生物制药研发

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和誉-B绩后涨近7% 中期纯利同比增长58.8%至3.28亿 公司年内持续回购股份
Zhi Tong Cai Jing· 2025-08-05 01:54
值得注意的是,和誉近日宣布,其研发的新型PRMT5*MTA抑制剂ABSK131,已在针对MTAP缺失的晚 期/转移性实体瘤患者的1期临床试验中完成首例患者给药。据悉,2024年12月,ABSK131获得美国食品 药品监督管理局的IND批准。2025年3月,ABSK131获中国国家药品监督管理局药品审评中心的IND批 准。 消息面上,和誉发布业绩,上半年收入6.12亿元人民币,同比增加23.1%;期内经调整利润3.36亿元, 同比增加56.03%;净利润3.28亿元,同比增加58.84%。公告称,收入主要为来自默克的授权收入。此 外,公司购回股份以提振市场信心及提升股东价值。截至2025年6月30日止6个月,公司共购回954.5万 股股份,累计金额7530万港元。于2024年,亦合计购回2259.4万股股份,累计金额6870万港元。 和誉-B(02256)绩后涨近7%,截至发稿,涨4.02%,报10.87港元,成交额1.46亿港元。 ...
两年亏损3.07亿!麦济生物估值增近45倍
IPO日报· 2025-08-04 02:02
Core Viewpoint - Hunan Maijizhi Biotechnology Co., Ltd. (referred to as "Maijizhi") has submitted an application for listing on the Hong Kong Stock Exchange, with CICC as the exclusive sponsor. The company has been experiencing continuous losses but has seen its post-investment valuation increase nearly 45 times over the past eight years [1][2][9]. Company Overview - Established in 2016, Maijizhi is a clinical-stage biopharmaceutical company focused on addressing unmet medical needs in allergic diseases, autoimmune diseases, and other inflammatory and immune diseases. The company currently has no products on the market, with its core product MG-K10 being a long-acting anti-IL-4Rα antibody with "best-in-class" potential [5][6]. Product Pipeline - MG-K10 targets atopic dermatitis (AD), a chronic inflammatory skin disease with a significant global burden, affecting at least 230 million people. In China, the prevalence of AD has increased by 25.65% from 1990 to 2019, with approximately 36.09 million patients currently, including about 9.63 million with moderate to severe cases [5][6]. - In addition to MG-K10, Maijizhi has two other self-developed products in clinical stages: MG-014, targeting asthma and COPD, and MG-013, an anti-MASP-2 monoclonal antibody aimed at rare and inflammatory diseases [6][7]. Financial Performance - For the first three months of 2023, 2024, and 2025, Maijizhi reported revenues of 8.72 million, 24,000, and 0, respectively, with corresponding net losses of 253 million, 178 million, and 27.3 million. The company incurred significant R&D expenses of 166 million and 150 million in 2023 and 2024, leading to a total adjusted net loss of approximately 307 million over these two years [7][8]. - In Q1 2025, the company recorded no revenue and continued to incur losses with R&D expenses of 24.3 million [8]. Valuation Growth - The company's valuation has seen substantial growth over the years, starting from 58 million in early 2017 to 2.64 billion in May 2025, reflecting a nearly 45-fold increase [9][10]. IPO Fund Utilization - The funds raised from the IPO will be used for ongoing and planned clinical trials of the core product MG-K10, as well as for MG-014 and MG-013, along with other preclinical and discovery-stage assets [11].
新股消息 和美药业拟港股上市 中国证监会要求补充说明前期进行A股上市辅导备案的详细情况等
Jin Rong Jie· 2025-08-01 15:46
Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for nine companies, including Hemei Pharmaceutical, which is seeking to list on the Hong Kong Stock Exchange. The CSRC is requesting detailed explanations regarding the company's previous A-share listing guidance and its future plans for A-share listing [1][2]. Group 1 - The CSRC has requested Hemei Pharmaceutical to clarify its previous A-share listing guidance and whether it plans to continue with the A-share listing, including any significant impacts on the current listing process [1][2]. - Hemei Pharmaceutical was established in 2002 and is an innovative biopharmaceutical company focused on discovering and developing small molecule drugs for autoimmune diseases and tumors, maintaining a leading position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [2]. - As of May 21, 2025, Hemei Pharmaceutical has developed seven small molecule drug candidates targeting high unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for twelve indications [2]. Group 2 - Hemei Pharmaceutical's core product, Mufemilast, is a novel small molecule phosphodiesterase 4B (PDE4B) protein expression blocker and PDE4 inhibitor, showing potential for treating a wide range of autoimmune diseases. According to Frost & Sullivan, Mufemilast may be a first-in-class drug with dual mechanisms of action [2].
