Potential blockbuster Drug for Dry Eye Disease, which affects over 200 million people in China, achieves critical milestone of meeting primary endpoint with Phase III Trial
R&D spend increases over 220% to RM123.4 million
HONG KONG, 18 August 2021 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapies that address significant unmet medical needs in China today announced its interim results for the six months ended June 30, 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 Ophthalmology expects to commercialize some of the drugs from as early as 2022, leading to near-term revenue.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are well-positioned to capture the opportunity of the rapidly growing Chinese ophthalmology market, which is projected to grow at a CAGR of over 20% in the next decade.”
“Our vision is to be continuously patient and physician centric, harnessing our scientific rigor and the large innovative and generic drug portfolio we have built to address the unmet medical needs in major eye diseases affecting both the front and back of the eye. We are dedicated to transforming visual health in China, eliminating as far as possible all preventable eye diseases and bringing hope to patients suffering from life-altering conditions.
We are delighted to announce that the Phase III clinical trial for our most advanced self-developed innovative drug, Cyclosporine A, (“CsA”) Ophthalmic Gel, has met its primary endpoint. This is a strong validation of our capabilities across research and development and manufacturing and we look forward to bringing this drug to market as early as 2023,” continued Dr. Li. He added, “This drug has the potential to be a blockbuster one. Currently over 200 million people in China have dry eye disease, and I believe our CsA Gel can present a solution for many of these patients.”
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”), wet age-related macular degeneration (“wAMD”), diabetic macular edema (“DME”), myopia and glaucoma.
For the six months ended June 30, 2021, Zhaoke Opthalmology recorded an adjusted total loss of RMB 123.3 million and a total loss of RMB1,987.7 million, as compared with RMB42.9 million and RMB66.6 million, respectively, for the six months ended June 30, 2020. The significant majority of the difference between adjusted and unadjusted total loss for the period ended June 30, 2021, of RMB 1,763.5 million, is attributed to the changes in the carrying amount of preferred shares liability in relation to the redemption amount and conversion features for the Company’s Series A Preferred Shares and Series B Preferred Shares and is non-cash in nature. Both Series A and B Preferred Shares have been converted into ordinary shares on the Listing Date.
Zhaoke Ophthalmology is dedicated to enhancing and expanding its drug pipeline by leveraging its research and development capabilities. For the six months ended June 30, 2021, the Company’s research and development expenses reached RMB123.4 million, an increase of approximately 224.1% compared with the six months period ended June 30, 2020, primarily due to the increased expenses incurred for clinical trials, as well as research and development activities for the Company’s clinical stage products. The Company expects its research and development team to grow to 80 professionals by the end of 2021.
The Company’s manufacturing facility will be ready for commercial-scale production by the end of the year. The Company currently has five manufacturing lines, with the ability to expand capability. In anticipation of the commercialization of the Company’s drug candidates, it has increased investment in its manufacturing facility to augment its capacity and reach commercial scale. The production capacity for single dose drugs has already increased ten times.
Expanding the Company’s sales and marketing organization and strengthening its commercial capabilities is a critical focus area for its development. The Company will continuously strive for innovation in its sales and marketing approach and seek to adapt a multi-pronged approach to grow its relationships with its most important stakeholders. With marketing expertise, , market access and sales already in place, the Company’s aim is to expand its commercialization team from its current size to 200 - 300 members in the next five years.
The Company has established licensing partnerships with eight United States,European and Chinese pharmaceutical companies, not only to bring first-in-class and best-in-class drugs to the Chinese ophthalmology market, but also to build the Company’s visibility in the global market. As the most recent example, in the first quarter of 2021, the Company entered into a license and supply agreement with NTC, an Italian pharmaceutical company specializing in ophthalmology and other therapeutic areas. The Company obtained an exclusive license and distribution right to develop and sell NTC010, a fixed dose combination of antibiotics and steroids that prevents infection and inflammation for patients undergoing cataract surgery for China.
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:
· April 2021: completed patient enrollment for the Phase III clinical trial.
· 12 July 2021: completed the drug treatment for the last patient enrolled for the Phase III clinical trial.
· 17 August 2021: announced the Phase III clinical trial has met its primary endpoint in inferior fluorescein corneal staining score (ICSS). The patient group receiving CsA Ophthalmic Gel (0.05%, q.d.) has demonstrated statistically significant (P<0.0001) and clinically meaningful improvements in ICSS compared to the patient group receiving a comparator treatment. Detailed results are expected to be announced at an upcoming medical meeting after the comprehensive statistical analysis is complete.
· The Company aims to submit a New Drug Application (“NDA”) to the National Medical Products Administration (“NMPA”) by the end of 2021 and commercialize the new treatment as early as 2023.
NVK-002 (Atropine) for Myopia (partnered with Nevakar) – 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 NVK-002 is Vyluma Inc., a wholly owned subsidiary of US-based Nevakar. Updates:
· 14 July 2021: the investigational new drug (“IND”) application of NVK-002 for initiating a phase III clinical trial in China has been accepted for review by the Center for Drug Evaluation (“CDE”) of the NMPA.
· Upon receiving the IND approval from the CDE, the Company will initiate a Phase III bridging clinical trial in China.
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 corneal transplant, 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.
· The CED Phase II clinical study is currently ongoing, with patient enrollment starting in 2020, and the Company expects to complete the Phase II clinical study by the end of this year.
· The Company is also conducting a pharmacokinetics (“PK”) study using tears samples, with results expected by the end of 2021.
· The Company has received approval of the use of ZKY001 in the treatment of NK from the Ethics Committee of Xiamen Eye Centre of Xiamen University on 25 June 2021, and the first patient is expected to receive drug treatment by the end of 2021.
TAB014 (Bevacizumab) for wAMD (partnered with TOT BIOPHARM) – TAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Updates:
· Phase III clinical trials will commence in the third quarter of 2021.
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, is the leading cause 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 planning to commence a Phase II bridging study in China in 2023, leveraging PanOptica’s trial results for wAMD, and to commence a Phase III pivotal trial in wAMD in 2025.
Bimataprost – 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 patients’ comfort during treatment and avoid side effects caused by preservatives. Updates:
· The Company expects to receive approval of the Abbreviated New Drug Application (“ANDA”) and launch the commercialization in 2022. Bimatoprost is expected to be the first drug to be commercialized by Zhaoke Ophthalmology.
Bimatoprost Timolol – Bimatoprost Timolol is a potential first-to-market generic bimatoprost timolol in China targeting glaucoma, at more advanced stages of the disease, with increased pressure in the eye. Updates:
· Zhaoke Ophthalmology has passed the on-site Good Manufacturing Practice (“GMP”) inspection for the manufacturing facility of Bimatoprost Timolol in May 2021, which ensures that such products will be consistently produced and controlled according to stringent quality standards.
· The drug is currently under ANDA review with the NMPA, and the Company expects to receive approval of the ANDA and launch the commercialization in 2022.
Epinastine – 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. Updates:
· June 2020: Zhaoke Ophthalmology submitted an ANDA to the NMPA.
· May 2021: Zhaoke Ophthalmology has passed the on-site GMP inspection for the 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 the Company’s operations and is implementing measures to improve the sustainability of its business. 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.
Looking forward, Zhaoke Ophthalmology remains committed to its ambitious growth strategy. This includes advancing various assets through pre-clinical and clinical stages, strengthening foundational
capabilities across research and development, manufacturing, clinical, commercial and digital infrastructure. The Company will continue to explore partnerships and collaboration opportunities with world leading pharmaceutical firms and research institutions.
