Delving into the Latest Updates on Organon NV with Synapse

主要目的：评估接受了至少7天泊沙康唑注射液和/或泊沙康唑肠溶片作为一线方案治疗侵袭性曲霉病的中国成人患者中第42天的全因死亡率。次要目的：1.评估接受一线治疗方案泊沙康唑注射液和/或泊沙康唑肠溶片治疗侵袭性曲霉病的中国成人患者在泊沙康唑治疗结束时（最短治疗持续时间42天，最长治疗持续时间12周，即84天）的总应答率（完全或部分应答）。2.评估接受泊沙康唑注射液和/或泊沙康唑肠溶片作为挽救方案治疗侵袭性曲霉病的两性霉素B、伏立康唑、伊曲康唑或艾沙康唑难治性3或者对上述药物不耐受的中国成人患者在泊沙康唑治疗结束时（最短治疗持续时间7天，最长治疗持续时间12周，即84天）的总应答率（完全或部分应答）。3. 描述接受泊沙康唑注射液和/或泊沙康唑肠溶片作为一线或挽救方案治疗侵袭性曲霉病的中国成人患者的研究人群特征，包括基线、临床特征和治疗模式。

开始日期2023-11-15

申办/合作机构

Schering-Plough Corp.

[+3]

CTR20231215 / Completed临床4期

中国常规临床实践中使用诺科飞的上市后安全性监测项目

描述在中国真实使用诺科飞注射液和/或肠溶片的参与者中发生1起或多起不良事件、严重不良事件或不良反应的参与者数量和百分比

开始日期2023-05-22

申办/合作机构

Schering-Plough Corp.

[+3]

NCT03316131 / Completed临床2期

Quantifying Uric Acid Excretion With RDEA3170, Febuxostat and Dapagliflozin

This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit

开始日期2017-10-25

申办/合作机构

AstraZeneca PLC

[+5]

100 项与 Organon NV 相关的临床结果

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0 项与 Organon NV 相关的专利（医药）

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12

项与 Organon NV 相关的文献（医药）

2016-10-01·Journal of clinical psychopharmacology4区 · 医学

A Phase 2 Randomized Dose-Finding Study With Esmirtazapine in Patients With Primary Insomnia

4区 · 医学

Article

作者: Ijzerman-Boon, P. ; Ruwe, Frank ; Roth, Thomas ; Ivgy-May, Neely ; Zammit, Gary

Abstract:

The antidepressant mirtazapine is an alternative to classical hypnotics, and this study investigated the efficacy and safety of esmirtazapine (Org 50081, the maleic acid salt of S-mirtazapine) in patients given a diagnosis of primary insomnia after acute (2-day) treatment. Patients aged 18 to 65 years with primary insomnia were randomized to receive placebo or 1.5-, 3.0-, or 4.5-mg esmirtazapine in a balanced 4-way crossover study; 2 sleep laboratory nights with polysomnography were separated by 5-day, single-blind placebo washout periods. Polysomnography-determined total sleep time (primary end point) and patient-reported total sleep time improved by at least 25 minutes with all 3 doses of esmirtazapine (P ≤ 0.001 vs placebo). Polysomnography-measured wake time after sleep onset (P ≤ 0.0001) and latency to persistent sleep also improved vs placebo (P ≤ 0.01, 3.0 and 4.5 mg). Patient-reported sleep quality improved with 3.0- and 4.5-mg esmirtazapine (P ≤ 0.01 and P ≤ 0.05, respectively, vs placebo). Morning alertness and contentment were not altered after esmirtazapine, and calmness increased with 4.5-mg esmirtazapine vs placebo. Evening questionnaires showed no difference in duration of daytime naps but reduced energy and ability to work/function after esmirtazapine treatment periods vs placebo (P < 0.05), although this effect was limited to the first night of each 2-night period. There were few adverse events, no serious adverse events, or clinically relevant treatment differences in vital signs, laboratory values, or electrocardiogram. Esmirtazapine doses of 1.5 to 4.5 mg/day significantly improved quantity and quality of sleep and were generally well tolerated, with no evidence of safety concerns or consistent pattern of residual effects.

1999-04-01·FEMS microbiology letters4区 · 生物学

Cell–cell recognition and pheromone response of the yeast Saccharomyces globosus

4区 · 生物学

作者: Fujimura, Hiro-aki

Sexual agglutination and pheromone interaction between cells of two mating types, a and α, in the yeast Saccharomyces globosus were studied.S. globosus was shown to produce mating-type-specific factors analogs to a- and α-mating pheromones of Saccharomyces cerevisiae and to undergo the sexual agglutination reaction between cells of two mating types.While the sexual agglutination of cells of different species was not observed, mating type a cells of each species were shown to respond to α-factors produced by the other species.Thus, the mating response of S. globosus was shown to be identical to what has been observed in two other species of the same genera: S. cerevisiae and Saccharomyces kluyveri.