百奥泰:BAT5906获药物临床试验批准通知书
news flash· 2025-08-01 08:11
百奥泰公告,近日收到国家药品监督管理局核准签发的关于公司在研药品重组抗VEGF人源化单克隆抗 体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑水肿(CRVO-ME)和病理性近视的脉络膜新生血管 (pmCNV)的《药物临床试验批准通知书》。BAT5906是百奥泰自主研发生产的重组人源化单克隆抗体创 新药物,为IgG1型全长抗体,分子量为149KDa,能与人VEGF-A165进行特异性结合,抑制新生血管生 成。在体外血管生成模型上,BAT5906能够阻断VEGF与其相应的受体结合,抑制内皮细胞的增殖和新 生血管形成。在动物实验中,BAT5906的血清半衰期比结构为Fab片段的雷珠单抗更长,可能会支持临 床中更长的注射周期。在用药安全性上,不会触发抗体依赖的细胞介导的细胞毒性作用(ADCC),因而 全身不良反应小,临床应用可能更安全。 ...
瑞银重申康方生物买入评级 目标价一举升至197.5港元
news flash· 2025-08-01 05:49
瑞银重申康方生物买入评级 目标价一举升至197.5港元 金十数据8月1日讯,瑞银发表研究报告指,康方生物(09926.HK)核心产品AK112(ivonescimab)在非小 细胞肺癌(NSCLC)外的适应症展现巨大潜力,除NSCLC的6项适应症外,公司另启动6项三期临床试 验,覆盖胆管癌、三阴性乳腺癌、胰腺癌等一线治疗领域,适应症广度居同类药物之首。瑞银指,该药 物自今年1月纳入国家医保目录后销售快速增长,5月获批NSCLC一线治疗新适应症,有望通过2025年 医保谈判进一步贡献增量收入,将AK112在中国及全球销售高峰值上调至12亿及146亿美元,重申买入 评级,并将目标价从112.1港元大幅上调至197.5港元。 ...
两年亏损3.07亿!麦济生物估值增近45倍
Guo Ji Jin Rong Bao· 2025-07-31 15:59
Core Viewpoint - Hunan Maijiz Biological Technology Co., Ltd. has submitted an application for an IPO on the Hong Kong Stock Exchange, with CICC as the sole sponsor [1] Company Overview - Maijiz Biological was established in 2016 and is a clinical-stage biopharmaceutical company focused on unmet medical needs in allergic diseases, autoimmune diseases, and other inflammatory and immune diseases [3] - The company currently has no products on the market, with its core product MG-K10 being a long-acting anti-IL-4Rα antibody, which is considered to have "best-in-class" potential [3] Financial Performance - The company has reported continuous losses, with a total adjusted net loss of approximately 307 million yuan over the past two years [5] - Revenue for the first three months of 2023, 2024, and 2025 was 872,200 yuan, 24,000 yuan, and 0 yuan respectively, with corresponding net losses of 253 million yuan, 178 million yuan, and 27.3 million yuan [4] Product Pipeline - In addition to MG-K10, Maijiz Biological has two other self-developed pipelines that have entered clinical stages: MG-014 targeting TSLP for asthma and COPD, and MG-013 targeting MASP-2 for rare and inflammatory diseases [4] - The company has several other preclinical candidates, including MG-012, MG-015, MG-018, MG-208, and MG-242, which are in development [4] Valuation and Funding - The company has undergone multiple rounds of financing, raising over 700 million yuan, with a post-money valuation growth of nearly 45 times over eight years [7] - The valuation increased from 58 million yuan in early 2017 to 2.64 billion yuan in May 2025 [10] Shareholding Structure - The controlling shareholder, Zhang Chenghai, holds approximately 42.65% of the company, while other significant shareholders include Kangzhe Pharmaceutical and Hunan Guochuang [10] Use of IPO Proceeds - The funds raised from the IPO will be used for ongoing and planned clinical trials of the core product MG-K10, as well as for MG-014, MG-013, and other preclinical and discovery-stage assets [10]
Ipsen delivers strong results in the first half of 2025 and upgrades its full-year guidance
Globenewswire· 2025-07-31 05:00
Core Insights - Ipsen reported strong financial results for H1 2025, with total sales reaching €1,819.8 million, a 9.7% increase compared to H1 2024, and 11.4% growth at constant exchange rates (CER) [2][3] - The company achieved a core operating income of €655.8 million, reflecting a 21.9% increase, and a core operating margin of 36.0%, up by 3.6 percentage points [2][3] - Ipsen upgraded its full-year 2025 financial guidance, expecting total sales growth greater than 7.0% at CER, and a core operating margin exceeding 32.0% [3][4] Financial Performance - Total sales for H1 2025 were €1,819.8 million, compared to €1,659.3 million in H1 2024, marking a 9.7% increase [2] - Core operating income rose to €655.8 million from €538.0 million, a growth of 