Grand Pharmaceutical Expands Ophthalmology Portfolio with Global Innovative Asset CBT001

　　【Pharmaceutical Network | Industry Trends】On April 13, Grand Pharmaceutical Group Limited announced that it had acquired the production (including technology transfer) and commercialization rights in the Greater China region for CBT001, a global innovative product developed by Cloudbreak Pharma, for a total consideration not exceeding RMB 74.5 million. Meanwhile, the company subscribed for certain shares of Cloudbreak Cayman for approximately USD 5.63 million, holding about 7% of the shares after the completion of the restructuring, and obtained one board seat at Cloudbreak Cayman.
 

Pursuant to the agreement, the aforementioned rights include the indication of CBT001 for the treatment of pterygium in the Greater China region, as well as other potential indications; meanwhile, with respect to other pipeline products under development by Cloudbreak Pharma, the Group also enjoys the right of first refusal for cooperation in the Greater China region.
 

Pterygium is a common chronic inflammatory proliferative disease of the ocular surface. CBT001 is an innovatively improved product based on nintedanib, a marketed drug for the treatment of pulmonary fibrosis. It inhibits both neovascularization and tissue fibrosis, and is the first globally innovative therapeutic product for pterygium.
 

Regarding the progress of this product, CBT001 has currently completed Phase 2 clinical trials in the United States, demonstrating a favorable safety profile and significant clinical efficacy. It can reduce pterygium hyperemia and control disease progression. Additionally, the product is expected to expand its indications to conditions such as ocular redness and swelling, post-glaucoma surgery, and post-corneal transplantation, thereby further broadening the applicable patient population.
 

CBT001 is planned to conduct a global, multicenter Phase 3 clinical trial in 2021 to support its market launch. The inclusion of the China region in this global, multicenter Phase 3 clinical trial is currently under evaluation. Once approved for inclusion, it is expected to accelerate the approval and market launch of CBT001 in China.
 

Public information indicates that Cloudbreak Pharma is a globally renowned ophthalmology company. Its current R&D pipeline comprises seven products, with the exception of CBT001, all of which are in the research and preclinical stages.
 

Industry experts believe that Grand Pharmaceutical Group’s substantial investment in acquiring this product is driven by its significant market potential. Statistics show that the overall prevalence of pterygium is approximately 10%, with the rate increasing steadily with age. In China, the prevalence among individuals aged 40 and above is 13.4%, affecting nearly 90 million patients.
 

According to available information, Grand Pharmaceutical Group Limited is an integrated enterprise engaged in the research and development, manufacturing, and sales of ophthalmic pharmaceuticals, with its core business covering three major therapeutic areas: cardiovascular and cerebrovascular diseases, oncology, and respiratory systems. Its product portfolio encompasses pharmaceutical formulations, medical devices, biotechnology products, health products, and premiumActive Pharmaceutical Ingredient (API)Three Major Business Segments.
 

The author notes that Grand Pharmaceutical Group Limited has been highly active this year. At the beginning of the year, it secured the rights for the development and commercialization in Greater China of BRM421, a global dry eye disease treatment product from Quanfu Biotech. In February, its acquisition of OncoSec was approved by OncoSec’s shareholders’ meeting, and the commercialization rights for the licensed products took effect. In March, the company acquired the global rights to APAD, a new drug developed by Antisheng Bio for the treatment of sepsis. The company announced its unaudited financial results for 2019, reporting revenue of HK$6.59 billion, a year-on-year increase of 10.6%, and net profit of HK$1.15 billion, a year-on-year increase of 61.4%.
 

Grand Pharmaceutical Group Limited has further expanded its portfolio by securing another globally innovative product. The Company stated that it remains committed to the development and introduction of new products in the ophthalmology sector. This collaboration further enriches the product pipeline in the ophthalmology segment, characterized by high innovation barriers, thereby providing strategic reserves for the Group’s medium- to long-term development. Meanwhile, the equity investment in Cloudbreak Pharma (Cayman) lays the foundation for in-depth cooperation and product development between both parties, helping to fully leverage the extensive experience of its management and core R&D team in large-scale enterprise management and research and development, thus providing technical support for the development of new products.