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远大医药(00512):全球创新眼科药物GPN00884在中国开展的I期临床研究完成了首例患者入组给药

Grandpharma (00512): The Phase I clinical study of innovative ophthalmic drug GPN00884 has completed the first patient enrollment in China.

Zhitong Finance ·  Jun 11 18:51

Grandpharma (00512) announced that it has developed a global innovative ophthalmic drug GPN0 to delay the progress of myopia in children...

According to the announcement by Grandpharma (00512), the phase I clinical study of the global innovative ophthalmic drug GPN00884, which the group uses to delay the progression of myopia in children and is carried out in China, has completed the first patient dosing.

It is reported that GPN00884 eye drops is a new mechanism of action innovative drug that slows the progression of myopia in children. Compared with low-concentration atropine eye drops, GPN00884 eye drops does not cause the effect of pupil dilation, and there are no adverse reactions such as photophobia and decreased regulation. The administration period is not limited and can improve patient compliance. At present, there is a shortage of drugs in China that have clear efficacy and safety in delaying the progression of myopia in children, and there exists unsatisfied clinical demand in this field. GPN00884 eye drops is expected to provide doctors and patients with a new clinical treatment plan to delay the progression of myopia in children.

Myopia is one of the most serious public health problems globally. According to the World Vision Report issued by the World Health Organization, the global myopia population reached 2.6 billion in 2020, with particularly high myopia prevalence of 53.4% in high-income countries in the Asia-Pacific region, far higher than those in Australia, Europe, Americas, and other regions. China has the largest number of myopia patients globally. According to the survey results of the National Health Commission of China, the myopia prevalence rate among Chinese adolescents ranks first in the world. In 2020, the overall myopia rate among children and adolescents in China was 52.7%. Frost & Sullivan predicts that the number of myopia patients under 20 years old in China will reach 190 million by 2030. The incidence of myopia in children and adolescents is showing a trend of early onset, rapid progress, and severe degree, and the incidence rate continues to rise. In 2018, the Ministry of Education of China, together with the National Health Commission and other eight departments, jointly issued the Implementation Plan for Comprehensive Prevention and Control of Myopia in Children and Adolescents. Myopia prevention and control has become one of the national strategies. Driven by a large number of patients, the clinical and market demand for myopia treatment products will continue to expand.

As one of the major comprehensive enterprises in China engaged in research and development, production, and sales of ophthalmic drugs, the group has a pipeline of products that ranks among the forefront of the industry. It covers multiple departments such as ophthalmology, otolaryngology, and stomatology, covering chemical preparations, traditional Chinese medicine preparations, and health products, including prescription drugs, OTC, medical devices, consumer goods, and other categories, with full-channel coverage in and out of the hospital, creating a “Prevention + Treatment + Health Maintenance” integrated "Big Five Sense Ecological Circle." In terms of innovative research and development, the group has reserved multiple global innovative products for the treatment of myopia, dry eye syndrome, pterygium, postoperative anti-inflammatory analgesia in ophthalmology, Demodex blepharitis, and seborrheic gland dysfunction caused by Demodex. Among them, the innovative product CBT-001 for the treatment of pterygium was approved for phase III clinical research in China in March 2023; the small molecule peptide drug GPN00136(BRM421) for the treatment of dry eye syndrome was approved for phase II clinical research in China in April 2023; the steroid nano-suspension eye drops GPN00833 for anti-inflammatory and analgesia were administered to the first patient in the phase III clinical trial in China in October 2023. In terms of overseas registration, the product has been approved by the US FDA and launched in March 2024; the global innovative ophthalmic preparation TP-03 for the treatment of Demodex blepharitis and seborrheic gland dysfunction caused by Demodex completed phase III clinical research in China in October 2023, and was approved by the US FDA for overseas registration in July 2023. It is currently the first and only drug approved by the FDA for the treatment of Demodex blepharitis. In the future, this sector will uphold the development strategy of integrating Chinese-Western medicine and medical devices, progressively enhancing industry influence, and achieving new breakthroughs in business areas.

The announcement stated that the group has always attached great importance to the research and development of innovative products and advanced technologies, with patient needs as the core and technological innovation as the driving force, increasing investment in global innovative products and advanced technologies for unmet clinical needs, enriching and improving product pipelines and industry layouts, adopting a “global operation layout, dual-cycle operation development” strategy, forming a new pattern of domestic and international dual-cycle linkage development and mutual promotion, fully exerting the group's industrial advantages and research and development strength, quickly landing and launching technological innovative products, providing more advanced and diversified treatment plans for global patients.

The translation is provided by third-party software.


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