HAOHAI BIOTEC (06826.HK): Subsidiary's Trifocal Toric IOL Obtains Medical Device Registration Certificate, Becoming First Domestically Approved Trifocal Toric IOL in China
NewTimeSpace News: Shanghai Haohai Biological Technology Co., Ltd. (stock code: 06826) issued an overseas regulatory announcement stating that its controlling subsidiary, Henan Saimaishi Biological Technology Co., Ltd. (Saimaishi), has recently received the "Medical Device Registration Certificate of the People's Republic of China" issued by the National Medical Products Administration (NMPA) for its trifocal toric intraocular lens (IOL) product.
The announcement disclosed that the product is registered under the name of Henan Saimaishi Biological Technology Co., Ltd., with models and specifications covering eight models from STF1-T0 to STF1-T7. The product is intended for the vision correction of aphakic eyes in adult patients with cataract combined with corneal astigmatism, aiming to improve near, intermediate and far vision while correcting corneal astigmatism and reducing dependence on spectacles; the IOL is designed for implantation in the capsular bag. The registration certificate is valid from 4 August 2026 to 3 August 2031.
The announcement noted that the product has passed the special review and approval procedure for innovative medical devices in China, becoming the first domestically approved trifocal toric IOL to be launched in the country. The product innovatively integrates trifocal diffractive optical design with toric astigmatism correction technology, effectively correcting corneal astigmatism while improving far, intermediate and near vision for cataract patients, providing a more complete full-range vision solution for patients with corneal astigmatism.
In terms of business layout, following the successive launches this year of the multifocal aspheric IOLs by the Company's Henan Universe IOL Research & Development Co., Ltd. and the trifocal IOLs by Saimaishi, the approval of this product further deepens the Company's layout in the high-end refractive IOL segment. As such, the Company has formed a product matrix covering differentiated clinical needs including monofocal and monofocal toric correction, multifocal and multifocal toric correction, which will enhance the Company's comprehensive competitiveness in the high-end refractive cataract market and inject new momentum into the sustained and steady development of its ophthalmic business.
The announcement also reminded that as the product has not yet generated sales, it will not have a material impact on the Company's recent results; the actual sales of the product after approval will be affected by factors such as policy changes, market conditions and sales channels, and future sales remain subject to significant uncertainty.
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