微芯生物公告，公司自主研发的西达本胺针对一线治疗弥漫大B细胞淋巴瘤(DLBCL)关键性III期临床试 验(DEB研究)已于近日获得最终结果的顶线分析数据，试验组无事件生存期(EFS)显著优于对照组，达 成研究主要终点。微芯生物表示，西达本胺联合R-CHOP是全球首个在III期临床中完全缓解(CR)率显著 优于R-CHOP的一线DLBCL治疗方案。此次顶线分析中，试验组无事件生存期(EFS)较对照组展现具统 计学显著意义的差异，进一步验证了西达本胺联合方案可为初治MYC和BCL2双表达DLBCL患者带来显 著且可持续的疗效，且安全性良好。公司正在准备该适应症常规批准的申报。同时，该研究最终结果的 全面分析也将于后续学术会议或期刊中呈现。 ...

Summary of Jasper Therapeutics (JSPR) Update / Briefing July 07, 2025 Company Overview - **Company**: Jasper Therapeutics (JSPR) - **Focus**: Development of therapies for chronic spontaneous urticaria (CSU) using the drug vaprolimab Key Points Industry and Company Context - The conference call was focused on updated data from the BEACON trial and initial data from the open label extension study evaluating vaprolimab in patients with CSU [4][20] Core Findings from the BEACON Trial - **Efficacy**: - A greater than 25 drop in UAS7 (Urticaria Activity Score over 7 days) was observed in the 240 mg and 360 mg single dose cohorts, with 78% complete response and 89% well-controlled disease by week four [4][21] - In the open label extension study, 73% of patients achieved complete response and 82% well-controlled disease at the 12-week assessment with a mean reduction in UAS7 scores of greater than 25 points [17][22] - **Safety Profile**: - Vaprolimab demonstrated a favorable safety profile with no dose-limiting toxicities reported. Treatment emergent adverse events were similar in both active and placebo groups [13][22] - Mild transient adverse events were observed, including taste changes and neutrophil count reductions, but these were self-resolving and did not lead to discontinuations [14][15] Issues Identified - **Confounding Results**: - Two cohorts (240 mg Q8 weeks and 240 mg followed by 180 mg Q8 weeks) showed confounded results due to an issue with a specific drug product lot (lot A34954), which resulted in lower than expected drops in mean tryptase levels and no discernible effect on UAS7 in 10 out of 10 patients dosed with this lot [5][12] - An investigation into the affected lot is ongoing, with results expected in the coming weeks [6][20] - **Next Steps**: - Additional 10 to 12 patients will be enrolled in the affected cohorts to ensure a robust data set for the Phase IIb CSU study expected to commence mid-2026 [6][20] Financial and Operational Insights - **Cash Runway**: - Current guidance into the fourth quarter remains unchanged, but the company is evaluating its cost structure and may need to raise additional capital to extend its runway [54] - **Regulatory Communication**: - The company is in communication with the FDA regarding the lot issue, but there are no safety concerns associated with the affected lot [48][41] Additional Observations - **Durability of Responses**: - The data suggests that the depth of triptase reduction correlates with the depth of UAS7 reductions, indicating a potential for durable effects with the 180 mg dosing regimen [55] - **Patient Management**: - Patients who received the inactive dose from the compromised lot will be transitioned to a new drug product that has demonstrated efficacy in other cohorts [20][48] Conclusion - Jasper Therapeutics is optimistic about the potential of vaprolimab as a differentiated therapeutic option for CSU, despite the setback from the compromised drug lot. The company is taking proactive steps to address the issue and continue its clinical development program.

ST葫芦娃（605199）公告，近日收到国家药监局核准签发的关于肺热咳喘颗粒的《药物临床试验批准 通知书》，同意本品开展用于成人流行性感冒的临床试验。该药品是在公司持有的已上市的"小儿肺热 咳喘颗粒"基础上进行改良研制，在原功能主治的基础上增加"流行性感冒属热毒袭肺证者"，同时增 加"成人"适用人群。适用于清热解毒，宣肺止咳，化痰平喘。用于感冒，支气管炎，喘息性支管炎，支 气管肺炎属痰热壅肺证者。流行性感冒属热毒袭肺证者。 ...

6月3日，东营市人民医院(山东省立医院集团东营医院)心血管内科召开"一项在近期有急性心肌梗死病 史的受试者中评估自行皮下注射selatogrel预防全因死亡和治疗急性心肌梗死有效性和安全性的多中心、 随机、双盲、安慰剂对照、平行分组研究"启动会。 此次启动会的成功召开，彰显了东营市人民医院在心血管疾病领域的临床研究实力。医院药物临床试验 机构将继续秉持科学严谨的态度，深化国内外科研合作，推动临床研究规范化建设，为提升医院综合实 力和学科影响力注入新动力。(大众新闻记者巩奕含) 本研究的主要目的是评估有急性心肌梗死(AMI)复发风险的受试者发生提示AMI症状后自行给予 selatogrel的临床有效性。启动会由山东省立医院派驻心血管内科名誉主任韩伟中主持。药物临床试验机 构办公室主任李振卿及成员、心血管内科专业研究团队、CRO代表等相关人员参加启动会议。此项目 是东营市人民医院心血管内科启动的首个注册类全球多中心药物临床试验，该项目由韩伟中担任主要研 究者。 会上，CRA就项目研究背景、方案研究设计、入选标准、排除标准、疗效指标、安全性指标、给药方 案等内容，从临床试验情况、研究评估指标、禁忌伴随用药、知情同意 ...

