· Significant Progress in the Development of Potential Blockbuster Drug for the Treatment of Dry Eye Disease
· First Patient Enrolled for Phase III Clinical Trial for Myopia Control Treatment with the Most Advanced Clinical Stage Low Dose Atropine Program Globally
· Commercialization of First Generic Treatment for Glaucoma Expected in 2022
· Development of a Unique Hybrid Commercialization Strategy
· Over RMB2 Billion Available to Fund Research Development and Commercialization
HONG KONG, 23 March 2022 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, today announced its financial results for the year ended 31 December 2021.
Zhaoke Ophthalmology is strategically focused on treatments that cover a wide range of ophthalmic diseases, with one of the largest and most comprehensive drug portfolios of 25 innovative and generic treatments covering the five major eye diseases across both the front and back of the eye. The Company’s portfolio includes several potential blockbuster innovative drug candidates and Zhaoke expects to commercialize its first generic product for glaucoma in 2022, leading to near-term revenue.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “China has the largest number of eye disease cases globally, and there is still significant unmet demand from a rapidly growing patient base.”
“Our vision is to be relentlessly patient and physician centric. We are well-positioned to capture the rapidly growing Chinese ophthalmology market and will continue to strive to become a leader in ophthalmology. With a strong focus on research and development, our aim is to provide new treatment solutions and transform visual health in China.”
Our team has met significant milestones in 2021. We have completed China’s largest DED (Dry Eye Disease) trial for our proprietary CsA Ophthalmic Gel, which resulted in a positive outcome demonstrating significant improvements for patients. We also completed treatment for the last patient in our Phase II trial for ZKY001 for the initial indication of CED (Corneal Epithelial Defect) in early 2022. Finally, we established a clear path for the Phase III clinical trials for NVK002 for the progression control of myopia with the CDE (Center for Drug Evaluation) of the NMPA (National Medical Products Administration), which will be one of the most comprehensive and robust Phase III clinical trials for low dose atropine use in the world. In fact we just recruited the first patient for this Phase III trial” continued Dr. Li.
He added, “We are excited about the commercialization of our first generic product for the treatment of glaucoma, Bimatoprost Timolol, which is expected in 2022. In anticipation of this and for future launch of our other drugs, we have developed a go-to-market model which includes digital, social, and e-commerce channels combined with the traditional channels and key partnerships.”
The Company’s portfolio is well balanced, with 13 innovative drugs and 12 generic drugs, and a strategic emphasis on five major ophthalmic indications in China in terms of market potential, including dry eye disease (DED), myopia, wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and glaucoma.
For the year ended 31 December 2021, Zhaoke Ophthalmology recorded total loss of approximately RMB2,129.8 million, as compared with approximately RMB727.0 million for the year ended 31 December 2020, primarily due to the changes in the carrying amount of the preferred shares liability in relation to the redemption amount and conversion features for the Series A Preferred Shares and Series B Preferred Shares, before they were converted into ordinary Shares on the Listing Date (29 April 2021).
Zhaoke Ophthalmology ended its fiscal year 2021 with a strong cash and cash equivalent position of approximately RMB2,128.4 million on its balance sheet. This provides ample capital to fund the clinical development of its assets as well as its innovative commercial model.
During the period Zhaoke Ophthalmology continued to enhance its research and development capabilities. For the year ended 31 December 2021, the Company’s R&D expenses totaled approximately RMB220.1 million, compared to approximately RMB81.8 million for the year ended 31 December 2020.
In 2022 the Company will concentrate its efforts on the advancement of key clinical programs to enhance and expand its drug pipeline, with a focus on commercialization. Major anticipated milestones for late stage clinical assets include: submission of NDA for CsA Ophthalmic Gel, completion of patient recruitment for Phase III clinical trial for NVK002, and patient recruitment for Phase III clinical trial for TAB014 and Phase II clinical trials for ZKY001.
