On 2 August, 2021, Zhaoke Ophthalmology announced that NTC010 (Leviosa), an innovative eye drop for preventing and treating cataract surgery-related inflammation and infection, was approved by the Hainan Provincial Medical Products Administration on July 27, 2021, as an urgently needed drug for use by patients in the Hainan Province under The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port. The Boao Super Hospital in the Hainan Province will handle the approval of NTC010 for use in patients. The first patient to receive NTC010 has been identified and the treatment is expected to commence as early as August 2021 for a clinical study of NTC010 in Hainan.

As NTC010 has been approved and marketed in certain European Union (the “EU”) countries, the Company is in consultation with the National Medical Products Administration about a clinical trial waiver and submission of a New Drug Application in the People’s Republic of China (the “PRC”) using the existing European clinical data.

ABOUT NTC010

NTC010 is an eye drop for preventing and treating inflammation and infection related to cataract surgery. NTC010 is a fixed dose combination of 0.5% levofloxacin (a quinolone broad-spectrum antibiotic) and 0.1% dexamethasone (a corticosteroid anti-inflammatory drug). NTC010 has been approved for a one-week treatment in Europe. Compared with other fixed dose combination of corticosteroids/antibiotics, NTC010 can reduce the duration of antibiotic use and the risk of bacterial drug resistance, and it better conforms to the consensus of experts on prevention and treatment of inflammation and infection after cataract surgery in the PRC. Compared with the continuous medication by use of single corticosteroid and single antibiotic eye drops, NTC010 is more convenient to use by reducing the application times and improves the treatment compliance of elderly cataract patients.

As of February 2021, NTC010 is available in six EU countries, and is expected to be further rolled out across Europe in the coming months. According to the information from China Insights Consultancy, NTC010 is the first eye drop product marketed in the EU that combines a quinolone antibiotic with an anti-inflammatory steroid.

In February 2021, the Company entered into a license and supply agreement (NTC010 license) with Ntc s.r.l and obtained the exclusive license and distribution rights to distribute and sell NTC010 in the PRC.