Precancerous Conditions

Epigenetic test for risk-stratification impacts gastroenterologists' decision making and improves confidence when caring for patients with Barrett's esophagus. BALTIMORE, Oct. 28, 2024 /PRNewswire/ -- Previse, a gastrointestinal health company, today announced the company presented prospective real-world clinical utility data for Esopredict at the 2024 American College of Gastroenterology Annual Scientific Meeting (ACG) being held October 25-30 in Philadelphia, PA and virtually. This presentation, awarded for Outstanding Poster Presentation, underscores Previse's commitment to clinicial impact and innovation with Esopredict, the first and only clinically validated and commercially available epigenetic test designed to aid gastroenterologists in optimizing care of patients diagnosed with precancerous Barrett's esophagus. About the poster presentation: Presentation Title: A COMMUNITY-BASED STUDY TO ASSESS A PROGNOSTIC ASSAY'S IMPACT ON GASTROENTEROLOGISTS' BARRETT'S ESOPHAGUS PATIENT SURVEILLANCE AND TREATMENT RECOMMENDATIONS The prospective study evaluates the clinical utility of real-world Esopredict testing in patients with Barrett's esophagus (BE) at multiple gastroenterology centers throughout the United States. Results demonstrate increased intensive surveillance and endoscopic treatment in higher risk patients, reduced surveillance in lower risk patients, and higher confidence in surveillance and treatment decisions. "The ACG Annual Scientific Meeting provides a premiere forum to showcase the real-world versatility of Esopredict, a prognostic solution that offers clinical value to gastroenterologists to support patient needs across the BE care spectrum," said Daniel Lunz, Chief Executive Officer at Previse. "This data demonstrates how Previse is transforming the care and treatment landscape for patients living with Barrett's esophagus." About Previse and Esopredict Established in 2018, Previse is a gastrointestinal health company with a primary focus on chronic acid reflux related diseases, including esophageal cancer. Previse's mission is to save lives and improve patient health through prevention and early detection. Previse leverages groundbreaking biomarker technology developed by Stephen Meltzer, M.D., and his GI Early Detection Biomarker Lab at the Johns Hopkins University School of Medicine. This technology, backed by funding from the National Institutes of Health (NIH) and decades of research, forms the foundation of Previse's commitment to combating GI diseases, including cancer. At the forefront is Esopredict, a highly sensitive epigenetic test designed to predict the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in patients with precancerous Barrett's esophagus. With a turnaround time of about two weeks after a sample is received, Esopredict empowers gastroenterologists to tailor effective treatment strategies, marking a pivotal advancement in the battle against esophageal cancer. For additional information about Esopredict, please visit . SOURCE Previse WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Data from a wide range of the Sun Pharma dermatology portfolio, including data on alopecia areata, psoriasis, acne and actinic keratosis products, will be highlighted during the meeting. