Reference is
made to the announcement of China Medical System Holdings Limited dated 27 June 2019 (the “Previous
Announcement”) related to signing a License Agreement of Cyclosporine
A, 0.09% eye drops (the name in the clinical trial notice
currently obtained issued by the National Medical Products Administration
of the People’s Republic of China is “Cyclosporine Eye Drops 0.09%”) (the “Product”)
for the treatment of dry eye disease with Sun Pharmaceutical
Industries Ltd.. The Product is a nanotechnology
enabled-formulation in a clear, preservative-free, aqueous solution,
and has been approved by the U.S. Food and Drug Administration under
CEQUATM brand name for commercialisation in the USA.
The Company is pleased to announce that the
Product has been granted a clinical trial notice issued by the National Medical
Products Administration of the People’s Republic of China on 30 June 2020 and
agreed to carry out a clinical trial regarding increasing tear secretion in patients with keratoconjunctivitis sicca,
namely a randomized, double-blind, placebo-controlled, multi-center clinical
study on the safety and effectiveness of Cyclosporine
Eye Drops 0.09% for the treatment of keratoconjunctivitis sicca. The Group is currently actively preparing for initiating the clinical trial of the Product.