Financial Performance - Zhaoke Ophthalmology achieved a revenue of RMB30.4 million in 2024, a significant increase of 546.8% compared to RMB4.7 million in 2023, driven by breakthroughs in hospital listings[22]. - Zhaoke Ophthalmology recorded total revenue of RMB 69.3 million in 2024, a year-on-year increase of 268.6% from RMB 18.8 million in 2023[44]. - Revenue from drug sales amounted to RMB 32.6 million, driven by an enhanced sales network covering over 1,200 hospitals and eye institutions[44]. - Sales of key ophthalmic drug products increased over fivefold to RMB 30.4 million in 2024, compared to RMB 4.7 million in 2023, driven by breakthroughs in hospital listings[147]. - The company achieved a gross profit of RMB 51.8 million for 2024, compared to RMB 14.2 million in 2023, indicating a gross margin improvement[143]. - The total loss before taxation for 2024 was RMB 237.5 million, reduced from RMB 384.5 million in 2023, reflecting a decrease of approximately 38.3%[145]. - The adjusted loss for the year was RMB 228.8 million, down from RMB 363.0 million in 2023, showing a significant reduction in losses[143]. - Other income rose to approximately RMB 87.3 million in 2024, up from RMB 82.0 million in 2023, primarily due to increased government subsidies for R&D activities[154]. - R&D expenses decreased significantly to approximately RMB 203.7 million in 2024, down from RMB 333.1 million in 2023, reflecting a focus on late-stage drug assets[28]. - General and administrative expenses were approximately RMB70.8 million in 2024, a decrease of RMB13.6 million from RMB84.4 million in 2023, mainly due to reduced equity-settled share-based payment expenses[169]. Clinical Development - The Phase III clinical trial for NVK002 completed in August 2024, with positive topline results announced in October 2024[15]. - CsA Ophthalmic Gel received regulatory approval to proceed with a Phase III clinical trial in August 2024, and the company is preparing to resubmit the New Drug Application[17]. - TAB014 successfully completed its Phase III clinical trial in September 2024, meeting all primary and key secondary endpoints, and is preparing for a Biologics License Application submission[18]. - The ongoing clinical development of promising drug assets includes receiving Investigational New Drug approval for BRIMOCHOL™ PF and CARBACHOL™ PF in January 2024[19]. - The Phase III clinical trial for TAB014, targeting wet age-related macular degeneration, was successfully completed in September 2024, achieving all primary and key secondary endpoints[23]. - The Phase III trial for CsA Ophthalmic Gel enrolled 644 patients across 41 centers, demonstrating faster onset of action with efficacy observed around the two-week mark, compared to seven to eight weeks for traditional treatments[62][63]. - The completion of the last patient visit for TAB014's Phase III trial occurred in September 2024, marking a significant milestone in the clinical development process[70][71]. - The IND application for an additional Phase III clinical trial of CsA Ophthalmic Gel was approved in July 2024, based on updated clinical trial guidelines[62][63]. - ZKY001, a seven-amino acid peptide, is being developed for the treatment of CED after eye surgery, with plans to initiate discussions for a Phase III clinical trial protocol[73][76]. Market Expansion and Partnerships - Zhaoke Ophthalmology signed a distribution agreement with Kwangdong Pharmaceutical Co., Ltd. in January 2024, expanding its presence in South Korea[21]. - Partnerships were established in March 2024 with Pharmaniaga Logistics in Malaysia and TRB Chemedica in Thailand to enhance market reach[21]. - The company is focused on expanding its footprint in key global markets through strategic partnerships and distribution agreements[21]. - The company is expanding its market presence in the Asia-Pacific region, including South Korea, Malaysia, Thailand, Australia, and New Zealand, while exploring opportunities in North America[31]. - A strategic partnership with KDP was announced, granting exclusive distribution rights for BRIMOCHOL™ PF in South Korea[103]. - The licensing agreement with Tenpoint now includes exclusive rights for BRIMOCHOL™ PF and CARBACHOL™ PF in multiple regions, including Hong Kong and Australia[104]. - The company has expanded its licensing agreement with Vyluma for NVK002 to include new territories such as Australia and the Middle East[105]. Product Portfolio and Innovation - The company aims to have eight products available in the market by the end of 2025, including anticipated regulatory approval for Epinastine HCl[30]. - The company has established a comprehensive portfolio addressing six major eye diseases, including DED, myopia, and wAMD[46]. - Zhaoke Ophthalmology has made significant progress in developing a portfolio of innovative assets, including NVK002 for myopia and ZKY001 for corneal epithelial defects[36]. - NVK002 has a proprietary formulation with patent protection in the U.S. and China, and it is preservative-free with an expected shelf life of over 24 months[57]. - Zhaoke Ophthalmology's NVK002 has completed two Phase III clinical trials, involving a total of 1,303 patients across 34 centers, with positive topline results expected in October 2024[58][62]. - Zhaoke Ophthalmology is preparing for the commercialization of Epinastine HCl for allergic conjunctivitis, expecting marketing authorizations in the coming months[131]. Manufacturing and Sustainability - Zhaoke Ophthalmology operates a state-of-the-art production facility in Guangdong, China, with four manufacturing lines to scale production effectively[112][113]. - The manufacturing of NVK002 has been successfully transferred to the Guangdong facility, which will reduce manufacturing time and costs[114]. - The company is committed to enhancing sustainability and has organized health seminars to raise awareness of glaucoma and corneal diseases[116]. - Zhaoke Ophthalmology has four production lines operational at its facility in Guangdong, ensuring compliance with international standards and enabling large-scale production of various eye drops[119]. - The company successfully transferred the production of NVK002 to its advanced facility in Nansha, Guangzhou, which is expected to significantly reduce production time and costs[119]. Regulatory Approvals and Submissions - The ANDA for NVK002 (low-dose atropine) was accepted for review by the NMPA in January 2025, positioning the company as second to market in China[44]. - Zhaoke Ophthalmology received regulatory approval for the Bimatoprost Eye Drop in September 2024, followed by additional approvals for other glaucoma treatments in December 2024 and March 2025[50]. - The company plans to resubmit the NDA for CsA Ophthalmic Gel and the BLA for TAB014 in 2025[29]. - Zhaoke Ophthalmology is planning to refile an NDA submission for CsA Ophthalmic Gel after obtaining regulatory approval for an additional Phase III clinical trial[44]. Corporate Governance and ESG - The company published its fourth ESG report in April 2024, enhancing transparency and stakeholder understanding of its socially responsible practices[124].
兆科眼科(06622) - 2024 - 年度财报