Yuanda Pharmaceutical (00512) completed the international multi-center phase III clinical trial of CBT-001, a global innovative ophthalmology drug, completed the enrollment of all patients

Zhitong Finance App News, Yuanda Pharmaceutical (00512) announced that the Group has carried out an international multi-center phase III clinical trial of CBT-001 (GPN00153), a globally innovative ophthalmology drug used to treat 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 to include 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 disease. 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 of China. The scope of authorization covers CBT-001's research indications, namely preventing pterygium growth and reducing conjunctival congestion.

Pterygium is a common chronic inflammatory proliferative ocular surface disease. It usually occurs in the conjunctiva at the corner of the eye and gradually invades the cornea, causing astigmatism or blocking the pupil, leading to decreased vision or even blindness. According to the “World Vision Report” published by the World Health Organization, the global prevalence of pterygium is 10.2%, and in rural China it is as high as 33%. According to relevant literature, the prevalence rate among people aged 40 and above in China is 13.4%, and it continues to increase with age. Currently, there are no specific drugs to treat pterygium. Clinically, the focus is on off-label drugs such as artificial tears, non-steroids, and glucocorticoid eye drops, but existing treatments have not shown accurate curative effects and there are long-term safety risks. Serious patients can be treated with surgery, but the recurrence rate for pterygium after sclerectomy is 30-80%. Multiple recurrences can cause eyelid adhesions and affect eye movement. As can be seen, there is still a huge unmet clinical need for treatment of pterygium.

The Group has always taken the field of ophthalmology as one of the important strategic development directions, continuously focusing on ophthalmic drug innovation, adhering to the path of specialized development, and continuously improving its position in the industry and market competitiveness. At present, the Group has built a “specialized, full-range, multi-variety” innovative drug product system, and has stocked a number of innovative global products for the treatment of “myopia,” “dry eye,” “pterygium,” “post-ophthalmic anti-inflammatory pain,” “demodex blepharitis,” and “blepharoid dysfunction caused by peristalsis,” and has made significant R&D progress. It is expected that many innovative products will be approved for launch in the next 3 years.

Among them, varenicline tartrate nasal spray (OC-01) for treating dry eye syndrome is currently the world's first and only preservative-free, multi-dose, sterile nasal spray approved to treat mild, moderate, and severe dry eyes. The product was approved for marketing in the US in October 2021, approved by the China Drug Administration (“FDA”) in November 2024, and has been sold in the Guangdong-Hong Kong-Macao Greater Bay Area. It will soon be marketed in mainland China; the hormonal nano-suspension PNG00833 eye drops for anti-inflammatory analgesia will be marketed in 2024 In November, the domestic phase III clinical study was completed and the clinical endpoint was reached; GPN01768 (TP-03, lotirana eye drops, 0.25%), a global innovative ophthalmic drug used to treat demodex blepharitis submitted a new drug marketing application to the Drug Administration in December 2024 and was approved for listing by the Drug Administration of the Macau Special Administrative Region Government in May 2025; GPN00884, a global innovative ophthalmology drug used to slow the progression of myopia in children completed the first phase I clinical study in China in June 2024 . In the future, the Group will accelerate the comprehensive and differentiated layout of R&D pipelines and continuously enrich innovative product reserves in the field of ophthalmology. In addition, the Group has attracted and trained a group of professionals with both clinical experience and marketing experience in the field of ophthalmology, established a customer-centered and academically-oriented professional marketing team, and established long-term stable cooperation with large pharmaceutical distribution companies and pharmacy chains, forming a nationwide marketing network. As innovative ophthalmology products continue to be approved, the Group will give full play to its core advantages in this field, continue to deepen the cutting-edge ophthalmology innovation circuit, further strengthen the specialized promotion and brand building of core products, and provide new momentum for the Group's sustainable and healthy development.

The Group has always attached great importance to research and development of innovative products and advanced technology, with patients' needs as the core, scientific and technological innovation as the core, increasing investment in innovative global products and advanced technology, enriching and improving product pipelines and industrial layout in response to unmet clinical needs, adopting a “global operation layout, dual cycle business development” strategy to form a new pattern of domestic and international dual cycle linkage development and mutual promotion, give full play to the Group's industrial advantages and R&D strength, and quickly launch innovative scientific and technological products on the market to provide patients around the world with more advanced and diverse treatment plans.