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佈之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公佈全部或任何部分內容而產生或因 倚賴該等內容而引致之任何損失承擔任何責任。 茲提述(i)億勝生物科技有限公司（「本公司」）日期為二零二零年十月十五日之公佈（「該公 佈」），內容有關受許人（均為本公司之全資附屬公司）與上海復宏漢霖生物技術股份有限公司 （「復宏漢霖」）訂立共同開發許可協議，以根據共同開發許可協議之條款共同開發許可產品及 向受許人授出有關許可產品之獨家權利；及(ii)本公司於二零二一年一月至二零二五年四月期 間刊發之若干公佈，內容有關上述事項的若干最新情況。許可產品為內含重組抗血管內皮生 長因子人源化單克隆抗體（「anti-VEGF」）作為原料藥之生物藥品，擬用於治療滲出性（濕性） 老年性黃斑部病變（「濕性AMD」）。除另有指明者外，本公佈所用詞彙與該公佈所界定者具有 相同涵義。 有關開發HLX04-O之進一步最新情況 （於開曼群島註冊成立之有限公司） （股份代號：1061） 有關滲出性（濕性）老年性黃斑部病變之治療 許可產品 生物製品許可申請已受理 現時市況 截至本 ...

Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for treating wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [2][4]. Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, blocking its interaction with receptors on endothelial cells, thereby inhibiting endothelial cell proliferation and reducing neovascularization [2]. - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [3]. - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [3]. Group 2: Market Context - Currently, there are no approved bevacizumab formulations for treating ophthalmic diseases in China, making HLX04-O a significant addition to the market [4]. - The only other application for a bevacizumab ophthalmic formulation, TAB014, was submitted by Zhaoke Ophthalmology and Dongyao Pharmaceutical in June 2023 for the treatment of wAMD [4].

Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for the treatment of wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [1][2][3] Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, inhibiting its interaction with receptors on endothelial cells, thereby reducing neovascularization associated with wAMD [1] - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against Ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [2] - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [2] Group 2: Market Context - Currently, there are no approved bevacizumab formulations for ophthalmic diseases in China, making HLX04-O the second reported application for such a drug after TAB014 [3]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 億勝生物科技有限公司 呈交日期: 2025年8月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01061 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | HKD | | 0.1 HKD | | 100,000,000 | | 增加 / 減少 (-) | | | 0 | | | HKD | | 0 | | 本月底結存 | | | 1,000,000,000 | HKD | | 0.1 HKD | | 100,000,000 | 本月底法定/註冊股本總額： HKD 100,00 ...

Group 1 - Valiant Biotech-B's dark market saw a maximum increase of 134.28%, reflecting market recognition of its antibody drug development pipeline in oncology and autoimmune diseases [1] - The company has one core product and 13 other candidates, with 6 having successfully entered clinical stages [1] - Long-term value will depend on the commercialization capabilities of new drugs [1] Group 2 - Hengrui Medicine's subsidiary received approval for clinical trials of HRS-1893 tablets, a selective myosin inhibitor aimed at treating heart failure with preserved ejection fraction [2] - The project has accumulated R&D investment of approximately 60.67 million yuan [2] - If clinical trials proceed successfully, it could become the first drug in this unmet clinical need, enhancing the company's competitiveness [2] Group 3 - 3SBio announced the formal effectiveness of a licensing agreement with Pfizer for the global development and commercialization rights of the PD-1/VEGF bispecific antibody SSGJ-707, excluding mainland China [3] - The agreement includes a total option and exercise fee of up to 150 million USD [3] - This partnership allows 3SBio to leverage Pfizer's resources for accelerated project development and commercialization [3] Group 4 - Zhonghui Yuantong updated its prospectus, indicating that its core products have been commercialized, alongside 11 vaccines in development [4] - The company has raised a total of 999.5 million yuan through three rounds of financing from notable investors [4] - The upcoming Hong Kong listing is expected to accelerate R&D and market expansion in the vaccine sector [4] Group 5 - Eddingpharm received approval for the registration and commercialization of multi-dose diquafosol sodium eye drops in China, which contains 3% diquafosol sodium [5] - The product is intended for the treatment of dry eye syndrome [5] - This approval enhances the treatment options for dry eye disease and is expected to contribute to the company's growth in the ophthalmic market [5]

