Group 1 - Jichuan Pharmaceutical's "Children's Constipation Granules" has received a registration application acceptance notice, marking it as the first innovative traditional Chinese medicine specifically for treating pediatric constipation [1] - The product is expected to be the first Class 1 pediatric-specific drug for constipation following the release of the clinical research guidelines in 2024 [1] Group 2 - Innovent Biologics' drug Daberat® has become the first KRAS G12C inhibitor approved in Macau, providing a new targeted therapy for patients with advanced non-small cell lung cancer [2] - In a Phase II clinical trial, Daberat® demonstrated an objective response rate (ORR) of 49.1%, a median progression-free survival (PFS) of 9.7 months, and a 12-month overall survival (OS) rate of 54.4% [2] Group 3 - Sinovac Biotech's special shareholders meeting approved the election of 10 new directors proposed by SAIF Partners, who committed to support the company's dividend distribution plan [3] - The new board members aim to work closely with management to restore trading of the company's common stock and enhance long-term shareholder value [3] Group 4 - Ganli Pharmaceutical expects a net profit increase of 100.73% to 114.12% for the first half of 2025, with projected profits between 600 million to 640 million yuan [4] - The company achieved market share expansion through two rounds of insulin procurement, with a significant 32.6% increase in agreement volume during the 2024 procurement [4] Group 5 - Ascentage Pharma's new Bcl-2 inhibitor, Lisangtuo® (APG-2575), has been conditionally approved for marketing in China, becoming the first Bcl-2 inhibitor for chronic lymphocytic leukemia/small lymphocytic lymphoma [5] - This marks Ascentage Pharma's second innovative drug to be approved and enter the commercialization stage [5] Group 6 - United Biomedical's UBT37034 injection has received FDA approval for clinical trials, showing significant weight reduction effects when combined with GLP-1 analogs in preclinical studies [6] - The combination therapy demonstrated superior weight loss effects compared to other investigational drugs [6]

安全性方面，治疗相关不良事件以1-2级为主，包括贫血、各类检查相关的不良反应，通过剂量调整及 支持治疗可有效控制，未观察到预期外的严重毒性反应。氟泽雷塞片在刚发布的《2025 CSCO非小细胞 肺癌诊疗指南》中获KRAS G12C突变治疗一级推荐，为KRAS G12C突变患者提供了兼具精准靶向性、 持久疗效与良好耐受性的治疗新选择。 该推文指出，此次达伯特®在澳门获批上市，标志着信达生物创新药物在大中华区的又一重要突破。信 达生物达伯舒®、达攸同®、信必乐®、达伯坦®等创新产品已在印度尼西亚、中国香港、中国澳门、 中国台湾等多个地区获批上市。另外多款产品在巴西、墨西哥、哥伦比亚、印度等地拟注册申报上市 中，有望为广大拉丁美洲、东南亚地区患者带去更多创新疗法。 （企业公众号） 7月9日，信达生物官方公众号发布消息。披露首款中国企业自主研发的KRAS G12C抑制剂达伯特® （氟泽雷塞片，Fulzerasib）已正式获得中国澳门特别行政区药品监管部门批准上市，成为澳门首个获 批的中国自主研发KRAS G12C抑制剂，为澳门KRAS G12C突变型晚期非小细胞肺癌（NSCLC）患者带 来全新精准靶向治疗方案。 推文 ...

聚焦肿瘤、自体免疫和炎症性疾病领域。 本文为IPO早知道原创 作者｜罗宾 2021年，劲方医药与信达生物（1801.HK）就GFH925达成授权交易，授予信达生物于大中华区开 发及商业化GFH925权益，以及在中国以外的全球地区开发及商业化此款产品的中国境外选择权。 2024年1月，双方签订GFH925补充协议，终止上述协议中的中国境外选择权。 劲方正在推进GFH925的海外临床开发，包括在EMA监管区域内国家进行与cetuximab（一款靶向 EGFR的抗体药物）联用作为一线治疗晚期NSCLC的联合疗法的Ib/II期临床试验。公司认为此款联 合疗法有望在抑制EGFR-RAS通路方面实现协同效应。 劲方医药另一款核心产品GFH312为劲方医药自主研发的高效小分子抑制剂，能针对受体相互作用的 丝氨酸/苏氨酸蛋白激酶1（RIPK1）并抑制其激酶活性， GFH312已获得FDA关于在美国开展第II 期临床试验的IND批准 ，以评估GFH312对外周动脉疾病（PAD）伴间歇性跛行（IC）患者的安全 性和疗效。与全球其他临床阶段的RIPK1抑制剂相比，劲方医药聚焦 GFH312的差异化临床计划， 针对一些可能严重影响患 ...