Fermentation process development and cGMP manufacture of SY161 therapeutic protein using recombinant .

作者: Lin, Wenglong R. ; Perrin, Dana ; Sorensen, Todd ; Broderick, Tim ; Mistry, Firoz ; Morehead, Randall

This work describes a fermentation development effort to design a high cell d., high yield Escherichia coli fermentation for the cGMP production of a therapeutic protein used for disrupting occluded coronary arteries in patients suffering from acute myocardial infarction.Developmental fermentations were used to improve the scale-up, yield and reproducibility of the process.Fermentation parameters tested include oxygen supplementation, inoculum volume, fermentation temperature, and medium modification.The final process is a batch fermentation with the medium consisting of a yeast extract base with potassium phosphate salts to buffer the solution and glycerol being used as the carbon source.The process is controlled at 37^oC and pH 7.0 throughout the fermentationThe airflow rate is set constant at 1 VVM and the dissolved oxygen (DO) is maintained at 30% through a cascade control of variable agitation and oxygen supplementation.The culture is induced with 67 mM IPTG when the OD₆₀₀ is 55 and allowed to continue for 2 h with a final harvest OD₆₀₀ of 70-80.Our final process yielded a two-fold protein recovery increase over the original process.Utilizing this process we were able to scale to 140L successfully and produce SY161 under cGMP conditions for Phase I/II clin. trials.

19

项与 Organon NV 相关的新闻（医药）

2024-11-01

·佰傲谷BioValley

复宏汉霖又一款生物类似药在美国申请上市

中国上海和美国新泽西，2024年10月30日，复宏汉霖（2696.HK）与Organon（NYSE: OGN）共同宣布，在研PROLIA/XGEVA（地舒单抗）生物类似药HLX14的生物制品许可申请（BLA）获美国食品药品监督管理局（FDA）受理。目前地舒单抗已在多个国家和地区以不同商品名获批用于如骨折高风险的绝经后妇女的骨质疏松症等一系列适应症。复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予其对包括HLX14在内的两款候选生物类似药在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。此次递交主要基于一系列的头对头比对研究，包括质量对比研究和两项临床研究。其中一项为在中国男性健康受试者中开展的两阶段I期临床试验。该临床试验第一阶段为开放标签、随机、平行对照、单次给药、双臂的预试验研究，主要研究目的为比较HLX14和欧盟市售的原研地舒单抗（PROLIA）在皮下给药后的药物代谢动力学参数，以进一步为第二部分临床研究方案设计提供依据。第二阶段是一项双盲、随机、平行对照、单次给药、四臂的研究，主要目的为比较HLX14与美国、欧盟及中国市售的原研地舒单抗（PROLIA）的药物代谢动力学特征的相似性。另一临床试验为一项随机、双盲、国际多中心、平行对照的III期临床试验，旨在比较HLX14与欧盟市售原研地舒单抗（PROLIA）在高危骨折风险的绝经后骨质疏松症女性受试者中的有效性、安全性、耐受性和免疫原性。 * XGEVA和PROLIA为安进公司（Amgen Inc.）在美国的注册商标关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。关于Organon Organon是一家专注于守护女性全生命周期健康的全球化独立医疗健康公司。Organon提供超过60种女性健康相关药物和医疗解决方案的产品组合，另有持续增长的生物类似药业务和覆盖一系列疾病治疗领域的大量经典品牌业务。依靠现有业务，Organon能够以强健的现金流优势，持续投资女性健康和生物类似药领域的创新和未来增长机会。此外，Organon也在积极探求与生物制药创新企业开展合作，发挥公司在快速增长的国际市场中的规模与资源优势，帮助它们实现产品的商业化。 Organon在全球已实现大规模、广覆盖的发展，并具备世界一流的商业运营能力，总部设在美国新泽西州泽西市，全球约有10,000名员工。 - 关于前瞻性声明的注意事项 - 本新闻稿包含的某些陈述和披露属于1995年《美国私人证券诉讼改革法案》安全港条款所指的“前瞻性陈述”，包括但不限于基于Organon与复宏汉霖之间授权许可和供应协议的预期表述。前瞻性陈述可通过“愿景”、“寻求”、“未来”、“期望”、“将”或具有类似含义的措辞识别。这些前瞻性陈述基于Organon管理层当前的计划和预期，并受到重大风险和不确定性的影响，这些因素可能导致实际结果可能与前瞻性陈述中所述的结果存在重大差异。 Organon不承担因新信息、未来事件或其他因素公开更新任何前瞻性声明的义务。Organon在提交给美国证券交易委员会（SEC）的资料中列出了可能导致实际结果与前瞻性声明中描述内容产生显著偏差的其它因素，包括在表格10-K中提交的Organon最新年报和之后提交给SEC的文件。详情可在SEC网站（www.sec.gov）查阅。提供网站参考和链接仅供参考，任何此类网站上的信息均不构成本新闻稿的一部分，也不通过引用并入本新闻稿。Organon不对第三方网站内容负责。 US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) Shanghai, China & JERSEY CITY, NJ – October 30, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries and regions under different trade names for a range of different indications, such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. The filing is based on data from a series of head-to-head studies for HLX14, including comparative quality analytical studies and two clinical studies. The first was a two-part phase 1 clinical study in Chinese healthy adult male subjects. Part 1 was an open-label, randomized, parallel-controlled, single-dose, two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection to provide further basis for the study design of part 2. Part 2 was a double-blind, randomized, parallel-controlled, single-dose, four-arm study with the primary objective to compare the pharmacokinetic similarity of HLX14 with US-, EU-, and China-sourced PROLIA after subcutaneous injection. The second was a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study comparing the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference PROLIA in postmenopausal women with osteoporosis at high risk for fracture. *XGEVA and PROLIA are trademarks registered in the United States in the name of Amgen Inc. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s license and supply agreement with Henlius and the respective business goals and objectives of each company. Forward-looking statements may be identified by words such as “vision,” “pursuing,” “future,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward- looking statements. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

