GRANDPHARMA leads a new era in dry eye treatment with the successful national launch of the world's first dry eye nasal spray OC-01

According to the Zhitong Finance APP, in July this year, the ophthalmic spray of Varenicline tartrate (OC-01) was launched in mainland China, innovating the treatment experience for dry eye patients through nasal spray. Recently, GRANDPHARMA (00512) successfully held the national launch conference for OC-01, taking advantage of the "Caring for Dry Eye Patients, Welcoming the Era of Native Tears - 2025 New Advances in Dry Eye Diagnosis and Treatment and the Construction of Ocular Surface Health Ecosystem Conference" at the 11th Global Dry Eye Academic Conference, officially announcing the arrival of a new era in dry eye treatment from "external substitution" to "internal awakening."

It is reported that this conference was hosted by the Ophthalmology Professional Committee of the Cross-Strait Medical and Health Exchange Association and co-organized by the China Association of Geriatric Health. It is the largest industry academic event in the field of ocular surface and tear fluid in China. At this conference, many ophthalmology experts and industry professionals gathered, including Professor Liu Guoguang, Director of the Ophthalmology Research Institute of Xiamen University, Professor Zhang Mingchang from the Union Hospital of Huazhong University of Science and Technology, Professor Jin Xiuming from the Eye Hospital of Zhejiang University, Professor Ke Ying from Beijing Tongren Hospital affiliated with Capital Medical University, Professor Wan Pengxia from the First Affiliated Hospital of Sun Yat-sen University, and Mr. He Yong, Founder and Secretary-General of the Zhongguancun Precision Medicine Foundation. Mr. He Yong presented the "Caring for Eye Health Public Welfare Ambassador" plaque to actress Huang Shengyi. Participants discussed the current challenges in eye health faced by society and the clinical application of OC-01, exploring the present and future of dry eye prevention and treatment.

Innovative Mechanism of Action and Nasal Administration Promote Natural Tear Secretion, Benefiting Hundreds of Millions of Patients and Revolutionizing Dry Eye Treatment Landscape

In today's modern society, where "everyone has a screen," the public's eye habits have quietly changed, and the resulting eye health issues have become an important public health topic affecting the quality of life of citizens. Especially dry eye syndrome, as one of the most common ocular surface diseases, accounts for more than 30% of the total outpatient visits in ophthalmology departments. According to the "Chinese Clinical Diagnosis and Treatment Expert Consensus on Dry Eye (2024)," the prevalence of dry eye in China has reached 21.0%-52.4%, with a conservative estimate that 1 in 5 people suffers from dry eye. Moreover, patients are increasingly showing a trend of younger age, with the "2024 National Eye Health Annual Report" indicating that the incidence of dry eye in the 18-35 age group has reached 63%, a 400% increase compared to ten years ago Despite the prevalence of dry eye syndrome in daily life, effective treatment remains challenging in clinical practice. Existing treatments primarily based on eye drops can alleviate dry eye symptoms, but their effectiveness is limited, and long-term use of preservative-containing eye drops can lead to corneal damage. Additionally, the reliance on patients for frequent administration of eye drops can affect patient compliance to some extent.

Against this backdrop, the launch of OC-01 directly addresses the aforementioned treatment pain points and is expected to reshape the current treatment landscape for dry eye syndrome. OC-01 is described as a highly selective nicotinic acetylcholine receptor agonist that can increase tear secretion in dry eye patients by activating the parasympathetic pathway of the trigeminal nerve. This treatment approach shifts from the passive "rehydration" of eye drops to actively promoting the eye's own "water production" through neuroregulation, improving natural tear secretion at the source, enhancing tear film stability, and interrupting the vicious cycle of dry eye pathophysiology.

Compared to traditional eye drops, the nasal administration of OC-01 offers significant advantages. Patients only need to administer the nasal spray twice a day, avoiding the hassle of frequent eye drops and reducing direct irritation to the ocular surface. This makes it more convenient for both patients who regularly use eye drops and those who wear contact lenses and find it inconvenient to use eye drops.

From the existing sales landscape, the value of OC-01 has been fully validated in the global market. Since its approval for sale in the United States in October 2021, OC-01 has issued over 97,000 prescriptions within just one year, achieving approximately $42 million in sales revenue in the U.S. in 2023. Domestically, OC-01 also has ample clinical cases to support it, and the product has successfully entered Macau, Taiwan, and mainland China, achieving its first batch of commercial prescriptions this year.

As the only nasal spray product approved for increasing tear secretion in dry eye patients in China, OC-01 is expected to occupy an important position in the dry eye drug market, which is projected to reach 18 billion yuan, bringing more effective and convenient treatment experiences to hundreds of millions of dry eye patients in China. It may also directly disrupt the current drug landscape dominated by local eye drop administration, leading China's dry eye diagnosis and treatment into a new phase aimed at "tear gland repair."

Ophthalmology pipeline entering a harvest period, differentiated innovation strategy showing results

In addition to dry eye syndrome, ophthalmic diseases represented by myopia are widely spreading with the popularity of electronic products. The ophthalmic medical sector, known for its "golden eyes and silver teeth," is becoming increasingly competitive. According to Frost & Sullivan, the Chinese ophthalmic drug market is expected to reach 44 billion yuan by 2025 and climb to 108.4 billion yuan by 2030 Against the backdrop of rapid growth in the ophthalmic drug market in China, GRANDPHARMA has built a "specialized, full-series, and multi-variety" innovative drug product system after years of deep cultivation, reserving several globally innovative products for the treatment of "dry eye syndrome," "demodex blepharitis," "post-operative anti-inflammatory analgesia," "pterygium," and "myopia," steadily enhancing the company's market position in the ophthalmic field.

Represented by OC-01, GRANDPHARMA's ophthalmic innovation pipeline has recently achieved significant milestones: In May of this year, the globally innovative ophthalmic drug GPN01768 (TP-03, Loteprednol Etabonate Eye Drops, 0.25%) for the treatment of demodex blepharitis was approved for marketing by the Macao Special Administrative Region Government's Drug Regulatory Authority, and its new drug application in mainland China was accepted by the National Medical Products Administration in December 2024. In June, the innovative modified new drug GPN00153 (CBT-001) for the treatment of pterygium completed patient enrollment for the international multicenter Phase III clinical study globally, and this product is expected to fill the clinical treatment gap for pterygium. Additionally, the hormone nano-suspension eye drops GPN00833 for anti-inflammatory analgesia completed domestic Phase III clinical research in November 2024 and achieved clinical endpoints.

These R&D advancements fully demonstrate that GRANDPHARMA has formed a comprehensive product layout in several important subfields of ophthalmology, and related products are steadily delivering clinical progress and commercialization expectations—multiple innovative products are expected to be approved for marketing in the next three years, and with the continuous advancement of GRANDPHARMA's "Go Global" strategy, there is also hope for empowering more innovative products for international market expansion, providing strong momentum for the company's sustained growth.

Looking ahead, GRANDPHARMA stated that it will accelerate the global differentiated layout of its R&D pipeline, continuously enrich its innovative product reserves, and will continue to leverage its industrial advantages and R&D strength to rapidly bring technological innovation products to market, providing global patients with more advanced and diverse treatment options