Financial Performance - The group's revenue for the fiscal year ending December 31, 2024, was approximately HKD 1,669,800,000, a decrease of 3.9% compared to the previous year[9]. - Despite the revenue decline, the group achieved a net profit of approximately HKD 307,200,000, an increase of 11.6% year-on-year[9]. - Cash and cash equivalents as of December 31, 2024, were approximately HKD 557,200,000, an increase from HKD 509,800,000 in 2023[12]. - Total assets rose to HKD 2,983.0 million, a 5.5% increase from HKD 2,827.6 million in 2023[65]. - The gross profit margin for 2024 was 89.8%, slightly down from 89.9% in 2023[66]. - The net profit margin improved to 18.4% in 2024, compared to 15.8% in 2023[66]. - Administrative expenses for the year were approximately HKD 217 million, an increase from HKD 213.9 million in the previous year[76]. - Total R&D expenses for the year amounted to approximately HKD 156.6 million, accounting for 9.4% of revenue, compared to 9.5% in the previous year[76]. - The company reported a mid-term dividend of HKD 0.06 per share, paid on September 24, 2024, and proposed a final dividend of HKD 0.06 per share for the fiscal year ending December 31, 2024, subject to shareholder approval[111]. Revenue Breakdown - The ophthalmology and surgical divisions contributed approximately 46.2% and 52.7% to the total revenue, respectively[11]. - The flagship biopharmaceutical products, Beifu Shou® and Beifu Ji® series, accounted for approximately 84.5% of the total revenue, with Beifu Shou® and Beifu Ji® contributing 35.1% and 49.4% respectively[11]. - The ophthalmology segment contributed approximately HKD 771.5 million to revenue, a 2.2% increase from HKD 755.1 million in 2023[73]. - The surgical segment recorded revenue of approximately HKD 879.9 million, a decrease of 9.3% from HKD 970.4 million in 2023[73]. - The bFGF series products accounted for approximately 84.5% of the group's total revenue during the review year[36]. Research and Development - The group has initiated a five-year development plan to enhance its R&D capabilities and solidify its position in the ophthalmology field[22]. - As of the report date, there are 16 R&D projects in various stages, with 4 ophthalmology projects currently in clinical stages, viewed as mid-term growth drivers[22]. - The group holds a total of 100 patents, including 70 invention patents, 15 utility model patents, and 15 design patents[23]. - The company has established multiple R&D bases in Zhuhai, Boston, London, and Singapore to support the development of new therapies[23]. - The group maintains a robust R&D pipeline, emphasizing single-dose ophthalmic products and biologics such as growth factors and antibodies[115]. Market and Distribution - The group operates a vast distribution network with 44 regional sales offices in China, covering over 14,000 hospitals and medical institutions[16]. - The distribution network allows the company's therapeutic products to be prescribed in over 14,000 hospitals and medical institutions, as well as approximately 1,810 pharmacies across major cities, provinces, and counties in China[49]. - The company aims to increase patient accessibility in lower-tier cities in China and expand clinical indications for its commercialized products[17]. - The company is actively seeking new therapies in oncology, orthopedics, and neurology through strategic investments[115]. Corporate Governance and Compliance - The board has adhered to the corporate governance code as outlined in Appendix C1 of the Listing Rules during the review year[191]. - The board is responsible for preparing true and fair consolidated financial statements according to Hong Kong Financial Reporting Standards and the Companies Ordinance[200]. - Internal controls are required to prevent significant misstatements due to fraud or error in the financial statements[200]. - The company emphasizes compliance with various local laws and regulations, including those related to drug production and environmental standards[141]. Shareholder Information - The board has proposed a final dividend of HKD 0.06 per ordinary share for 2023, up from HKD 0.045 in 2022, with a total dividend of HKD 0.12 per share for 2024[26]. - The company has a distributable reserve of HKD 37,074,533 as of December 31, 2024, with HKD 34,027,740 proposed for the final dividend for the review year[166]. - The top five customers accounted for approximately 52.3% of the total sales, with the largest customer contributing about 27.0%[168]. - The top five suppliers represented approximately 53.1% of total purchases, with the largest supplier accounting for about 17.8%[168]. Legal and Regulatory Matters - The company is actively defending against allegations from Guangxi Wanshoutang Pharmaceutical Co., Ltd. regarding a sales agency agreement and has filed a counterclaim for outstanding payments[60]. - The Chinese government has initiated a national drug procurement program focused on volume-based purchasing, aiming to lower drug prices through competitive bidding[132]. - The implementation of this program may negatively impact the company's existing operations and commercialization strategies in China[132]. Employee and Social Responsibility - The group provides stock options and bonuses to employees based on performance and financial results, as determined by the board of directors[90]. - Employee development is a priority, with competitive compensation and training programs offered to enhance skills[144]. - The group made charitable donations totaling approximately HKD 887,000 during the review year, compared to HKD 481,000 in 2023[167]. - The company is committed to creating an environmentally friendly work environment by promoting energy conservation and recycling[133].

