Cloudbreak Pharma Secures $130 Million Series C Financing to Advance Global Leadership in Ophthalmic Innovation

VCBeat learned at the first time that, on January 1,Cloudbreak Pharma, Inc. (hereinafter referred to as "Cloudbreak Pharma") announced the completion of a $130 million Series C financing round. This round was led by CDH Baitong, with participation from several well-known institutions including GaoTec Investment, DeYi Capital, CCB International, Envision Capital, Guanzi Capital, Yingke Capital, Xinyin Yuanda Healthcare Investment, Industrial Securities Capital, Oriental Fortune Capital, and YueJun Investment.The financial advisor for this round of financing was "Fir Capital," with Huatai United Securities serving as the co-financial advisor. The proceeds from the Series C financing will be used for clinical trials, registration, and commercialization preparation for multiple product pipelines, construction of GMP pilot production facilities, enhancement of the company’s international-standard production capacity, and expansion of the team.

Dr. Jinsong Ni, Founder, Chairman and Chief Executive Officer of Cloudbreak PharmaCloudbreak Pharma was founded in California, USA, in 2015, established its Guangzhou, China office in 2018, and set up its Suzhou branch while building R&D and production facilities in 2021. Cloudbreak Pharma is an international biopharmaceutical company focused on the research, development, and commercialization of innovative ophthalmic drugs. Adhering to the philosophy of "Global Market, Global New," we emphasize the innovation and differentiation of our products. All products are self-developed with global rights, and most are first-in-class new drugs with internationally pioneering indications or mechanisms. Our pipeline covers major ophthalmic diseases such as ocular surface conditions, retinal disorders, and glaucoma. Among these, two indications are in international multicenter Phase III clinical trials, three are in Phase II clinical trials in the United States, two are at the stage of clinical trial application, and there are three preclinical research projects. With a robust pipeline, the company is committed to becoming a globally leading ophthalmic pharmaceutical enterprise, and the team is highly confident.

Currently, the number of patients with eye diseases worldwide exceeds 1.7 billion, and the drug market size surpasses 30 billion US dollars. Eye diseases seriously affect human physical and mental health. However, due to the slow progress in new drug development for ophthalmic diseases and the small number of new drugs produced, clinical needs are becoming increasingly urgent. Especially in recent years, with the acceleration of population aging, changes in lifestyle, the popularity of electronic products, and the increase in work intensity, the prevalence of ophthalmic diseases has been continuously rising. In the next decade, the international ophthalmic drug market size will exceed 60 billion US dollars, and the Chinese ophthalmic drug market size will also surpass 10 billion US dollars. With the outbreak of ophthalmic diseases, both international and domestic ophthalmic markets are receiving increasing attention. The growth potential of the ophthalmic new drug industry is clear, making it a new investment hotspot.

As a rising star in the international ophthalmic pharmaceutical industry, Cloudbreak Pharma is accelerating the globalization of its ophthalmic new drug research and development by establishing R&D centers in both China and the U.S. The U.S. team focuses on original project screening, international patent development, and non-clinical and clinical research, while the Chinese team emphasizes formulation R&D and production. The company adheres to a dual-driven strategy of "repurposing existing drugs and developing innovative drugs." The repurposing strategy primarily targets "new indications and new fields," utilizing three approaches—changing dosage forms, indications, and administration routes—to develop several "world-first new indication drugs." At the same time, the company has built a small molecule drug screening platform and an Antibody-Drug-Small molecule conjugates (ADS) R&D platform to strengthen the development of innovative compounds, with a focus on first-in-class innovative drugs. The company’s patents are comprehensively protected, forming a strong product moat through "technical barriers and first-mover advantages."

Pterygium, a very common degenerative conjunctival disease, has a prevalence rate of 9.84% among people aged 15 and above in China, with nearly 100 million patients. However, there are currently no approved drugs for pterygium in the global market. Clinically, artificial tear-based topical medications are mainly used to alleviate symptoms, while severe cases require surgical treatment, which carries a recurrence rate of approximately 15%. Cloudbreak Pharma's core product, CBT-001, as the world’s first innovative drug (new indication) for treating pterygium, has completed Phase II clinical trials in the United States, achieving effective endpoints and demonstrating good safety and efficacy. It has also been approved to enter international multicenter Phase III clinical trials. This drug is an effective multi-kinase inhibitor topical eye drop that acts on three targets, blocking VEGFR (1-3), PDGFR, and FGFR (1-3) signaling pathways to inhibit neovascularization and fibrosis, which are key factors in the pathogenesis of pterygium. If approved, the product is expected to become the global "new" gold standard for pterygium treatment.

Cloudbreak Pharma's Innovative Drug CBT-006 for Meibomian Gland Dysfunction (the Cause of Over 70% of Dry Eye Cases) has been Approved by the U.S. FDA for Phase IIb Clinical Trials, with Patient Enrollment in the U.S. Nearing Completion. There are approximately 1 billion dry eye patients globally and nearly 300 million in China, yet approved treatments still fail to meet clinical needs. CBT-006, developed by Cloudbreak Pharma, is the world’s first drug based on a "lipid-dissolving and meibomian gland-clearing" mechanism—unique, fast-acting, and long-lasting—offering a new, safe, and effective treatment option for patients with dry eye caused by meibomian gland dysfunction.

Cloudbreak Pharma boasts an international founding team. The founders and core team members are former senior R&D executives and elites from Allergan, a globally renowned ophthalmic pharmaceutical company based in the U.S. They possess extensive experience in international management of new ophthalmic drug development. The founding team has been dedicated to the research and development of new ophthalmic drugs for over two decades and has successfully brought multiple ophthalmic drugs to market. The scientific advisory board consists of leading figures in the fields of U.S. ophthalmic drug development and clinical trials, with abundant experience in new drug R&D, clinical trials, and international product registration. They have also participated in editing international ophthalmology journals and enjoy an excellent reputation and standing within the industry.

Unlike general departments, ophthalmic drugs have stronger consumer attributes and enjoy excellent "immunity to medical insurance" effects. In the context of centralized medical insurance procurement, they demonstrate higher risk resistance. Cloudbreak Pharma's CBT-001 can be directly linked with commercial insurance in the United States, while CBT-006 and CBT-008 will become dual-span products covering both prescription and OTC markets in the future. Other products also possess unique advantages. These blockbuster products will be the first to gain global market approval, featuring patented technological barriers, strong resistance to centralized procurement, and innovative designs that provide robust momentum for the company’s commercialization efforts.

The lead investor of this round of financing, Ying Wei, Managing Partner of CDH FundCloudbreak Pharma is a highly representative and outstanding company in the field of ophthalmic innovative drugs. The founding team has many years of experience in the research and development of ophthalmic drugs, with extensive industry expertise. While adhering to innovation in its pipeline layout, the company enhances the success rate of product development and market prospects through the 505b(2) product development model and differentiated positioning. DCH Beyond is honored to lead this round of financing, and we hope to continue supporting the company’s progress in ophthalmic new drug development, helping it become a leading enterprise in the next generation of ophthalmic pharmaceuticals.

This time, the financial advisor is Xiang Zhou, partner of "Fir Kangzhou".We are honored to provide comprehensive assistance to Cloudbreak Pharma in completing this round of financing. The company boasts a professional and experienced international team dedicated to the research and development of ophthalmic drugs, with a rich and forward-looking product pipeline, highly efficient clinical advancement, and all products being self-developed, demonstrating strong innovation. Their strategy of "new indications, new tracks" is also a rare opportunity; we believe Cloudbreak Pharma will undoubtedly become an outstanding innovative enterprise with international competitiveness.