CsA Ophthalmic Gel is an innovative drug being developed by Zhaoke Ophthalmology for the treatment of DED. It is a single daily dose hydrogel which eliminates daytime administration and the associated discomfort and inconvenience, and aims to dramatically improve patients’ treatment compliance and quality of life. It is a proprietary hydrogel with patent(s) registered in China and internationally. This novel formulation enhances the pharmacokinetic profiles of CsA on the ocular surface allowing similar efficacy to that of the Cyclosporine A products currently available for DED. However, unlike the current treatment, CsA Ophthalmic Gel’s unique formulation stays on the eye for longer, requiring only once-a-day dosing compared with traditional twice-a-day dosing, hence reducing the treatment duration.

RGN-259, an eye drop indicated for moderate-to-severe DED. This is a therapeutic peptide (Thymosin _x0002_4), with cellular and tissue protective as well as repair and regeneration enhancement properties. RGN-259 has a novel mechanism with dual effects of corneal repair and anti-inflammation. Studies suggest that it has fast onset efficacy in multiple outcomes of signs and symptoms. RGN-259 shows efficacy as early as 15 days after administration. Cyclosporine, a first-line DED therapy, generally shows efficacy after three to six months of use according to CIC. RGN-259 has also demonstrated an excellent safety profile in such trial.

An innovative combination eye gel with dual mechanisms of anti-inflammation and tear film stabilization, with potentially better efficacy for patients having inadequate response to topical CsA (estimated to account for 20% to 30% of all moderate-to-severe DED patients globally, according to CIC). In our preclinical studies, the CsA/rebamipide ophthalmic gel showed meaningful improvement in DED signs and symptoms in a rabbit DED model.

An eye drop composed of highly selective and potent Syk tyrosine kinase inhibitor with broad anti-inflammatory effects which has also shown general efficacy in reducing signs of allergic conjunctivitis. We obtained an exclusive license from IACTA to develop, make and sell IC-265 in Greater China and certain Southeast Asia countries. Phase II clinical trial for the treatment of allergic conjunctivitis was completed.

Low concentration atropine is the only medication to date that is consistently effective in myopia progression control amongst children and adolescents. Zhaoke Ophthalmology’s innovative treatment, NVK002, is potentially the world’s first approved ophthalmic solution to control or slow myopia progression in children and adolescents. This treatment has a proprietary formulation that successfully addresses the instability of low-concentration atropine and is preservative-free with an expected shelf life of over 24 months. The clinical development of NVK002 involves two different concentrations of preservative-free atropine (0.01% and 0.02%) to determine the efficacy, safety and tolerability in children and adolescents with myopia, offering a choice for doctors and patients.

BRIMOCHOL™ PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct for the loss of near vision associated with presbyopia. BRIMOCHOL PF is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a “pinhole effect” so that only centrally focused light rays are able to enter the eye, thereby sharpening near and intermediate images. The result is clarity of vision for near tasks like reading or using a smartphone, and intermediate tasks, such as looking at a computer screen. In the VIVID Phase 2 study, both formulations met primary and secondary endpoints, demonstrating a 3-line improvement in near visual acuity with no loss of distance vision out to nine hours. BRIMOCHOL PF and Carbachol PF were well tolerated with no serious adverse events.

TAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically validated anti-VEGF drug. Globally, bevacizumab is approved for oncology treatment through intravenous infusion. However, there has been increasing offlabel use of bevacizumab via intravitreal injection for treatment of wAMD. Zhaoke Ophthalmology has obtained an exclusive license from TOT BIOPHARM to commercialize TAB014 for neovascularization-related eye diseases in China.

PAN-90806 is an innovative drug indicated in the treatment of wAMD, as well as DME, the leading cause of blindness in diabetic patients worldwide. PAN-90806 is a novel eye drop formulation, decreasing the number of injections required. If approved, PAN-90806 will bring significant convenience and a less invasive treatment alternative for patients as a maintenance therapy. This will reduce the frequency of intravitreal injections and other associated treatment issues with mainstream antiVEGF therapies while at the same time maintain visual stability. PAN90806 is expected to significantly reduce treatment discontinuation, and therefore slow underlying disease progression through improved patient comfort, acceptance, convenience and compliance.

ZK002, a protein with a novel mechanism of action to contain inflammation (i.e., anti-inflammation effect) and vascular flood leakage (i.e., anti-permeability effect), which has potentially better efficacy advantages over existing mainstay treatments for DME. ZK002 is expected to lower treatment burden by reducing the number of intravitreal injections required and improve treatment compliance. ZK002 also has anti-angiogenesis effect in addition to anti-permeability and anti-inflammatory properties. As such, we believe ZK002 has the potential to be a foundational agent, either as monotherapy or in combination with anti-VEGF agents, to address proliferative diabetic retinopathy in addition to DME.

Also, ZK002, the protein with anti-angiogenesis and anti-inflammation effects, and therefore is an ideal drug candidate for pterygium, in which vascular angiogenesis and inflammation play prominent roles.

PAN-90806 is an innovative drug indicated in the treatment of wAMD, as well as DME, the leading cause of blindness in diabetic patients worldwide. PAN-90806 is a novel eye drop formulation, decreasing the number of injections required. If approved, PAN-90806 will bring significant convenience and a less invasive treatment alternative for patients as a maintenance therapy. This will reduce the frequency of intravitreal injections and other associated treatment issues with mainstream antiVEGF therapies while at the same time maintain visual stability. PAN90806 is expected to significantly reduce treatment discontinuation, and therefore slow underlying disease progression through improved patient comfort, acceptance, convenience and compliance.

In addition to the wAMD indication, we are also developing PAN-90806 for DME.

Bimatoprost is a generic drug used in the treatment of glaucoma. Zhaoke Ophthalmology submitted an ANDA to the NMPA in August 2019. According to CIC, this will potentially be the first preservative-free generic drug commercialized in China, which will help improve patients’ comfort during treatment and lower the risk of patient allergies.

Levobetaxolol HCl is a generic eye drop used in the treatment of glaucoma to lower pressure in the eye. On September 2, 2021, Levobetaxolol HCl eye drops for the treatment of intraocular pressure (“IOP”) in patients with primary open-angle glaucoma or ocular hypertension has met its primary endpoint in decreasing IOP in eight weeks compared to the baseline.

One of the most frequently prescribed PGAs for open-angle glaucoma in China.

Bimatoprost Timolol is a potential first-to-market generic bimatoprost timolol in China targeting glaucoma. This drug is used for more advanced stages of the disease, with increased pressure in the eye.

A PGA and β blocker combination eye drop targeting glaucoma.

A potential first-to-market generic travoprost timolol in China targeting glaucoma.

One of the most frequently prescribed PGAs for open-angle glaucoma in China.