Group 1 - The core viewpoint of the news is that the phase III clinical trial (AURA-1) for HLX04-O, a treatment for wet AMD in Chinese patients, has met its primary endpoint [1] - AURA-1 is a multicenter, randomized, double-blind, positive-controlled non-inferiority trial comparing the efficacy and safety of HLX04-O with ranibizumab in newly diagnosed wet AMD patients [1] - The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) from baseline at week 48, and the results showed that HLX04-O was non-inferior to ranibizumab [1] Group 2 - HLX04-O is developed based on Hanbio's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [2] - In addition to AURA-1, an international multicenter phase III clinical study (AURA-2) for HLX04-O is ongoing in multiple European countries, Australia, the United States, and China, expected to complete in January 2025 [2]

Financial Performance - The company's revenue for the year ended December 31, 2024, was HKD 1,669,817, a decrease of 3.9% compared to HKD 1,736,972 in 2023[3] - Net profit for the year increased by 11.6% to HKD 307,222 from HKD 275,260 in the previous year[3] - Total comprehensive income for the year was HKD 260,658, an increase from HKD 244,925 in 2023[4] - Total external customer revenue for the year ended December 31, 2024, was HKD 1,662,297,999, a decrease from HKD 1,731,873,976 in 2023[16] - The group's revenue for the year ending December 31, 2024, was approximately HKD 1,669.8 million, a decrease of 3.9% from HKD 1,737.0 million in 2023[68] - Despite the revenue decline, the group achieved a net profit of approximately HKD 307.2 million, an increase of 11.6% from HKD 275.3 million in 2023[68] Assets and Liabilities - Total assets rose by 5.5% to HKD 2,983,045, while total liabilities decreased by 4.9% to HKD 859,325[3] - The company's total assets increased to HKD 1,246,836,875 in 2024, up from HKD 1,153,040,731 in 2023, marking an increase of approximately 8.1%[25] - The company’s total liabilities related to intangible assets increased to HKD 929,878,947 in 2024, up from HKD 854,313,383 in 2023, reflecting an increase of about 8.8%[25] - The group’s debt-to-asset ratio was 28.8% as of December 31, 2024, down from 32.0% in 2023[77] Cash Flow and Dividends - The company's cash and cash equivalents increased by 9.3% to HKD 557,167 from HKD 509,845 in 2023[3] - The company declared a total dividend of HKD 0.12 per share, a 33.3% increase from HKD 0.09 in 2023[3] - The proposed final dividend is HKD 0.06 per share for 2024, compared to HKD 0.045 per share in 2023, representing a 33.3% increase[22] - The group's cash and cash equivalents amounted to approximately HKD 557,200,000 as of December 31, 2024, compared to HKD 509,800,000 as of December 31, 2023[77] Research and Development - The company plans to continue expanding its market presence and investing in new product development[3] - Research and development costs recognized as expenses were HKD 25,009,026 in 2024, down from HKD 39,144,729 in 2023[19] - The group plans to increase R&D investment and strengthen collaborations with research institutions and universities to foster innovation[66] - The company is actively pursuing multiple R&D projects at various clinical stages, focusing on single-dose ophthalmic products and biologics[44] Product Development and Market Potential - The company received NMPA approval for preservative-free single-dose sodium hyaluronate eye drops and sodium hyaluronate (0.3%) in August and September 2024, respectively, expanding its product offerings[42] - The estimated number of moderate to severe dry eye patients in China is around 111,600,000 by 2024, indicating a significant market potential for SkQ1[47] - The