Changes in Hong Kong stocks | Yuanda Pharmaceutical (00512) rises more than 3%, global innovative ophthalmology drug CBT-001 launches international multi-center phase III clinical trial

The Zhitong Finance App learned that Yuanda Pharmaceutical (00512) rose more than 3%. As of press release, it had risen 3.02% to HK$8.89, with a turnover of HK$124 million.

According to the news, Yuanda Pharmaceutical announced that the Group has carried out an international multi-center phase III clinical trial of CBT-001 (GPN00153), a global innovative ophthalmology drug for the treatment of pterygium, and recently completed the enrollment of all patients in the global center. The study is a randomized, double-blind, placebo-controlled phase III clinical trial. It is intended to enroll 660 patients with pterygium with conjunctival congestion aged 12 and above to evaluate the safety and efficacy of CBT-001 eye drops in reducing conjunctival congestion and preventing progression of pterygium. This time, the enrollment of all patients in the clinical study of this product is another major milestone in the group's ophthalmology direction in the field of facial features.

CBT-001 was developed by Cloudbreak Pharma Inc., and is an innovative improved product of nidanib, the main component of OFEV, which has been marketed to treat pulmonary fibrosis. It has inhibitory effects on angiogenesis and tissue fibrosis. It has previously completed phase II clinical trials in the US. It is highly safe and has clinical efficacy. It can inhibit the growth of pterygium and control the progression of the condition. It can be used for mild to severe stages of pterygium and to prevent recurrence after surgery.

After China joined the international multi-center phase III clinical trial of CBT-001, the first patient was enrolled in the Phase III clinical study in China in March 2024. The Group has exclusive production (including technology transfer) and commercialization rights for CBT-001 in mainland China, Hong Kong Special Administrative Region of China, Macau Special Administrative Region of China, and Taiwan Province of China. The scope of authorization covers CBT-001's ongoing indications, namely preventing pterygium growth and reducing conjunctival congestion.