Core Viewpoint - Zhaoke Ophthalmology is considered an undervalued innovative ophthalmic drug company, with significant potential for growth as it approaches a clinical drug harvest period and has seen a stock price increase of approximately 140% this year, despite a low price-to-book ratio of less than 1 [4][15]. Product Pipeline and Market Potential - Zhaoke Ophthalmology has a comprehensive pipeline focusing on three main products: NVK002 for myopia control, a modified cyclosporine A eye gel for moderate to severe dry eye syndrome, and TAB014 for wet age-related macular degeneration (wAMD) [5][10][11]. - The NVK002 product, a low-concentration atropine eye drop, has received significant regulatory attention, with a simplified new drug application accepted and a new drug listing application approved for the 0.02% concentration [5][7]. - The market for myopia treatment is substantial, with over 40 million children in China being potential users, indicating a large growth opportunity for NVK002 [7][9]. Competitive Landscape - The competition for NVK002 is intense, with other companies like Xingqi Eye Medicine already having launched similar products. Zhaoke aims to differentiate itself by enhancing patient compliance and addressing the stability issues of atropine [8][9]. - The modified cyclosporine A eye gel has shown promising clinical results, with a patient compliance rate of 98.94%, and is expected to receive faster approval due to proactive communication with regulatory authorities [10][11]. Future Outlook - Zhaoke Ophthalmology aims to have a total of 12 products on the market within the next 18 months, which would significantly enhance its influence in the ophthalmic field [14][15]. - The company has also received orphan drug designation from the FDA for a treatment for retinoblastoma, indicating its commitment to expanding its product offerings [12]. - The CEO expressed confidence in the company's future, emphasizing the importance of timely product approvals and the potential for market growth in various ophthalmic conditions [17].

Performance Summary - Ningde Times (03750.HK) reported a revenue of 178.886 billion yuan for the first half of the year, an increase of 7.27% year-on-year, with a net profit of 30.512 billion yuan, up 33.02% year-on-year [2] - Hisense Home Appliances (00921.HK) achieved a total operating revenue of 49.34 billion yuan, a year-on-year increase of 1.44%, and a net profit of 2.077 billion yuan, up 3.01% year-on-year [2] - New Oriental-S (09901.HK) recorded a net revenue of 4.9 billion USD for the fiscal year 2025, a year-on-year increase of 13.6%, with a net profit of 372 million USD, up 20.1% year-on-year [2] - Weisheng Holdings (03393.HK) reported an operating income of 1.368 billion yuan, a year-on-year increase of 11.88%, and a net profit of 305 million yuan, up 12.24% year-on-year [2] - Yingda Real Estate (00432.HK) had a total revenue of 736 million HKD, a year-on-year growth of 35%, but reported a net loss of approximately 249 million HKD, an increase of 62.75% year-on-year [2] - Saint Bella (02508.HK) announced a profit alert, expecting a net profit of over 320 million yuan, turning from loss to profit year-on-year [2] - Aoneng Construction (01183.HK) issued a profit alert, expecting a net profit increase of over 125% to no less than 18 million MOP year-on-year [2] - Da Cheng Corn Group (03889.HK) issued a profit warning, expecting a net loss of approximately 65 to 85 million HKD, turning from profit to loss year-on-year [2] Company News - Sinopec Oilfield Services (01033.HK) announced that its subsidiary won a natural gas pipeline engineering project with a bid amount of 3.597 billion yuan, accounting for 4.44% of the 2024 revenue [2] - CSPC Pharmaceutical Group (01093.HK) signed an exclusive licensing agreement with MADRIGAL for SYH2086, with potential total payments of up to 2.075 billion USD [2] - China Biopharmaceutical (01177.HK) reported successful external licensing cooperation for LM-299, with a milestone payment of 300 million USD expected to be received soon [2] - Chunquan Industrial Trust (01426.HK) reported an average rental rate of approximately 86% for Huamao Property in the second quarter [2] - Sihuan Pharmaceutical (00460.HK) completed the first patient enrollment in a Phase III clinical trial for the new indication of the innovative drug Annelazole Sodium for gastroesophageal reflux disease [2] - Zhaoke Ophthalmology-B (06622.HK) received orphan drug designation from the FDA for Mephalan for the treatment of retinoblastoma in children [2] - Yunnan Construction Investment Concrete (01847.HK) continues to sign concrete supply contracts for the expansion project of Kunming Changshui International Airport, with a contract amount of approximately 283 million yuan [2] Buyback and Increase Dynamics - Vitasoy International (00345.HK) repurchased 2.122 million shares for approximately 19.6 million HKD at a price range of 9.2 to 9.26 HKD [2] - China Eastern Airlines (00670.HK) spent approximately 7.2536 million HKD to repurchase 2.5 million shares at a price range of 2.89 to 2.92 HKD [2]

