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健康元:重组抗人IL-17A/F人源化单克隆抗体注射液Ⅲ期临床试验达到主要研究终点
news flash· 2025-07-21 10:48
健康元(600380)公告,控股子公司丽珠集团(000513)控股附属公司珠海市丽珠单抗生物技术有限公 司与北京鑫康合生物医药科技有限公司联合开发的"重组抗人IL-17A/F人源化单克隆抗体注射 液"(LZM012)的Ⅲ期临床试验达到主要研究终点。该临床试验是一项在中重度斑块型银屑病患者中开展 的多中心、随机、双盲、阳性对照(司库奇尤单抗)的临床试验,主要疗效终点为第12周时达到银屑病面 积与严重程度指数(PASI)100的受试者比例。结果显示,LZM012的第12周PASI100应答率为49.5%,对 照组司库奇尤单抗为40.2%,显示出LZM012非劣效于司库奇尤单抗且优效于司库奇尤单抗。第4周 PASI75应答率,LZM012为65.7%,对照组司库奇尤单抗为50.3%,显示出LZM012起效速度更快;第52 周PASI100应答率,LZM012320mg Q4W和320mg Q8W维持治疗组分别为75.9%和62.6%,显示银屑病患 者可持续提升获益。安全性方面,本品整体安全性良好,常见不良事件发生率与对照组各类不良事件发 生率相当。丽珠集团近期已就LZM012治疗成人中重度斑块状银屑病适应症,向国家 ...
直击股东大会|智翔金泰透露商业化策略:国内销售外包+海外授权,盈利拐点预计在2027年
Mei Ri Jing Ji Xin Wen· 2025-06-19 11:30
Core Viewpoint - The company has made significant changes in its fundamentals since its listing two years ago, highlighted by a licensing agreement with Cullinan Therapeutics for the GR1803 dual antibody, which could yield over $712 million in total payments and revenue sharing [1][2][3]. Group 1: Licensing Agreement and Financial Implications - The licensing agreement with Cullinan Therapeutics grants them global rights for GR1803 outside of China, while the company retains rights within China [2][3]. - The agreement includes an upfront payment of $20 million and potential milestone payments of up to $692 million, along with revenue sharing, totaling over $712 million [1][3]. - The GR1803 injection is currently in Phase II clinical trials and is aimed at treating relapsed/refractory multiple myeloma, with promising early clinical data showing an overall response rate of 85% [3]. Group 2: Product Commercialization and Market Challenges - The company’s first commercialized product, Selecitinib (IL-17A monoclonal antibody), achieved sales of 30 million yuan after receiving approval for psoriasis treatment, but missed the opportunity for insurance reimbursement negotiations [1][6]. - The company reported a significant revenue increase of 2384.1% year-on-year, reaching 30.09 million yuan, but still faced a net loss of 797 million yuan [6]. - The company is actively working to negotiate for Selecitinib's inclusion in the insurance reimbursement list to enhance market penetration and sales volume [6][7]. Group 3: Future Strategies and Market Environment - The company plans to adopt a dual strategy for future growth, utilizing a sales outsourcing model domestically while pursuing early licensing agreements internationally [4]. - The innovative drug market is experiencing favorable conditions, with a surge in business development activities, as evidenced by a total of $45.5 billion in domestic innovative drug business development in the first five months of 2025 [4][7]. - The company anticipates that profitability may not be achieved until 2027, despite plans for two additional product launches in the future [7].
76亿并购梦碎、15个月努力归零,负增长下的新诺威危机四伏
Tai Mei Ti A P P· 2025-05-08 07:28
Core Viewpoint - New Nuo Wei (300765.SZ) announced the termination of its application for the acquisition of Shiyao Chuangxin Pharmaceutical Co., Ltd. and the associated fundraising, ending a 15-month effort for a significant restructuring deal worth 7.6 billion yuan [2][3]. Group 1: Termination of Acquisition - The termination was due to changes in the pharmaceutical industry and capital market environment since the initial planning of the restructuring, leading to a decision made in the interest of long-term shareholder benefits [2][3]. - The market reacted rationally to the termination, influenced by factors such as stock price fluctuations, increasing performance burdens, and declining acquisition targets [2][3]. Group 2: Financial Performance and Challenges - New Nuo Wei's revenue and profit have been declining, with a 21.98% year-on-year decrease in revenue to 1.981 billion yuan and an 87.63% drop in net profit to 54 million yuan in 2024 [8]. - The company's core revenue from functional foods and raw materials fell by 24.90% to 1.84 billion yuan, while the biopharmaceutical sector contributed only 87.8 million yuan, despite a 153.0% increase [10]. Group 3: Acquisition Details and Valuation - The acquisition target, Shiyao Baike, has a core product, Jinyouli, which is facing growth challenges, with a significant reliance on a single product and limited growth potential [4][7]. - The valuation for Shiyao Baike was set at 7.622 billion yuan, representing a 78.25% premium over its book value of 4.276 billion yuan, raising concerns about the high price for low-growth assets [6][7]. Group 4: R&D and Future Prospects - New Nuo Wei's R&D expenses increased by 25.44% to 842 million yuan in 2024, primarily due to the inclusion of Shiji Biological's R&D costs, indicating a significant financial burden [10][11]. - The company is under pressure from negative cash flows, with net cash flow from operating activities at -1.235 billion yuan in 2024 and -87 million yuan in the first quarter of 2025 [12][13].