VivaVision Biotech Strengthens Ophthalmic Drug Pipeline with Proprietary Capabilities Targeting High-Difficulty Molecular Targets

20，25。

VIVAVISION Biotechnology Co., Ltd. (hereinafter referred to as “VIVAVISION”) boasts a senior R&D team that has dedicated the majority of their careers and passion to the field of innovative drug development, with the aspiration of leveraging their expertise to drive advancement in China’s innovative drug R&D sector.

Measured in years, 20 and 25 years are the time they have spent on innovative drug development.

Reflecting on the 25-year milestone, Dr. Shen Wang, CEO of VIVAVISION, remarked, “This figure may seem lengthy, but it is far too short compared to the breakthroughs we have achieved in innovative drug development.”

Dr. Shen Wang, CEO of VIVAVISION

Over the past 25 years, Dr. Shen Wang has engaged in small-molecule drug development at companies including Abbott, Sunesis, Amgen, and Kanion USA, leading the development of the anticancer drug Venetoclax (approved by the FDA in April 2016) and Lifitegrast for the treatment of dry eye disease (approved by the FDA in July 2016).

Although Dr. Shen Wang considers 25 years to be a short period, Dr. Li Yong, Vice President of the Pharmacology Department at VIVAVISION, views the breakthroughs made by Dr. Shen Wang during these 25 years as numerous.

“Over the course of more than two decades, two drugs were developed and launched on the market."Such achievements have left me deeply impressed, as they cannot be attained by mere coincidence but require genuine capability. It was precisely Dr. Shen Bo’s expertise that led me to join VIVAVISION. Our shared goal of bringing our extensive R&D experience to China is what motivates me to collaborate with Dr. Shen Bo for the long term," said Dr. Li Yong.

Dr. Yong Li, Vice President of Pharmacology

This firm belief stems fromDr. Li Yong has nearly 20 years of experience in innovative drug research and development.Having served as a Professor at the Singapore Eye Research Institute, a Senior Scientist at Allergan, and an ophthalmologist with over ten years of clinical experience, he made pivotal contributions to the development of Ozurdex® and the investigational drug DARPin (which completed Phase 3 trials in 2019), offering unique insights into ocular research.

Dr. Li Yong told VCBeat, “Joining VIVAVISION may yield a ‘1+1>2’ effect. I also hope that Dr. Shen and I can bring innovative concepts back to China, enabling the country to produce world-class companies capable of competing on the global stage in the next 10 to 20 years.”

In Shen Wang’s view, the development of China’s innovative drug industry has remained uncertain in terms of market and policy conditions, and industry standards have yet to be established.In 2016, when Shen Wang observed that China’s innovative drug policies were gradually becoming more open, he decided to return from the United States to establish VIVAVISION. In just four years since its inception, VIVAVISION has secured three rounds of financing.Capital investors’ favor is not only an affirmation of VIVAVISION’s core strengths but also a vote of confidence in this sector.

“Currently, the prices of imported drugs remain prohibitively high for the general public even after their introduction into the Chinese market. We look forward to leveraging our years of experience accumulated abroad to support the research and development (R&D) of new drugs domestically. Meanwhile, I am confident in our ability to develop novel therapeutics, replace imported drugs with domestically produced innovative medicines, and subsequently expand into overseas markets. This approach will yield benefits for both the nation and its citizens.“Dr. Shen Wang said.”

As Dr. Shen Wang stated, the current domestic ophthalmic drug market is still dominated by imported products, leaving significant room for domestic substitution. VIVAVISION has not only targeted this market opportunity,Guided by clinical needs and biological insights, the company has prioritized dry eye disease as its strategic focus and continues to expand its innovative drug portfolio into ophthalmic conditions with limited treatment options, such as uveitis, glaucoma, and blepharitis, thereby establishing a robust product pipeline.

VIVAVISION has currently developed three drug candidates: VVN001, VVN539, and VVN461e. Holding multiple R&D patents, VIVAVISION’s exploration path and research achievements warrant in-depth analysis.

In the medical field, dry eye disease is defined as an ocular surface disorder caused by multiple factors, characterized by ocular surface discomfort, visual changes, and tear film instability, accompanied by potential ocular surface damage, increased tear osmolarity, and inflammatory responses of the ocular surface.

According to Frost & Sullivan data,The number of dry eye disease patients in China increased from 210 million in 2015 to 240 million in 2019, and is projected to reach 270 million by 2030, with a compound annual growth rate (CAGR) of approximately 2.7%.