Core Viewpoint - The company has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare pediatric eye cancer [1] Group 1 - The ODD provides a clear regulatory pathway for the company to submit a New Drug Application (NDA) in the United States [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. following the NDA approval [1] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, ensuring that the FDA cannot approve any other RB indication products based on Mephalan, even if the formulation is modified [1]

Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622), has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare childhood eye cancer [1] Regulatory Pathway - Obtaining ODD establishes a clear regulatory pathway for the company to submit a New Drug Application (NDA) in the United States [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. following the NDA approval [1] Market Exclusivity - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity rights [1] - Importantly, even if the formulation is innovated, the FDA cannot approve any other RB indication products based on Mephalan [1]

Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622.HK), has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare childhood eye cancer [1] Group 1: Regulatory Approval - The ODD provides a clear regulatory pathway for the company to submit a new drug clinical trial application in the U.S. [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. post-approval [1] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, preventing the FDA from approving any other RB indication products based on Mephalan, even if the formulation is modified [1] Group 2: Drug Mechanism and Current Use - Mephalan is an alkylating agent that interferes with DNA replication and cell division, blocking the growth and spread of cancer cells [1] - Currently, Mephalan is primarily used as a pre-treatment for autologous hematopoietic stem cell transplantation in multiple myeloma patients or for palliative treatment in cases where oral therapy is not applicable [1]

Zhaoke Ophthalmology Limited （於英屬處女群島註冊成立並於開曼群島存續的有限公司） （股份代號：6622） 兆科眼科有限公司 自 願 性 公 告－ 用於治療兒童視網膜母細胞瘤的美法侖 取得美國FDA孤兒藥資格認證 本 公 告 乃 由 兆 科 眼 科 有 限 公 司（「本公司」）董 事 會（「董事會」）自 願 作 出。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 取 得ODD為 在 美 國 提 交 新 藥 臨 床 試 驗 申 請（「新藥試驗申請」）建 立 清 晰 的 監 管 路 徑。再 者，如 果 美 法 侖 獲 成 功 研 發 並 獲 批 准，本 公 司 將 在 新 藥 上 市 申 請（「新 藥 申 請」）批 准 後 享 有 七 年 美 國 市 場 獨 家 權 利。此 項 完 善 保 護 涵 蓋 上 市 許 可 持 有 人 （marketing authoriza ...

Core Viewpoint - Alcon's FDA approval of Tryptyr 0.003% eye drops for dry eye disease (DED) marks a significant development in the ophthalmic market, while the stock performance of Zhaoke Ophthalmology (06622) reflects broader trends in the pharmaceutical sector, with a notable increase in stock prices across the industry [1][5]. Company Developments - Zhaoke Ophthalmology's stock surged by 19.21% on the same day as Alcon's announcement, continuing a trend where the company's stock has doubled in value over recent months, with a maximum increase of 147.69% since April [1][3]. - The company received FDA approval for a new drug clinical trial application for cyclosporine eye gel, a core product aimed at treating moderate to severe dry eye disease, which is expected to enhance its market position [3][5]. Market Dynamics - The dry eye treatment market in China is projected to grow significantly, with an estimated market size of approximately 160 billion yuan in 2024 and expected to exceed 200 billion yuan by 2025, reflecting a compound annual growth rate (CAGR) of over 15% [5][12]. - Current treatments for dry eye, primarily sodium hyaluronate eye drops, have limitations, leading to a shift towards more effective alternatives like cyclosporine eye gel, which is gaining market share due to its superior efficacy and lower side effects [5][11]. Product Efficacy - Cyclosporine A (CsA) eye gel has shown to significantly improve symptoms in moderate to severe dry eye patients, with a clinical trial indicating a marked improvement in patient outcomes compared to control groups [6][12]. - The formulation of cyclosporine eye gel enhances its bioavailability, achieving peak concentrations in the cornea and conjunctiva that are significantly higher than traditional formulations, thus improving treatment effectiveness [6][7]. Financial Performance - Zhaoke Ophthalmology reported a substantial revenue increase of 268.6% in 2024, with drug sales contributing significantly to this growth, although the company remains in a loss position [12][13]. - The reduction in research and development expenses, alongside increased revenue, has led to a narrowing of losses, indicating a potential turnaround for the company [12][13]. Future Prospects - The anticipated approval and commercialization of cyclosporine eye gel could position Zhaoke Ophthalmology favorably in the market, especially given the high patient compliance rates associated with its formulation [7][11]. - The company is also advancing its pipeline with NVK002, a low-dose atropine product for myopia management, which has received regulatory attention and could further enhance its market presence [13].

