Our late-stage Core Product and an eye gel indicated for DED based on the CsA compound. Compared with Restasis, the first CsA ophthalmic drug approved in the United States, which is an oil-based emulsion, our CsA drug is in an innovative hydrogel formulation. It diffuses faster on the ocular surface and stays longer. In an ex vivo preclinical study, our CsA ophthalmic gel demonstrated significantly greater local bioavailability in the tear film and ocular surface tissues compared to Restasis. In a Phase II exploratory study in moderate-to-severe dry eye patients, once-daily dosing of our CsA ophthalmic gel was able to deliver similar efficacy and safety compared to the twice a day dosing of Restasis. These clinical findings are supported by the higher exposure delivered in the front of the eye by our CsA ophthalmic gel compared to Restasis in preclinical experiments. In addition, studies have shown that the most common reason for which patients discontinue Restasis is the transient burning sensation immediately after topical application of the drug. By eliminating all daytime administrations and the associated discomfort and inconvenience, our CsA ophthalmic gel, administered once every night, is expected to significantly improve patients’ compliance and quality of life.

We are conducting a Phase III clinical trial in China to evaluate the efficacy and safety of CsA ophthalmic gel in patients with moderate-to-severe DED, and expect to complete the trial in the third quarter of 2021. We plan to submit an NDA to the NMPA in the fourth quarterof 2021.

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. We plan to submit an IND application to the NMPA for the CsA/rebamipide ophthalmic gel candidate in the first half of 2022 and commence a Phase I clinical trial in China in the second half of 2022.

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. IACTA plans to initiate another Phase II clinical trial in the United States in the second quarter of 2021. We plan to initiate a Phase II clinical trial for IC-265 in China in the first half of 2022, and may decide to directly move to Phase III clinical trial in China, depending on our licensing partner’s Phase II clinical results. We also intend to develop IC-265 for the treatment of uveitis, and plan to file an IND for the indication of uveitis in the forth quarter of 2021.

The first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically validated anti-VEGF drug. Globally, although bevacizumab is only approved for oncology treatment through intravenous infusion, there has been increasing off-label use of bevacizumab via intravitreal injection for treatment of wAMD. The WHO Essential Medicines List has also listed bevacizumab for eye disease treatment. TAB014 is registered with the NMPA under the Class 1 new drug pathway for the wAMD indication in China. We obtained an exclusive license from TOT BIOPHARM to commercialize TAB014 for neovascularization-related eye diseases in China. We expect the Phase III clinical trial of TAB014 to be initiated in the second quarter of 2021 and be completed in 2023. We plan to submit an NDA to the NMPA for TAB014 by 2024.

An anti-VEGF drug for wAMD and DME,in a novel eye drop formulation.PAN-90806 is a small-molecule compound that targets VEGFR2 and has optimal physicochemical properties in penetrating the anterior segment of the eye to allow for topical delivery to the back of the eye. If approved, it will bring significant convenience of convenience and a less invasive treatment alternative for patients as a maintenance therapy, reducing the frequency of intravitreal injections and other associated treatment burden of mainstream anti-VEGF therapies while maintaining visual stability. We obtained an exclusive license from PanOptica to develop and commercialize PAN-90806 in Greater China, South Korea and certain other Southeast Asian countries. We plan to file an IND application with the NMPA for PAN-90806 in the first half of 2022. In addition to the wAMD indication, we are also developing PAN-90806 for DME.

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. We plan to submit an IND application to the NMPA for ZK002 for DME in 2023.

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. We plan to submit an IND application to the NMPA for pterygium in the second half of 2022.

An anti-VEGF drug for wAMD and DME,in a novel eye drop formulation.PAN-90806 is a small-molecule compound that targets VEGFR2 and has optimal physicochemical properties in penetrating the anterior segment of the eye to allow for topical delivery to the back of the eye. If approved, it will bring significant convenience of convenience and a less invasive treatment alternative for patients as a maintenance therapy, reducing the frequency of intravitreal injections and other associated treatment burden of mainstream anti-VEGF therapies while maintaining visual stability. We obtained an exclusive license from PanOptica to develop and commercialize PAN-90806 in Greater China, South Korea and certain other Southeast Asian countries. We plan to file an IND application with the NMPA for PAN-90806 in the first half of 2022.