In 2022, in anticipation of the launch of its commercial products, Zhaoke Ophthalmology is developing its innovative commercialization strategy, which leverages a combination of traditional sales channels and new channels including digital, social and e-commerce.
In September 2021, Zhaoke Ophthalmology launched its first content driven platform Zhaoke Boshi (兆科博視) to showcase cutting-edge research in ophthalmology globally and to allow leading key opinion leaders (KOLs) to share their insights and best practices, and at the same time to facilitate discussions in the ophthalmology community. Zhaoke Boshi’s follower base has grown to over 3,000 members as of the date of announcement, because of consistently high quality content.
Zhaoke Ophthalmology has established multiple licensing partnerships with leading companies in China, the United States, and Europe and will continue to build its footprint globally. In 2021, the Company initiated engagement with US advisors to evaluate its product pipeline for potential development in North America, and in February 2022 the Company announced a collaboration with the world-leading private research institute, Johns Hopkins University’s Wilmer Eye Institute. In addition, Zhaoke Ophthalmology recently signed strategic partnership agreements with three leading Chinese pharmaceutical companies: Shanghai Pharma; CR Pharmaceutical; and Sinopharm in March 2022. These partnerships will focus on distribution and collaboration opportunities in areas such as procurement, logistics and R&D.
The Company has made a number of strategic hires, including Dr. Albert Tsai Jr. as Chief Medical Officer, and Dr. Xie Zhijun as the Head of pre-clinical R&D. And, in 2021, Zhaoke Ophthalmology significantly increased the size of its R&D team, which now includes approximately 80 professionals.
Zhaoke Ophthalmology highlighted several pipeline updates as a part of the results announcement:
CsA Ophthalmic Gel for DED (self-developed) – this is an innovative drug for the treatment of DED. It is a single daily dose hydrogel that eliminates daytime administration and the associated inconvenience of the current treatment that requires two daily doses, and aims to dramatically improve patient usage and quality of life. Updates:
· 12 July 2021: completed treatment for the last patient enrolled for the Phase III clinical trial, which was the largest DED trial conducted in China with 644 patients across 41 centres.
· 29 October 2021: announced the full results of the Phase III clinical trial at the 7th National Dry Eye Conference in Shanghai, where it was revealed that the Phase III clinical trial of CsA Ophthalmic Gel had met its primary endpoint in inferior fluorescein corneal staining score (“ICSS”). Analysis of the results showed that the patient group who received CsA Ophthalmic Gel demonstrated statistically significant improvements, when compared to the patient group receiving the placebo treatment. At the end of the treatment, 73.7% of CsA Ophthalmic Gel- treated patients showed a one point or greater improvement in ICSS versus 53.2% of patients on vehicle (p<0.0001). The mean change from baseline in Eye Dryness Score (EDS) on day 84 was 29.2mm (p<0.001) or 44.3% improvement in EDS over baseline.
· Zhaoke Ophthalmology plans to submit the NDA to the NMPA in short order in 2022. Due to the treatment’s potential to benefit millions of people globally, the Company is also exploring opportunities outside of China, planning to submit a pre-IND filing to the FDA to explore the clinical pathway for CsA Ophthalmic Gel in the U.S.
· Zhaoke Ophthalmology continues to target commercialization of CsA Ophthalmic Gel as early as 2023.
NVK002 (Atropine) for Myopia (partnered with Vyluma Inc.) – this is one of the world’s most advanced atropine drug candidates to control or slow myopia progression, with the potential to become the first such product to be approved by the United States Food and Drug Administration (FDA) Zhaoke Ophthalmology’s licensing partner for NVK002 is Vyluma Inc., a wholly owned subsidiary of US-based Nevakar Inc. Updates:
· 27 September 2021: Zhaoke Ophthalmology received approval from the CDE to initiate two concurrent Phase III clinical trials, including a two-year Phase III clinical trial (“China CHAMP”) and a one-year Phase III bridging trial (“Mini-CHAMP”) in China. The latter will be combined with global data from Vyluma Inc.’s Phase III clinical trial in the U.S. and Europe, making the Phase III clinical trial for NVK002 one of the most comprehensive and robust Phase III clinical trials for low dose atropine use in the world.
o The main objective of the China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 in myopia progression control of children and adolescents from 3 to 17 years old. The China CHAMP trial will involve 19 centres and enroll 770 patients, led by Professor Wang Ning Li from Beijing Tongren Hospital as the Principal Investigator. The Mini-CHAMP trial will involve 18 centres and enroll 526 patients, led by Professor Qu Xiao Mei from Eye and ENT Hospital of Fudan University as the Principal Investigator.