21.9% [2] - Core consolidated net profit increased by 27.3% to €508.3 million, with core earnings per share rising to €6.07 from €4.78 [2] - IFRS operating income was €451.6 million, up 42.1%, with an IFRS operating margin of 24.8%, an increase of 5.7 percentage points [2] Therapeutic Areas Performance - Sales growth was driven by three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology [3] - The rare liver disease franchise showed particularly strong momentum, contributing significantly to overall sales growth [3] Pipeline and Regulatory Updates - Ipsen received European Commission approval for Cabometyx in advanced neuroendocrine tumors on July 23, 2025, marking the sixth indication for the drug [3][6] - The company is anticipating pivotal study results for fidrisertib in fibrodysplasia ossificans progressiva (FOP) and proof-of-concept data for LANT in aesthetics in the second half of 2025 [3][4] - Recent pipeline developments include the initiation of a Phase II study of LANT in cervical dystonia and the presentation of Iqirvo® data at a major liver congress [5][6] Future Outlook - The company expects a negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe, but remains optimistic about overall growth [4][11] - Ipsen's strategy focuses on external innovation and a commitment to scientific excellence, positioning the company for continued positive impact in the biopharmaceutical sector [4]
百奥泰生物制药股份有限公司2025年半年度业绩预告的自愿性披露公告
Shang Hai Zheng Quan Bao· 2025-07-29 17:36
Group 1 - The company expects a net loss attributable to shareholders of the parent company for the first half of 2025 to be between -110 million and -140 million yuan, representing a reduction in loss of 96.84 million to 126.84 million yuan compared to the same period last year [2] - The expected net loss attributable to shareholders after deducting non-recurring gains and losses is projected to be between -160 million and -190 million yuan, indicating a reduction in loss of 80.33 million to 110.33 million yuan [2] - The previous year's net loss attributable to shareholders was -236.85 million yuan, with a net loss after deducting non-recurring gains and losses of -270.33 million yuan [4] Group 2 - The company anticipates a decrease in losses due to increased market expansion, with sales of Adalimumab injection (Geleli) expected to rise, contributing an additional revenue of 20 million to 50 million yuan compared to the previous year [6] - Research and development expenses are expected to decrease by 40 million to 70 million yuan compared to the previous year, primarily because several R&D projects have completed Phase III clinical trials, with BAT2206, BAT2306, and BAT2506 currently in the application stage for market approval [6] - BAT2206 has already received FDA approval for market launch in the United States, which has contributed to the reduction in R&D expenses [6]
上海医药:B019新适应症获得临床试验批准
news flash· 2025-07-29 07:59
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its self-developed drug "B019" for the treatment of refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, aimed at treating refractory systemic lupus erythematosus [1] - The project has accumulated research and development expenses of approximately 149,000 RMB for this new indication [1]
丽珠医药(01513) - 自愿公告 重组抗人IL-17A/F人源化单克隆抗体注射液Ⅲ期临床试验达到...
2025-07-21 11:53
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。 自願公告 重組抗人 IL-17A/F 人源化單克隆抗體注射液Ⅲ期臨床試驗 達到主要研究終點 近日,麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*(「本公司」)控股附 屬公司珠海市麗珠單抗生物技術有限公司(「麗珠單抗」)與北京鑫康合生物醫藥科技 有限公司聯合開發的"重組抗人IL-17A/F人源化單克隆抗體注射液"(「LZM012」或「本 品」)的Ⅲ期臨床試驗達到主要研究終點。現將有關詳情公告如下: 一、藥品基本情況 藥品名稱:重組抗人IL-17A/F人源化單克隆抗體注射液 英文名/拉丁名:Recombinant anti-human IL-17A/F Humanized Monoclonal Antibody Injection 劑型:注射劑 註冊分類:治療用生物製品1類 規格:160 mg(1.6mL)/瓶 上市申請人:珠海市麗珠單抗生物技術有限公司 本公司 ...