Chinese biotech Harbin Gloria Pharmaceuticals took a $600 million stake in a subsidiary of SINOPHARM GROUP whose lead product is an oral insulin candidate being codeveloped with Israeli biotech Oramed Pharmaceuticals.
3 years ago Sinopharm gained the marketing rights to oral insulin candidate ORMD-0801 with a $50 million licensing deal in milestones plus 10% royalties on net sales. ORMD-0801 has already shown in early phase II trials that it can keep nighttime glucose in a tight range through the night, a nagging problem for those on insulin injections which can lower fasting nighttime blood glucose too quickly, causing fluctuations in the night.
What Sinopharm’s ORMD-0801 still has to show is that it can lower or stabilize HbA1c blood sugar levels too, the 90-day measure that is the gold standard endpoint of nearly all insulin-related clinical trials. This has never been proven before.
The 90-day trial, enrolling 240 patients, is scheduled to complete in about 10 months. If it succeeds, a pivotal Phase III trial with the same endpoint is planned. Sinopharm is trying to carve out a new market by prolonging the time between diagnosis and the initiation of daily injectable insulin therapy.