Ocedurenone

新加坡 2025年8月13日 /美通社/ -- KBP Biosciences Pte. Ltd.（"公司/KBP"）今日发布声明，就新加坡国际商事法庭（"SICC"）作出的进一步裁定予以回应。裁定决定维持对公司及其创始人黄振华博士（"黄博士"）的临时禁令，以支持公司与Novo Nordisk A/S（"诺和诺德"）各自启动的仲裁程序。 KBP已先于诺和诺德启动仲裁程序。在SICC作出判决后，诺和诺德所申请禁令的有效性将会在仲裁程序中予以判定。更为重要的是，在判决过程中，SICC审查了争议核心的一系列问题，包括临床试验的开展及尽职调查的充分性。SICC的结论将由仲裁庭进一步审查；相对于SICC，仲裁庭有更充裕的审查时间，也可听取现场证词。 1. 试验指导委员会成员的独立证词 判决引用了由指导委员会成员、在相关领域极具声望的Bertram Pitt博士和Janet Wittes博士提供的独立陈述。这些证据包括Pitt博士和Wittes博士于2024年12月18日发表的公开信函，信中指出"无论是[诺和诺德]还是KBP均未能提供令人信服的证据证明[保加利亚试验中心]的结果造假"。该公开信在此前的单方面听证会上未被提交给SICC。 判决书还指出，若保加利亚试验中心确实存在严重违规或欺诈，"美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）本应采取行动。然而，他们并未回应，而诺和诺德"在先前的单方面（ex parte）听证中也"未披露这一事实"。 2. 统计错误以及"无效性"判定结果 在收购Ocedurenone后的第八个月，诺和诺德以试验"无效"（futile）为由终止了相关临床试验。然而，Parexel International (IRL) Ltd.（"Parexel"）后期"通知诺和诺德，在数据汇总过程中存在统计错误"。判决还指出： " 被告方（KBP ）认为诺和诺德未披露无效性判定（Futility Determination ）中存在的错误。在作出无效性判定后，Parexel 告知诺和诺德，在数据汇总过程中存在统计错误。经纠正后，Ocedurenone 仅符合两项无效性标准中的一项（即符合SBP 无效性标准，但不符合p 值无效性标准），因此，预期假设为"治疗效应有统计学显著性，但幅度有限"，Ocedurenone 仍值得"按既定计划继续开发"，而非"毫无价值"[ …] 。" 3. 未披露所提供的信息和文件 判决强调，诺和诺德获准访问"KBP提供的完整电子资料库"，足以使其自行开展分析。这些文件包括了"每位参与第II期临床试验患者的生命体征数据，标注了其所在的试验中心及其收缩压（SBP）"。判决进一步指出： " 被告方称诺和诺德未披露一项重要事实，即在尽职调查期间，KBP 向诺和诺德提供了以‘生命体征数据清单'（Vital Signs Data Listing ）和‘CTA 文件包' 形式的原始数据。诺和诺德并未打开这些文件，更未要求以其他格式提供数据。" 每一家制药企业都肩负着关爱患者、满足未被满足医疗需求的企业社会责任。公司创始人兼董事长黄振华博士表示： "KBP 认为，诺和诺德终止Ocedurenone 的开发是错误的，因为该药物有望惠及患者。KBP 将向仲裁庭证明这一点。" KBP已在Ocedurenone的开发上投入了大量时间和资源，并将继续坚定推进公司使命。因此，公司及黄振华博士将始终努力与诺和诺德新一届管理层沟通，寻求Ocedurenone的未来发展路径。此外，KBP将在已启动的各项法律程序中积极主张其权利，包括就新加坡法院裁决提起可能的上诉。 所有媒体咨询均可直接发送至： info@kbpbiosciences.com<\/a>  <\/p> 关于KBP <\/b> Biosciences<\/b><\/p> KBP Biosciences是一家总部设在新加坡的全球性临床阶段生物科技公司，专注于针对存在巨大未满足医疗需求的严重心肾疾病和感染性疾病进行小分子治疗的发现和研发，并对其进行商业化应用。<\/p>

Bagsværd, Denmark, 29 July 2025 – Novo Nordisk today announced sales and operating profit growth at constant exchange rates (CER) for the first six months of 2025 and updated full-year sales and operating profit outlook at CER. In the first six months of 2025, Novo Nordisk’s sales increased by 18% and operating profit increased by 29%, both at CER. Sales growth in the first six months of 2025 was positively impacted by gross-to-net sales adjustments related to prior years, including an adjustment related to the 340B provision of around DKK 3 billion in the second quarter of 2025. Operating profit growth is positively impacted by the ocedurenone impairment in the second quarter of 2024, partially countered by impacts related to the acquisition of the three Catalent manufacturing sites. Novo Nordisk has updated the full-year outlook for 2025, with sales growth now expected to be 8-14% and operating profit growth expected to be 10-16%, both at CER. Sales and operating profit growth reported in Danish kroner is now expected to be 4 and 7 percentage points lower than at CER, respectively, primarily due to depreciation of the USD/DKK exchange rate 1 . The lowered sales outlook for 2025 is driven by lower growth expectations for the second half of 2025. This is related to lower growth expectations for Wegovy ® in the US obesity market, lower growth expectations for Ozempic ® in the US GLP-1 diabetes market, as well as lower-than-expected penetration for Wegovy ® in select IO markets. For Wegovy ® in the US, the sales outlook reflects the persistent use of compounded GLP-1s, slower-than-expected market expansion and competition. Despite the expiry of the FDA grace period for mass compounding on 22 May 2025, Novo Nordisk market research shows that unsafe and unlawful mass compounding has continued, and that multiple entities continue to market and sell compounded GLP-1s under the false guise of ‘personalisation’. Novo Nordisk is pursuing multiple strategies, including litigation, to protect patients from knockoff ‘semaglutide’ drugs. Novo Nordisk is deeply concerned that, without aggressive intervention by federal and state regulators and law enforcement, patients will continue to be exposed to the significant