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12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: 山東博安生物技術股份有限公司 呈交日期: 2026年1月6日 因本公司是於中華人民共和國註冊成立的公司，「法定股本」之概念不適用於本公司，在上述「法定/註冊股本」部分顯示的資料是指本公司的註冊股本 FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06955 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 622,333,694 | RMB | | 1 RMB | | 622,333,694 | | 增加 / 減少 (-) | | | 0 | | ...

Core Insights - The pharmaceutical and biotechnology index experienced a decline of 0.64% during the week, underperforming the Shanghai Composite Index by 1.34 percentage points, ending a two-week upward trend [4] - The National Healthcare Security Administration released the 2025 National Basic Medical Insurance Drug List, which included 114 products, achieving a success rate of 88% in negotiations, the highest in recent years [5] - The launch of the commercial health insurance innovative drug list included 19 drugs, complementing the basic medical insurance list and indicating a shift towards a multi-tiered healthcare system in China [5][19] Weekly Market Performance - The A-share market saw significant gains for Haiwang Bio, which rose by 71.20%, while Zhongsheng Pharmaceutical increased by 15.56% [2] - In the Hong Kong market, Jinxin Reproductive Medicine and Boan Biotechnology saw increases of 7.53% and 8.62%, respectively [2] Clinical Trials and Innovations - Kangfang Biopharma's dual-antibody drug, Kadunilumab, has initiated a Phase II clinical trial for esophageal squamous cell carcinoma, a prevalent cancer type in China [13][14] - A clinical trial for a gout treatment, polyethylene glycol-uricase injection (HZBio1), has also commenced, targeting patients with poorly controlled uric acid levels [17][18] New Drug Developments - Baoyi Pharmaceutical's stock surged nearly 140% on its first trading day, with a market capitalization of HKD 20.5 billion, despite a significant net loss of CNY 183 million in the first half of 2025 [6][7] - The company has 12 self-developed products, with SJ02 being the first long-acting FSH-CTP product approved in China [7] Industry Trends - The trend of "innovation + internationalization" remains a core direction for the pharmaceutical sector, supported by policies and increasing global competitiveness [5] - The demand for more effective and safer uric acid-lowering drugs is rising due to the increasing prevalence of gout, particularly among younger populations in China [18]

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11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 山東博安生物技術股份有限公司 呈交日期: 2025年12月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06955 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 622,333,694 | RMB | | 1 RMB | | 622,333,694 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 622,333,694 | RMB | | 1 RMB | | 622,333,694 | 本月底法定/註冊股本總額： RMB 622,333 ...

Core Insights - Shandong Boan Biotechnology Co., Ltd. has received approval from the National Medical Products Administration of China for its self-developed product, Bo Youjing (Aflibercept intravitreal injection solution), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1][2] - Boan Biotechnology plans to commercialize the product in collaboration with leading domestic ophthalmic pharmaceutical company, Oculis [1] - The company is also pursuing international market opportunities, having granted exclusive sales rights to Shenzhen Kexing Pharmaceutical Co., Ltd. in specific regions outside of mainland China, the EU, the UK, the US, and Japan [1] Company Performance - Boan Biotechnology's Bo Youjing is the fifth product approved in the last five years, showcasing the company's strong technical capabilities and efficient transformation from R&D to commercialization [2] - The company is projected to achieve a revenue of 730 million yuan in 2024, representing a year-on-year growth of 17.5%, with a net profit of 73.19 million yuan, marking a significant increase of 190 million yuan and the first annual profit [2] - The company is also advancing its innovative antibody development, focusing on key products such as BA1302 (anti-CD228 ADC), PR201 (PD-1/IL-2), PR203 (TL1A/IL-23 bispecific), BA1106 (non-IL-2 blocking anti-CD25 antibody), BA1304 (EGFR/B7H3 ADC), and BA1301 (anti-Claudin18.2 ADC) [2]

Core Viewpoint - The approval of the company's self-developed product, Bo You Jing (Aflibercept intravitreal injection solution), by the National Medical Products Administration of China marks a significant milestone for the company, enabling it to treat age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults [1] Group 1: Product Approval and Market Impact - Bo You Jing has received official approval for use in treating nAMD and DME, which are prevalent eye diseases [1] - Following the announcement, the company's stock rose nearly 7% in early trading, indicating positive market sentiment [1] - The product is a biosimilar to EYLEA, with a broader target action compared to anti-VEGF monoclonal antibodies, enhancing its market potential [1] Group 2: Collaboration and Commercialization - The company will collaborate with a leading ophthalmic pharmaceutical platform, Eucan Vision, to commercialize Bo You Jing in mainland China [1] - The company has also authorized a subsidiary of Sinovac Biotech to exclusively sell the product in specific regions outside of China, the EU, the UK, the US, and Japan, indicating a strategic approach to global market expansion [1] Group 3: Product Characteristics and Efficacy - Bo You Jing's active ingredient, Aflibercept, is a humanized fusion protein that binds to VEGF-A, VEGF-B, and PlGF, providing a wider range of action [1] - The product is expected to have a long duration of effect in inhibiting intraocular VEGF, which can significantly improve vision and has good overall safety and tolerability [1]

