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博安生物:成交量异常变动及地舒单抗在玻利维亚获批上市
Zhi Tong Cai Jing· 2026-01-11 10:36
董事会欣然宣布,其自主研发的地舒单抗注射液(60mg)(代号BA6101)已获玻利维亚国家药品和卫生技术 局(AGEMED)批准上市。 BA6101为原研参照药Prolia的生物类似药,在全球范围内Prolia广泛应用于骨质疏松症的治疗。BA6101 的适应症与原研参照药相同。BA6101基于本公司全球研发策略开发,并计划在全球多个国家及地区开 展商业化。2022年,BA6101(博优倍)作为首个国产地舒单抗注射液在中国率先获批上市。当前, BA6101在英国的上市许可申请正处于审批阶段,本公司计划在欧洲、美国、日本等国家和地区提交上 市许可申请。 BA6101的研发过程严格遵循中国、美国、欧盟、日本的生物类似药相关指导原则,通过一系列分析、 非临床、人体药代动力学及临床研究,确证其与原研参照药的整体相似性。具体而言,BA6101在质 量、安全性和有效性方面均证实与原研参照药高度相似,无临床意义上的差异。此外,BA6101的生产 亦遵循国际最高标准,为其海外拓展提供品质保障。 博安生物(06955)发布公告,本公司董事会注意到本公司股份(H股)于2026年1月9日的成交量有所上升。 经就本公司作出在有关情况下 ...
博安生物(06955):成交量异常变动及地舒单抗(60MG)在玻利维亚获批上市
智通财经网· 2026-01-11 10:29
董事会已获其控股股东绿叶制药集团有限公司(绿叶制药,连同其附属公司统称"绿叶制药集团")通知, 于2025年12月12日,绿叶制药的全资附属公司Luye Geneora Holding Limited(发行人)已发行若干可交换 优先股(可交换优先股)。该等可交换优先股赋予其持有人权利,可将有关股份交换为绿叶制药集团所持 有的本公司现有H股。 董事会欣然宣布,其自主研发的地舒单抗注射液(60mg)(代号BA6101)已获玻利维亚国家药品和卫生技术 局(AGEMED)批准上市。 BA6101为原研参照药Prolia®的生物类似药,在全球范围内Prolia®广泛应用于骨质疏松症的治疗。 BA6101的适应症与原研参照药相同。BA6101基于本公司全球研发策略开发,并计划在全球多个国家及 地区开展商业化。2022年,BA6101(博优倍®)作为首个国产地舒单抗注射液在中国率先获批上市。当 前,BA6101在英国的上市许可申请正处于审批阶段,本公司计划在欧洲、美国、日本等国家和地区提 交上市许可申请。 BA6101的研发过程严格遵循中国、美国、欧盟、日本的生物类似药相关指导原则,通过一系列分析、 非临床、人体药代动力学 ...
博安生物(06955) - 公告(1)成交量异常变动及(2)地舒单抗(60MG)在玻利维亚获批上市
2026-01-11 10:15
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。 本公司董事會(「董事會」)注意到本公司股份(「H股」)於2026年1月9日的成 交 量 有 所 上 升。經 就 本 公 司 作 出 在 有 關 情 況 下 屬 合 理 之 查 詢 後,董 事 會 確 認,除 下 文 所 披 露 者 外,其 並 不 知 悉(i)任 何 導 致 該 等 成 交 量 變 動 的 原 因; (ii)任 何 須 公 佈 以 避 免 本 公 司 證 券 出 現 虛 假 市 場 的 資 料;或(iii)任何根據香 港法例第571章證券及期貨條例第XIVA部 須 予 披 露 的 內 幕 消 息。 董事會已獲其控股股東綠葉製藥集團有限公司(「綠葉製藥」,連 同 其 附 屬 公司統稱「綠葉製藥集團」)通 知,於2025年12月12日,綠 葉 製 藥 的 全 資 附 屬 公 司Luye Geneora Holding Limited ...
博安生物(06955) - 截至二零二五年十二月三十一日止月份之股份发行人的证券变动月报表
2026-01-06 08:41
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 | | ...
康方生物双抗药物启动II期临床,适应证为中国人高发的食管鳞癌;宝济药业登陆港交所,上半年净亏损扩大 | 掘金创新药
Mei Ri Jing Ji Xin Wen· 2025-12-11 07:59
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]
博安生物(06955) - 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-03 08:41
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 ...
博安生物:博优景在国内获批上市 正积极推进海外布局
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]
博安生物早盘涨近7% 阿柏西普眼内注射溶液获国家药监局批准上市
Zhi Tong Cai Jing· 2025-11-27 01:41
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]
智通港股早知道 蔚来-SW(09866)三季度财报超预期 量化派(02685)暗盘涨近200%
Jin Rong Jie· 2025-11-27 01:17
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]
博安生物眼科用药博优景获批上市
Zhong Zheng Wang· 2025-11-26 12:21
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]