Jeil Pharmaceutical Co., Ltd.

The European Commission approved Pierre Fabre Laboratories’ Obgemsa (vibegron) for the symptomatic treatment of overactive bladder (OAB) syndrome in adults, more than three years after being cleared by the FDA. The decision follows a positive stance adopted by the European Medicines Agency's (EMA) drug advisory body in April. Eric Ducournau, CEO of Pierre Fabre said the approval “will allow European patients to benefit from a new therapeutic option for OAB,” which is estimated to affect more than 70 million people in the region. The approval was backed by findings from the Phase III EMPOWUR trial and a 52-week extension study, which showed that the 75-mg daily dose of Gemtesa significantly improved urgency, increased urination frequency, and urge urinary incontinence in patients with OAB compared with placebo.In 2022, Pierre Fabre gained an exclusive license to commercialise vibegron in the EU from Sumitomo Pharma’s subsidiary Urovant Sciences, which markets it as Gemtesa in the US. The once-daily oral drug is also approved to treat symptoms of OAB in Japan and South Korea under the name Beova, where it is marketed by Kyorin Pharmaceutical and JEIL Pharmaceutical, respectively.

韩国首尔 2024年4月25日 /美通社/ -- 韩国领先的生物技术公司Onconic Therapeutics今天宣布，韩国食品药品安全部(MFDS)已批准JAQBO（zastaprazan柠檬酸盐）用于治疗成人侵蚀性胃食管反流病(GERD)。 JAQBO作为下一代钾竞争性阻断剂(P-CAB)，有望成为胃酸相关疾病治疗的新标准。它能够通过竞争方式直接与质子泵结合，减少胃酸分泌。这种创新机制无论胃酸水平如何，都能迅速发挥作用，立即缓解症状。此外，JAQBO的胃酸抑制作用持续时间更长，且不受食物摄入的影响，从而为胃食管反流病的治疗提供了新的典范。 MFDS批准JAQBO的依据主要基于其在韩国28个地点进行的III期临床试验的综合结果。该研究证明了JAQBO对侵蚀性食管炎具有疗效，治疗8周后的治愈率高达97.9%。这些成果已在2023年10月举行的欧洲联合胃肠病学周(United European Gastroenterology Week)上公布。 Onconic Therapeutics的目标是，在韩国申请国家医疗保险报销后，于今年推出JAQBO。JAQBO在韩国国内的销售工作将由Onconic Therapeutics的母公司Jeil Pharmaceutical负责。 2023年3月，JAQBO被授权给中国领先的质子泵抑制剂(PPI)销售商丽珠医药集团进行大中华区的开发和商业化，交易价值为1.275亿美元。 Onconic Therapeutics致力于通过不断扩大适应症范围来加强胃肠道治疗并改善患者预后。 关于 Onconic Therapeutics Onconic Therapeutics 是韩国开发新型药物的佼佼者，专注于创新研究和卓越临床实践。该公司致力于提升患者的治疗效果，为癌症和胃肠道疾病提供优质医疗解决方案。 前瞻性陈述 本新闻稿包含前瞻性陈述，这些陈述基于我们当前的预期、预测和假设。这些陈述涉及风险和不确定性，可能导致实际结果与预期或预测的结果存在实质性差异。前瞻性陈述包括有关我们未来财务业绩、业务战略、计划和目标的陈述。可能导致这些差异的因素包括但不限于经济状况、市场需求、竞争压力和监管变化。我们没有义务更新任何前瞻性声明以反映本新闻稿发布日期之后的事件或情况。

SEOUL, South Korea, April 25, 2024 /PRNewswire/ -- Onconic Therapeutics, a leading biotechnology company in Korea, today announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in adults. JAQBO is a next-generation potassium competitive blocker (P-CAB) expected to become the new standard treatment in the market for gastric acid related diseases. JAQBO directly binds to proton pumps in a competitive manner to reduce gastric acid secretion. This novel mechanism allows quick onset of action regardless of the acidity level in the stomach, offering immediate symptom relief. In addition, longer duration of acid suppression with no food effect could provide a new paradigm in GERD treatment. The MFDS approval of JAQBO is based on comprehensive results including the Phase III clinical trial across 28 sites in Korea. The study demonstrated JAQBO's effectiveness on erosive esophagitis, with a healing rate of 97.9% after 8 weeks of treatment. These results were presented at the United European Gastroenterology Week in October 2023. Onconic Therapeutics aims to launch JAQBO this year after listing for National Healthcare Insurance Reimbursement in Korea. Domestic sales of JAQBO will be handled by Jeil Pharmaceutical, Onconic Therapeutics's parent company. In March 2023, JAQBO was licensed out to Livzon Pharmaceutical Group, the leading seller of PPIs in China for development and commercialization, in a deal value of $127.5 million for Greater China. Onconic Therapeutics is committed to enhancing gastrointestinal treatment and improving patient outcomes by expanding additional indications. About Onconic Therapeutics Onconic Therapeutics is a Korean leader in developing novel drugs. With a focus on innovative research and clinical excellence, Onconic Therapeutics is dedicated to improving patient outcomes and providing quality healthcare solutions for cancer and gastrointestinal disorders. Forward-Looking Statement This press release contains forward-looking statements that are based on our current expectations, forecasts, and assumptions. These statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected. Forward-looking statements include statements about our future financial performance, business strategy, plans and objectives. Factors that could cause such differences include but are not limited to economic conditions, market demand, competitive pressures, and regulatory changes. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. SOURCE Onconic Therapeutics