Core Viewpoint - Lupu Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor. The company focuses on drug design, discovery, clinical development, and commercialization for cancer and autoimmune diseases, with a product pipeline that includes six major candidates. The core product, LP-168, is the first covalent and non-covalent dual mechanism BTK inhibitor in clinical trials for treating relapsed/refractory mantle cell lymphoma (R/R MCL) and is currently at the NDA stage. However, the company faces multiple challenges in value realization due to intense competition and the presence of strong competitors with established advantages [1][10]. Financial Performance - The company has no main business revenue as its products have not yet been commercialized. From 2023 to the first half of 2025, the company generated other income of CNY 25.536 million, CNY 12.072 million, and CNY 6.774 million, with over half coming from government subsidies, totaling CNY 30.697 million over three and a half years. Net profits for the same periods were -CNY 159 million, -CNY 3.385 million, and CNY 35.9 million. The company achieved book profits in 2024 and the first half of 2025 mainly due to a significant increase in "fair value change of preferred shares" in its financial statements, which resulted from a decrease in overall company valuation [2][11][12]. - The post-investment valuation of the company peaked at USD 420 million during the 2023 Pre-B round financing but fell to USD 311.25 million in the 2025 B round, with the per-share cost dropping from USD 23.19 to USD 10.69 [12]. Research and Development - The company has seen a decline in R&D spending, with expenditures of CNY 168 million and CNY 150 million in 2023 and 2024, respectively. In the first halves of 2024 and 2025, R&D spending was CNY 69.6 million and CNY 53.2 million, showing a year-on-year decrease in the last two reporting periods [3][13]. - The company’s core operations continue to incur cash burn, with net cash outflows of CNY 134.2 million, CNY 113.4 million, and CNY 47.4 million in 2023, 2024, and the first half of 2025, respectively [3][12]. Competitive Landscape - The market for BTK inhibitors is highly competitive, with six approved or NDA-submitted BTK inhibitors already in the market. Established products like ibrutinib and zanubrutinib have been included in China's national medical insurance directory, solidifying their standard treatment status and creating significant pricing barriers [7][17]. - LP-168, as a latecomer, must demonstrate its efficacy and safety in head-to-head or real-world studies to capture market share. It also faces potential price reductions due to medical insurance negotiations, which could severely impact its pricing power and profit margins [9][20]. Product Pipeline - Lupu Pharmaceutical has established a product pipeline that includes six major candidates, with three core assets in the new drug application and clinical stages: LP-168, LP-108, and LP-118. LP-168 is currently the only covalent and non-covalent dual mechanism BTK inhibitor in clinical trials for R/R MCL, with its NDA stage indicating significant development progress [4][14].

公司专注于发现和开发针对自身免疫性疾病和肿瘤的自主研发小分子药物，截至最后实际可行日期，公 司已开发出包含七个小分子候选药物的产品管线，其中包括两种核心产品Mufemilast和Hemay022，涵盖 三种自身免疫候选药物和四种肿瘤候选药物。核心产品Mufemilast是一种自主研发的PDE4B表达阻断剂 和PDE4抑制剂，具有双重作用机制。该药已于2025年9月获得中国国家药监局的新药上市申请 （NDA）批准，用于治疗中重度斑块状银屑病。核心产品Hemay022是一种全球拥有的1类小分子抑制 剂，同时靶向EGFR和HER2。公司正进行一项针对晚期ER+/HER2+乳腺癌的III期联合疗法临床试验， 计划于2027年向中国国家药监局提交NDA。 和美药业已建立覆盖小分子药物开发全流程的综合技术体系，包括模块化化合物库构建平台、生物标志 物动物模型筛选平台、肿瘤微环境激活组合化疗药物设计平台和差异化临床设计平台。全球和中国自身 免疫性疾病药物市场均呈现显著增长趋势。中国自身免疫性疾病药物市场预计到2032年将达到263亿美 元；中国银屑病药物市场预计到2032年将达到人民币871亿元。 和美药业向港交所主板递交 ...

智通财经APP获悉，据港交所12月1日披露，赣州和美药业股份有限公司(简称：和美药业)递表港交所主 板，国投证券国际为其独家保荐人。和美药业在识别、开发和商业化生物技术及其他候选药剂制品方面 做出了重大努力。其综合研发能力通过成功的往绩记录得到了验证，包括成功开发核心产品 Mufemilast，该药物已于中国获得NDA批准用于治疗中重度Ps。截至最后实际可行日期，公司已经开发 出一条由七种候选药物组成的强大产品管线。 招股书显示，和美药业成立于2002年，是一家生物制药公司，致力于发现和开发针对自身免疫性疾病和 肿瘤的自主研发小分子药物，并在Ps、BD和IBD和化学疗法开发方面拥有成熟的专业知识。 截至最后实际可行日期，和美药业已经开发包含七个小分子候选药物的产品管线(包括两种核心产品 Mufemilast及Hemay022)，涵盖多种具有未满足医疗需求的适应症。其中包括三个自身免疫候选药物和 四个肿瘤候选药物。 Mufemilast是一种自主研发的小分子PDE4B表达阻断剂和PDE4抑制剂，具有广泛的自身免疫性疾病治 疗潜力。根据弗若斯特沙利文，Mufemilast是一种具有双重作用机制的全球药物。Mufe ...

Group 1 - The core viewpoint of the news is that Nuo Cheng Jian Hua (09969) has shown significant growth in its financial performance, with a notable increase in revenue and a reduction in net loss [1] - For the first half of 2025, the company reported a revenue of 730 million yuan, representing a year-on-year growth of 74.3%, driven by the strong sales of its core product, Obinutuzumab, and an upfront payment from Prolium [1] - The sales of Obinutuzumab reached 637 million yuan, marking a year-on-year increase of 52.8%, while the net loss narrowed to 82 million yuan, a reduction of 67.4% compared to the previous year [1] Group 2 - The company is enhancing its drug discovery platform, focusing on B-cell and T-cell signaling pathways, aiming to develop innovative therapies for autoimmune diseases with unmet medical needs [2] - Nuo Cheng Jian Hua is accelerating multiple Phase III clinical trials in the autoimmune sector, including the combination of Obinutuzumab with ICP-248 for first-line CLL/SLL-FDT treatment, and has completed patient enrollment for these trials [2] - The company aims to create a differentiated autoimmune pipeline and is targeting "first-in-class" or "best-in-class" therapies, which have significant market potential globally [2]

Group 1 - The core viewpoint of the news is that Nuo Cheng Jian Hua (09969) has shown significant growth in its financial performance, with a notable increase in revenue and a reduction in net loss for the first half of 2025 [1][2] - For the first half of 2025, the company reported a revenue of 730 million yuan, representing a year-on-year growth of 74.3%, primarily driven by the strong sales of its core product, Obinutuzumab, and an upfront payment from a licensing agreement with Prolium [1] - The sales of Obinutuzumab reached 637 million yuan, marking a year-on-year increase of 52.8%, while the net loss attributable to shareholders narrowed to 82 million yuan, a reduction of 67.4% compared to the previous year [1] Group 2 - The company is enhancing its drug discovery platform, focusing on B-cell and T-cell signaling pathways, aiming to develop innovative therapies for autoimmune diseases with significant unmet needs [2] - Nuo Cheng Jian Hua is accelerating multiple Phase III clinical trials in the autoimmune sector, including the combination of Obinutuzumab with ICP-248 for first-line CLL/SLL-FDT treatment, and has completed patient enrollment for these trials [2] - The company aims to create a differentiated autoimmune pipeline with the goal of providing "first-in-class" or "best-in-class" therapies, which have broad market potential globally [2]