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced it will present more than a dozen posters at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. The presentations will include data from across the Sun Pharma dermatology portfolio, including study results for LEQSELVI™ (deuruxolitinib), WINLEVI® (clascoterone), ILUMYA® (tildrakizumab-asmn), ODOMZO® (sonidegib) and LEVULAN® KERASTICK® (aminolevulinic acid HCl) + BLU-U® (blue light photodynamic therapy). "As an organization dedicated to supporting the dermatology community, the Fall Clinical Dermatology Conference offers a vitally important forum to present new data and highlight how Sun's innovative dermatology portfolio can support those living with alopecia areata, psoriasis, acne and other skin-related diseases," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We look forward to sharing data from across our portfolio with the dermatology research community and our esteemed industry colleagues." Six abstracts, accepted for poster presentations, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib). Approved earlier this year by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata, LEQSELVI™ is an oral JAK inhibitor that interrupts the pathways thought to contribute to hair loss in severe AA and delivered statistically significant efficacy at 24 weeks across two Phase 3 clinical trials. LEQSELVI™ data being presented at Fall Clinical showcase pooled long-term results for ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata. Additionally, two posters will present patient and clinician preferences for the treatment of alopecia areata. The WINLEVI® poster presentations will include new data showing significant reductions in casual facial sebum levels from baseline, stability in the presence of other commonly prescribed acne medications, and efficacy and safety from a pilot study in patients with skin of color. The conference will also feature data from three additional WINLEVI® studies. Sun Pharma will present the following posters at the 2024 Fall Clinical Dermatology Conference: LEQSELVI™ Presentations: Deuruxolitinib results in ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata: Pooled long-term efficacy and safety data from the open-label extension studies Patient Preferences for the Treatment of Alopecia Areata A Discrete Choice Experiment to Assess Clinician Preferences for the Treatment of Alopecia Optimization of deuruxolitinib dosing in adult patients with alopecia area: Results from a randomized, parallel-group, multicenter Phase 2 trial Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials WINLEVI® Presentations: Clinical evaluation of the sebum reduction induced by clascoterone cream 1%: Week 12 interim analysis Assessment of clascoterone cream 1% levels when layered with other topical acne medications Efficacy and safety of clascoterone cream 1% in patients with acne with skin of color: 16-week interim analysis