Market Performance - Jinli Permanent Magnet (06680) rose over 17% due to significant increases in overseas medium and heavy rare earth prices, which are expected to gradually transmit to the domestic market [1] - Zhixing Technology (01274) increased over 3% after securing a platform-based logistics vehicle contract with a leading domestic brand [1] - Weimeng Group (02013) surged over 9% as its upgraded Weimeng Guide Agent product is anticipated to benefit from the growth of WeChat e-commerce [1] - Zhaoke Ophthalmology-B (06622) gained over 8% following FDA approval for a new drug trial application for cyclosporine eye gel [1] - Zai Ding Pharmaceutical (09688) rose over 5% after reporting excellent data from the low-dose group of ZL-1310 [1] - Lianlian Digital (02598) saw a mid-session increase of over 5% as it partnered with BVNK to provide stablecoin payment solutions for its merchants [1] - Reading Group (00772) increased over 7% after acquiring a 26.67% stake in Yihua Kaitian, with its IP+AI strategy expected to unlock more value [1] - NIO opened nearly 4% higher, projecting a year-on-year revenue growth of 11.8%-15% for Q2 [1] - Kuaishou-W (01024) rose over 6% as its Kecing AI recently launched a new 2.1 series model, with institutions optimistic about its profitability [1] - Meituan (03690) surged over 3%, reaching a nearly two-month high, with southbound funds continuing to accumulate for 13 consecutive days [1] US Market Highlights - Applied Digital (APLD.US), a stock related to Nvidia, surged nearly 30%, with a 94% increase over three trading days, as long-term contracts are expected to generate $7 billion in revenue [2] - Tesla (TSLA.US) fell 3.55% due to declines in both the Chinese and European automotive markets, with a 15% year-on-year drop in China's May wholesale sales of new energy passenger vehicles [2] - MongoDB (MDB.US) saw a nearly 15% increase in after-hours trading following better-than-expected Q1 results and an $800 million stock buyback plan [2] - Broadcom (AVGO.US) rose over 3% before earnings, reaching a new historical high, with Morgan Stanley stating that AI is operating at full speed, expecting strong Q2 results [3] - Meta increased over 3% as it was reported to be accelerating the development of ultra-lightweight open-headset projects [3] - Guidewire Software (GWRE.US) surged over 16% after exceeding Q3 earnings expectations and raising its guidance [3] - Dollar Tree (DLTR.US) fell over 8% after warning of potential 50% declines in adjusted earnings due to tariffs and weak consumer spending [3] - STMicroelectronics (STM.US) rose nearly 11% amid reports that Italy and France are considering splitting its joint management rights [3]

Group 1 - As of June 3, a total of 105 stocks reached their 52-week highs, with Huayin International Holdings (00989), Dingyifeng Holdings (00612), and Youquhui Holdings (02177) leading the high rate at 57.26%, 37.93%, and 23.02% respectively [1] - The closing prices and highest prices for the top three stocks are as follows: Huayin International Holdings at 1.370 and 1.950, Dingyifeng Holdings at 0.770 and 0.800, and Youquhui Holdings at 3.550 and 3.580 [1] - Other notable stocks that reached their 52-week highs include China Antibody-B (03681) with a high rate of 21.62% and Fengcheng Holdings (02295) at 19.52% [1] Group 2 - The report also lists stocks that reached their 52-week lows, with Des Holdings (08437) showing the largest decline at -38.79%, followed by Dimi Life Holdings (01667) at -20.50% [3] - The closing prices and lowest prices for the top three stocks that reached their lows are: Des Holdings at 0.177 and 0.071, Dimi Life Holdings at 0.140 and 0.128, and Lujizhi Technology (01745) at 0.197 and 0.194 [3] - Other stocks with significant declines include GBA Group (00261) at -11.48% and Baide International (02668) at -10.88% [3]

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].