Filling a clinical gap! GRAND PHARMA (00512) CBT-001 significantly controls pterygium lesions, deepening its presence in the innovative ophthalmic drug track and targeting a blue ocean market worth tens of billions

In the field of innovative ophthalmic drugs, pterygium has long been a neglected treatment blind spot with a huge patient base, and this clinical dilemma has recently received significant positive news. On November 5, GRAND PHARMA (00512) announced that its globally innovative ophthalmic drug CBT-001 (GPN00153) has met the primary clinical endpoint in its international multicenter Phase III clinical trial, and CBT-001 has been proven capable of altering the disease progression of pterygium. This means that CBT-001 is the world's first drug to demonstrate a therapeutic effect on pterygium through statistically significant improvement in hyperemia and lesion size, and is expected to fill the treatment gap for pterygium in the future, bringing a brand-new option to patients worldwide. The world's first therapeutic product for pterygium, significantly controlling lesions to benefit 900 million patients globally According to the announcement, CBT-001 is a novel multi-kinase inhibitor (MKI) eye drop that inhibits multiple kinase receptor pathways, blocking neovascularization and tissue fibrosis, thereby intervening at the root of the pathological basis of pterygiumfibrovascular proliferationrather than merely alleviating clinical symptoms. Earlier clinical trials showed that the product can significantly and sustainably inhibit vascular proliferation and ocular hyperemia symptoms of pterygium, with a good safety profile. Its applicable scope covers mild, moderate, and severe stages of pterygium, and it can also be used for recurrence prevention after pterygium surgery. In June 2022, the international multicenter Phase III clinical study of CBT-001 was initiated in the United States and subsequently expanded to China, New Zealand, Australia, and India. The top-line study results summary report covered 659 patients. The study set up dual-dose groups (0.1% and 0.2%) and a placebo control, with primary efficacy endpoints including reduction in conjunctival hyperemia associated with vascularized pterygium lesions at Month 3 and inhibition of pterygium growth at Month 12. Clinical trial results showed that both dose groups of CBT-001 demonstrated excellent clinical effects. In terms of improving conjunctival hyperemia, the CBT-001 group showed signals of conjunctival hyperemia improvement as early as the second week after treatment; compared with the control group at Month 3, CBT-001 0.2% and CBT-001 0.1% administered twice daily showed highly statistically significant improvement (p value <0.001). In addition, compared with the control group at Month 12, both doses of CBT-001 showed highly statistically significant reduction in pterygium lesion length (p value <0.001); in terms of lesion size, the benefit of the treatment group compared with the placebo control group was approximately 10% of baseline. This result validates the feasibility of multi-kinase inhibition, represented by CBT-001, in intervening at the root of fibrovascular proliferation, opening a replicable path for drug development for ocular surface proliferative diseases. At the same time, based on these data, CBT-001 may smoothly advance to the new drug application stage and is expected to become the world's first and only targeted drug for pterygium. Pterygium is a common chronic inflammatory proliferative ocular surface disease that usually occurs in the conjunctiva at the canthus and gradually invades the cornea, causing astigmatism or obscuring the pupil, thereby leading to decreased vision and even blindness. From a market perspective, the patient population for pterygium is already very large. According to the World Health Organization's World Report on Vision, the global prevalence of pterygium is 10.2%, meaning approximately one in every ten people worldwide has pterygium; in rural areas of China, the prevalence rate is as high as 33%. Frost & Sullivan data show that the number of pterygium patients worldwide exceeded 900 million in 2023 and is expected to grow to 1.059 billion by 2033; among them, there are approximately 150 million patients in China. The scarcity of the competitive landscape further amplifies the potential value of CBT-001. Currently, there is no approved drug for the treatment of pterygium worldwide. Products such as artificial tears and low-concentration glucocorticoid eye drops can only be used to relieve inflammatory symptoms, have no definitive efficacy, and carry long-term medication safety risks. Surgical excision is the only direct treatment method, but the postoperative recurrence rate is as high as 31-83%; multiple recurrences can cause serious complications such as symblepharon, conjunctival sac shortening, restricted eye movement, strabismus, and diplopia, making treatment outcomes far from ideal. This means that if CBT-001 is approved for marketing in the future, it will rely on its "world's first" market exclusivity to be the first to enter a track that has long been blank, solving the dilemma that