Ponsegromab

记得关注我们。 6月3日，云南白药宣布其自主研发的INB301注射液获美国FDA临床试验许可，拟用于肿瘤恶病质，这是云南白药历史上首个治疗用生物创新药获得中美两国双批。 从目前披露的信息看，INB301属于单抗类药物，但具体靶点与作用机制尚未对外公开。 其研发节点如下： 2026年2月24日，INB301注射液IND正式获CDE受理，被纳入创新药审评审批30日快速通道。 2026年3月30日，NMPA颁发药物临床试验批准通知书（编号2026LP01002）。截至该时点，该项目累计研发投入约4,347.2万元。 2026年4月27日，云南白药向美国FDA递交IND申请。 2026年6月2日，IND获FDA许可，批准开展临床试验。累计研发费用随之升至约5066.5万元。 从IND受理到中美双批，INB301前后耗时不到4个月。 肿瘤恶病质是晚期肿瘤患者最常见的并发症之一。数据显示，60%至 80%的晚期肿瘤患者会出现不同程度的恶病质症状，约20%的肿瘤患者直接死于恶病质而非肿瘤本身。 目前，全球范围内尚无针对肿瘤恶病质的特异性靶向治疗药物获批上市，临床治疗主要依赖孕激素类药物和糖皮质激素来改善患者食欲，但这些药物无法从根本上阻止骨骼肌的消耗，所以INB301一旦成功，先发优势很大。 目前，全球范围内针对肿瘤恶病质的药物研发主要集中在 GDF-15 靶点。辉瑞的Ponsegromab是该领域进度最快的药物，已进入注册临床阶段。 另外2026年ASCO年会上，劲方医药GFS202A（GDF15/IL-6双抗）亦展示了良好的安全性和初步疗效。 附：云南白药2025年研发投入4.23亿元，较上年增长21.51%，2026年第一季度研发费用7679.01万元，同比增长27.72%。但相较于其2025年160.16亿元的工业收入体量，研发投入占比（2025年占工业收入2.64%）仍偏低。

GenFleet Therapeutics (2595.HK) announced the preliminary phase I data of GFS202A, a novel GDF15/IL-6 bispecific antibody for cancer cachexia, were featured in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) annual meeting on May 30 (local time). As the world’s first GDF15/IL-6 bispecific antibody, GFS202A demonstrated a favorable safety/tolerability profile in preliminary phase I data, alongside promising efficacy for cancer cachexia and robust pharmacodynamic properties. Starting from the 200 mg Q3W dose level, complete and constant inhibition of GDF15 was achieved, coupled with clinically relevant weight gain and improved maintenance of skeletal muscle among patients. Cachexia is a complicated metabolic syndrome, characterized by an array of wasting symptoms, that frequently occurs in multiple chronic diseases. Cancer represents a primary cause of cachexia, which contributes to approximately 30% of all cancer-related deaths. Notably, cachexia affects more than 50% of patients with gastrointestinal malignancies including pancreatic cancer. To date, no targeted therapies for cachexia have been approved by either FDA or NMPA. Abnormal expressions of GDF15 and IL-6 have been identified as closely associated with the onset and progression of cachexia; trials of overseas monoclonal antibodies targeting either factor have reported positive data treating cachexia or malignant tumors. Through dual inhibition of GDF15 and IL-6 signaling pathways, GFS202A may bring about superior efficacy relative to single-target monoclonal antibodies. Yu Wang, M.D., Ph.D. Chief Medical Officer of GenFleet “GFS202A is the world’s first bispecific antibody targeting cachexia and has advanced into clinical development. We are encouraged by the preliminary data that demonstrated its therapeutic potential in cachexia patients with improvements in key parameters such as body weight, skeletal muscle mass, and appetite, alongside reductions in tumor-associated inflammation and nutritional depletion. Cachexia significantly impairs treatment tolerance and shortens overall survival in patients with cancer and other chronic diseases. We expect GFS202A to deliver a novel supportive therapy and bring renewed hope for longer survival in cachexia patients.” A first-in-human (FiH) phase I study of GFS202A, a GDF15/IL-6 bispecific antibody, in advanced cancer patients with pre-cachexia or cachexia（Abstract No.: 12055） As of March 11, 2026, a total of 19 patients with solid tumors - including non-small cell lung cancer, pancreatic cancer and colorectal cancer - received treatment at doses ranging from 5 mg to 400 mg Q3W. 94.7% of the patients (18/19) were diagnosed as stage IV at baseline, and 78.9% (15/19) had received two or more prior lines of systemic therapy. During the study period, 68.4% of trial participants (13/19) received concurrent anti-tumor treatment, and whom 26.3% (5/19) were administered with platinum-based regimens; no dose-limiting toxicities were observed, and the maximum tolerated dose was not reached. Efficacy Preliminary data showed that pharmacokinetic exposure of GFS202A increased along with dose escalation, and without obvious accumulation. Complete and constant GDF15 inhibition was attained at 200 mg Q3W dose level and above. An average of at least 5% weight gain was observed at 200 mg Q3W dose level and above after administration of GFS202A for 6 weeks, suggesting its potential to reverse cancer-related weight loss. As evaluated by the Independent Review Committee (IRC), the mean L3 skeletal muscle index (L3SMI) rose by 2.94 cm²/m² following six weeks of GFS202A treatment at 200 mg Q3W, which demonstrates its potential to mitigate cancer-triggered muscle wasting. Additionally, most patients also reported improved appetite after treatment.  Most patients had improved modified Glasgow prognostic score (mGPS) after treatment with GFS202A, including a notable decrease in C-reactive protein (CRP) and an increase in albumin. The improvement indicates GFS202A may alleviate tumor-associated systemic inflammation and nutritional depletion. Week 6 Week 12 Mean decrease of C-reactive protein 39.81 mg/L 49.42 mg/L Mean increase of albumin 3.4 g/L 2.8 g/L Safety As of data cut-off date, preliminary phase I data exhibited a favorable profile of safety and tolerability. 