Workflow
生物制药研发
icon
Search documents
Apogee Therapeutics (NasdaqGM:APGE) Update / Briefing Transcript
2026-01-06 14:02
Apogee Therapeutics (NasdaqGM:APGE) Update / Briefing January 06, 2026 08:00 AM ET Company ParticipantsDavid Nierengarten - Managing Director of Equity ResearchMichael Henderson - CEOMario Castro - Chief of Pulmonary Critical Care and Sleep Medicine DivisionNoel Kurdi - VP of Investor RelationsCarl Dambkowski - Chief Medical OfficerJeff Hartness - Chief Commercial OfficerAlex Thompson - Managing Director of BiotechnologyPhoebe Tan - Senior Biotechnology Equity Research AssociateDavid Huang - VP of Equity Re ...
君实生物20251230
2025-12-31 16:02
君实生物目前的估值非常便宜,公司正处于一个多方位的转折点。首先,在管 理层面,公司整体管理水平有所提升;其次,在销售方面,产品销售增长迅速; 最后,在研发管线推进方面也取得了显著进展。公司现有四款正在销售的产品, 包括 PD-1 特瑞普利单抗、TNF-α 药物、新冠药 VV116 和 PCSK9 抑制剂。这 些产品预计可实现 75 亿人民币的销售峰值,我们给予 3 倍 PS,对应 240 亿港 币左右的估值。目前君实生物在港股市场上的市值仅反映了现有产品的价值, 而未充分体现其研发管线潜力。 君实生物有哪些主要在售产品及其市场表现预期? 君实生物目前有四款主要在售产品:PD-1 特瑞普利单抗、TNF-α 药物、新冠 药 VV116 和 PCSK9 抑制剂。其中,特瑞普利单抗今年(2025 年)的预计销 售额为 20 亿元,明年(2026 年)预计同比增长 35%至 40%。后年的增长将 更多依赖于皮下注射形式获批后的放量,整体峰值预计在 50 亿至 60 亿元人民 币之间。其他三款药品合计销售峰值为 75 亿元人民币。 君实生物 20251230 摘要 君实生物现有四款在售产品,包括 PD-1 特瑞普利单抗、 ...
智飞生物(300122.SZ):德谷门冬双胰岛素注射液(CA508注射液)获得Ⅲ期临床试验总结报告
智通财经网· 2025-12-29 09:55
智飞生物(300122.SZ)发布公告,公司于近日获悉,由控股子公司重庆宸安生物制药有限公司(以下简 称"宸安生物")研发的德谷门冬双胰岛素注射液(CA508注射液)获得了Ⅲ期临床试验总结报告。宸安生物 研发的德谷门冬双胰岛素注射液(CA508注射液)在有效性和安全性上与原研药德谷门冬双胰岛素注射液 (诺和佳®)相当,符合《治疗糖尿病药物及生物制品临床试验指导原则》对有效性与安全性评价的设计 要求。 ...
智飞生物:德谷门冬双胰岛素注射液(CA508注射液)获得Ⅲ期临床试验总结报告
Zhi Tong Cai Jing· 2025-12-29 09:49
智飞生物(300122)(300122.SZ)发布公告,公司于近日获悉,由控股子公司重庆宸安生物制药有限公 司(以下简称"宸安生物")研发的德谷门冬双胰岛素注射液(CA508注射液)获得了Ⅲ期临床试验总结报 告。宸安生物研发的德谷门冬双胰岛素注射液(CA508注射液)在有效性和安全性上与原研药德谷门冬双 胰岛素注射液(诺和佳)相当,符合《治疗糖尿病药物及生物制品临床试验指导原则》对有效性与安全性 评价的设计要求。 ...
华芢\生物港股上市首日破发跌29% 2年9个月共亏4.5亿
Zhong Guo Jing Ji Wang· 2025-12-22 09:01
Core Viewpoint - Huazhen Biotechnology (Qingdao) Co., Ltd. (stock code: 02396.HK) was listed on the Hong Kong Stock Exchange, opening below the issue price at HKD 33.80 and closing at HKD 27.00, reflecting a decline of 29.32% from the final offer price of HKD 38.20 [1][4]. Group 1: Offering Details - The total number of shares offered globally was 17,648,800 H-shares, with 1,765,000 shares available for public offering in Hong Kong and 15,883,800 shares for international offering [2]. - The final offer price was set at HKD 38.20, with total proceeds amounting to HKD 674.18 million, and net proceeds after estimated listing expenses of HKD 74.36 million were HKD 599.82 million [4][5]. Group 2: Use of Proceeds - The net proceeds from the global offering are intended to fund the ongoing clinical development and commercialization of core products Pro-101-1 and Pro-101-2, purchase professional equipment related to R&D and quality control, and cover third-party service fees and costs for clinical research of other PDGF products [6]. Group 3: Financial Performance - The company reported revenues of RMB 472,000 in 2023 and RMB 261,000 in 2024, with no revenue generated from product sales during the reporting period [7][8]. - The net losses for 2023 and 2024 were RMB 105.2 million and RMB 212.3 million, respectively, with total accumulated losses of RMB 451.9 million over the two years and nine months [7][8]. - Operating cash flow for the years 2023 and 2024 was negative, with net cash used in operating activities amounting to RMB 57.9 million and RMB 90.1 million, respectively [9].