Inflammation is the most critical factor in the pathogenesis of dry eye disease (DED), but other mechanisms, such as apoptosis and sex hormone fluctuations, also contribute to its development. Typically, DED is managed with eye drops and tear substitutes; however, these two approaches have clear limitations given the multifactorial etiology of the condition. Their efficacy is largely confined to symptom relief rather than addressing the underlying causes of DED.

To address this pain point, VIVAVISION has developedVVN001—A second-generation LFA-1 antagonist, serving as the foundation for the planned development of multiple combination products for the treatment of dry eye disease. Compared with cyclosporine, a traditional medication for dry eye disease, LFA-1 antagonists offer superior solubility, higher molecular potency, and an improved safety profile.

Dr. Shen Wang explained:“Due to the complex formulation process of cyclosporine and its certain irritancy to the eyes, it is not an ideal drug. In contrast, LFA-1 antagonists have better water solubility and correspondingly lower ocular irritancy. Meanwhile, LFA-1 antagonists take effect more quickly, requiring only two weeks to become effective, whereas cyclosporine takes at least six weeks to reach maximum efficacy.”

So, how exactly do LFA-1 antagonists work?

LFA-1 binds to its ligand ICAM-1 and activates T cells, causing them to adhere to the endothelial cell surface, which triggers an inflammatory response. The LFA-1 antagonist VVN001 blocks the interaction between LFA-1 and ICAM-1, thereby effectively controlling the inflammatory response in dry eye disease.

VIVAVISION has improved upon the chemical structure of Lifitegrast, the first-generation LFA-1 antagonist, to enhance its molecular activity and solubility while reducing potential adverse reactions associated with its use. These findings have been validated through the establishment of relevant animal models.

Currently, the Phase II clinical trial of VVN001 has been approved by the FDA and is about to begin patient enrollment.

“Wherever there is demand, we go,” said Dr. Li Yong.

Glaucoma has currently become the second leading cause of blindness worldwide. According to WHO projections, the number of global primary glaucoma cases will reach 79.64 million in 2020, with 11.2% of patients progressing to blindness. In China, the total number of primary glaucoma patients is expected to reach 21.82 million, accounting for 27.4% of the global total. Behind these figures lies a significant market demand for glaucoma management.

Furthermore, VIVAVISION has developed a ROCK inhibitor for glaucoma, pioneering a novel approach to lowering intraocular pressure (IOP) via the trabecular meshwork. By employing a dual-targeting mechanism (ROCKi+), it achieves dual IOP-lowering effects, effectively reducing intraocular pressure. Controlled experiments have demonstrated that its efficacy surpasses that of netarsudil, the current market leader. Additionally, it can be used in combination with other anti-glaucoma medications to further enhance IOP reduction.

VIVAVISION’s achievements in innovative drug development clearly demonstrate its R&D capabilities. The company not only strategically selects specific indications for a particular eye disease to build a comprehensive product portfolio, but also establishes an entire product line, leveraging its deep industry expertise and strength.

Uveitis is an inflammatory response occurring in the intraocular tissues, which can also lead to a series of severe complications and sequelae, resulting in blindness.

However, the current therapeutic landscape for uveitis is dominated by imported drugs, with few domestically produced alternatives available. Although the patient population for uveitis is smaller compared to other ocular diseases, treatment options for this condition remain scarce. Addressing this unmet need, VIVAVISION has developed the first JAK1 inhibitor in an ophthalmic drop formulation for the treatment of immune-mediated or inflammatory eye diseases.

VIVAVISION has experimentally confirmed that VVN461e exhibits excellent target selectivity and target organ concentration, with significant selectivity for JAK1 and TYK2, enabling high drug accumulation in ocular tissues such as the choroid.

In the future, the indications for VVN461e could be expanded to include Sjögren's syndrome, chronic graft-versus-host disease (GvHD), severe dry eye disease, and conjunctivitis.

“As we are positioned in the field of ocular therapy, we do not limit ourselves to any specific disease; we explore all conditions related to the eye."Dr. Li Yong said."

Driven by the original aspiration to contribute to the R&D of innovative drugs for ocular diseases in China and to replace imported medicines with domestically produced ones, VIVAVISION continuously seeks new breakthroughs in the treatment of eye diseases, bridging basic medical research with clinical practice and leveraging its team’s scientific research capabilities to develop new drugs.

Meanwhile, the entire industry is undergoing transformation driven by policy. Since the release of the unified planning policy at the end of 2015, the National Medical Products Administration (NMPA) has continuously issued multiple related policies, establishing a priority review mechanism to accelerate the clinical and market approval processes for innovative drugs. Policies such as the Marketing Authorization Holder (MAH) system have further promoted a more standardized and consolidated future development of the pharmaceutical industry. Although the development of innovative drugs may take time, it is already underway.