The efficacy and safety of clascoterone cream 1% for the treatment of acne vulgaris are not dependent on patient age and sex: Results of a post hoc analysis Improvement in skin moisturization and lack of barrier damage with clascoterone cream 1% treatment: Results of a randomized, single-blind, split-face study in acne-prone individuals Comparison of the efficacy of clascoterone vs trifarotene and tazarotene for the treatment of acne vulgaris at Week 12: A systematic review and meta-analysis ILUMYA® Presentation: A systematic literature review and meta-analysis of the real-world effectiveness, quality of life, and safety of tildrakizumab for moderate-to-severe plaque psoriasis ODOMZO® Presentation: Lower rate of discontinuation of sonidegib compared to vismodegib in a real-world analysis of patients with basal cell carcinoma LEVULAN® KERASTICK® + BLU-U® Presentation: Evaluating the safety and efficacy of aminolevulinic acid 20% topical solution activated by blue light in the treatment of facial cutaneous squamous cell carcinoma in situ About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

全球药物批准/研发动态 01 全球新药批准情况 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）共有6个新药获批上市。其中，BLA批准2个，新适应症批准4个。与上个统计周期相比，本次增加2个批准新药。 10月15日，君实生物宣布抗PD-1单抗药物特瑞普利单抗的上市申请已先后在印度和中国香港获批上市，用于复发/转移性鼻咽癌的治疗。此次获批的适应症分别为：1）特瑞普利单抗联合顺铂/吉西他滨作为转移性或复发性局部晚期鼻咽癌成人患者的一线治疗；2）特瑞普利单抗单药治疗既往含铂治疗过程中或治疗后疾病进展的复发性、不可切除或转移性鼻咽癌的成人患者。研究结果显示，特瑞普利单抗联合化疗使患者的疾病进展风险降低48%，死亡风险降低37%，PFS对比单纯化疗延长了13.2个月。 10月18日，德琪医药宣布，MFDS已批准希维奥®（塞利尼索片）的补充新药上市申请，联合硼替佐米和地塞米松用于治疗至少接受过一种先前治疗的多发性骨髓瘤成人患者。塞利尼索片是一款全新机制的口服选择性核输出蛋白（XPO1）抑制剂。通过抑制核输出蛋白XPO1，该产品可促使肿瘤抑制蛋白和其他生长调节蛋白的核内储留和活化，并下调细胞浆内多种致癌蛋白水平。 全球（不含中国）新药批准情况（部分） 02 全球新药申报进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）共有10个新药申报上市。其中，NDA申报8个，BLA申报2个。与上次统计周期相比，本次增加4个NDA/BLA申报。 10月15日，恒瑞医药公告称其重新提交的注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片用于不可切除或转移性肝细胞癌患者的一线治疗的BLA获得FDA受理。研究结果显示，此疗法具有显著的生存获益和可耐受的安全性，中位PFS为5.6个月，中位OS达到23.8个月。 NDA/BLA申报（部分） 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）共有4个药物获监管机构特殊资格认定。其中，化学药2个，生物药1个，疫苗1个。与上次统计周期相比，本次减少2个获监管机构特殊资格认定的药物。 10月15日，Immuneering宣布FDA已授予IMM-1-104孤儿药资格认定，用于治疗胰腺癌。IMM-1-104旨在通过每日一次给药对MAPK通路的深度循环抑制，实现普遍的RAS活性，即选择性地影响癌细胞。IMM-1-104目前正在晚期实体瘤（包括胰腺癌）患者中进行IIa期临床试验，其中最近报道了联合改良吉西他滨/白蛋白结合型紫杉醇治疗的一线胰腺癌患者的阳性初始反应数据。 10月16日，Theriva Biologics宣布EMA已授予VCN-01孤儿药产品资格，用于治疗视网膜母细胞瘤。VCN-01是一种全身给药的溶瘤腺病毒，旨在选择性和侵袭性地在肿瘤细胞内复制并降解肿瘤基质。这种独特的作用方式使VCN-01能够通过以下方式发挥多种抗肿瘤作用：（i）选择性感染和裂解肿瘤细胞;（ii）加强联合给药化疗产品的可及性和灌注;（iii）增加肿瘤免疫原性并使肿瘤暴露于患者的免疫系统和联合给药的免疫治疗产品。全身给药使VCN-01能够对原发肿瘤和转移瘤发挥作用。 特殊资格认定情况（部分） 03 全球新药研发进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）新药临床研发状态更新共计46条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及免疫系统疾病等共计13个领域。 其中，感染领域临床进展更新居各领域之首，为10条：涉及化学药3条，生物药3条，细胞疗法2条。 10月15日，Celltrion公布了皮下注射英夫利昔单抗（CT-P13 SC）的2年事后分析结果，强调剂量递增是管理炎症性肠病反应丧失的一种选择。分析表明，对于最初有反应但随后失去反应的患者，静脉内（IV）诱导后CT-P13 SC的剂量递增在102周的延长时间内显示出临床疗效，患者UC的平均改良Mayo评分和CD的平均CDAI评分具有统计学意义降低。 10月16日，长春高新发布公告称，其子公司金赛药业GenSci122片项目获得FDA新药临床试验默示许可。GenSci122是具有新型结构的小分子KIF18A抑制剂，KIF18A抑制剂与染色体不稳定（CIN）及全基因组加倍（WGD）+构成合成致死。与正常二倍体细胞相比，KIF18A在CIN肿瘤细胞中高表达，具有CIN特性的肿瘤细胞对KIF18A具有依赖性。靶向抑制KIF18A可作为肿瘤的潜在治疗策略，同时不会显著影响正常二倍体细胞的增殖。 