Core Viewpoint - The company announced that its PD-L1/4-1BB bispecific antibody, Velesin™ (Oparizumab, LBL-024), received orphan drug designation from the European Commission for the treatment of pulmonary neuroendocrine carcinoma, marking a significant milestone in its global development process after previously receiving similar recognition from the FDA [1]. Group 1 - The European Commission's orphan drug designation is granted to drugs intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions with a prevalence of less than 5 in 10,000 in the EU [2]. - The orphan drug designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on research design related to drug quality, benefits, and risks [2]. - The designation grants a 10-year market exclusivity period in the EU from the date of marketing authorization, during which no similar drugs for the same indication can be approved [2]. Group 2 - Additional incentives include fee reductions for regulatory guidance, marketing authorization applications, and post-marketing changes, as well as access to funding from the EC, Horizon Europe, and other sources [2]. - There are also extra incentives for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance, along with fee reductions [2].

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。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 自願公告 維利信™（PD-L1/4-1BB雙特異性抗體 奧 帕 替 蘇 米 單 抗，LBL-024） 用於治療肺外神經內分泌癌 獲歐盟委員會授予孤兒藥認定（ODD） 本公告由南京 維 立志博生物科技股份有限公司（「本公司」）自 願 作 出，以 告 知 本 公 司 股 東 及 潜 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本公司欣然宣布於2026年1月22日，歐 盟 委 員 會（「EC」）發布關於PD-L1/4-1BB雙 特 異性抗體 維利信™（奧 帕 替 蘇 米 單 抗，LBL-024）用於治療肺外神經內分泌癌獲 ...

Group 1 - The company *ST Bio (000504.SZ) has disclosed its annual performance forecast for 2025, expecting a net profit attributable to shareholders of between 28.5 million and 32.5 million yuan, indicating a turnaround from losses to profits [1] - The net profit after deducting non-recurring gains and losses is projected to be between 8.5 million and 12.5 million yuan [1]

Company Overview - Hangzhou Bangshun Pharmaceutical Co., Ltd. (Bangshun Pharmaceutical) is a biotechnology company focused on oncology and autoimmune diseases, with a pipeline that includes one new drug application (NDA) candidate (Bezeixinib), one clinical-stage candidate (CX1440), and five preclinical candidates (CX03, CX12, CX13, CX15, and CX16) [3] - Bezeixinib is expected to be one of the first three domestically approved JAK inhibitors for treating myelofibrosis (MF) in China, with clinical trials ongoing for MF, polycythemia vera (PV), and essential thrombocythemia (ET) [3] - CX1440 is a leading BTK inhibitor for treating immune thrombocytopenia (ITP) and is in Phase III clinical trials, with significant market potential in ITP, chronic urticaria (CU), and autoimmune hemolytic anemia (AIHA) [4] Financial Information - For the fiscal year 2024, Bangshun Pharmaceutical reported revenues of approximately CNY 943,000, with losses of approximately CNY 88.44 million [5][6] - The company has only one customer during the reporting period, and its revenue primarily comes from technology transfers related to preclinical projects [4] Industry Overview - The global market for myeloproliferative neoplasms (MPN) is projected to grow from USD 6.6 billion in 2020 to USD 8.3 billion in 2024, with a compound annual growth rate (CAGR) of 6.0%, and is expected to reach USD 12.7 billion by 2030 [8] - The Chinese MPN drug market is also growing, with a projected increase from USD 700 million in 2020 to USD 900 million in 2024, and expected to reach USD 1.6 billion by 2030 [8] - The market for JAK inhibitors in MF is expected to reach USD 300 million in China by 2024, with a CAGR of 3.5% from 2020 to 2024 [11] - The global market for PV drugs is anticipated to grow from USD 2.1 billion in 2020 to USD 2.7 billion in 2024, with a CAGR of 6.5% [13] - The market for autoimmune disease drugs in China is projected to grow from USD 2.5 billion in 2020 to USD 4.6 billion in 2024, with a CAGR of 15.9% [19]

证券日报网讯1月22日，瑞普生物（300119）在互动平台回答投资者提问时表示，截至2026年1月20日， 公司股东总户数为25567户。 ...