42.1% (8/19) of patients experienced at least one treatment-related adverse event (TRAE): all TRAEs were graded 1 or 2, except one single case of asymptomatic grade-3 hypertension that was resolved following adequate treatment. No TRAEs have led to treatment discontinuation or interruption; neither infusion-related reaction (IRR) nor adverse events of special interest (AESI, defined as infection) occurred. About GFS202A, GDF15 and IL-6 GFS202A, as the world’s first bispecific antibody for cachexia, entered clinical stage in 2025. In preclinical research of GFS202A (a GDF15/IL-6 bispecific antibody), the body weight, adipose tissue and muscle mass increase dose-dependently in animal models; additionally, GFS202A effectively reduces C-reactive protein levels and alleviates inflammatory responses. According to poster presentation in 2025 AACR annual meeting, comparative analysis demonstrated similar efficacy between GFS202A and ponsegromab (a GDF15 antibody) in restoring body weight, muscle, and fat mass at equimolar doses. Notably, GFS202A exhibited greater CRP reduction at lower dosage than ponsegromab. Cachexia is a frequent complication of chronic diseases, and GFS202A holds the potential to serve as a therapeutic option for cachexia associated with heart failure, chronic obstructive pulmonary disease (COPD), chronic kidney disease, etc.  GDF15 (Growth Differentiation Factor-15) is a member of the TGF-β (Transforming Growth Factor-beta) superfamily of proteins, while the glial cell-derived neurotrophic factor receptor alpha (GFRAL) is the specific receptor for GDF15. Numerous studies have indicated that the level of GDF15 is significantly elevated in cancer patients. GDF15 can activate downstream signaling pathways, thereby promoting growth, migration, and proliferation of cancer cells. Additionally, it inhibits dendritic cell-mediated T-cell stimulation and the activation and infiltration of cytotoxic T cells. IL-6 (Interleukin-6) is a member of the glycoprotein 130 (gp130) family. IL-6 can enter the central nervous system and, through the hypothalamic-pituitary-adrenal (HPA) axis and the hypothalamic-pituitary-gonadal (HPG) axis, induce atrophy in peripheral tissues such as muscle. It can also act peripherally by activating MAPK and other signaling pathways, inducing apoptosis in skeletal muscle cells and the breakdown of adipose tissue. Persistent high levels of IL-6 are strongly associated with shorter survival. About GenFleet Therapeutics With a focus on cutting-edge therapies, GenFleet Therapeutics is dedicated to serving significant unmet medical needs globally in oncology and immunology. Leveraging its deep understanding of disease biology and translational medicine, GenFleet has established a proprietary and fully integrated R&D system that yields a robust pipeline of multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates spanning small molecules and biologics. Its pipeline comprises numerous programs that have advanced to later-stage or pivotal clinical trials across China, the United States and Europe.  The company has set up a highly differentiated RAS-targeted matrix including selective and pan-RAS inhibitors of diverse molecular types, with most assets leading their categories in clinical progress in China or globally. In addition, the company has pioneered a series of first-in-class combination therapies based on dual-target synergistic mechanisms. By integrating clinical needs and insights, GenFleet is dedicated to expanding its portfolio into major therapeutic areas including pancreatic cancer, NSCLC, and cachexia. Furthermore, it's strengthening its commercial collaborative network through strategic out-licensing agreements or clinical cooperations with prestigious listed companies across the world.  Forward-looking Statements Specific information in this press release may contain or constitute forward-looking words that are not historical facts. They can be identified by using forward-looking terminology, such as "predict", "believe", "plan", "predict", "expect", "will", "may", "should" and other words of similar meanings. Based on the management's current beliefs, plans, estimates and expectations of the company's operation and market trends subject to changes beyond control, the forward-looking terminology reflects GenFleet Therapeutics' beliefs, plans, estimates and expectations of future development. Actual outcome in the future may differ significantly from forward-looking words owing to market, policy, and R&D uncertainties, among others. Subject to the above-mentioned uncertainties, GenFleet Therapeutics makes no expressed or implied guarantee as to the accuracy, completeness or feasibility of this presentation, and you are cautioned not to solely rely on such forward-looking words. Neither the company nor any of its directors, officers, employees, shareholders, agents, related parties, consultants or representatives will be liable to you or any other person for consequences resulting from using this presentation. Investors are advised to exercise due diligence with reference to the company's official disclosures for decision-making.