Group 1: Influenza Situation - The influenza activity in China has reached an epidemic level, with most provinces reporting a rapid increase in cases [1] - The latest report indicates that flu-like cases in sentinel hospitals have reached the highest proportion in nearly four years, with northern provinces showing higher rates than southern ones [1] - A total of 955 flu-like outbreaks were reported nationwide, with 741 caused by the H3N2 strain [1] Group 2: Stock Market Overview - The U.S. stock market experienced gains, with the Dow Jones Industrial Average rising by 314.67 points, or 0.67%, to close at 47,427.12 points [2] - The S&P 500 and Nasdaq also saw increases of 46.73 points (0.69%) and 189.1 points (0.82%), respectively [2] - Retail stocks strengthened ahead of the Black Friday shopping season, with Walmart reaching a historic high [2] Group 3: Hong Kong Real Estate Market - The private residential property price index in Hong Kong rose by 0.4% in October, marking five consecutive months of increases [3] - The latest index does not yet reflect the positive impacts of recent interest rate cuts and significant agreements reached during the U.S.-China summit [3] Group 4: Financial Innovations - The Industrial and Commercial Bank of China has successfully conducted offshore foreign currency tri-party repurchase transactions, becoming the first domestic bank to participate in this international market [4] - This innovation enhances the bank's pricing power and operational efficiency while reducing risks and costs associated with traditional bilateral repurchase agreements [4] Group 5: AI Product Launch - Meituan has launched its first AI IDE product, CatPaw, which focuses on agent-driven programming and includes features like code completion and project debugging [5] Group 6: Pharmaceutical Approvals - Boan Biotech's Abicipar injection has received approval for marketing in China, targeting age-related macular degeneration and diabetic macular edema [6] - Eucan Vision Biotech's OT-702, a biosimilar to EYLEA, has also been approved for the same indications in China [7] Group 7: Financial Performance - Haidilao's overseas business reported a revenue of $214 million for Q3, reflecting a year-on-year growth of 7.8% [8] - Yao Cai Securities reported a net profit of HKD 327 million for the six months ending September 30, marking a 4.77% increase year-on-year [9] - NIO's Q3 revenue reached RMB 21.79 billion, with a strong delivery growth of 40.8% year-on-year, and a Q4 revenue guidance of RMB 32.758 billion to RMB 34.039 billion [10] Group 8: Debt Restructuring - Ocean Group's debt restructuring plan for seven domestic bonds, totaling approximately RMB 13.05 billion, has been approved by bondholders [11] Group 9: New Stock Performance - The new Hong Kong stock Quantitative Party saw a nearly 200% increase in its dark market trading, reflecting strong investor interest [12] Group 10: Company Earnings - Alibaba Health reported a net profit of RMB 1.266 billion for the six months ending September 30, a 64.7% increase year-on-year, with total revenue of RMB 16.697 billion [13]

Core Insights - The company, Boan Biotech, has received approval from the National Medical Products Administration of China for its self-developed product, Bo Youjing (Aflibercept intravitreal injection solution), marking the second new product approved this year [1] - Bo Youjing is a biosimilar to EYLEA, targeting various retinal diseases and demonstrating long-term efficacy and good safety profile [1] - The CEO of Boan Biotech highlighted the significant clinical value of Aflibercept and the growing demand for treatment of retinal diseases [2] Product Development - Boan Biotech has successfully launched five products in the past five years, all of which are biosimilars [2] - The company’s first product, Bo Youping, was approved in August as the first domestic Dula-glutide [1][2] Commercialization Strategy - Boan Biotech has partnered with Eucan Vision for commercialization, leveraging a team of hundreds in the ophthalmology field and a network covering over 20,000 hospitals nationwide [1] - The company has also granted exclusive sales rights for Bo Youjing to a subsidiary of Sinovac Biotech in specific regions [1] Financial Performance - For 2024, Boan Biotech projects revenue of 730 million yuan, a year-on-year increase of 17.5%, and a net profit of 73.19 million yuan, marking a turnaround with a profit increase of 190 million yuan [2] - The successful commercialization of new products like Bo Youping and Bo Youjing is expected to enhance the company's profitability and commercial capabilities [2]

Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its self-developed product, Bo You Jing (Aflibercept Injection), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1] Group 1: Product Development and Approval - Bo You Jing is a biosimilar to EYLEA, with a broader target action compared to anti-VEGF monoclonal antibodies, effectively inhibiting intraocular VEGF and improving vision with long-term efficacy and good overall safety [1][2] - The development process of Bo You Jing strictly followed biosimilar guidelines, demonstrating high similarity in quality, efficacy, safety, and immunogenicity to the reference drug [2] Group 2: Market Demand and Growth - The market for anti-angiogenic drugs for eye diseases in China is rapidly growing, with a projected increase from RMB 1.27 billion in 2018 to RMB 4.99 billion by 2024, reflecting a compound annual growth rate of 25.6% [3] - The significant patient population affected by eye diseases such as DME and nAMD drives the demand for effective treatments, with an estimated 148 million adults aged 20 to 79 suffering from diabetes in China by 2024, and 5.2% of them having DME [2] Group 3: Strategic Partnerships and Commercialization - The company has partnered with leading ophthalmic pharmaceutical platform, OcuMedi, to commercialize Bo You Jing in mainland China, leveraging OcuMedi's extensive commercial network and expertise [3] - The collaboration aims to enhance patient access to the medication and reduce treatment burdens while creating new growth opportunities for the company [3]

Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its self-developed drug, Bo You Jing (Aflibercept intravitreal injection solution), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1][2] Group 1: Product Development and Approval - Bo You Jing is a biosimilar to EYLEA, with its active ingredient Aflibercept being a humanized fusion protein that binds to VEGF-A, VEGF-B, and PlGF, offering a broader target compared to anti-VEGF monoclonal antibodies [1][2] - The development process of Bo You Jing strictly followed biosimilar guidelines, demonstrating high similarity in quality, efficacy, safety, and immunogenicity with the reference drug [2] - Phase I clinical trial results showed comparable safety and tolerability between Bo You Jing and the reference drug, while Phase III trials indicated significant improvements in best-corrected visual acuity (BCVA) at multiple time points [2] Group 2: Market Potential and Patient Demographics - Eye diseases, including nAMD and DME, are significant causes of blindness, with DME being a major complication of diabetes affecting vision [3] - In 2024, approximately 148 million adults aged 20 to 79 in China are expected to have diabetes, with 5.2% of them suffering from DME; the prevalence of nAMD among the elderly population over 70 is 20.2% [3] - The market for anti-angiogenic eye drugs in China is projected to grow from RMB 1.27 billion in 2018 to RMB 4.99 billion by 2024, reflecting a compound annual growth rate of 25.6% [3] Group 3: Strategic Partnerships and Commercialization - The company has partnered with leading ophthalmic pharmaceutical platform, OcuVision, to jointly conduct Phase III clinical trials and grant exclusive commercialization rights for Bo You Jing in mainland China [4] - OcuVision has a comprehensive capability in the full-cycle development of ophthalmic drugs, with a portfolio of 43 products and a commercial network covering over 20,000 hospitals nationwide [4] - The company is also pursuing international expansion for Bo You Jing, having authorized a subsidiary of Sinovac Biotech for exclusive sales in specific regions outside of China, the EU, the UK, the US, and Japan [4]

Core Viewpoint - The approval of Boao Bio's product, Bo Youjing® (Aflibercept intravitreal injection solution), by the National Medical Products Administration of China marks a significant advancement in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults, with plans for commercialization in collaboration with a leading ophthalmic pharmaceutical platform, EOCON Vision [1][3]. Group 1 - Bo Youjing® is a biosimilar to EYLEA®, with its active ingredient Aflibercept being a humanized fusion protein that targets a broader range of factors compared to anti-VEGF monoclonal antibodies, effectively inhibiting intraocular VEGF and improving vision with long-term efficacy and good overall safety [1][2]. - EYLEA® has been approved globally for multiple indications, including nAMD, DME, retinal vein occlusion (RVO) related macular edema, diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV), and retinopathy of prematurity (ROP), while in China, it is approved for nAMD and DME [1]. Group 2 - The development of Bo Youjing® adhered strictly to biosimilar guidelines, demonstrating high similarity to the reference product in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences [2]. - Phase I clinical trial results indicated comparable safety and tolerability between Bo Youjing® and the reference product, while Phase III trials showed significant improvements in best-corrected visual acuity (BCVA) at multiple time points, achieving all study endpoints [2]. Group 3 - To expedite the availability of Bo Youjing® to more patients, the company partnered with EOCON Vision in 2020 to conduct Phase III clinical trials and granted EOCON exclusive promotion and commercialization rights in mainland China [3]. - EOCON Vision, as a leading ophthalmic pharmaceutical platform, focuses on integrated development capabilities in research, manufacturing, and commercialization, with a portfolio of 43 products and a professional commercial team covering over 20,000 hospitals nationwide [3].