Cloudbreak Pharma and Santen Announce Licensing Agreement for CBT-001, an Innovative Ophthalmic Drug for Pterygium

2024Year8Month6Day- [Hong Kong, China]International Clinical Ophthalmic Drug CompanyCloudbreak Pharma Inc.(Headquarters: California, USA; hereinafter referred to as“Cloudbreak Pharma”) and specialized ophthalmology company Santen Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; hereinafter referred to as“Santen Pharmaceutical”) announced the signing of a licensing agreement, under which Cloudbreak Pharma will develop its multi-kinase inhibitor for the treatment of pterygium.CBT-001, authorized to Santen Pharmaceutical, covering Southeast Asia regions including Japan, South Korea, Vietnam, Thailand, Malaysia, the Philippines, Singapore, and Indonesia (hereinafter referred to as“Region”). According to the terms of the agreement, Cloudbreak Pharma has granted Santen Pharmaceutical (China) Co. Ltd. the rights to develop, manufacture, and commercialize in the region.CBT-001Medicine.

CBT-001It is an emulsified nintedanib eye drop developed by Cloudbreak Pharma, mainly used for the treatment of pterygium. Nintedanib is a multi-kinase inhibitor, primarily used forVEGF(Vascular Endothelial Growth Factor) Receptor,PDGF(Platelet-Derived Growth Factor) Receptor andFGF(Fibroblast Growth Factor) receptor, thereby inhibiting angiogenesis and fibrosis.CBT-001Completed in the United StatesIIPhase clinical trials are currently being conducted on a large scale in the United States, China, Australia, New Zealand, and India as part of a global multicenter effort.IIIPhase Clinical Trial.CBT-001Can provide doctors and patients with a new treatment option for pterygium through eye drops, inhibiting the progression of the condition.

Pterygium is a non-malignant abnormal proliferation of fibrovascular tissue on the ocular surface, which starts from the bulbar conjunctiva and extends to the corneal surface. Pterygium has an invasive growth tendency, with a recurrence tendency and non-metastatic characteristics. Although pterygium is non-malignant, it can cause significant ocular symptoms, including congestion, irritation, pain, and foreign body sensation, thus affecting patients' quality of life. Currently, there are no approved drugs for the treatment of pterygium on the market, and doctors often prescribe artificial tears and short-term topical ocular steroids that lack clinical trial validation. However, these medications may be ineffective or unsafe for long-term use. Surgical excision is usually required when the pterygium invades the visual axis or causes persistent congestion. Although various surgical methods exist, such as transposition surgery and conjunctival flap transplantation, all approaches have a tendency for recurrence, which is considered a challenge in pterygium surgery. Since ultraviolet (UV) exposure is associated with the onset and progression of this condition, pterygium is most commonly observed in sunny regions at lower latitudes. Studies indicate that globally, approximately10%of the population is affected by this, and in Japan, approximately400Ten thousand patients. In Japan,40The prevalence of pterygium in people aged above is estimated to be4%,This population in Korea is3.8%, in Vietnam, Malaysia, the Philippines, and Thailand for10.1%。

Rie Nakajima, Chief Operating Officer of Santen PharmaceuticalIndicates:“For a long time, pterygium has been mainly treated through surgery. We are delighted to collaborate with Cloudbreak Pharma to develop and launchCBT-001. This innovative therapy in the form of eye drops is expected to provide a new treatment option for patients with pterygium.CBT-001Incorporating this into our R&D pipeline not only benefits patients with pterygium worldwide but also demonstrates our determination as a specialized ophthalmology company to take on new challenges. We will continue to focus on patients' needs, strive to fill the gaps in medical demands, and provide more innovative treatment options.”

Dr. JinSong Ni, Founder and CEO of Cloudbreak Pharma, said:“We are very pleased to cooperate with Santen Pharmaceutical. Santen Pharmaceutical has always prioritized patients' eye health and is renowned in the industry for its pursuit of innovation and quality. This collaboration leverages the strengths of both parties, laying a solid foundation for achieving our goals. We look forward to bringing this innovative product to the market as soon as possible, benefiting pterygium patients in Japan and around the world.”

According to the agreement, Cloudbreak Pharma will receive a total amount of up to9100Million USD as upfront and milestone payments. In addition, Cloudbreak Pharma will also receive a double-digit percentage of the product’s future net sales as royalties for this product.

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AboutCloudbreak Pharma Inc.

“Cloudbreak Pharma”Cloudbreak Pharma is an innovation-driven clinical ophthalmic biotechnology company dedicated to developing innovative and differentiated therapies. Cloudbreak Pharma2015Established in the United States, Cloudbreak Pharma has its headquarters in Irvine, California, with additional branches in mainland China and Hong Kong, China. We are committed to the independent development and commercialization of first-in-class or best-in-class ophthalmic drugs to address unmet medical needs. Cloudbreak Pharma has built a broad and innovative pipeline comprising eight drug candidates, covering major diseases of both the anterior and posterior segments of the eye. Among them, four are in clinical stages, and four are in preclinical stages. Our mission is to help the world:“Seeing Life Better Through Medicine＂｡

For more information, please refer toCloudbreak PharmaWebsitehttps://cloudbreakpharma.com/

About Santen Pharmaceutical Co., Ltd.

Santen, as a company focused on visual health, is committed to providing valuable products and services to patients, consumers, and healthcare professionals worldwide, aiming to improve everyone's“Happiness with Vision”. Establishment140Since the year, in core concept“Participate in Santen Pharmaceutical (China) Co. Ltd.”Guided by the principle of "Comprehending the laws of nature to contribute to human health," Santen Pharmaceutical is committed to helping people maintain and improve eye health. Santen Pharmaceutical engages in global research and development, manufacturing, and the sales and marketing of ophthalmic products, serving communities worldwide.60Multiple countries and regions5000Santen: Safeguarding the Eye Health of Ten Thousand People. Santen’s mission is to leverage our professional expertise in the field of ophthalmic healthcare, always considering the needs of patients, to create a variety of products and services. We continuously provide new value to patients and society, exploring and delivering significant advancements in the prevention, diagnosis, and treatment of eye diseases. To ensure that as many patients and consumers as possible can lead happy and fulfilling lives in the future, Santen Pharmaceutical will spare no effort. We aim to create the best visual experiences so that everyone can enjoy the happiest life possible.

For more information, please visit the website of Santen Pharmaceutical (China) Co. Ltd.https://www.santen.com/en