Berberine Ursodeoxycholate

6月24日，周一，港股18A上市的Biotech公司君圣泰医药开盘即下跌，盘中最大跌幅一度超过61%，触及1.38港元续创上市新低，最终收盘跌幅57.66%。 君圣泰医药于2023年12月22日在港交所敲钟，距离其上市时间不过半年而已。此次IPO，君圣泰医药发行价格为每股11.5港元，首日收盘价格为12.38港元/股，此后曾经创下13.18港元/股的最高价，市值一度超过60亿港元。 值得注意的是，该股上市半年来股价一路向下。昨日收盘股价定为1.52港元/股，也就是说，在短短半年之内，君圣泰医药的股价，已经从最高点下跌近9成。 下跌原因，众说纷纭，比较主流一种说法是解禁了。 在上市前，君圣泰医药背后的投资方阵容就十分豪华。招股书显示，2011年-2022年，君圣泰医药共获得7轮投资，包括泰格医药、中信证券等20余家机构合计获得约14.4亿元人民币。 但值得注意的是，君圣泰医药的天使投资人——深圳海普瑞医药此前便已频频套现离场。根据君圣泰披露的招股书信息，君圣泰医药大股东海普瑞分别在2022年4月、9月和10月向第三方转让63.18万股、46.1万股和37.17万股股份，累计套现788.08万美元。 君圣泰医药成立于2011年，致力于原创药物开发，专注于慢性肝病、胃肠道疾病及代谢疾病领域，以满足全球巨大的临床需求目前已自主开发包含5款候选产品，涵盖9种适应症，其中的5个适应症项目已处于临床开发阶段。但管线中尚未实现产品商业化也没有营业收入。 具体来看，产品主要聚焦在代谢领域。核心产品HTD1801目前已经在国内开展临床Ⅲ期试验，适应症是II型糖尿病，其他适应症是代谢异常性脂肪性肝炎等，基本都在II期或之前，进度比较缓慢。 其他还包括用于酒精性肝炎治疗的HTD4010的早期临床开发、治疗肥胖症的HTD1804、治疗代谢疾病的HTD1805、治疗炎症性肠病的HTD2802等。进度较慢，短期内不会有上市的可能。 从年报来看，由于持续大额的研发投入，君圣泰医药近年亏损不断。数据显示，2022年和2023年，君圣泰医药的研发投入分别为1.83亿元和3.12亿元。而同期经调整净亏损分别达到1.84亿元和2.88亿元。 此外，在现金流方面，2023年公司经营性现金流净流出高达3.58亿元，同比扩大107.63%，账上尚有现金6亿人民币，短期运营无风险。 君圣泰医药就股价不寻常波动声明，经作出合理查询后，确认并不知悉任何有关股份价格近期出现波动的原因，亦确认集团的业务营运维持正常，且业务营运及财务状况并无发生任何重大不利变动。截止发稿，今日股价上涨15%。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信 wfj_GM 商务合作 稿件征集 点击了解详情 往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

ROCKVILLE, MD and SHENZHEN, CHINA, HighTide Therapeutics, Inc. (Stock Code: 2511.HK), a clinical stage biopharmaceutical company specializing in the development of multi-targeted therapies for chronic liver and metabolic diseases, announced that it will make multiple presentations at the European Association for the Study of the Liver (EASL) Congress, taking place from June 5-8, 2024 in Milan, Italy. The presentations include post-hoc analyses of the Phase 2a clinical study of berberine ursodeoxcyholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM) (NCT03656744). “These data provide additional insight on the potential benefits of HTD1801, a novel, multifunctional therapy being developed for the treatment of patients with MASH and T2DM. The ongoing multi-regional Phase 2b study (CENTRICITY, NCT05623189), now fully enrolled, evaluates the histologic benefit of HTD1801 in this same patient population. We look forward to the results of CENTRICITY which is on track to read out in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide. “Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM” (Abstract SAT-227, Poster Presented June 8) About the Abstract: As GLP-1 Receptor Agonists (GLP-1RAs) are prominently used in patients with T2DM and gaining attention as a potential treatment for MASH, this post-hoc comparative efficacy analysis evaluated ongoing GLP-1RA use compared to newly initiated HTD1801 treatment. This analysis suggests that HTD1801 provides greater benefit across multiple cardiometabolic endpoints compared to ongoing GLP-1RA use. These findings are important as they suggest that patients with MASH and T2DM, on concomitant GLP-1RA treatment, could achieve additional benefit with HTD1801 in terms of further glucose and lipid lowering as well as weight loss. “Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance” (Abstract SAT-225, Poster Presented June 8) About the Abstract: Insulin resistance is a significant risk factor for T2DM, obesity and MASH. HTD1801 enhances the utilization of glucose and fats through activation of AMP-activated protein kinase (AMPK), thereby improving insulin sensitivity. As HTD1801 is under development as a treatment for patients with MASH and T2DM, the objective of this post-hoc analysis was to evaluate the effects of HTD1801 based on degree of insulin resistance. These data demonstrate that HTD1801 can alleviate the metabolic inhibitory effects caused by hyperinsulinemia, leading to even greater metabolic benefits in patients with MASH and more severe insulin resistance and therefore may offer a unique therapeutic approach for individuals with MASH and T2DM. “Time Course of Onset, Incidence, and Prevalence of Gastrointestinal Adverse Events with HTD1801 (Berberine Ursodeoxycholate) in Patients with MASH and T2DM” (Abstract SAT-243, Poster Presented June 8) About the Abstract: The most commonly occurring adverse events (AEs) in studies of HTD1801 across several indications have been mild to moderate gastrointestinal (GI) AEs, primarily diarrhea and nausea. The purpose of this post-hoc analysis was to characterize the time course and severity of GI AEs in patients with MASH and T2DM treated with HTD1801 for 18 weeks. Diarrhea and nausea, the most commonly occurring of GI AEs, followed a trend that was consistent with all reported GI AEs; they showed early onset (within the first 4 weeks), were mild or moderate in severity, and importantly, showed a decreasing incidence and prevalence over the course of treatment. These data demonstrate that with continued treatment with HTD1801, GI tolerability improves supporting its potential for long-term use for the treatment of chronic disease, such as MASH. About HighTide Therapeutics HighTide Therapeutics, Inc. (HKEX: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project. Disclaimer The information contained herein is based solely on events or data available as of the date of this document. Unless required by law, we are under no obligation to update or publicly revise any forward-looking statements or events beyond those anticipated, even if new information, future events, or other circumstances arise after the date of the forward-looking statement. Please review this document carefully and be aware that our actual future performance or results may significantly deviate from expectations. All statements in this document are made as of the publication date and may change considering future developments. For more information, please visit Contact: pr@hightidetx.com