Core Viewpoint - The approval of Boan 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] 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] - The global indications for EYLEA® include nAMD, DME, retinal vein occlusion (RVO) with 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 drug in quality, efficacy, safety, and immunogenicity, with Phase I and III clinical trials showing significant improvements in best-corrected visual acuity (BCVA) compared to the reference group [2] - The Phase III clinical trial results indicated that Bo Youjing® achieved clinically significant improvements in BCVA at multiple time points (4, 8, 12, 16, 20, and 24 weeks), meeting all study endpoints with rapid and sustained efficacy [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 capabilities in research, manufacturing, and commercialization, with a portfolio of 43 products and a professional commercial team covering over 20,000 hospitals nationwide [3] - The collaboration aims to enhance the market launch of Bo Youjing®, improve patient accessibility to medication, reduce treatment burdens, and create 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 product, Bo You Jing (Aflibercept intravitreal injection solution), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1] Group 1: Product Overview - Bo You Jing is a biosimilar to EYLEA, with the active ingredient Aflibercept, which binds to a broader range of targets compared to anti-VEGF monoclonal antibodies [1] - Aflibercept is an essential first-line treatment for various retinal diseases, effectively improving vision with long-lasting efficacy and good overall safety and tolerability [1] Group 2: Clinical Development - The development of Bo You Jing strictly followed biosimilar guidelines, demonstrating high similarity to the reference drug in quality, efficacy, safety, and immunogenicity [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 3: Market Potential - 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 company has partnered with a leading ophthalmic pharmaceutical platform, Eucan Vision, to conduct Phase III clinical trials and grant exclusive commercialization rights in mainland China [3] Group 4: Patient Demographics - 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 [2] - Age-related macular degeneration (AMD) is a leading cause of vision loss in the elderly, with a prevalence of 20.2% in individuals over 70 years old in China [2]

Core Viewpoint - Oculentis Biotech-B (01477.HK) announced that OT-702 (Aflibercept intravitreal injection, EYLEA® biosimilar) has been approved by the National Medical Products Administration for the treatment of adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1] Group 1 - OT-702 is developed by the company's partner, Boan Biotech (06955.HK) [1] - The collaboration and exclusive promotion agreement was established in October 2020, under which both parties are to jointly advance the Phase III clinical trial of OT-702 [1] - The company has been granted exclusive rights to promote and commercialize the product in China [1]

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 就 因 本 公 告 的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。 Shandong Boan Biotechnology Co., Ltd. 山東博安生物技術股份有限公司 （於 中 華 公 司） 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 （股 份 代 號：6955） 自願性公告 博優景®的 研 發 過 程 嚴 格 遵 循 生 物 類 似 藥 相 關 指 導 原 則，通 過 藥 學、非 臨 床、臨 床 一 系 列 逐 步 遞 進 的 研 究，完 整 而 嚴 謹 的 確 證 了 其 與 原 研 藥 的 整 體 相 似 性。二 者 在 質 量、有 效 性、安 全 性 和 免 疫 原 性 上 高 度 相 似，無 臨 床 意 義 上 的 差 異。博 優 景®的I期 臨 床 試 驗 結 果 顯 示，博 優 景®組 與 原 研 參 照 藥 組 的 安 全 性、耐 受 性 一 致 並 可 比；Ⅲ 期 臨 床 試 ...

Core Viewpoint - Luye Pharma's subsidiary, Luye Geneora, has issued exchangeable preferred shares worth approximately $150 million, which can be exchanged for up to 100 million shares of Boan Biologics, potentially affecting its subsidiary status [1] Group 1: Company Actions - Luye Geneora issued 4.75% exchangeable preferred shares to Bluebell Asset [1] - The funds raised will be used for general operational purposes of the group [1] Group 2: Market Reaction - Following the announcement, Luye Pharma's stock fell by 3.58% to HKD 2.96 [1] - Boan Biologics' stock also declined by 2.92% to HKD 10.63 [1] Group 3: Potential Impact - If all preferred shares are exchanged, Boan Biologics will no longer be a subsidiary of Luye Pharma [1]

