Building a Healthy Ecosystem for Ophthalmic Innovative Drug R&D Amid Surging Capital and Market Enthusiasm

In recent years, with population aging, changes in lifestyle, and the widespread use of electronic products, the incidence of eye diseases such as ocular infections, conjunctivitis, macular degeneration, and dry eye syndrome has increased. Meanwhile, public awareness of eye care has continued to rise, driving sustained growth in the market size of ophthalmic drugs. According to data from China Business Industry Research Institute, the market size of ophthalmic drugs in China grew from USD 1.9 billion in 2016 to USD 2.8 billion in 2020, representing a compound annual growth rate (CAGR) of 10.17%. It is projected to reach USD 3.4 billion in 2021.

As the market size for ophthalmic drugs continues to expand, interest in innovative ophthalmic pharmaceuticals within China is steadily growing. Policymakers, enterprises, and investors are all increasing their attention and investment in this sector, leading to the emergence of numerous innovative drug companies and several major financing rounds. Traditional pharmaceutical companies are also actively competing by accelerating R&D efforts or introducing new drugs.

To gain insights into the domestic market for innovative ophthalmic drugs, VCBeat recently conducted an exclusive interview with Dr. Zhang Fei, founder of Ruiming New Drug.

Dr. Zhang Fei earned his Ph.D. from Columbia University in the United States and brings nearly two decades of experience in new drug research and development (R&D), having held key R&D positions at Merck and Novartis. In March 2018, Dr. Zhang founded Ruiming New Drug, a company dedicated to the R&D of therapeutic small-molecule ophthalmic drugs. The company has established a globally leading medicinal chemistry design platform focused on drug penetration and treatment within ocular tissues, particularly for fundus diseases. In this exclusive interview, Dr. Zhang compares the advantages and disadvantages of various ophthalmic drugs, outlines the differences between the Chinese and U.S. landscapes in ophthalmic new drug R&D, reviews the current state of ophthalmic new drug development in China, and discusses the future direction of the industry.

Ophthalmic drugs are primarily categorized into three major classes. The first comprises traditional pharmaceuticals, typically referring to small-molecule chemical drugs; the second consists of large-molecule biologics, which currently dominate the pipeline of ophthalmic drugs under development in China; and the third encompasses gene and cell therapies, which have emerged in recent years.

Discussing the potential of various ophthalmic drugs, Dr. Zhang Fei quoted a saying: “It doesn’t matter whether a cat is black or white; as long as it can catch mice, it is a good cat.” Each drug cannot be evaluated simply as “good” or “bad,” as each has its own characteristics. “ButFrom the perspective of administration route alone, small-molecule drugs offer distinct advantages.”

For other diseases, the choice between oral and injectable administration makes little difference in terms of patient compliance; however, for ocular diseases, there are significant differences among topical administration via eye drops, oral administration, and injectable administration.

We all know that the eye is a unique organ, primarily due to its highly enclosed nature. Consequently, the body has evolved numerous static and dynamic “mechanisms” to protect the eye from external disturbances, but this also makes it difficult to deliver drugs into the eye, particularly to diseased tissues in the fundus.

At present, macromolecular drugs and gene- or cell-based therapies are generally administered via injection, while small-molecule drugs are typically administered locally as eye drops or orally.

Oral administration undergoes gastrointestinal absorption and systemic circulation, resulting in very low drug concentrations at the ocular site while causing significant systemic exposure. The severe side effects associated with this high systemic burden greatly limit the application of oral delivery in treating ocular diseases. Intravenous or intravitreal injection of macromolecules often leads to poor patient experience and, consequently, low compliance. For gene-based therapies administered via injection, key concerns include the lack of an on/off switch mechanism and the need for further evidence regarding their systemic or local effects. Therefore, regulatory authorities both domestically and internationally impose stricter oversight on gene-based ophthalmic drugs.

The drug delivery logic of small-molecule eye drops differs from that of invasive injectable administration. For ophthalmic diseases, the advantages of eye drops are difficult to replace. Dr. Zhang Fei stated: “As the most convenient, accessible, compliant, least side-effect-prone, and cost-effective treatment option available today, small-molecule eye drops will remain irreplaceable for a considerable period.”

It is precisely because of the long-term advantages of small-molecule eye drops that Dr. Zhang Fei chose them as his entrepreneurial focus, even as research and development in macromolecular and gene-based therapies have progressed vigorously in recent years.

China and the United States are the two major players in the ophthalmic drug R&D market. Dr. Zhang Fei stated, “The landscapes of new ophthalmic drug development in China and the United States are distinctly different.”