· 16 March 2022: the first patient was enrolled for the two-year Phase III clinical trial (China CHAMP).
· The treatment could be available in the mainland Chinese market as early as 2024, making Zhaoke Ophthalmology potentially one of the first companies to commercialize a myopia drug in the mainland Chinese market.
ZKY001 (self-developed) for corneal epithelial disease (CED) – this is a novel eye drop formulation targeting CED. ZKY001 has broad application in corneal wound healing and can potentially be used in multiple corneal repair indications. In addition to the ongoing Phase II clinical study for CED, the Company is currently exploring three additional indications for ZKY001, including Transepithelial Photorefractive Keratectomy (TPRK), also known as myopia surgery; pterygium, which is an epithelial growth in the cornea or conjunctiva; and neurotrophic keratitis (NK), which is a rare degenerative corneal disease. Updates:
· 16 October 2021: the first patient was enrolled for the investigator-initiated trial (IIT) of ZKY001 for NK disease. The IIT trial plans to enrol a total of 40 patients by the second quarter of 2022.
· February 2022: the last patient enrolled completed his/her treatment in the Phase II clinical trial of ZKY001 for CED. The main objective of the CED trial is to evaluate the efficacy and safety of ZKY001 in the treatment of corneal epithelial defects and to assess the optimal dosage of ZKY001. The Phase II clinical trial for CED has enrolled 105 patients and is a multi-centre, randomized, double-masked, placebo-controlled study.
· 16 March 2022: the first patient was enrolled for the Phase II clinical trial of ZKY001 for pterygium disease.
· The Company is also expecting the first patient enrolment for Phase II clinical trial for TPRK shortly.
TAB014 (Bevacizumab) for wAMD (partnered with TOT BIOPHARM) – this is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Updates:
· On 9 March 2022, the Group entered into a supplemental agreement with TOT BIOPHARM, pursuant to which Zhaoke Guangzhou will have full control and responsibility in the execution of clinical trials and the ultimate decision-making power in the development and commercialization of TAB014 in China, Hong Kong and Macau. Zhaoke Guangzhou is also entitled to develop TAB014 for other ophthalmic indications in addition to wAMD or novel formulations for ophthalmic indications. TOT BIOPHARM will continue to be responsible for manufacturing of TAB014 for clinical trial and commercial purposes.
· The Company is expecting the first patient enrollment for Phase III clinical trial of TAB014 in the short order in 2022.
PAN-90806 (VEGFR2 inhibitor) for wAMD and DME (partnered with PanOptica) – this is an innovative drug indicated for the treatment of wAMD, as well as DME, two of the leading causes of blindness in diabetic patients worldwide. PAN-90806 is a novel eye drop formulation, that may be used as a maintenance therapy to decrease the frequency of injections typically required. Updates:
· Zhaoke Ophthalmology is currently focused on optimizing the formulation of PAN-90806. Subject to regulatory approvals and completion of animal study, the Company plans to commence human study in China.
NTC010 – this is a fixed dose combination of antibiotics and steroids to prevent infection and inflammation for patients undergoing cataract surgery. The drug belongs to a new generation of antibiotics, which increases efficiency and covers a wider range of bacteria. The drug also shortens the duration of the treatment by half, from 14 to seven days, making it beneficial for patients’ overall health and helping to prevent antibiotic overuse. The drug has already been approved in seven countries in Europe. Updates:
· 27 July 2021: NTC010 was approved by the Hainan Provincial Medical Products Administration as an urgently needed drug for use by patients in Hainan Province, under The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone, of the Hainan Free Trade Port. The Company plans to submit an NDA to the NMPA in 2022.
