Zhitong Financial and Economic APP News, recently, the Hong Kong stock technology innovative pharmaceutical enterprise Broad Pharmaceutical (00512) ophthalmology plate innovative drugs came good. According to the company's announcement on October 24th, the domestic III phase clinical trial of its anti-inflammatory and analgesic hormone nano-suspension eye drops GPN00833 has completed the first patient administration, which is another important research and development progress of Broad Pharmaceutical in the field of ophthalmic disease treatment.
Global clinical progress is smooth, and GPN00833 is expected to fill the market demand for hormone ophthalmic preparations.
The announcement shows that GPN00833 is an anti-inflammatory and analgesic hormone nano-suspension eye drops, and its main active ingredient clobetasol propionate is a powerful glucocorticoid with high local anti-inflammatory activity and strong capillary contractility, while the product's unique nano preparation process effectively solves the low bioavailability and safety risks caused by low water solubility of hormone products.
The first patient was enrolled in a multicenter, randomized, double-blind, placebo-controlled, parallel-grouped phase III clinical trial. The purpose of this study was to evaluate the efficacy and safety of GPN00833 in the treatment of inflammation and pain after cataract surgery in Chinese population.
Overseas clinical research, GPN00833 has also made important progress, the product overseas phase II clinical studies and two phase III clinical studies have successfully reached the clinical end point. The clinical results show that GPN00833 is effective and safe in the treatment of anti-inflammation and analgesia after ophthalmic surgery. The product has submitted a market license application (NDA) to FDA in the first half of this year.
It is reported that hormone ophthalmic preparation including GPN00833 is one of the most commonly used and effective drugs for the treatment of ophthalmic inflammatory reaction, which can quickly and effectively control the inflammatory reaction and condition after ophthalmic surgery. However, due to the technical ability of ophthalmic preparations, the market of hormone ophthalmic preparations in China is mainly dominated by imported products, and there are no new products on the market in the past ten years.
From the point of view of the currently listed hormone ophthalmic preparations such as dexamethasone and prednisolone, most of them are traditional glucocorticoids. There are many adverse reactions when these drugs are used for a long time, which may lead to the increase of intraocular pressure (IOP) and lead to steroid-induced glaucoma and hormonal cataract, thus inducing or aggravating infection. Strong hormone eye drops with high safety are urgently needed in the market. Based on the safety and effectiveness advantages that have been proven in clinical trials, GPN00833 is expected to fill this urgent clinical need in the future.
The certainty of the industry is highlighted, and the forward-looking layout is waiting for the outbreak of the plate.
In recent years, the layout of Broad Pharmaceutical Ophthalmology track has achieved good development, and the smooth global clinical progress of various innovative products shows the strong strength of the company's innovation and research and development. at the same time, the rapid growth of the industry also confirms the company's development strategy. it has brought "Dongfeng" to its long-term development.
According to Frost & Sullivan, China's ophthalmology market has reached 210 billion yuan in 2021. According to the data of Burning knowledge Consulting, the size of China's ophthalmic drug market is expected to grow at a compound annual growth rate of 22.9% to about 20.2 billion US dollars in 2030, exceeding the growth of the global ophthalmic drug market in the same period. at the same time, the agency expects that China's cataract surgery market will reach about 33.9 billion yuan by 2025.
In addition, according to the National Health Vision report, there are about 700 million myopic patients in China in 2020, while the penetration rate of refractive surgery is only about 0.3%, which is equivalent to 1% of that of the United States, which has great potential to rise in the future. With the increasing aging of the population and the introduction of policies related to ophthalmology health and other dividends, the ophthalmology market in China is expected to achieve further growth in the future. According to Southwest Securities, China's ophthalmology market is expected to grow from 41.77 billion in 2014 to 256.31 billion yuan in 2024, with a compound annual growth rate of about 20 per cent. With the further growth of the market space and surgery volume of the ophthalmology industry, the market space of hormone ophthalmic preparations is bound to further expand, and the future market space is very considerable.
Long-term layout in the field of ophthalmology, selling in the research and development of double-line and stable product moat
As one of the major ophthalmic drug R & D, production and sales enterprises in China, Broad Pharmaceutical has been deeply cultivated in the field of ophthalmology for more than ten years. The company sells nearly 30 ophthalmological products, mainly focusing on dry eyes, fundus bleeding, glaucoma, cataract, anti-inflammation, myopia and other mainstream indications, including prescription drugs, OTC, devices, consumer goods and other categories. The company also took the lead in the industry to create a "public eye protection ecosystem" that integrates "prevention, treatment and health care".
Among the existing products on sale, there is no lack of star products recognized by the market, such as Ruizhu, as the first preservative-free eye drops listed in China, which has not only won the favor of consumers, but also won the "healthy Chinese Brand list" for seven consecutive years. It has also been recommended by many experts, such as "Chinese expert consensus on prevention and treatment of dry eyes in perioperative period of cataract (2021)" and "Chinese dry eye expert consensus (2020)". In addition, the company and Xuemingmu tablet, which has been on the market for more than 20 years, is a national exclusive variety and a national protected variety of traditional Chinese medicine. the product has been included in the national medical insurance catalogue (2022 edition) and the national essential medicine catalogue (2018 edition). And entered a number of guidelines and consensus.
In terms of ophthalmology innovation and R & D, the company also has 4 global innovative products for the treatment of myopia, xerophthalmia, pterygium and anti-inflammation and analgesia after ophthalmology surgery. Among them, CBT-001, an innovative product for the treatment of pterygium, was approved to conduct phase III clinical studies in China in March this year, and GPN00136 (BRM421), a small molecular peptide drug for the treatment of xerophthalmia, was approved to conduct phase II clinical studies in China in April this year.
It can be predicted that under the background of the accelerated development of the industry track, with the steady progress of clinical research and listing process of relevant innovative products, the Broad Pharmaceutical Ophthalmology sector is expected to achieve a stronger source of business growth. and will further strengthen the company's leading position in the field of ophthalmology.
Broad Pharmaceutical said that in the future, the company will continue to increase investment in global innovative products and advanced technology, enrich and improve product pipelines and industrial layout, give full play to industrial advantages and R & D strength, quickly launch scientific and technological innovative products on the market, constantly strengthen the influence of the industry, and achieve innovative breakthroughs in the business field by adhering to the development strategy of "leading by heavy innovative pharmaceutical equipment and based on the products of the public eye protection ecosystem." And provide more advanced and diverse treatment options for patients around the world.