pterygium has no drug treatment. Institutional data outline a particularly considerable market prospect. According to a Frost & Sullivan report, the global market size for pterygium treatment drugs is expected to reach nearly US$1.8 billion by 2033, with a compound annual growth rate of 58.6% from 2028 to 2033; among this, the U.S. market is expected to reach approximately US$815 million by 2033, and the China market is expected to reach approximately US$59.9 million, with a seven-year compound annual growth rate of approximately 59.1%. It is worth mentioning that GRAND PHARMA holds exclusive production (including technology transfer) and commercialization rights for CBT-001 in mainland China, the Hong Kong Special Administrative Region of China, the Macao Special Administrative Region of China, and the Taiwan region of China. If successfully approved for marketing, CBT-001 will become the world's first product for the treatment of pterygium, which will not only completely change the current clinical treatment landscape of pterygium and bring a brand-new non-surgical treatment option to hundreds of millions of patients, but will also build the company's differentiated competitive advantage in the field of ophthalmic anti-inflammatory and proliferative disease treatment. Differentiated pipeline blossoms at multiple points, tapping into the US$10 billion ophthalmic track Driven by both accelerating population aging and the surge in digital eye-use scenarios, ophthalmology is becoming widely recognized in the pharmaceutical industry as a "long slope with thick snow" track. According to industry data, the China ophthalmic drug market was approximately US$4.5 billion in 2025 and is expected to reach US$16.3 billion by 2035, making it one of the fastest-growing segments in the pharmaceutical industry, and the certainty of long-term growth in the ophthalmic drug market is becoming increasingly prominent. On this rapidly expanding track, GRAND PHARMA is accelerating the realization of its differentiated competitive advantage as an important participant in innovative ophthalmic drugs through an echeloned ophthalmic pipeline of "a batch on the market, a batch in clinical advancement, and a batch in reserve." Through a strategy combining collaborative introduction and independent research and development, the company has built a reserve of multiple globally innovative products for "dry eye disease," "demodectic blepharitis," "postoperative ophthalmic anti-inflammatory and analgesic," "pterygium," and "myopia," precisely addressing rigid demand in the ophthalmic field and building differentiated competitive advantages, with the potential to provide patients with more treatment options. The forward-looking ophthalmic segment layout has already blossomed across the board. In recent years, multiple innovative drugs from GRAND PHARMA at the "world's first" or "world's only" level have entered the commercialization stage. In July 2025, the company's dry eye treatment (varenicline tartrate nasal spray, OC-01) achieved the first commercial prescriptions in mainland China after official approval. This product is currently the world's first and only preservative-free, multi-dose, sterile-packaged nasal spray approved for the treatment of mild, moderate, and severe dry eye, creatively opening the "native tear era" of dry eye treatment through intranasal administration. The globally innovative ophthalmic drug (lotilaner ophthalmic solution 0.25%, TP-03) for the treatment of demodectic blepharitis was approved for marketing by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region of China in May 2025, approved for marketing by China's National Medical Products Administration in March 2026, and achieved the first commercial prescriptions in mainland China in October of the same year. As the first and only clinical treatment targeting the etiology of demodectic blepharitis, fills the long-standing clinical gap in China in this field where there was no specific therapeutic drug. Solid commercialization capabilities provide important support for the performance realization of related products after launch. After years of deep cultivation, GRAND PHARMA has attracted and cultivated a group of professionals with both clinical and marketing experience in the ophthalmic field, established a customer-centered, academically led professional marketing team, and formed a nationwide marketing network. By continuously strengthening the construction of the product's clinical evidence-based medicine system and professional academic promotion system, the company can provide clinical experts with comprehensive disease diagnosis and treatment plans and detailed product service plans. Looking ahead, GRAND PHARMA stated that with the continuous approval of innovative ophthalmic products, the company will fully leverage its core advantages in this field, continue to deeply cultivate the frontier innovative ophthalmic track, further strengthen the professional promotion and brand building of core products, provide new momentum for the company's sustained and healthy development, and provide global patients with more advanced and diverse treatment options.