Bimatoprost Timolol – this is a potential first-to-market generic bimatoprost timolol in China targeting more advanced stages of glaucoma, with increased pressure in the eye. Zhaoke Ophthalmology submitted an ANDA (Abbreviated New Drug Application) to the NMPA in October 2020 and the drug is currently under review with the NMPA. Updates:
· May 2021: Zhaoke Ophthalmology passed the on-site Good Manufacturing Practice (GMP) inspection for the manufacturing facility of Bimatoprost Timolol, which ensures that such products will be consistently produced and controlled according to stringent quality standards.
· The Company expects to receive approval of the ANDA in 2022. Bimatoprost Timolol is expected to be the first drug to be commercialized by Zhaoke Ophthalmology.
Bimatoprost – this is a generic drug prostaglandin analogue for the treatment of glaucoma. This will potentially be the first preservative free generic commercialized in China, which will help improve patient comfort during treatment and avoid side effects caused by preservatives. Updates:
· After the completion of on-site GMP inspection carried out in 2021, we expected the ANDA review process will be completed in near future.
Levobetaxolol Hydrochloride (HCl) – this is a generic eye drop used in the treatment of glaucoma to lower pressure in the eye. Updates:
· 2 September 2021: Levobetaxolol HCl eye drops for the treatment of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension met its primary endpoint in decreasing IOP in eight weeks compared to the baseline.
· Analysis of the results shows that the patient group who received Levobetaxolol HCl eye drops demonstrated statistically significant (P<0.01) superior efficacy after eight weeks of treatment, when compared to the patient group receiving the comparator treatment, Betaxolol HCl (BETOPTIC®S).
Epinastine HCl – this is a generic antihistamine targeting allergic conjunctivitis with anti-inflammatory and mast cell stabilization properties. It is the first-line therapy for allergic conjunctivitis in China, and is therefore expected to be commercialized at a lower price than the currently available treatment, giving it a potential significant market advantage. In June 2020, Zhaoke Ophthalmology submitted an ANDA to the NMPA. Updates:
· May 2021: Zhaoke Ophthalmology passed the on-site GMP inspection for its manufacturing facility of Epinastine.
Committed to the development of a sustainable healthcare industry in mainland China, Zhaoke Ophthalmology rigorously monitors the environmental and social impact of its operations. In the first half of 2021, the Company defined the ESG responsibilities of the Board and the senior management and has established a sustainability steering committee (SSC) to assist the Board in its management and supervision of the progress and results of relevant initiatives. In July 2021, the Company was excited to publish its first ESG report.
Looking forward, Zhaoke Ophthalmology will benefit from strong momentum in the ophthalmologic industry, driven by a growing market demand and supportive public policies in China as indicated by the National Eye Health Plan included as part of the “Fourteenth Five-Year Plan for National Economic and Social Development of the PRC and the Outline of Vision Goals for 2035”. As part of this initiative, the Chinese government has designated three geographic areas, including, among others, the Greater Bay Area (GBA), as future centres of excellence for healthcare. Zhaoke Ophthalmology is one of the publicly listed healthcare companies headquartered in the GBA, and well positioned to capture the associated market opportunity.
Innovation and commercialization are Zhaoke Ophthalmology’s dual focuses for 2022. The Company expects the commercialization of its first generic product for glaucoma, Bimatoprost Timolol. At the same time, the Company expects significant progress with the key late-stage clinical trials including NVK002, TAB014 and ZKY001. The Company will also continue to explore global partnerships and collaboration opportunities with world leading pharmaceutical firms and research institutions, to help realize the potential of the globalization of the Company’s assets, including CsA Ophthalmic Gel for potential R&D and commercialization in North America, and NVK002 for out-licensing to Southeast Asia and South Korea.