The U.S. ophthalmic pharmaceutical market has an early start. Previously, the United States had many specialized ophthalmic drug R&D companies, including Alcon and Allergan. After a series of mergers and acquisitions, the current landscape of ophthalmic drug R&D in the U.S. is highly consolidated and focused. Whether small molecules, large molecules, or gene therapies, development is primarily concentrated among major corporations such as Novartis, Roche, and Bausch + Lomb.

China, however, presents a different landscape. In recent years, with the influx of capital and the return of outstanding scientists to launch startups, Chinese ophthalmic new drug companies have emerged in large numbers. Patented technologies are dispersed across various small firms, with high-quality enterprises present in each niche segment. For instance, in the small-molecule sector, there are Raynovent Therapeutics and Weimou Biopharma; in the large-molecule sector, notable players include Innovent Biologics and Kanghong Pharmaceutical. In other words,China has yet to produce a truly leading innovative ophthalmic pharmaceutical company.

Meanwhile, as China’s ophthalmic innovative drug sector is still in its nascent stage, certain challenges are inevitable.

First, the challenges arising from the capital level.

No industry can thrive without the impetus of capital. In the past, capital primarily focused on life-threatening conditions such as cancer and cardiovascular diseases. As economic standards have risen, attention has increasingly shifted toward diseases that impact quality of life, such as ocular disorders. Consequently, the pace of capital influx into the ophthalmology sector has accelerated significantly, with investor interest markedly increasing.

The massive influx of capital has inevitably led to the current ophthalmic innovative drug sector in China exhibiting logics and characteristics that are distinctly different from those in the United States.

“Funding for new drug R&D in China comes primarily from investment firms, which tend to be more risk-averse compared with their U.S. counterparts. Developing first-in-class drugs or therapies targeting entirely novel mechanisms poses significant risks that are difficult for both companies and investors to confront.” This has, to some extent, determinedCurrently, most innovative ophthalmic drugs under development carry "positive risk," relying primarily on external in-licensing rather than independent innovation, with few truly first-in-class drugs being developed.

“If we merely seek convenience by adopting existing foreign technologies, we may achieve some short-term gains and experience a sense of satisfaction; however, in the long run, this approach fails to address fundamental technical challenges, leaving us still vulnerable to foreign ‘chokehold’ constraints. It is therefore imperative that we intensify our efforts in independent innovation.”

Next are the challenges at the regulatory approval level.

Dr. Zhang Fei stated, “Given the relative scarcity of truly first-in-class innovative ophthalmic drugs in China, it is crucial to accelerate R&D efforts and narrow the development gap with comparable foreign agents.” However,The regulatory framework for innovative ophthalmic drugs in China is still being refined, and the approval communication process has become a major bottleneck constraining R&D speed.

“Currently, there are significant differences in the approval processes for innovative ophthalmic drugs between China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The United States has a well-established regulatory framework for innovative ophthalmic drugs, whereas the NMPA lacks extensive experience in approving such therapies for conditions like wet age-related macular degeneration and dry eye disease, resulting in slower approval timelines. In this context, it is essential for corporate teams to include members with overseas work experience who possess a thorough understanding of the U.S. approval process. By presenting relevant literature and submission records from U.S. approvals, these teams can collaborate with the NMPA to facilitate the drug approval process.”

When asked how to overcome challenges and promote the healthy development of the industry, Dr. Zhang Fei stated: “The Most Important Thing Is the Big-Picture Perspective, policies, capital, and various enterprises have joined forces in a strong alliance,Treat the R&D of innovative ophthalmic drugs as a competitive track rather than a single company, thereby invigorating all the players in the pool.can rapidly narrow the gap with the United States.”

From a corporate perspective, the ophthalmic drug sector is seeing an increasing number of players. Companies should identify precise positioning and leverage their core competencies by selecting appropriate disease areas, commercial operational models, and R&D and regulatory strategies. For instance, in terms of disease area selection, priority should be given to major diseases with high patient demand and a lack of effective treatments. Ruiming New Drugs strives to address unmet market needs by focusing on two major categories of ophthalmic diseases: vascular and neurological disorders.

From a capital perspective, it is necessary to clarifyExternal acquisition is merely a supplementary approach; the most critical factor remains in-house R&D capability.We hope that investment institutions will provide greater support for the R&D of high-risk, first-in-class drugs, extend more patience to scientists, further facilitate their independent development of new drugs, and attract more outstanding scientists to engage in the field of innovative ophthalmic drug development.

“We believe that as China cultivates a growing pool of innovative talent in ophthalmology, the industry becomes increasingly standardized, and investment institutions act with greater rationality, the gap between China and the United States in the research and development of innovative ophthalmic drugs will continue to narrow. This will foster a vibrant landscape characterized by a diverse array of drugs, therapies, and specialized sub-sectors, ultimately establishing a robust and sustainable ecosystem for the development of innovative ophthalmic pharmaceuticals.”