HONG KONG, December 11, 2025 - (ACN Newswire) – Since 2025, driven by both policy tailwinds and fundamental strengths, the innovative drug sector in the Hong Kong stock market has experienced a valuation recovery. Although it experienced some correction in the second half due to external environmental factors, its overarching growth logic remains intact. Institutional analysis indicates that innovative drugs continue to represent the clearest industry trend within the pharmaceutical sector, with promising development prospects ahead.

Among the players, Cloudbreak Pharma (2592.HK), a biotech company focused on ophthalmology, has recently demonstrated strong stock performance. As of December 9, its share price closed at HK$8.24, having accumulated a gain of over 80% in approximately two weeks, and making it a standout "star stock" in the capital markets. This impressive performance is not coincidental but rather the inevitable result of multiple positive catalysts converging, including breakthroughs in its core product pipeline, enhancements to its global intellectual property (IP) layout, and an upgrade of its core management team.

Securing Another Victory in Patent Layout, Accelerating Commercialization of Core Product

On November 27, Cloudbreak Pharma's wholly-owned subsidiary, ADS Therapeutics LLC, successfully secured two core patents in Japan and Europe. Both patents relate to ophthalmic topical compositions and their uses for the core product CBT-009, laying a legal foundation for its global commercialization.

As a novel atropine ophthalmic formulation for treating myopia in children and adolescents aged 5 to 19, CBT-009, with its unique non-aqueous formulation design, demonstrates potential advantages over traditional aqueous formulations in terms of drug stability, safety, and patient tolerability, positioning it as a potential best-in-class product. Currently, the product's development is progressing steadily. It received U.S. FDA approval to initiate Phase 3 clinical trial in September 2024. Juvenile animal toxicity studies in China commenced in February 2025, and preparations for Phase 3 clinical trial are actively underway.

The grant of these patents in Japan and Europe not only strengthens the global IP portfolio for CBT-009, but will also accelerate its commercialization process. Leveraging patent protection, the Company has the potential to establish partnerships with global pharmaceutical giants to advance the product's production and distribution in key markets like Japan and Europe, accelerating global market penetration. Given the severity of the global adolescent myopia issue, CBT-009 is expected to become a core engine for the Company's future performance growth.

Pipeline Progress Across Multiple Fronts; CBT-004 Advances Towards Phase 3

Beyond CBT-009, another promising drug candidate from Cloudbreak Pharma, CBT-004, has also reached a significant milestone. As a potential first-in-class drug for vascularized pinguecula, CBT-004 uses Multi-Kinase Inhibitor targeting Vascular Endothelial Growth Factor Receptor (VEGFR) and Platelet-Derived Growth Factor Receptor (PDGFR). According to the Company's latest disclosures, CBT-004 yielded positive results in a Phase 2 clinical trial evaluating its safety and efficacy in treating pinguecula. The Company has begun advancing its Phase 3 clinical development and is scheduled to meet with the United States Food and Drug Administration (the “FDA”) on December 10 (Pacific Standard Time, PST) at an End-of-Phase 2 meeting to establish a regulatory pathway for potential approval.

It is understood that there are currently no approved drugs globally specifically for treating vascularized pinguecula. Existing treatment options mostly offer temporary symptomatic relief, leaving significant unmet clinical needs. Should CBT-004 successfully complete development and gain approval, it would become the first targeted therapy, rapidly capturing market share with its unique efficacy advantages. This would create a new revenue stream for the Company while further solidifying its leading position in the field of ophthalmic innovative drugs.

Strengthened Executive Team Elevates Commercialization Capabilities

The success of innovative drugs relies not only on R&D prowess but also on robust commercialization capabilities to realize their value. On December 1, 2025, Cloudbreak Pharma announced the official appointment of Mr. Michael Rowe as its new Chief Business Officer (CBO), injecting key momentum into the Company's global commercial strategy.

Public information shows that Mr. Michael Rowe possesses substantial hands-on commercialization experience across senior management, marketing, sales management, and clinical operations. He is particularly skilled in driving organizational efficiency and achieving breakthroughs in innovative business areas. His industry resources and operational capabilities are expected to bring comprehensive enhancements to the Company.

This executive appointment coincides with Cloudbreak Pharma’s core products entering a critical preparatory phase for commercialization. Mr. Michael Rowe's joining will strengthen the Company's business development capabilities in European and American markets, accelerating the construction of its global commercial footprint. Currently, through collaborations with companies such as Grand Pharmaceutical Group and Santen, Cloudbreak Pharma has established a commercialization foundation in Greater China and the Asia-Pacific region (excluding China). With the new CBO onboard, the Company is poised to further expand its global partnership network, optimize commercialization strategies, and provide robust support for the market entry of its multiple core products.

With Sustained High Industry Growth, Valuation Re-rating Potential Remains

In recent years, the global incidence of ophthalmic diseases has continued to rise. Conditions like pterygium and adolescent myopia affect hundreds of millions of patients, while the supply of innovative drugs in related treatment areas remains severely inadequate, indicating a vast unmet market need. Concurrently, governments worldwide are increasing support for pharmaceutical innovation, providing a favorable policy environment for high-quality innovative drug companies. Within the Hong Kong stock market, the innovative drug sector is experiencing a favorable trend of valuation re-rating. Companies with solid R&D pipelines, clear commercialization pathways, and core competitiveness are seeing gradually rising valuation expectations.

As an innovative drug company dedicated to ophthalmology, Cloudbreak Pharma has built a rich pipeline covering 8 drug candidates targeting major diseases in both the anterior and posterior segments of the eye, forming a diversified product matrix. With steady progress in R&D and an increasingly refined global commercialization strategy, the Company already exhibits scarce growth attributes. The recent short-term surge in its stock price, catalyzed by multiple positive factors, is merely the beginning of value release. As these favorable initiatives are further implemented and pipeline value continues to be realized, Cloudbreak Pharma is poised to achieve dual enhancement in both performance and valuation.

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