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

A potential novel topical ophthalmic solution to control myopia progression. NVK-002 has a proprietary formulation that successfully addresses the instability of low-concentration atropine. It is preservative-free with an expected shelf life of as long as 24 months. According to CIC, NVK-002 is one of the most advanced atropine drug candidates globally for myopia progression control, and targets the broadest patient group, covering children and adolescents from 3 to 17 years old. We obtained an exclusive license to develop, manufacture, register, import and commercialize NVK-002 in Greater China, South Korea and certain countries in Southeast Asia. We plan to submit an IND application to the NMPA in the second quarter of 2021. Subject to IND approval from the NMPA, we plan to commence a Phase III bridging clinical trial in China in the fourth quarter of 2021, and submit an NDA to the NMPA in 2023.

A potential first-to-market generic in China targeting glaucoma and potentially the only bimatoprost eye drop without any preservatives. We submitted an abbreviated NDA to the NMPA in August 2019 and expect to receive approval in the fourth quarter of 2021.

A potential first-to-market generic levobetaxolol hydrochloride in China targeting glaucoma. We plan to submit an abbreviated NDA to the NMPA in the first half of 2022 and expect to receive approval in 2023.

One of the most frequently prescribed PGAs for open-angle glaucoma in China. We plan to submit an abbreviated NDA to the NMPA in the first half of 2022 and expect to receive approval in 2023.

A potential first-to-market generic bimatoprost timolol in China targeting glaucoma. We submitted an abbreviated NDA to the NMPA in October 2020 and expect to receive approval in the first half of 2022.

A PGA and β blocker combination eye drop targeting glaucoma. We plan to submit an abbreviated NDA to the NMPA in the first half of 2022 and expect to receive approval in 2024.

A potential first-to-market generic travoprost timolol in China targeting glaucoma. We plan to submit an abbreviated NDA to the NMPA in the second half of 2022 and expect to receive approval in 2024.

One of the most frequently prescribed PGAs for open-angle glaucoma in China. We plan to submit an abbreviated NDA to the NMPA in the first half of 2022 and expect to receive approval in 2023.

A fixed-dose combination of IC-265, a Syk tyrosine kinase inhibitor, and an antihistamine agent for the treatment of allergic conjunctivitis. The Syk tyrosine kinase inhibitor of IC-265 reduces redness and inflammation, and the antihistamine agent controls itching. By combining the two components, IC-270 has the potential to be a treatment for allergic conjunctivitis that addresses not only itching but also redness and inflammation associated with allergic conjunctivitis. We obtained an exclusive license from IACTA to develop, make and sell IC-270 in Greater China and certain Southeast Asia countries. We plan to commence a Phase III clinical trial in 2023 and submit an NDA to the NMPA in 2024.

One of our Core Products and a eye drop targeting corneal epithelial defects, or CED, through anti-inflammatory effects plus stimulation of epithelial cell migration. Compared to widely prescribed growth factor therapies, such as rh-EGF and rb-bFGF drugs, which stimulate angiogenesis and may cause edema and inflammation, ZKY001 showed better in vivo efficacy in reducing corneal swelling and suppressing abnormal ocular vessel growth in preclinical animal models. ZKY001 also has a favorable safety profile, well tolerated at all concentrations in one of our Phase I clinical trials. We believe ZKY001 has the potential to be a foundational therapy for a broad range of corneal epithelial diseases.

We have completed a Phase I clinical trial for the safety,tolerabillty and systemic pharmacokinetics of ZKY001. ZKY001 was well tolerated or all concentrations during the trial. Among the 34 subjects who received ZKY001, only three mild AEs were reported, including two incidents of elevated blood triglyceride level and one incident of increased white blood cells in urine, and no subject experienced treatment-related AE.

We also completed two preclinical studies to evaluate the efficacy of ZKY001. The first study compared the efficacy of ZKY001 against rh-EGF, levofloxacin lactate and saline on the treatment of CED after laminectomy, a surgery which removes a layer in the cornea and, inevitably, creates damages to the cornea. ZKY001 showed faster onset effects than rh-EGF and levofloxacin lactate. In comparison to the saline group, the healing of the corneas treated with ZKY001 (measured by decrease in the proportion of damaged epithelial cells) reached statistical significance 24 hours after the surgery (p=0.005, p<0.05), whereas healing of the corneas treated with rh-EGF (p=0.004, p<0.05) and levofloxacin lactate (p=0.001, p<0.05) reached statistical significance on day 3 and day 4 after surgery, respectively. On day 7, corneas treated with ZKY001 were completely healed, whereas some corneas treated with levofloxacin lactate and saline remained unhealed.

The second study compared the efficacy of ZKY001 at three concentrations against rh-EGF and saline on the repair of CED after corneal alkali burns, serious damages to the cornea after contact with alkaline chemicals. The study showed that cell migration in the ZKY001 treatment groups was significantly higher than that in the control groups, with 20 μg/ml ZKY001 and 40 μg/ml ZKY001 being more efficacious than the other groups. In addition, 20 μg/ml ZKY001 and 40 μg/ml ZKY001 significantly alleviated corneal opacity and edema, which are evidence for corneal healing.

