GP (HK) Obtains Exclusive Development and Commercialization Rights of Improved New Drug for Anti-inflammatory and Pain Relief after Ophthalmology Surgery, Enriches Its Product Pipeline of High-Barrier Drugs in the Ophthalmology Sector
(June 3, 2021 - Hong Kong) China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to that the Group recently reached an exclusive product licensing agreement (the “Licensing Agreement”) with Formosa Pharmaceuticals, Inc. (the “Formosa”). The Group will obtain the exclusive development and commercialization rights of an improved new drug hormone nanosuspension eye drops (“APP13007”) for anti-inflammatory and pain relief after ophthalmology surgery developed by Formosa in Mainland China, Hong Kong and Macau, with a milestone payment of not more than USD9.5 million and a certain percentage of sales commissions.
The Group always puts focus on the research and development (“R&D”) of innovative products and advanced technologies. Sticking to patients-centered and innovation-driven, the Group will continue to increase its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs, and enrich product pipeline and improve supply chain. As one of largest integrated enterprises in the R&D, production and sales of ophthalmic drugs in China, the Group's existing products cover various diseases of the ocular surface and fundus with good brand awareness. The Group has been committed to the development and introduction of new products in the ophthalmology field. It has now deployed a variety of innovative products for dry eye disease, pterygium and other indications. At the same time, it has created an eye-protection ecosystem and rapidly developed ophthalmic equipment and consumables.
Formosa, a subsidiary of Formosa Laboratories, Inc., was founded in 2010. It is a company dedicated to the research and development of improved new drugs and biosimilar drugs. The main active ingredient of APP13007 is a potent glucocorticoid, which has efficient local anti-inflammatory and strong capillary contraction effect. Due to the low water solubility of hormones, the hormone eye drops in Chinese market currently are ordinary suspension eye drops, which are required to be shaken vigorously before use, the particles are not uniformly distributed, and there is a risk of low bioavailability and safety. APP13007 uses a unique nano-preparation technique, the solution is translucent, and it has good effectiveness and safety at lower concentrations. The completed phase II clinical trial in the United States has shown that the product has good safety and effectiveness.
Hormone ophthalmic preparations are one of the most commonly used and effective drugs for the treatment of ocular inflammatory reactions. For the inflammatory diseases of cornea, ocular surface and after ophthalmic surgery, rational application of hormone ophthalmic preparations can quickly and effectively control the inflammatory response and condition. According to Frost&Sullivan's statistics, there were approximately 4.3 million cataract surgeries in China in 2019, with a 5-year CAGR of 15.5% from 2015 to 2019. According to the Report on National Vision Case in China (國民健康視覺報告), the population of myopia reached 600 million in 2018 and it will be about 700 million by 2020. The penetration rate of refractive surgery is only about 0.3%, equivalent to 1/3 of that of the United States. There is still great potential for future development. With the further increase in the volume of ophthalmic surgery, the market space for hormone ophthalmic preparations is bound to expand further. According to the data of Menet, the sales of domestic urban hospitals for hormone ophthalmic preparations reached RMB 700 million in 2019. However, due to the limitation of domestic ophthalmic preparation technology, the current hormone ophthalmic preparations are dominated by imported products. There are no new products on the market in this market segment in the past decade. There is an urgent need for strong hormonal eye drops with high safety in clinic, and APP13007 product is expected to fill the gap in clinical demand.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The cooperation with Formosa this time has further enriched the product pipeline of high-barrier drugs in the ophthalmology sector, providing strategic reserves for the Group’s medium and long-term development, and meanwhile consolidated the Group’s leading position in the industry of ophthalmic drugs. Looking ahead, the Group will continue to adopt the strategy of ‘global expansion and dual-cycle operation’, enhance cooperation with top-notch companies in the world, introduce innovative and high-quality products to benefit Chinese patients while creating greater value for shareholders.”