Jazz Pharmaceuticals Plc

A new kind of sleeplessness medicine developed by Takeda met its goals in late-stage testing, positioning the company to capitalize on what Wall Street analysts believe could be a multibillion-dollar market opportunity.The drug, formerly known as TAK-861 but now called oveporexton, was evaluated in two Phase 3 studies in a main type of narcolepsy. According to Takeda, oveporexton hit every main and secondary trial endpoint, helping improve patient-reported scores on measures of wakefulness, excessive daytime sleepiness, muscle weakness, and other symptoms after 12 weeks of treatment.The company didnt provide specifics, but said in a Monday statement that drug recipients had statistically significant and clinically meaningful improvements on those assessments, and achieved near normal ranges across studied symptoms.Oveporextons safety profile was consistent with whats been observed in previous clinical tests, Takeda said. The most common adverse events reported were insomnia as well as the sudden urge to urinate. No serious treatment-related side effects were reported, and more than 95% of study participants who completed the trials enrolled in a long-term extension study.The findings build on the transformative results we saw in our Phase 2b study, with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period, Andy Plump, Takedas R&D chief, said in the companys statement.Takeda will file an approval application in the U.S. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting.The results position Takeda as the first company to seek approval of a narcolepsy drug that works by stimulating proteins called orexin receptors. These proteins have an array of effects on the brain, among them a role in maintaining wakefulness. They have long been linked to narcolepsy Type 1, a type of chronic sleeplessness that involves muscle weakness. Theyve attracted the interest of several drug companies, among them Jazz Pharmaceuticals, Alkermes, Johnson & Johnson and Centessa Pharmaceuticals, all of which have brought orexin medicines into clinical testing for either sleep disorders or other conditions.There have been some setbacks. Takeda shelved an earlier orexin-targeting medicine due to liver toxicity, while Jazz stopped an early-stage trial after reporting eye and heart-related side effects.Takedas success in late-stage testing cement[s] [its] lead over its competitors, wrote Jefferies analyst Stephen Barker in a Monday client note. Its drug could achieve $3 billion in peak yearly sales in narcolepsy Type 1 alone, he added.Barker also predicted that Takedas broader portfolio of orexin drugs, which includes medicines in testing for Type 2 narcolepsy and idiopathic hyperinsomnia, may achieve more than double that total. The company, which restructured in 2024, is counting on these and other drugs in late-stage development to help improve growth in the years ahead.Takedas closest competitor in narcolepsy Type 1, Alkermes ALKS 2680, is currently in Phase 2 testing. '