We started a Phase II clinical trial in November 2020 to evaluate the efficacy and safety of ZKY001 and expect to complete the trial in the fourth quarter of 2021. We plan to initiate a Phase III clinical trial in the second half of 2022 and target to submit an NDA to the NMPA in 2024.

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. IACTA plans to initiate another Phase II clinical trial in the United States in the second quarter of 2021. We plan to initiate a Phase II clinical trial for IC-265 in China in the first half of 2022, and may decide to directly move to Phase III clinical trial in China, depending on our licensing partner’s Phase II clinical results. We also intend to develop IC-265 for the treatment of uveitis, and plan to file an IND for the indication of uveitis in the forth quarter of 2021.

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. IACTA plans to initiate another Phase II clinical trial in the United States in the second quarter of 2021. We plan to initiate a Phase II clinical trial for IC-265 in China in the first half of 2022, and may decide to directly move to Phase III clinical trial in China, depending on our licensing partner’s Phase II clinical results. We also intend to develop IC-265 for the treatment of uveitis, and plan to file an IND for the indication of uveitis in the forth quarter of 2021.

A fixed-dose combination of IC-265, a Syk tyrosine kinase inhibitor, and an antihistamine agent for the treatment of allergic conjunctivitis. The Syk tyrosine kinase inhibitor of IC-265 reduces redness and inflammation, and the antihistamine agent controls itching. By combining the two components, IC-270 has the potential to be a treatment for allergic conjunctivitis that addresses not only itching but also redness and inflammation associated with allergic conjunctivitis. We obtained an exclusive license from IACTA to develop, make and sell IC-270 in Greater China and certain Southeast Asia countries. We plan to commence a Phase III clinical trial in 2023 and submit an NDA to the NMPA in 2024.

is an eye drop indicated for the prevention and treatment of inflammation and infection associated with cataract surgery. It is a fixed combination of levofloxacin, a quinolone antibiotic with a broad spectrum of action, at 0.5% concentration and dexamethasone, a corticosteroid anti-inflammatory agent, at 0.1% concentration. We entered into a license and supply agreement with NTC in February 2021 and obtained an exclusive license and distribution right to distribute and sell NTC010 in the PRC.

is an eye drop under development for the indication of moderate-to-severe bacterial conjunctivitis. It is an innovative fixed combination of levofloxacin 0.5% and ketorolac trometamol 0.5%. We obtained an exclusive license and distribution rights of NTC014 through a license and supply agreement with NTC in December 2020. We were granted an exclusive license to develop and commercialize NTC014 in Greater China, South Korea and certain Southeast Asian countries.

An intravitreal injection of liposome-loaded urea for the treatment of vitreomacular traction, or VMT. Resolv ER is a urea solution encapsulated in liposomes, a type of biodegradable and biocompatible carrier that can provide sustained release for prolonged periods. By using Resolv ER, patients suffering from VMT may avoid invasive surgery and preserve vision. We obtained an exclusive license from Kato Pharmaceuticals to develop, make and sell Resolv ER in Greater China and certain countries in Southeast Asia. We plan to submit an IND application to the NMPA for in the second quarter of 2021 and initiate a Phase II clinical trial in the fourth quarter of 2021 to evaluate the safety and efficacy of Resolv ER in treating VMT.

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. We plan to submit an IND application to the NMPA for ZK002 for DME in 2023.

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. We plan to submit an IND application to the NMPA for pterygium in the second half of 2022.

A potential first-to-market generic in China targeting allergic conjunctivitis with a dual mechanism of action of anti-histamine and mast cell stabilization. We submitted an abbreviated NDA to the NMPA in June 2020 and expect to receive approval in the first half of 2022.

A single-dose preservative-free eye drop for skin disinfection before and after surgery. We plan to submit an abbreviated NDA to the NMPA in the third quarter of 2021 and expect to receive approval in 2023.

A single-dose preservative-free proparacaine HCl eye drop for short-acting surface anesthesia. We plan to submit an abbreviated NDA to the NMPA in the fourth quarter 2021 and expect to receive approval in 2023.

An antifungal ophthalmic eye drop used to treat fungal infections around the eye. We plan to submit an abbreviated NDA to the NMPA in 2022 and expect to receive approval in 2024.

A potential first-to-market generic in China and potentially the first fluorescein sodium in eye drop formulation. We plan to submit an abbreviated NDA to the NMPA in 2023.