ZHAOKE OPHTH-B (06622.HK): Dry Eye Drug Jingyuling Wins NMPA Approval

NewTimeSpace News: On 13 November 2026, ZHAOKE OPHTH-B (06622.HK) said in a voluntary announcement that China's National Medical Products Administration approved its self-developed innovative drug Jingyuling (cyclosporine ophthalmic gel) on 10 November 2026, for promoting tear secretion in patients with dry eye disease whose tear production is reduced, so as to improve ocular signs.

The gel is dosed once daily at bedtime, avoiding the discomfort and inconvenience of daytime dosing, and clinical benefit can be observed as early as two weeks after starting treatment. The product uses a delivery technology that combines nano-micelle solubilisation with an ophthalmic gel, giving mucosal adhesion and solubilisation that extend corneal residence time, enhance corneal permeability of cyclosporine and raise bioavailability. It is preservative-free and contains artificial tear excipients for ocular surface lubrication.

The Phase III COSMO study was a multicentre, randomised, double-blind, vehicle-controlled trial enrolling 644 patients with moderate to severe dry eye disease, who received once-nightly cyclosporine ophthalmic gel or vehicle, with assessments at days 14, 42 and 84. At day 84, 73.7% of patients on the gel had an improvement of at least 1 point in inferior corneal staining score from baseline versus 53.2% on vehicle, a statistically significant difference (P<0.0001) that met the primary endpoint; a significant treatment difference was already seen at day 14 (P<0.05).

Treatment-related ocular adverse events occurred in 12.5% of patients on the gel versus 5.4% on vehicle, with eye pain the most frequently reported reaction at 8.1% and all other reactions below 3%; no drug-related serious adverse events were reported. The announcement carried the Rule 18A.05 warning that the Company cannot guarantee it will ultimately commercialise the product.