Recently, the National Medical Products Administration approved the registration application of the trifocal intraocular lens of Henan Saimei Vision Biotechnology Co., Ltd. (hereinafter referred to as Saimei Vision), marking a new breakthrough for domestic high-end IOLs.

01
Sino-US joint venture
Focus on the research and development of high-end ophthalmic implant devices

Established in 2018, CEMIVIS is a Sino-US joint venture controlled by Shanghai Haohai Biological Technology Co., Ltd. and THERAMEDICELLC. Since its inception, it has focused on the research and development and production of high-end ophthalmic implantable devices. According to CEMIVIS' official website, its product pipeline is divided into two main categories: intraocular lenses and equipment/instruments , with a total of 7 products in the intraocular lens category .

According to data from Yaozhi Medical Devices, SEM currently has five products on the market in China (excluding the products launched this time shown in the image below), all of which are intraocular lenses. Two of these products are priority approval products, representing an important strategic move by Haohai Biotechnology in the field of high-end intraocular lenses.
Based on the deep collaboration between Chinese and American companies and the years of accumulation of expertise in the field of intraocular lenses, Simei has been granted 9 patents related to intraocular lenses, many of which involve multifocal intraocular lenses.

It is understood that the number of focal points in an intraocular lens is closely related to the range of vision covered after surgery. Traditional monofocal intraocular lenses can only provide clear vision at one distance, while bifocal intraocular lenses can provide clear vision at both near and far distances, but have a deficiency in intermediate vision. Trifocal intraocular lenses, through special optical design, distribute the light entering the eye to three focal points for far, intermediate, and near vision, enabling patients to obtain good uncorrected visual acuity when reading, using a computer, and looking into the distance.

The product launched by CEMIS this time is a trifocal intraocular lens, representing a major breakthrough for CEMIS in the field of high-end intraocular lenses. According to available information, this product is implanted within the capsular bag, featuring a refracting-diffraction hybrid surface, an advanced aspherical design , and an optimized C-shaped haptic.

Its material is a hydrophobic acrylate copolymer , which can block ultraviolet light and short-wave blue light. This product is suitable for vision correction in aphakic adults with cataracts, aiming to improve vision at near, intermediate, and far distances and reduce dependence on glasses.

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Shortlisted for centralized procurement
Is the market landscape poised to be reshaped?

China has one of the largest numbers of cataract patients in the world. With the aging population and increasing number of eye disease patients, the annual demand for intraocular lenses continues to rise. According to publicly available data, approximately 4.609 million cataract surgeries were performed in China in 2024 .

However, looking at the domestic intraocular lens market, it has long exhibited a relatively clear stratification pattern.

In the high-end market, multinational corporations such as Alcon, Johnson & Johnson Eye Care, Bausch & Lomb, and Carl Zeiss hold a dominant position due to their deep technological expertise and brand recognition. Regarding trifocal intraocular lenses, previously approved products in China included imported brands such as Alcon's AcrySof IQ PanOptix and Carl Zeiss's AT LISA tri 839MP , which dominated the market share.

However, guided by the trend of accelerated R&D and focus on innovative breakthroughs among Chinese medical device companies, domestically produced trifocal intraocular lenses have already made significant strides, with products from companies such as Century Kangtai and Leming Vision successively entering the market, filling gaps in related domestic fields. Overall, domestic substitution is spreading from low-end to high-end, with domestic medical device companies continuously striving to develop bifocal and trifocal lenses, and the technological gap is continuously narrowing.

However, it is worth noting that in recent years, against the backdrop of continuous improvement and expansion of centralized procurement, many types of high-value consumables have been included in national procurement, alliance centralized procurement, and local procurement. According to data from Yaozhi Medical Devices, there are currently 726,350 procurement records for intraocular lenses, with a procurement volume of 803,500 and a total value of 1.477 billion yuan .

In 2023, the government organized centralized bulk procurement of intraocular lenses (IOLs) for medical consumables, covering multiple categories including monofocal, bifocal, and trifocal lenses. This broad national procurement significantly reduced the price of IOLs, benefiting a large number of cataract patients and accelerating industry consolidation.

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Conclusion

The approval of this trifocal intraocular lens signifies that SEM has acquired the R&D capabilities for high-end intraocular lenses, becoming one of the few domestic companies capable of producing trifocal intraocular lenses. With policy support and continuous technological advancements, the "value" of domestically produced medical devices is increasing, and the domestic medical device industry is continuously shining brightly.

https://news.yaozh.com/archive/48250.html