是否活成一个NPC，是否不配有姓名？ 1月20日，历史上一个平淡的日子，唯一的热闹，可能是大寒之日上海飘雪。同日，另一场寒潮却无声 无息，恒生生物科技指数（HSHKBIO）成交额跌破100亿港币，与2025年最高点相比下降近80%，15家 港股18A公司日成交额不足100万港币。 创新药在研发主战场外，正在开辟争夺流动性的第二战场。 技术和资本，一体两面，是创新药企的两大属性。早期生物科技没有自我造血功能，全靠资本输血。成 熟创新药企在每一个重要节点，跃升到更高发展阶段，也靠资本支持。 当前，通过港股18A通道上市的生物科技企业已达85家(含摘B)，还有超过80家递表排队，而流动性却 在指缝间溜走。自研能力不够硬，又不做市值管理的公司，等于自动退出流动性争夺战，被边缘化，被 遗忘，直至丧失融资能力。 每家Biotech都曾经满怀绚丽的梦想，但时间会褪色一切，会否一不注意就成为创新药背景板上没有姓 名的NPC？ FDA敌意渐浓 进入2026年，FDA连续对多项生物制品上市申请（BLA）发出Complete Response Letter（CRL），拒绝 批准或要求补充关键临床与CMC（化学、生产与控制）证据，显 ...

Core Viewpoint - Fosun Pharma (600196.SH) plans to spin off its subsidiary Fosun Antigen for an independent listing on the Hong Kong Stock Exchange, maintaining control over the subsidiary post-split [1] Group 1: Company Strategy - The spin-off aims to establish Fosun Antigen as an independent platform for the vaccine business, enhancing its financing channels and financial strength through the Hong Kong capital market [1] - The move is expected to improve the incentive mechanisms within Fosun Antigen, thereby strengthening its comprehensive competitiveness, brand recognition, and market influence in the vaccine sector [1] Group 2: Industry Context - This spin-off aligns with national strategies to accelerate vaccine technology upgrades, promote the industrialization of new vaccine research and development, and enhance capabilities to respond to major infectious diseases [1] - The initiative supports the innovation and large-scale development of vaccines, contributing to the improvement of public health security systems and biosecurity measures [1]

据港交所1月22目披露，杭州邦顺制药股份有限公司(简称：邦顺制药)向港交所主板递交上市申请书， 中信建投（601066）国际为其独家保荐人。招股书显示，邦顺制药是一家接近商业化阶段的生物科技公 司，专注于肿瘤及自身免疫性疾病领域。公司已建立涵盖一款新药上市申请(NDA)阶段候选药物(贝泽 昔替尼)、一款注册性临床阶段候选药物(CX1440)及五款临床前阶段候选药物(CX03、CX12、CX13、 CX15及CX16)的管线。 Hangzhou Bangshun Pharmaceutical Co., Ltd. [編纂]數目 : [编纂]股H股(可予重新分配) [编纂]股H股(可予重新分配及 [編纂]數目 … 視乎[編纂]行使與否而定) 最高[編纂] : 每股H股[編纂]港元,另加1.0%經紀 佣金、0.00015% 會財局交易徵費 · 0.0027%證監會交易徵費及0.00565% 聯交所交易費(須於[編纂]時以港元繳 足,多繳款項可予退還) 面值 : 每股H股人民幣[1.00]元 [編纂] [編纂] : [編纂]項下的[編纂]數目 : [编纂]股H股(視乎[编纂] 行使與否而定) 獨家保薦人 ·[編纂] 電 ...

Group 1 - The core viewpoint of the article is that Sanofi's 613 project for acute gouty arthritis has submitted its application for market approval to the National Medical Products Administration, which has been accepted [2] - If the product is approved, the company will comply with the relevant regulations of the Shanghai Stock Exchange's Sci-Tech Innovation Board and will issue timely announcements [2]

证券日报网讯1月22日，天康生物（002100）在互动平台回答投资者提问时表示，截至2026年1月20日收 盘，公司股份持有人数为62780户。 ...