On June 27, 2025 NMPA approved the corneal preservation solution, developed by the team at Shandong First Medical University Affiliated Ophthalmic Hospital (Shandong Eye Hospital) and manufactured by Shandong Baiduoan Medical Devices Co., Ltd. This marks the approval of China’s first domestic corneal preservation solution with independent intellectual property rights.
Just as blood donation relies on a “blood bank” and cord blood stem cell storage depends on a “stem cell bank,” corneal donation and processing are managed by “eye banks.” Corneal transplantation is classified as a tissue transplantation, which differs significantly from organ transplants such as heart, liver, or kidney.
Unlike organ transplants, corneal transplants do not require HLA matching, and rejection rates are not affected by gender, race, blood type, or familial relationships. As a result, every donated cornea can be immediately used for patients in urgent need.
Market Size in China
China currently has an estimated 4 million patients suffering from corneal blindness, but only about 10,000 individuals regain sight annually through corneal transplantation. Traditional preservation methods pose significant limitations. Domestically, the “whole eyeball moist chamber preservation” method has been widely used, which requires removing the donor’s entire eyeball rather than just the cornea. With this approach, preserved corneas must be transplanted within 48 hours, creating a very narrow time window. This often complicates surgical scheduling and results in wasted corneas that cannot be matched in time with suitable recipients.
Unlike organ transplants that require urgent transplantation, corneas can remain viable for several days or even up to a month in specialized preservation solutions, maintaining intact cellular function and freshness. Importantly, all patients with corneal blindness are eligible for these preserved corneas.
In special cases, corneas may also be stored through dehydration for several years. However, dehydrated corneas lack viable endothelial cells and can only be used for certain corneal blindness conditions.
Compared with organ transplantation, corneal transplantation has a very low rejection rate. Patients do not need lifelong systemic immunosuppressants; instead, topical eye drops are sufficient, typically for about a year post-surgery.
Overseas Products and Technical Features
At present, Chinese hospitals primarily rely on imported corneal preservation solutions, including EUSOL-C from ALCHIMIA (Italy) and Optisol from the United States. Other solutions such as K-SOL, CSM, and Dexsol are also used clinically to varying degrees.
- EUSOL-C: Can preserve corneas at room temperature, effectively maintaining them for up to 14 days at 4°C. It stabilizes the microenvironment, reduces bacterial growth, provides nutrition, maintains corneal structure and thickness, and preserves transparency.
- Optisol: A commonly used medium-term corneal storage solution containing antibiotics (gentamicin sulfate and streptomycin sulfate). It is a serum-free medium with basal medium, buffer, chondroitin sulfate, dextran, vitamins, and ATP precursors. By providing nutrients, regulating osmotic pressure and pH, it sustains endothelial cell viability, reduces metabolism, and extends storage time.
- K-SOL, CSM, Dexsol: Generally contain nutrients, buffers, and antibiotics. They create a favorable nutritional and osmotic environment, inhibit bacterial growth, and slow endothelial apoptosis. Clinical outcomes vary depending on study conditions and sample size.
With the approval of China’s first domestically developed corneal preservation solution, locally manufactured products are expected to gradually replace some imported solutions.
Unlike abroad—where corneal preservation solutions are not categorized as drugs or medical devices—in China, numerous patents exist. The product is somewhat similar to laboratory-prepared solutions such as serum-free media: as long as it supports cell survival, is convenient, and safe, it can be effective.
Although considered a niche device, with annual demand of around 20,000–30,000 vials, corneal preservation solution is an essential and irreplaceable product for patients.
Baiduoan’s success in classifying the product as a Class III medical device represents a leap from laboratory use to market availability. With no existing national standards or precedents, the process was like venturing into “uncharted territory.” The deep involvement of regulatory authorities proved critical.
The NMPA listed corneal preservation solution as a key support project, providing comprehensive guidance in product design, quality control, animal studies, and clinical trials to strengthen safety and efficacy evaluations. Meanwhile, the Shandong Provincial Medical Products Administration leveraged its innovation service platform to provide targeted assistance and ensured smooth technology transfer. With collaborative efforts, product registration and approval were achieved within just 18 months.