Botulinum toxin type A(HSM)

药·械 追踪Products NewsNo.1 /礼来阿尔兹海默病候选药Donanemab拟优先审评近日，据CDE最新公示，礼来旗下Donanemab注射液拟纳入优先审评程序，用于治疗早期阿尔茨海默病。治疗应该在患者处在疾病轻度认知障碍阶段或轻度痴呆阶段时开始，该人群也是临床试验中开始Donanemab治疗的人群。靶向淀粉样蛋白是阿尔茨海默病新药开发的重要方向之一。Donanemab此前已获得美国FDA授予突破性疗法认定，并被中国CDE纳入突破性治疗。->点击阅读原文，解锁完整双语新闻No.2 /亿腾医药心血管领域创新药上市申请获受理11月14日，亿腾医药旗下心血管创新药唯思沛（二十碳五烯酸乙酯）的上市申请获得NMPA受理，适应证为唯思沛与他汀类药物联合使用，用于确诊心血管疾病或糖尿病伴≥2 种其他心血管疾病危险因素，合并高甘油三酯血症的成年患者，以预防和降低心血管事件风险。唯思沛由AMARIN公司开发，是美国FDA在2013年批准的首款采用专利技术生产的高度纯化的二十碳五烯酸（EPA）乙酯，用于降低严重高甘油三酯血症（≥500 mg/dL）成人患者的甘油三酯水平。->点击阅读原文，解锁完整双语新闻No.3 /广生堂新冠口服药泰中定上市申请获NMPA受理近日，广生堂发布公告称，旗下抗新冠病毒口服1类创新药泰中定（GST-HG171片联合利托那韦片）的新药上市申请获得NMPA受理。泰中定是150mg GST-HG171（阿泰特韦）片与100mg利托那韦片的药物组合。利托那韦是针对病毒蛋白酶的多种口服抗病毒药物的药代动力学增强剂，由艾伯维原研，国内首仿来自歌礼。->点击阅读原文，解锁完整双语新闻企业动态Companies NewsNo.1 /东诚药业与EZP集团达成合资及同位素产研合作近日，东诚药业宣布，其全资子公司东诚核医疗与 Eckert & Ziegler Radiopharma Projekte UG签署了《合资协议》。基于《合资协议》，双方就齐康原及共同合作开发医用同位素达成一致意向。东诚核医疗与EZP将各支付2000 万欧元。->点击阅读原文，解锁完整双语新闻No.2 /华东医药投资重庆誉颜，达成肉毒产品YY001独家战略合作11月14日，华东医药与重庆誉颜制药宣布签署股权投资协议，同时双方达成注射用重组A型肉毒毒素YY001独家经销协议。截至目前，YY001是国内首个获批进行临床试验的重组A型肉毒毒素在研产品，其亦为全球唯一临床阶段的重组A型肉毒毒素在研产品。->点击阅读原文，解锁完整双语新闻No.3 /天勤生物与吉凯基因达成合作，加速药物研发近日，天勤生物与吉凯基因签署战略合作协议。双方达成共识，将在一体化药物毒理安全性评价、临床科研转化项目落地以及资源调配等方面开展深化合作、携手共进。->点击阅读原文，解锁完整双语新闻行业政策Industry PoliciesNo.1 /第四批国家耗材集采将于11月30日在天津开标近日，国家联采办发布《国家组织人工晶体类及运动医学类医用耗材集中带量采购文件（GH-HD2023-1）》，将对人工晶体和运动医学类医用耗材开展带量采购。增材制造技术（即3D打印）类产品可自愿参加。人工晶体类相关耗材：获得中华人民共和国医疗器械注册证的人工晶体耗材（不包括硬性人工晶体、有晶体眼人工晶体，下同）、粘弹剂。人工晶体耗材须包含可与其配套使用的推注器。运动医学类相关耗材：获得中华人民共和国医疗器械注册证的带线锚钉、免打结锚钉、固定钉、固定板、修复用缝线、软组织重建物、骨类重建物（不包括应用于颅颌面产品；含有骨形态发生蛋白BMP类产品可自愿参加）。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20愈年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

PARIS, FRANCE, 3 October 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that its partner Galderma has confirmed receipt from the FDA of a Complete Response Letter related to its Biologics License Application for liquid botulinum toxin type A (QM-1114), noting certain deficiencies related to chemical, manufacturing and controls (CMC) processes. Furthermore, on 28 September 2023, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision on arbitration proceedings that Galderma initiated against Ipsen. This dispute was initiated in July 2021 following a difference of opinion on the regulatory submission strategy for QM-1114 related to the potency-assay testing method used in the release of commercial batches of QM-1114 in the United States, Canada and Australia. The result of this arbitration is that any regulatory applications for QM-1114 in the partnership territories submitted by Galderma shall be assigned to Ipsen as the owner of the intellectual property and marketing authorization of QM-1114. Galderma remains responsible for development, regulatory filing strategy, manufacturing and commercialization. As such, the Tribunal declared that Galderma has the right to decide on QM-1114’s regulatory strategy. On 27 July 2023, Ipsen confirmed that it had notified Galderma of its decision to terminate the Parties’ joint R&D collaboration entered into in July 2014 related to the parties’ respective neurotoxin programs, including the development of IPN10200 (longer-acting neurotoxin). ENDS About Ipsen Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,300 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com About Dysport Dysport®, Ipsen’s botulinum toxin type A, is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm. It was initially developed for the treatment of movement disorders such as cervical dystonia, blepharospasm, hemifacial spasms and spasticity affecting the upper and/or lower limbs in adults and children aged 2 years or older. Dysport® has marketing authorizations in more than 90 countries worldwide. The product is currently referred to as Dysport® for medical and aesthetic markets, and as Azzalure® in aesthetic indications in the E.U. Alluzience®, Ipsen’s botulinum toxin type A is a neuromuscular blocking toxin in liquid formulation, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. About QM-1114 (relabotulinumtoxinA) QM-1114, is an investigational liquid formulation botulinum toxin A (supported by READY-1 / READY-2 / READY-3 / READY-4 Phase III trials sponsored by Galderma), seeking registration for the improvement of both glabellar and lateral canthal lines in adult patients. For further information: Contacts Investors Craig Marks Vice President, Investor Relations +44 (0)7584 349 193 Nicolas Bogler Senior Manager, Investor Relations +33 6 52 19 98 92 Media Amy Wolf VP, Head of Corporate Brand Strategy & Communications +41 79 576 07 23 Ioana Piscociu Senior Manager Global Media Relations +33 6 69 09 12 96 Ipsen’s forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. Attachment Ipsen PR_QM-1114_03102023