risks posed by knockoff ‘semaglutide’ drugs made with illicit or inauthentic foreign active pharmaceutical ingredients. As unsafe and unlawful mass compounding continues, the Wegovy ® penetration within the cash channel has been lower-than-expected. Within this channel, NovoCare ® Pharmacy was launched in March 2025. Wegovy ® prescriptions via NovoCare ® Pharmacy (including TeleHealth collaborations) amount to around 11,000 total weekly prescriptions, in addition to around 20,000 weekly prescriptions in the retail cash channel. Novo Nordisk will continue to invest in the expansion of direct-to-patient initiatives such as NovoCare ® Pharmacy and further collaborations with telehealth organisations. Within the insured channel, despite the initiation of new commercial activities of Wegovy ® in the first half of 2025, the sales outlook also reflects lower-than-expected penetration for Wegovy ® , mainly due to slower market expansion and competition. Novo Nordisk continues to engage in additional commercial initiatives and expects a regulatory decision around the Wegovy ® MASH indication during the second half of 2025. Moreover, Novo Nordisk continues to expect a positive contribution from changes to the CVS national template formulary effective 1 July 2025, where Wegovy ® is now the only GLP-1 medicine covered for obesity. For Ozempic ® , the updated outlook is negatively impacted by competition in the US. Novo Nordisk continues to invest in commercial activities and label updates towards driving further market penetration of Ozempic ® . Finally, while IO Wegovy ® sales are growing at high rates and launches are progressing, the sales outlook reflects lower-than-expected penetration for Wegovy ® in select IO markets due to slower market expansion and competition. With around 1 billion people living with obesity globally and only a few million on treatment, the outlook reflects a continued global rollout of Wegovy ® to more markets. The updated expectation for operating profit growth reflects the lower sales growth outlook, partially countered by reduced spending. A negative mid-single-digit operating profit growth impact related to the acquisition of the three former Catalent manufacturing sites remains included in the guidance. Novo Nordisk now expects financial items (net) for 2025 to amount to a gain of around DKK 3 billion. This is mainly driven by expected gains on hedged currencies, primarily the US dollar, partially offset by interest expenses related to funding of the debt-financed Catalent transaction. Finally, the free cash flow is now expected to be DKK 35-45 billion, reflecting the lower-than-planned expected sales growth, mainly driven by lower volume growth of GLP-1-based treatments in the US and related cash flow implications amplified by the US gross-to-net system. Novo Nordisk’s full disclosure of the financial results for the first six months of 2025 will be published on 6 August 2025, where more information will be available. The above expectations are based on additional assumptions, including assumptions described on pages 14 and 15 of the Financial report for the first three months of 2025 (Company Announcement No 14/2025). The forward-looking statements on page 23 in the Financial report for the first three months of 2025 (Company Announcement No 14/2025) also apply to this company announcement. Conference call Novo Nordisk will host a conference call for investors at 14.30 CEST on 29 July 2025, corresponding to 8.30 am EST. For more information on how to listen, please visit the investor section of novonordisk.com. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information Publication of inside information pursuant to Market Abuse Regulation, Article 17 1 Based on exchange rates of 23 July 2025 with e.g. a USD/DKK spot rate of 635. Full currency overview to be released as part of Novo Nordisk’s full disclosure of the financial results on 6 August 2025 Company announcement No 18 / 2025