Financial Performance - Revenue for the first half of 2025 was RMB 15,803,000, a decrease of 68.3% compared to RMB 49,769,000 in the same period of 2024[11]. - Gross profit for the first half of 2025 was RMB 8,467,000, down 80.2% from RMB 42,840,000 in the first half of 2024[11]. - Loss for the period was RMB 116,623,000, compared to a loss of RMB 75,802,000 in the first half of 2024, indicating a 53.9% increase in losses[11]. - Non-HKFRS adjusted loss for the period was RMB 115,274,000, up from RMB 75,689,000 in the same period last year, reflecting a 52.4% increase[13]. - Total comprehensive income for the period was RMB (195,373,000), significantly lower than RMB (15,351,000) in the first half of 2024[11]. - Other income decreased to approximately RMB 26.3 million for the six months ended June 30, 2025, down from RMB 44.5 million in 2024, mainly due to the absence of a one-off government subsidy of RMB 5.1 million received in the prior period[165]. - The total comprehensive loss for the period was RMB 195.4 million, compared to RMB 15.4 million in the previous year, reflecting the impact of foreign exchange translation differences[154]. - The company recorded a loss of approximately RMB 116.6 million for the six months ended June 30, 2025, compared to a loss of approximately RMB 75.8 million for the same period in 2024[180]. Research and Development (R&D) - R&D expenses increased to RMB 113,050,000, representing a 25.9% rise from RMB 89,797,000 in the previous year[11]. - R&D expenses were reported at RMB113.1 million, with cash and equivalents totaling RMB1,051.3 million, ensuring strong financial foundations for future growth[26]. - Clinical trial professional service fees accounted for RMB57.8 million in R&D expenses for the six months ended June 30, 2025, up from RMB31.2 million in 2024[172]. - The increase in R&D expenses was primarily driven by the commencement of Phase I and II clinical trials for BRIMOCHOL™ PF and CARBACHOL™ PF[170]. - The R&D team consists of approximately 70 specialists, supporting the company's focus on rapid product development[95]. - The R&D pipeline has made significant progress, with three core assets—Atropine Sulphate Eye Drops (0.01% and 0.02%), CsA Ophthalmic Gel, and Bevacizumab Intravitreal Injection—advancing to the NDA stage[137]. Product Development and Regulatory Approvals - The company achieved critical milestones with three core drug candidates now at the New Drug Application (NDA) stage, highlighting its commitment to innovation[15]. - Three core drug candidates are currently in the New Drug Application (NDA) stage, with significant regulatory breakthroughs achieved for Atropine Sulphate Eye Drops (NVK002) in January and July 2025[17]. - The re-NDA for CsA Ophthalmic Gel was accepted by the NMPA in May 2025, and the BLA for Bevacizumab Intravitreal Injection (TAB014) was accepted in June 2025[21]. - The FDA approved the IND application for CsA Ophthalmic Gel in June 2025, allowing the start of a Phase III trial in the U.S.[22]. - The U.S. FDA accepted the NDA for BRIMOCHOL™ PF for the treatment of presbyopia in June 2025[76]. - The company is preparing for the commercialization of key products, including Atropine Sulphate Eye Drops, Cyclosporine A Ophthalmic Gel, and Bevacizumab Intravitreal Injection, set to launch next year[111]. Market Expansion and Strategic Partnerships - The global capital environment showed steady improvement in the first half of 2025, validating the company's strategic priorities and growth trajectory[15]. - The company formed strategic alliances with several pharmaceutical partners, including a distribution agreement with AFT Pharmaceuticals in January and a partnership with Interpharma in April 2025[24]. - The company expanded into Indonesia through a distribution partnership with PT Ferron Par Pharmaceuticals in July 2025[25]. - A significant partnership was formed in June 2025 with Jamjoom Pharmaceuticals to market CsA Ophthalmic Gel in Saudi Arabia, UAE, Bahrain, Kuwait, Oman, and Qatar[120]. - Zhaoke Ophthalmology has established strategic partnerships with Somerset Therapeutics LLC and FAREVA Group to enhance its manufacturing capabilities[54]. - The company is strategically expanding into new markets including Australia, New Zealand, Thailand, the Middle East, and Indonesia through partnerships with local pharmaceutical companies[51]. Financial Position and Liquidity - As of June 30, 2025, total current assets were approximately RMB 1,475.0 million, a decrease from RMB 1,614.9 million as of December 31, 2024[188]. - Current liabilities amounted to approximately RMB 335.1 million, including bank borrowings of approximately RMB 247.6 million[190]. - The current ratio decreased to 4.4 as of June 30, 2025, compared to 5.2 as of December 31, 2024[198]. - The company primarily funded its working capital requirements through net proceeds from the Global Offering during the reporting period[189]. - The company maintains a conservative treasury policy, centralizing cash management to minimize funding costs[192]. - The company closely monitors cash usage and strives to maintain healthy liquidity for operations[189]. Commitment to Social Responsibility - Zhaoke is committed to sustainability and social responsibility, organizing health seminars to raise awareness about eye health conditions[135]. - The company publishes an annual ESG report to share progress and priorities with stakeholders, reflecting its commitment to transparency and compliance[136].
兆科眼科(06622) - 2025 - 中期财报