华芢生物-B(02396)12月12日至12月17日招股 拟全球发售1764.88万股H股 预计12月22日上市
智通财经网· 2025-12-11 23:17
智通财经APP讯,华芢生物-B(02396)于2025年12月12日-2025年12月17日招股,公司拟全球发售1764.88 万股H股,其中,香港公开发售占约10%,国家发售占约90%,另有15%超额配股权。每股发售价格为 38.2-51港元。每手200股H股,预计H股将于2025年12月22日上午九时正(香港时间)开始在香港联交所买 卖。 集团成立于2012年,是一家总部位于中国的生物制药公司,致力于开发疗法,重点是针对有医疗需求及 市场机会的适应症开发蛋白质药物。集团的主攻方向是发现、开发和商业化伤口愈合的疗法,目前为 PDGF药物。截至最后实际可行日期,集团的管线包含十款候选产品,其中七款为PDGF候选药物,包 括两款核心产品,即用于治疗烧烫伤的Pro-101-1及用于治疗糖足的Pro-101-2,是rhPDGF-BB药物。 假设超额配股权未获行使,经扣除集团就全球发售已付及应付的包销佣金及其他估计发售开支后,并假 设发售价为每股股份44.60港元(即指示性发售价范围38.20港元至51.00港元的中位数),集团估计将自全 球发售获得所得款项净额约7.09亿港元。集团拟按下文所载用途及金额使用全球发售 ...
港股异动 荣昌生物(09995)盘中涨超7% 公布PD-1/VEGF双抗非小细胞肺癌临床数据
Jin Rong Jie· 2025-12-11 03:57
Core Viewpoint - Rongchang Biopharma (09995) experienced a significant stock increase, with a rise of over 7% during trading, closing at 81.5 HKD, with a transaction volume of 310 million HKD, following the presentation of clinical trial data for its PD-1/VEGF bispecific antibody RC148 at the ESMO-IO conference in London [1] Group 1: Clinical Trial Data - The clinical study (RC148-C001) for RC148, a PD-1/VEGF bispecific antibody, was presented at the ESMO-IO conference, showing promising results for treating non-small cell lung cancer [1] - The study reported an overall response rate (ORR) of 66.7% and a disease control rate (DCR) of 95.2% for the RC148 20 mg/kg Q3W combined with docetaxel treatment [1] - Among PD-L1 positive patients (TPS≥1%), the ORR reached 80%, with a median follow-up time of approximately 7 months and a median progression-free survival (mPFS) of 8.3 months [1] Group 2: Regulatory Approvals and Market Potential - RC148 received FDA approval in August to initiate a Phase II clinical trial in the United States, marking its entry into global clinical development [1] - The drug has also been approved in China for clinical research in monotherapy and combination therapy for advanced solid tumors [1] - The increasing global business development (BD) activity in the PD-1/VEGF space, with companies like CanSino Biologics and 3SBio leading the way, indicates strong market potential for RC148 [1]
复宏汉霖(02696) - 自愿公告 - HLX22(重组人源化抗HER2单克隆抗体注射液)联合注射...
2025-12-09 09:14
自願公告 HLX22(重組人源化抗HER2單克隆抗體注射液)聯合 注射用HLX87(靶向HER2抗體偶聯藥物)分別用於 HER2陽性乳腺癌(BC)一線治療與HER2陽性乳腺癌新輔助治療 (BC neo)的2/3期臨床試驗申請獲國家藥品監督管理局批准 A. 緒言 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全部或任何部分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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2696) 本公告由上海復宏漢霖生物技術股份有限公司(「本公司」)自願作出,以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會(「董事會」)欣然宣布,近日,HLX22(重組人源化抗HER2單 克隆抗體注射液)(「HLX22」)聯合注射用HLX87(靶向HER2抗體偶聯藥物) (「HLX87」)(1)用於HER2陽性乳腺癌(BC)一線治療,以及(2)用於HER2陽性 乳腺癌新輔助治療(B ...
上海君实生物医药科技股份有限公司 自愿披露关于偌考奇拜单抗注射液新药上市申请获得受理的公告
Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has received a notice of acceptance from the National Medical Products Administration for its new drug application for JS005, a monoclonal antibody injection for treating moderate to severe plaque psoriasis in adults [1][2]. Drug Basic Information - Drug Name: JS005 (Rocacitinib Injection) - Application: Domestic production drug registration and marketing license - Acceptance Number: CXSS2500129, CXSS2500130 - Applicant: Shanghai Junshi Biosciences Co., Ltd. - Specifications: 150mg (1ml) per pre-filled syringe and 150mg (1ml) per pre-filled auto-injector - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Drug Development and Clinical Research - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases like psoriasis [2]. - The drug works by binding to IL-17A and blocking its interaction with receptors, thereby alleviating symptoms of autoimmune diseases [2]. - A pivotal Phase III clinical study (JS005-005-III-PsO) involving 747 moderate to severe plaque psoriasis patients showed significant improvement in psoriasis area and severity index (PASI) scores after 12 weeks of treatment, with sustained efficacy over 52 weeks [3].
天坛生物下属企业获得临床试验总结报告
Zhi Tong Cai Jing· 2025-12-04 09:19
Core Viewpoint - Tiantan Biological (600161.SH) announced that its subsidiary, Guizhou Biological Pharmaceutical Co., Ltd., has completed Phase III clinical trials for "Prothrombin Complex Concentrate" and received the clinical trial summary report [1] Group 1: Clinical Trial Results - The clinical trial results indicate that the Prothrombin Complex Concentrate significantly enhances coagulation factor levels II/VII/IX/X in patients with Hemophilia B [1] - The treatment improves coagulation function and alleviates bleeding symptoms and signs in patients with Hemophilia B, demonstrating good efficacy [1] - Safety analysis results show that the drug has a favorable safety profile during clinical application for patients with Hemophilia B [1]