生物类似药上市批准临床3期临床1期

2024-10-31

·GBIHealth

业内传奇人物“被带走”——阿斯利康中国总裁王磊配合调查，骗保风波愈演愈烈

药械追踪 No.1 / 复宏汉霖地舒单抗生物类似药在美上市申请获受理 2024年10月30日，复宏汉霖（2696.HK）与Organon（NYSE: OGN）共同宣布，在研PROLIA/XGEVA（地舒单抗）生物类似药HLX14的生物制品许可申请（BLA）获美国FDA受理。地舒单抗是由安进公司开发的一种新型RANKL抑制剂，是RANKL的全人化单克隆IgG2抗体，对可溶性、跨膜形式的人RANKL具有高度亲和力和特异性。 HLX14是复宏汉霖自主研制的地舒单抗生物类似药，2022年6月复宏汉霖将HLX14的海外权益授予Organon，协议覆盖美国、欧盟、加拿大等市场。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 阿斯利康中国总裁王磊配合调查继多位高管被带走配合调查之后，2024年10月30日晚间，阿斯利康中国官网宣布消息称，阿斯利康全球执行副总裁、国际业务主席及中国总裁王磊正在中国配合调查。阿斯利康方面表示，阿斯利康中国在现任总经理赖明隆的带领下正常运营。 2013年，阿斯利康招来了职业经理人王磊，出任消化、呼吸和麻醉事业部负责人，这位导游出身、没有任何医药背景、在罗氏工作过的打工人，仅仅一年时间，便升任阿斯利康大中华区总裁。四年后，升任全球执行副总裁，打破了制药领域长期以来华人在跨国药企的天花板。在王磊带领下，阿斯利康一度成为在华收入排名第一的跨国药企。 2021年7月，深圳市医疗保障局根据举报线索，揭露了阿斯利康部分工作人员涉嫌欺诈骗保的行为，其中涉及公司明星产品泰瑞沙。国家医保局基金监管司负责人曾在2022年1月份表示，前期根据群众举报线索，国家医保局督促成立专案组，犯罪嫌疑人已全部被批捕。但三年以来，该骗保事件有愈演愈烈趋势，被调查的人员有扩大趋势。据2024年7月彭博社报道，阿斯利康部分员工因涉及数据隐私泄露和进口未经许可药品被拘留。近日，百济神州大中华区首席商务官殷敏也在配合相关调查。殷敏配合调查背后，跟她此前在阿斯利康的任职经历有关。此次王磊配合调查，对阿斯利康中国业务的影响目前有待观察。 ->点击文末阅读原文，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余年的深耕细作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 ▶ zhangxinyue13@baidu.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

