倍诺达

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药明巨诺-B发布中期业绩 毛利6511.7万元 同比增加48.86%
Zhi Tong Cai Jing· 2025-08-27 11:36
药明巨诺-B(02126)发布截至2025年6月30日止六个月中期业绩,收入1.06亿元(人民币,下同),同比增 加22.5%;毛利6511.7万元,同比增加48.86%;研发开支9204.1万元。 集团的领先产品倍诺达在商业化方面持续取得进展。此外,集团已完成倍诺达用于不符合移植条件的复 发或难治性(r/r)大B细胞淋巴瘤(LBCL)患者的二线治疗临床试验的患者入组;基于此适应症,国家药监局 于2025年1月授予倍诺达"突破性疗法认定",集团已经于2025年5月就此递交了补充新药申请(sNDA)。 另外,集团已开发了自有的平台工艺,并已成功生产出用于制造倍诺达的慢病毒载体,从而进一步减低 产品的成本。分析和临床研究显示了其与目前的慢病毒载体相当的结果。目前,集团已经完成了这些载 体的临床研究用新药申请(IND)的患者入组。此外,集团在研发具有全球商业化潜力的创新产品方面取 得了重大进展。 公告称,截至2025年6月30日止六个月及截至本公告日期,作为一家专注于开发、生产及商业化细胞免 疫治疗产品的独立的创新型生物科技公司,集团的业务取得进一步重大进展,并实现重要里程碑,运营 效率全面提升,例如毛利率维持稳定 ...
恒润达生IPO迷局:未盈利却估值百亿元,是创新先锋还是资本泡沫|创新药观察
Hua Xia Shi Bao· 2025-07-10 08:37
Core Viewpoint - Hengrun Dazheng, a biotech company focused on immune cell therapy, is attempting to go public on the Sci-Tech Innovation Board despite being unprofitable and facing significant financial losses. The company has not yet commercialized any products and is at risk of delisting if it fails to meet financial performance criteria post-IPO [1][2][5]. Financial Performance - Hengrun Dazheng has reported substantial losses over the past three years, with net losses of CNY 274 million, CNY 283 million, and CNY 188 million from 2022 to 2024. As of the end of 2024, the cumulative undistributed profits stand at -CNY 904 million [2][3]. - The company has incurred high R&D expenses, amounting to CNY 242 million, CNY 256 million, and CNY 152 million from 2022 to 2024, contributing to its financial losses [3]. - Cash flow from operating activities has been negative, with net cash flows of -CNY 209 million, -CNY 226 million, and -CNY 141 million during the same period, leading to a significant reduction in liquid assets [3]. Liquidity and Solvency - Hengrun Dazheng's liquidity ratios, including current and quick ratios, have been declining, indicating insufficient debt repayment capacity. The debt-to-asset ratio has increased significantly, reaching 84.76% by the end of 2024, which is considerably higher than the average of comparable companies [3][4]. Product Development and Market Position - The company is developing a pipeline of 11 projects, including CAR-T and CAR-NK therapies, with the most advanced products HR001 and HR003 expected to enter the market by 2025. However, these products face competition from at least six already approved CAR-T therapies in China [7][8]. - The efficacy and safety of Hengrun Dazheng's core products have been questioned, with HR001 showing an overall response rate (ORR) of 68%, which is lower than competitors, and HR003 showing an ORR of 86%, also below market standards [9][10]. IPO and Valuation - Hengrun Dazheng plans to issue up to 50 million shares, aiming to raise CNY 2.539 billion for R&D and operational expenses. The estimated post-IPO valuation exceeds CNY 10 billion, which is considered high given the competitive landscape and the company's current lack of revenue [11].