Marketing application of Diquafosol Sodium eye drops has been officially accepted by the China National Medical Products Administration (NMPA)

HONG KONG SAR 23 January 2024 – Uni-Bio Science Group Limited (“Uni-Bio Science”, “the Group”, stock code: 0690.HK), a fully integrated biopharmaceutical company, is pleased to announce the acceptance of its marketing application for Diquafosol Sodium eye drops by the China National Medical Products Administration (“NMPA”) on 23 January 2024, with the acceptance number “CYHS2400318”. This acceptance marks a pivotal step in expanding the Group’s ophthalmology drug repertoire and providing patients with more diverse treatment options upon successful marketing approval.Diquafosol Sodium eye drops complement the Group’s robust ophthalmic drug portfolio, following GeneSoft®, which is expected to be approved for marketing in the first quarter of 2025. Aligned with the surging demand within China’s ophthalmic drug market, the Group identifies the significant potential, as over 360 million patients suffer from dry eye disease in the country. Zhuoshi Consulting forecasts that the market for dry eye medication is expected to experience substantial growth, reaching over 42 billion yuan by 2030, expanding at a compound annual growth rate of 28.4%.

Diquafosol Sodium represents the next generation of dry eye medication, offering cutting-edge therapy through its novel mechanism as a P2Y2 receptor agonist to stimulate tear and mucin secretion, addressing the underlying causes of dry eye syndrome, normalizing the tear layer and improving corneal epithelial damage. Since the introduction of the original imported version in Japan in 2010 and its subsequent arrival in China in 2017, anticipation has grown for domestic product launches that will likely increase market penetration and sales volume.

To capitalize on this opportunity, the Group has undertaken a strategic expansion of its sales force, which has more than doubled in size this year. The Group has also adopted a forward-thinking sales strategy, integrating online e-commerce platforms to diversify sales channels and enhance customer engagement. This approach is set to reinforce the Group’s stronghold within the ophthalmology market.

The Group has also significantly enhanced its manufacturing prowess with the inauguration of a new Dongguan-based production facility. This site is primed for the production of Diquafosol Sodium eye drops, employing the latest Blow-Fill-Seal (BFS) technology to ensure a seamless, aseptic process from bottle creation to filling and sealing. The adoption of this technology is a strategic move that not only upholds stringent safety standards but also affords the Group greater control over production costs. The Dongguan facility has been meticulously designed to produce preservative-free, single-dose packaging, a feature that caters to modern patient needs for convenience and aligns with the trends towards single-use dosing in medications.

Complementing the technological advancements at the Dongguan site, the Group has also established strategic partnerships with API manufacturers. This collaboration has been instrumental in securing active pharmaceutical ingredients at favorable costs, well below market averages. The synergy between the Group’s direct control over its BFS production line and these cost-effective procurement strategies ensures that the manufacturing of Diquafosol Sodium eye drops is both high in quality and economically efficient, positioning the Group competitively in the market.

Uni-Bio Science is committed to the dual-track development of innovative biopharmaceuticals and high-value generic drugs. The introduction of Diquafosol Sodium eye drops is anticipated to significantly contribute to the diversification and growth of the Group’s ophthalmology pipeline, becoming a new driver of sales growth and furthering the Group’s dedication to innovation in the field of biopharmaceuticals.