全球医疗行业每日重点资讯文 | 苏丁企业动态7月8日，跨国生物制药企业诺和诺德与天津经开区管委会签署合作谅解备忘录，约定投资约8亿元建设天津生产厂质量检测实验室扩建项目。项目启动活动同日举行。诺和诺德天津生产厂质量检测实验室扩建项目总建筑面积约1.8万平方米，包括化学实验室、微生物实验室和生物实验室等，计划于2026年底建设完成。2024年，投资40亿元的无菌制剂扩建项目启动，时隔一年，又启动了实验室扩建项目，目前，诺和诺德在天津经开区的累计投资已经超过百亿元。Renee Gala将接替爵士制药(Jazz Pharmaceuticals) 的联合创始人Bruce Cozadd，接管该公司。Cozadd于去年12月宣布打算辞职，结束他16年的首席执行官任期。Gala已经在Jazz工作了五年，在2023年10月晋升为首席运营官之前担任首席财务官。她的任命将于8月11日生效。在接管Jazz后，53岁的Gala成为经营制药公司的少数女性首席执行官之一。深圳海王集团股份有限公司与苏州高新区签约，在高新区建设华东区域总部。海王集团是一家医药类大型综合性集团公司，计划在苏州高新区设立海王集团华东区域总部，建设海王制造生产基地项目。该项目分两期建设，总投资50亿元，将建设海王优品保健品生产基地、海王中药谷研发和生产基地。在科兴生物特别股东大会上，投票通过了赛富基金提出的两项提案：罢免公司现任董事，并选举由赛富提名的十位具备高度资质的董事候选人进入公司董事会，新董事会具体成员包括：西蒙·安德森（Simon Anderson，原董事会董事）、付山（维梧资本，原董事会董事）、焦树阁（独立董事）、李嘉强（强新资本）、卢毓琳（独立董事，原董事会董事）、裘育敏（永恩资本）、王宇（独立董事）、肖瑞平（独立董事）、阎焱（赛富基金）、尹卫东（原董事会董事长）。科兴生物确认，公司此前宣布的每股普通股55美元特别现金分红正按计划执行。该分红将发放给截至2025年7月7日交易结束时持有科兴股份的合法股东。太极集团公告，拟分别以“1元”的价格受让间接控股子公司德阳大中药业和四川太极大药房持有的运城数智中药90%股权、10%股权，其全资子公司涪陵制药厂拟分别以284万元的价格受让桐君阁股份和西南药业分别持有的太极海洋药业20%股权。对于交易的原因，前者太极集团称是为了整合内部资源，优化股权架构与管理关系；后者则是为了进一步聚焦主责主业，优化资源配置及资产结构，提高运营效率。药明康德发布2025年半年度业绩预增公告。预计2025年上半年，营业收入约人民币208.0亿元的，同比增长约20.6%，其中持续经营业务收入同比增长约24.2%；经调整Non-IFRS归母净利润约人民币63.1亿元，同比增长约44.4%；扣非归母净利润约人民币55.8亿元，同比增长约26.5%；归母净利润约人民币85.6亿元，同比增长约101.9%。阿里达摩院分享多癌早筛AI的最新进展。其中，达摩院创新性地提出“平扫CT+AI”技术路线，基于门诊和体检大量使用的平扫CT影像，利用AI识别人眼难以发现或容易忽略的病变。达摩院近期与新加坡、沙特阿拉伯等国家的医疗机构达成合作，全球合作网络现已覆盖9个国家和地区，为2000万人次提供AI多癌早筛服务。产业动态艾伯维与Ichnos Glenmark Innovation旗下的IGI Therapeutics达成一项独家许可协议，获得由其专有BEAT蛋白平台所开发的主打疗法ISB 2001在肿瘤及自身免疫疾病领域的全球开发与商业化权利。根据协议条款，艾伯维将获得ISB 2001在北美、欧洲、日本及大中华区的独家开发、生产与销售权。IGI将获得7亿美元首付款，并有望根据后续开发、监管和商业进展，额外获得最多12.25亿美元的里程碑付款。卫材（中国）药业有限公司宣布，创新药多替诺雷片（商品名：优乐思）首批商业化产品正式从卫材中国苏州工厂放行。多替诺雷是中国首个高选择性URAT1抑制剂。苏州工厂内，智能化生产线高效运转，经过严格质量检验的首批多替诺雷产品被有序装箱。亚盛医药宣布，公司自主研发的新型Bcl-2选择性抑制剂利沙托克拉获中国药监局附条件批准上市，用于既往经过至少包含布鲁顿酪氨酸激酶（BTK）抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者。该药也成为中国首个上市用于治疗CLL/SLL的Bcl-2抑制剂，也是全球第二个上市的Bcl-2抑制剂。联系美通社+86-10-5953 9500info@prnasia.com

The European Commission (EC) has granted conditional approval to Jazz Pharmaceuticals’ Ziihera (zanidatamab) to treat a subset of advanced biliary tract cancer (BTC) patients. The human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody has been authorised for use as a monotherapy in adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC who have received at least one prior line of systemic therapy. The EC’s decision was supported by results from the phase 2b HERIZON-BTC-01 trial, which included a cohort of 80 BTC patients with centrally confirmed HER2-positive tumours (cohort one). The study met its primary endpoint of confirmed objective response rate (cORR) in cohort one, with Ziihera demonstrating a cORR of 41.3%, including two complete responses, at a median follow-up of 21.9 months. The median duration of response (DoR) was 14.9 months, and the median overall survival (OS) was 15.5 months. Data from a pre-specified subgroup analysis in 62 patients with IHC 3+ tumours also showed that Ziihera demonstrated a cORR of 51.6%, with a median DoR of 14.9 months and median OS of 18.1 months. BTCs, including gallbladder cancer and cholangiocarcinoma, are a rare and aggressive group of cancers that are often diagnosed at an advanced stage, when curative surgery is no longer an option. Approximately 26% of BTC patients globally have HER2-positive disease, which is associated with poorer outcomes compared to HER2-negative disease. Robert Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, said the conditional approval “represents significant progress” for patients with advanced HER2-positive BTC. “Ziihera is the first HER2-targeted therapy authorised in the EU specifically for this population, and the EC’s decision reflects both the strength of the HERIZON-BTC-01 data and the urgency for innovation in rare gastrointestinal cancers,” Iannone said. In line with EC’s conditional approvals pathway, continued authorisation for Ziihera in this indication is contingent on the verification of clinical benefit in the ongoing phase 3 HERIZON-BTC-302 trial, which is evaluating the drug in combination with standard-of-care therapy in the first-line setting for patients with HER2-positive BTC.