全球新药研发进展详情（部分） 04 全球医药交易事件 本次统计周期（2024.10.12-10.18）全球（含中国）医药交易时间共计33起，涉及药物权益转让、公司并购等多起交易事件。 全球医药交易时间汇总表（部分） 国内药物批准/研发动态 01 国内新药批准情况 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有4个新药获NMPA批准上市。其中，BLA批准1个，新适应症批准3个。与上次统计周期相比，本次减少4个NMPA批准新药。 10月14日，NMPA官网公示，Roche的法瑞西单抗（Faricimab）注射液新适应症上市申请获得批准，用于治疗视网膜中央静脉阻塞（CRVO）继发黄斑水肿。法瑞西单抗可同时靶向阻断两条致病关键通路，在原有抑制新生血管生成的基础上同时提高血管稳定性，降低血管异常渗漏，改善患者的视力。研究表明，对于由CRVO引起的黄斑水肿患者，每4周接受法瑞西单抗注射（长达24周）视力获得具有非劣效性，从基线到第24周，法瑞西单抗能使患者的视网膜液迅速干燥。 10月14日，NMPA官网公示由Daiichi Sankyo申报的注射用德曲妥珠单抗（Enhertu）已经获得上市批准，用于治疗存在HER2激活突变且既往接受过至少一种系统治疗的不可切除或转移性成人非小细胞肺癌（NSCLC）患者。研究结果显示，在既往经治HER2突变NSCLC中国患者中实现ORR近60%，DCR超过91%，多个疗效指标显示德曲妥珠单抗带来了具有临床意义和持久的缓解，而且安全性可控。 国内新药批准情况（部分） 02 国内新药临床默示许可进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有59个新药获临床默示许可，涉及100个受理号。其中，化学药29个，治疗用生物制品28个，预防用生物制品2个。与上次统计周期相比，本次增加66个临床默示许可获批受理号。 本周国内新药临床默示许可进展（部分） 03 国内新药申报进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有18个新药申报上市，涉及29个受理号。其中，化药8个，治疗用生物制品8个，预防用生物制品2个。与上个统计周期相比，本次增加9个新药申报上市受理号。 国内新药申报上市情况（部分） 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有67个新药申报临床，涉及100个受理号。其中，化学药36个，治疗用生物制品30个，预防用生物制品1个。与上次统计周期相比，本次增加69个临床申报受理号。 国内新药临床申报情况（部分） 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有4个药物获NMPA特殊资格认定。其中，化学药1个，生物药2个，疫苗1个。与上次统计周期相比，本次增加3个获监管机构特殊资格认定的药物。 10月15日，NMPA药品审评中心官网最新公示，和其瑞医药申报的1类新药HMI-115拟纳入突破性治疗品种，适应症为治疗子宫内膜异位症相关的中重度疼痛。HMI-115是一款靶向泌乳素受体（PRLR）的单抗新药，PRLR表达失调可能与子宫内膜异位症的发病机制有关，而靶向催乳素和催乳素受体的药物可能改善和控制该疾病相关的疼痛。研究公示信息显示，HMI-115的给药方式为皮下给药，只需每2周一次，共6个治疗周期。 同日，NMPA药品审评中心官网公示南京远大赛威信生物医药有限公司申报的1类新药TVAX-008注射液拟纳入突破性治疗品种，适用于治疗慢性乙型肝炎病毒（HBV）感染。TVAX-008利用多靶点乙肝表面抗原（HBsAg）和HBcAg联合CpG寡聚脱氧核苷酸佐剂，其中HBsAg/HBcAg促进体液免疫，恢复Th1/Th2平衡；CpG激活B细胞和pDC的TLR9，诱导针对乙肝病毒的细胞免疫。该产品可通过不同途径呈递乙肝抗原，打破机体的免疫耐受，有效诱导免疫应答，从而达到治疗和控制慢性乙肝感染的效果。 国内监管机构特殊资格认定药物 04 国内新药研发进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内新药临床研发状态更新共计4条，涉及肿瘤、消化系统、遗传和代谢疾病以及皮肤病共计4个领域。其中，化学药1条，生物药3条。与上次统计周期相比，本次减少2条国内新药临床研发状态更新。 10月13日，博瑞医药宣布BGM0504在非糖尿病的超重或肥胖受试者中开展的II期临床试验，达到主要终点和关键次要终点。BGM0504是一款靶向胰高血糖素样肽1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体双重激动剂，每周给药一次。非糖尿病24周平均减重18.5%和减腰围13.4cm，并显著降低多项心血管代谢风险指标，增加胰岛素敏感性，耐受性和安全性良好。 10月17日，信达生物宣布匹康奇拜单抗（IL-23p19抗体）治疗溃疡性结肠炎的II期临床研究达成主要终点：诱导治疗期第12周时，匹康奇拜单抗200mg组和600mg组达到临床缓解的受试者比例分别是20.0%和14.0%，达到临床应答的受试者分别为54.0%和68.0%，达到症状缓解、内镜缓解或黏膜愈合的受试者比例均高于安慰剂组，总体安全性良好。 国内新药研发进展（部分） 05 国内新药研发领域政策法规动态 关于公开征求《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》意见的通知 为进一步指导放射性治疗药物申报上市时的风险管理，我中心组织起草了《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》。 我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻 翰森制药「熬出头了」 2019年之前，翰森制药还是一家以仿制药为主的传统制药企业，仿制药业务收入和利润增速的放缓，让其下定决心转型创新药。 然而，创新转型并非一帆风顺。2022年，翰森制药创新药数量从2019年之前的1款增加到7款，创新药收入占比也首次超过了仿制药，达到了50.6%，但也就是在这一年，翰森制药营收和净利润首次出现负增长。 直到2024年中报业绩出炉，营收65.06亿元，同比增长44.21%，净利润27.26亿元，同比增长111.47%，创新药收入占比高达77.34%。一切质疑烟消云散，翰森制药进化到了势不可挡的阶段。更多资讯，请阅读原文 宜明昂科，下一代Biotech龙头浮出水面？ 随着双抗出海升温，研发管线以双抗为主的宜明昂科-B，股价自9月12日以来累计涨幅高达约100%。 资本市场的加持，加之双抗管线达成大额BD交易，下一代Biotech龙头正在浮出水面。 商业化近在咫尺 对于带“B”标签的Biotech，投资者最关心的问题就是：什么时候能实现扭亏为盈？ 随着越来越多Biotech凭借管线出海实现盈利，宜明昂科也紧跟这一趋势，达成了大额BD交易。更多资讯，请阅读原文 咨询、合作请联系作者 小D有话说 为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“1024创新药周报”，即可下载。