflozin monotherapy. These results support the development of a combination therapy of dorzagliatin with empagliflozin, which will provide improved benefits and better solutions to T2D patients.
Hua Medicine, a leading clinical stage biotechnology company based in Shanghai,has announced Dr. Fuxing Tang has joined Hua Medicine as Chief Technology Officer, VP of Formulation R&D and Product Development. He will also head up research and development functions for Hua Medicine in the United States.
When ARCH Venture Partners helped launch Hua Medicine with former Roche exec Li Chen, it marked one of the first bets on a Chinese biotech to deliver a world-class diabetes drug. Eight years later, their lead drug appears to have turned the corner and entered the final stretch.
So how is Hong Kong stock exchange’s biotech board doing one year after regulators opened up the listing regime to pre-revenue companies in the field?