陈波介绍，GLP-1R/GIPR双靶点长效多肽类激动剂HDM1005（poterepatide）注射液，正在开展体重管 理适应症II期临床试验，已于2025年4月完成II期全部受试者入组，预计2025年Q4进入III期临床研究。 此外，糖尿病适应症II期临床试验已于2025年4月完成首例受试者入组。报告期内，HDM1005注射液新 适应症IND申请先后获得NMPA批准，分别用于阻塞性睡眠呼吸暂停（OSA）合并肥胖或超重成人患者 的治疗、射血分数保留心力衰竭（HFpEF）合并肥胖或超重成人患者的治疗。 互动交流环节，华东医药董事会秘书陈波表示，口服小分子GLP-1受体激动剂HDM1002 （conveglipron），已于2025年4月完成体重管理适应症临床III期研究的首例受试者入组，计划于2025年 6月底前完成全部受试者入组。此外，糖尿病适应症临床II期研究正在顺利开展中，预计2025年Q3获得 顶线结果，并于2025年下半年进入III期临床研究。 他指出，FGF21R/GCGR/GLP-1R三靶点激动剂DR10624注射液目前正在中国开展治疗合并肝纤维化高 风险的代谢相关脂肪性肝病以及代谢合并酒精相关脂 ...

Core Insights - Trevi Therapeutics, Inc. reported positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), achieving the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups at week six [1][2]. Group 1: Trial Results - The 108 mg BID, 54 mg BID, and 27 mg BID dose groups achieved reductions from baseline of 60.2%, 53.4%, and 47.9%, respectively, compared to a placebo reduction of 16.9% [2]. - A rapid reduction in 24-hour cough frequency was observed at week two, with 65% of patients on 108 mg BID, 63% on 54 mg BID, and 60% on 27 mg BID experiencing a 50% reduction at week six, compared to 19% of placebo patients [5]. - Statistically significant improvements were noted in secondary endpoints for the 108 mg BID and 54 mg BID dose groups, including a mean reduction of 3.0 points for 108 mg BID and 3.2 points for 54 mg BID on the cough-severity numerical rating scale, compared to a 1.5-point reduction for placebo [5]. Group 2: Safety and Discontinuation - Discontinuation rates due to adverse events were similar between the Haduvio (5.6%) and placebo groups (5%) [4]. Group 3: Stock Performance - Following the announcement, Trevi Therapeutics' stock declined by 10.45%, trading at $5.83 [4].

Group 1 - The core viewpoint is that Zai Lab (09688) has seen a significant stock increase of over 10% following the release of its Q1 financial results, which showed a total revenue of $106 million, a year-on-year increase of 22.19% [1] - The company's R&D expenditure for the same period was $60.73 million, reflecting an 11.13% year-on-year increase [1] - Notably, the product revenue net for Q1 2025 reached $105.7 million, compared to $87.1 million in Q1 2024, marking a 21% year-on-year growth, and a 23% growth when adjusted for fixed exchange rates [1] Group 2 - The upcoming ASCO conference is expected to showcase updated data from the global phase 1a/1b clinical study (NCT06179069) focusing on DLL3 ADC for treating ES-SCLC, which is anticipated to be a significant catalyst for the company [2] - The ZL-1310 (DLL3 ADC) is highlighted as a key product in the pipeline, with updated data on ORR/DOR/safety expected to be presented at the ASCO conference, involving approximately 70 patients [2] - The company is projected to initiate a pivotal clinical trial for 2L+ SCLC in the second half of 2025, along with the potential for international licensing opportunities following the data update [2]

Financial Performance - Karyopharm Therapeutics reported quarterly losses of $2.77 per share, which was better than the analyst consensus estimate of losses of $4.16 per share [1] - The company reported quarterly sales of $30.02 million, missing the analyst consensus estimate of $35.24 million [1] Clinical Trial Update - The Phase 3 SENTRY trial in patients with JAKi-naïve myelofibrosis has passed its pre-specified futility analysis and continues as planned without modifications [2] - New data in hard-to-treat myelofibrosis patients showed spleen volume reduction, symptom improvement, hemoglobin stabilization, and evidence of disease modification with selinexor monotherapy [2] Sales Guidance and Market Reaction - Karyopharm affirmed FY2025 sales guidance of $140.00 million to $155.00 million, compared to market estimates of $149.32 million [3] - Following the earnings announcement, Karyopharm shares fell 15.6% to trade at $5.17 [3] Analyst Ratings and Price Targets - Baird analyst Michael Ulz maintained an Outperform rating and lowered the price target from $54 to $42 [8] - Barclays analyst Peter Lawson maintained an Overweight rating and raised the price target from $5 to $10 [8] - RBC Capital analyst Brian Abrahams maintained an Outperform rating and lowered the price target from $34 to $33 [8]