生物类似药高管变更

2024-10-30

·复宏汉霖

汉霖头条 | 复宏汉霖地舒单抗生物类似药HLX14美国上市许可申请获FDA受理

中国上海和美国新泽西，2024年10月30日，复宏汉霖（2696.HK）与Organon（NYSE: OGN）共同宣布，在研PROLIA/XGEVA（地舒单抗）生物类似药HLX14的生物制品许可申请（BLA）获美国食品药品监督管理局（FDA）受理。目前地舒单抗已在多个国家和地区以不同商品名获批用于如骨折高风险的绝经后妇女的骨质疏松症等一系列适应症。复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予其对包括HLX14在内的两款候选生物类似药在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。此次递交主要基于一系列的头对头比对研究，包括质量对比研究和两项临床研究。其中一项为在中国男性健康受试者中开展的两阶段I期临床试验。该临床试验第一阶段为开放标签、随机、平行对照、单次给药、双臂的预试验研究，主要研究目的为比较HLX14和欧盟市售的原研地舒单抗（PROLIA）在皮下给药后的药物代谢动力学参数，以进一步为第二部分临床研究方案设计提供依据。第二阶段是一项双盲、随机、平行对照、单次给药、四臂的研究，主要目的为比较HLX14与美国、欧盟及中国市售的原研地舒单抗（PROLIA）的药物代谢动力学特征的相似性。另一临床试验为一项随机、双盲、国际多中心、平行对照的III期临床试验，旨在比较HLX14与欧盟市售原研地舒单抗（PROLIA）在高危骨折风险的绝经后骨质疏松症女性受试者中的有效性、安全性、耐受性和免疫原性。 * XGEVA和PROLIA为安进公司（Amgen Inc.）在美国的注册商标关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。关于Organon Organon是一家专注于守护女性全生命周期健康的全球化独立医疗健康公司。Organon提供超过60种女性健康相关药物和医疗解决方案的产品组合，另有持续增长的生物类似药业务和覆盖一系列疾病治疗领域的大量经典品牌业务。依靠现有业务，Organon能够以强健的现金流优势，持续投资女性健康和生物类似药领域的创新和未来增长机会。此外，Organon也在积极探求与生物制药创新企业开展合作，发挥公司在快速增长的国际市场中的规模与资源优势，帮助它们实现产品的商业化。 Organon在全球已实现大规模、广覆盖的发展，并具备世界一流的商业运营能力，总部设在美国新泽西州泽西市，全球约有10,000名员工。 - 关于前瞻性声明的注意事项 - 本新闻稿包含的某些陈述和披露属于1995年《美国私人证券诉讼改革法案》安全港条款所指的“前瞻性陈述”，包括但不限于基于Organon与复宏汉霖之间授权许可和供应协议的预期表述。前瞻性陈述可通过“愿景”、“寻求”、“未来”、“期望”、“将”或具有类似含义的措辞识别。这些前瞻性陈述基于Organon管理层当前的计划和预期，并受到重大风险和不确定性的影响，这些因素可能导致实际结果可能与前瞻性陈述中所述的结果存在重大差异。 Organon不承担因新信息、未来事件或其他因素公开更新任何前瞻性声明的义务。Organon在提交给美国证券交易委员会（SEC）的资料中列出了可能导致实际结果与前瞻性声明中描述内容产生显著偏差的其它因素，包括在表格10-K中提交的Organon最新年报和之后提交给SEC的文件。详情可在SEC网站（www.sec.gov）查阅。提供网站参考和链接仅供参考，任何此类网站上的信息均不构成本新闻稿的一部分，也不通过引用并入本新闻稿。Organon不对第三方网站内容负责。 US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) Shanghai, China & JERSEY CITY, NJ – October 30, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries and regions under different trade names for a range of different indications, such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. The filing is based on data from a series of head-to-head studies for HLX14, including comparative quality analytical studies and two clinical studies. The first was a two-part phase 1 clinical study in Chinese healthy adult male subjects. Part 1 was an open-label, randomized, parallel-controlled, single-dose, two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection to provide further basis for the study design of part 2. Part 2 was a double-blind, randomized, parallel-controlled, single-dose, four-arm study with the primary objective to compare the pharmacokinetic similarity of HLX14 with US-, EU-, and China-sourced PROLIA after subcutaneous injection. The second was a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study comparing the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference PROLIA in postmenopausal women with osteoporosis at high risk for fracture. *XGEVA and PROLIA are trademarks registered in the United States in the name of Amgen Inc. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s license and supply agreement with Henlius and the respective business goals and objectives of each company. Forward-looking statements may be identified by words such as “vision,” “pursuing,” “future,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward- looking statements. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

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