Company Transition and Milestones - In 2022, Zhaoke Ophthalmology transitioned from a pure R&D company to a commercial pharmaceutical company, achieving significant milestones despite macro challenges[14] - The company launched its first commercialized product, the heat compress eyepatch 堡得视®, in 2022, marking its transition from a pure R&D company to a commercial pharmaceutical company[74] - The launch of the Heat Compress Eyepatch in August 2022 marked the beginning of Zhaoke's commercialization strategy, allowing direct engagement with consumers[52] Clinical Programs and Product Development - The company advanced key clinical programs with late-stage initiatives addressing major front-of-the-eye diseases, solidifying its leadership in the ophthalmology sector in China[15] - Zhaoke Ophthalmology submitted two New Drug Applications (NDAs) and initiated the commercialization of its first product on Tmall, enhancing its market presence[15] - CsA Ophthalmic Gel NDA application accepted for review by NMPA in June 2022, passed GMP standards in January 2023[6] - NVK002 completed patient recruitment for Phase III clinical trials in China ahead of schedule in July 2022, strengthening position in low-dose atropine market[6] - The NVK002 clinical trial is expected to be completed in summer 2023, with plans for NDA submission based on combined global studies[41] - The Phase III clinical trial for Epinastine is expected to be completed, followed by an NDA submission[41] - Zhaoke Ophthalmology aims to file an IND for a Phase Ib/II study for Brimochol later this year[41] - The company is actively reviewing results from three Phase II studies for ZKY001, aiming to progress to Phase III this year[41] Market Opportunities and Growth Projections - The market size for DED drugs in China is projected to grow from US$430 million in 2019 to US$6.7 billion by 2030, representing a CAGR of 28.4%[32] - The market for myopia treatment in China is expected to increase from US$200 million in 2019 to US$3.0 billion by 2030, with a CAGR of 35.9%[32] - China has the highest number of glaucoma patients globally, accounting for approximately 25% of the total, with the market for glaucoma drugs anticipated to rise from US$163 million in 2019 to US$2.0 billion by 2030, at a CAGR of 25.4%[32] - The ophthalmology drug market in China is projected to reach approximately US$11 billion by 2027, driven by increasing demand and supportive public policies[67] Financial Performance - The company reported a loss for the year of RMB 407,317,000 in 2022, a significant reduction from a loss of RMB 2,129,780,000 in 2021[59] - Total R&D expenses for 2022 were RMB 296,430,000, an increase from RMB 220,058,000 in 2021[59] - Non-HKFRS adjusted loss for the year was RMB 360,633,000, compared to RMB 228,311,000 in 2021[59] - As of December 31, 2022, total assets amounted to RMB 2,570,623, a slight decrease from RMB 2,605,407 in 2021[63] - Other income rose to RMB 38,041,000 in 2022, compared to RMB 21,133,000 in 2021, indicating growth in non-operational revenue streams[199] Product Pipeline and Regulatory Approvals - Zhaoke Ophthalmology has one of the largest drug portfolios in the industry, with advanced programs in Phase III or later for major front-of-the-eye diseases[68] - The glaucoma product line includes seven drugs and one home-use IOP measurement device, with five to six ANDA submissions anticipated in 2023[41] - The NDA submission for CsA Ophthalmic Gel was accepted for review in June 2022, and it passed all regulatory inspections by January 2023, marking a significant milestone[49] - CsA Ophthalmic Gel is expected to receive regulatory approval and commercialization in China by early 2024, with ongoing discussions for U.S. IND filing by the end of 2023[91] - The proprietary hydrogel formulation of CsA Ophthalmic Gel allows for once-a-day dosing, improving patient compliance compared to traditional treatments[89] Strategic Partnerships and Collaborations - Partnership with Visus established in May 2022 for Brimochol, targeting presbyopia, solidifying leadership in three major front-of-the-eye diseases[6] - Strategic partnerships established with leading pharmaceutical supply chain service providers in March 2022 for broad collaboration[24] - The company is committed to exploring partnerships with domestic and international pharmaceutical firms to expand its drug portfolio[171] - A corporate gift agreement was established with Johns Hopkins University to support translational research and academic exchange[169] Community Engagement and Corporate Culture - Zhaoke Ophthalmology built a leading content portal for Chinese ophthalmologists through its Boshi WeChat account, strengthening its engagement with the medical community[15] - The company aims to address public awareness of eye diseases through campaigns like the "Glaucoma Commonweal Campaign" and "National Eyecare Day Commonweal Campaign"[179] - Emphasis on strong corporate culture as a key to success, fostering collaboration and transparency among employees[28] - Approximately 53% of the company's total employees were women, with 42% of them in managerial and executive positions[178] Digital Innovation and Marketing Strategies - The company is committed to driving digital innovation and building a state-of-the-art business model to meet the unmet needs of patients[42] - The digital platform Zhaoke Boshi has over 11,000 followers and features contributions from over 60 leading KOLs and ophthalmologists, enhancing the company's outreach in the ophthalmic community[156] - The company launched a flagship store on Tmall to build brand awareness among Chinese consumers focused on eye care[164] - Zhaoke Ophthalmology's innovative model incorporates digital, social, and e-commerce channels to enhance brand visibility beyond traditional sales methods[150] Expansion Plans and Global Footprint - The company is committed to expanding its presence in the Greater Bay Area, benefiting from supportive measures from regional and local governments[31] - Zhaoke Ophthalmology aims to enhance its scientific and commercial leadership in ophthalmology while expanding its footprint outside of China, particularly in South Korea and Southeast Asia[42] - Zhaoke Ophthalmology entered a distribution agreement with Kwangdong Pharmaceutical Co., Ltd. for NVK002 in South Korea, expanding its global footprint[108]
兆科眼科(06622) - 2022 - 年度财报