total investment cost for SkQ1's clinical development and global rights amounts to approximately HKD 344,000,000, representing 11.5% of the company's total assets as of December 31, 2024[47] - The joint development agreement with Shanghai Junshi Biosciences for the anti-VEGF product has a maximum commitment investment of USD 67,000,000 (approximately HKD 520,300,000)[50] Operational Efficiency - The gross profit margin remained stable at 89.8%, while the net profit margin improved to 18.4% from 15.8%[3] - The current ratio improved to 1.81 from 1.54, indicating better short-term financial health[3] - Employee costs (excluding director remuneration) amounted to HKD 309,070,741 in 2024, compared to HKD 298,225,948 in 2023[19] - Distribution and selling expenses were approximately HKD 934.2 million, a decrease of 7.7% from HKD 1,012.0 million in 2023[70] Corporate Governance and Management - The company has adhered to the corporate governance code as per the listing rules throughout the year[90] - The audit committee has reviewed and recommended the approval of the audited consolidated financial statements for the year ending December 31, 2024[97] - The company has appointed Mr. Yan Xianlong as the CEO effective July 1, 2025, pending shareholder approval[91] - Mr. Yan Xianlong has over 10 years of experience in translational and therapeutic research prior to joining the company in 2015[92] Legal and Regulatory Matters - A court ruling in May 2024 ordered the contractor to pay approximately HKD 31.1 million as compensation for breach of contract, which is lower than the amount claimed by the company[63] - The company is actively defending against allegations from Guangxi Wanshoutang Pharmaceutical Co., Ltd. regarding exclusive sales agreements and has filed a counterclaim for outstanding payments[64]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 5.12, indicating a potential upside of 73% from the current price of HKD 2.95 [18][40][41]. Core Insights - The company experienced a temporary decline in performance due to adverse market conditions influenced by tightened regulatory policies in the healthcare sector, leading to a 9.8% decrease in revenue to HKD 812 million for the first half of 2024 [3][14]. - The company is advancing the research and development of Bevacizumab (HLX04-O), which is currently undergoing Phase III clinical trials in multiple regions including the US, EU, China, and Australia, with a new drug application expected to be submitted in 2025 [25][42]. - The potential market for Bevacizumab is significant, particularly for conditions like wet AMD and diabetic macular edema, with an estimated 15.8 million patients in China [25][42]. Financial Summary - The company reported a net profit of HKD 157 million for the first half of 2024, a decrease of 7.3% year-on-year [3][14]. - Revenue projections for 2024-2026 are estimated at HKD 16.82 billion, HKD 18.23 billion, and HKD 19.82 billion respectively, with corresponding EPS of HKD 0.47, HKD 0.50, and HKD 0.54 [12][18]. - The company’s total assets are valued at HKD 2.54 billion, with total liabilities of HKD 1.13 billion, indicating a solid financial position [8][20].

欢迎出席益生生物科技2024年度业绩发布会今天出席会议的有益生生物科技总术会主席闫明志先生 董事总经理方海舟先生Managing Director Mr. 方海舟大家好副董事总经理严贤龙先生Deputy Managing Director Mr. Malcolm Young大家好首席财务总监邱丽文女士Chief Financial Officer Mr. Agnes YaoHello, good morning以及首席科学家薛琪博士and Chief Scientific Officer Dr. Quinn Xue 益社生物科技是一间专注于研发、生产和销售基因工程药物BFGF的生物制药企业拥有包括背复书、背复记、背复心在内的六种基因工程药物在中国上市销售此外,公司还拥有包含一系列不含防腐剂干剂量的眼液和视力顺软灵石落合碘胶囊等多元化产品组合 主席我们我们马上开始了可以打开摄像头你有回音回音很厉害对刚才Jeffrey关掉了对现在OK吗可以 好的我也再次提醒一下大家整个业绩会过程中除了播放视频的时候之外其他时候我们的视频都是打开的所以观众都是可以看到我们的提醒一下那么我们现在就开始了尊敬的各位投资者分析师大家上午 ...