Core Viewpoint - Luye Pharma's subsidiary, Luye Geneora, has issued exchangeable preferred shares amounting to approximately $150 million, which can be exchanged for up to 100 million shares of Boan Biologics, potentially affecting its subsidiary status [1] Group 1 - Luye Pharma's stock price decreased by 3.58%, trading at HKD 2.96 [1] - Boan Biologics' stock price fell by 2.92%, trading at HKD 10.63 [1] - The funds raised from the issuance will be used for general operational purposes of the group [1] Group 2 - The exchangeable preferred shares have a coupon rate of 4.75% [1] - If fully exchanged, Boan Biologics will no longer be a subsidiary of Luye Pharma [1]

Group 1 - The company announced the issuance of 1.5 million exchangeable preferred shares at a total subscription price of $150 million, equivalent to $100 per share, with the right to exchange for shares of Boan Biologics [1] - Upon full exercise of the exchange rights, Boan Biologics will no longer be a subsidiary of the company, which currently holds approximately 361 million shares of Boan Biologics, representing about 57.94% of its issued share capital [1] - The company has agreed to guarantee the issuer's obligations under the subscription agreement [1] Group 2 - The board believes that issuing exchangeable preferred shares will provide an immediate source of cash while maintaining strategic flexibility [2] - The exchange mechanism allows the company to monetize its investment in Boan Biologics over a longer period at a price above the current market level, which is expected to yield better results compared to bulk disposals at discounted prices [2] - Proceeds from the subscription will be used for general working capital purposes [2]

Group 1 - The core viewpoint of the news highlights the strong performance of the Hong Kong Stock Connect Innovative Drug ETF, which has gained 1.2% with a trading volume of 351 million yuan and a total fund size of 2.079 billion yuan as of November 10 [1] - Key performing stocks within the ETF include InnoCare Pharma-B, Bionet, and Ascletis Pharma, with respective gains of 5.4%, 4.43%, and 4.37% [1] - Conversely, stocks such as Kangzhe Pharmaceutical, MIRXES-B, and Innovent Biologics showed weaker performance, with declines of 1.28%, 0.94%, and 0.65% respectively [1] Group 2 - The innovative drug sector is identified as the largest investment opportunity in the pharmaceutical sector for 2025, with a focus on dual/multi-target drugs, chronic disease medications addressing unmet clinical needs, and ADCs [2] - There is a noted improvement in domestic and international innovative drug financing data, with an upward trend in CXO industry orders, indicating a potential recovery in valuations and performance [2] - The medical device sector is experiencing accelerated approvals for innovative products, such as the approval of the chest and abdominal aortic stent system by Xianjian Technology, which is expected to enhance long-term profit margins [2] Group 3 - The Hong Kong Stock Connect Innovative Drug ETF and its linked funds passively track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, with the top ten weighted stocks including BeiGene, China Biologic Products, and Innovent Biologics [3]

Core Viewpoint - The company, 博安生物, has seen a stock increase of over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities [1] Group 1: Product Development - 博安生物's BA6101 (60mg) and BA1102 (120mg) are key products in its global development strategy, targeting orthopedic and oncology fields respectively [1] - The company plans to submit marketing applications for these products to major international regulatory bodies including EMA, FDA, and PMDA [1] Group 2: Market Potential - There is a significant global market potential for 地舒单抗, with projected combined sales of Prolia and Xgeva reaching approximately $6.6 billion in 2024 [1] - The company has established a comprehensive quality management system that meets international standards to support the global commercialization of its products [1]

Core Viewpoint - The company, Boan Biotech (06955), has seen its stock rise over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities in the orthopedic and oncology sectors [1] Group 1: Product Development - Boan Biotech announced that its self-developed monoclonal antibody injections, BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology, have received acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorization [1] - The company considers BA6101 and BA1102 as core products in its global development strategy and plans to submit applications to other international regulatory bodies, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [1] Group 2: Market Potential - There is a broad market outlook for the monoclonal antibody, denosumab, due to extensive clinical demand and significant clinical value, with global sales for Prolia and Xgeva projected to reach approximately $6.6 billion in 2024 [1] - To support its global commercialization goals, the company has established a comprehensive quality management system that meets international standards in China, Europe, the United States, and Japan, ensuring quality assurance for denosumab and future biopharmaceuticals [1]