Netupitant/Palonosetron Hydrochloride

（2024年8月27日，中国上海）8月27日，复星医药（“本集团”；股票代码：600196.SH；02196.HK）公布2024年度上半年（“报告期”）经营业绩。报告期内，复星医药实现营业收入204.63亿元人民币，不含新冠相关产品，营收同比增长5.31%；实现归母扣非净利润12.54亿元，其中，2024年第二季度实现归母扣非净利润6.46亿元，环比增加0.37亿元。 复星医药作为一家植根中国、创新驱动的全球化医药健康产业集团，持续推进创新转型和创新产品的开发落地，2024年上半年，复星医药创新药品收入超37亿元，保持稳健增长。 2024年，复星医药积极推动运营效率和盈利空间的提升，构建长期可持续发展的基础和保障。报告期内，毛利率减销售费用率同比提升1.72个百分点；剔除新并购企业的影响，管理费用下降约2亿元。报告期内，复星医药通过经营现金流优化、供应链管理以及控制资本性支出等多项措施，保障稳健的自由现金流，实现经营现金流19.07亿元，同比增长5.36%，优于当期经营性利润的增长。此外，持续推进资产结构优化，加速现金回流。2024年以来，复星医药已完成处置及已签约待收回的处置总额超20亿元。 01 创新成果持续兑现，进一步聚焦创新药和高值器械 2024年上半年，复星医药进一步聚焦创新药和高值器械，自主研发及许可引进的4个创新药/生物类似药共9项适应症于境内外获批，38个仿制药品种于境内外获批。 复星医药的核心制药业务在2024年上半年实现营收146.77亿元，创新药业务在实体瘤、血液瘤、免疫炎症等核心治疗领域取得了突破性进展，并在血液瘤、乳腺癌、肺癌等肿瘤领域有多项创新成果兑现，惠及全球患者。 复星医药自主研发的首款生物创新药汉斯状®（斯鲁利单抗注射液）作为全球首个一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，于2022年3月开始国内市场商业化上市，至今已覆盖四项适应症，广泛覆盖肺癌、消化道肿瘤等高发肿瘤，已惠及全球超7.5万名患者。目前，汉斯状的第五项适应症一线治疗非鳞状非小细胞肺癌（nsNSCLC）的上市注册申请也已获国家药监局受理。 报告期内，复星医药自主研发的生物类似药汉达远®（阿达木单抗注射液）4项新增适应症获国家药监局批准，本次获批后，汉达远已获批原研阿达木单抗在中国境内上市的全部8项适应症，为成人和儿童自身免疫疾病患者提供更多治疗选择。 复星医药坚持开放式创新策略，除自主研发外，还积极通过BD途径扩充产品管线，2024年6月，复星医药获独家商业化许可的苏可欣®（马来酸阿伐曲泊帕片）于中国境内新增获批第二项适应症（用于治疗既往治疗反应不佳的成人慢性原发免疫性血小板减少症（ITP）），可惠及更多患者。此外，包括双通道止吐药物奥康泽（奈妥匹坦帕洛诺司琼胶囊）、我国自主研发的首款钾离子竞争性酸阻滞剂（P-CAB）倍稳（盐酸凯普拉生片）、长效重组人粒细胞集落刺激因子产品珮金（拓培非格司亭注射液）及创新晶型的心衰和高血压治疗药物一心坦（沙库巴曲缬沙坦钠片）在内的已上市新品的入院及销售如期推进。 在疫苗领域，复星医药已搭建以细菌性疫苗、病毒性疫苗两大技术平台为核心的自主研发体系，2024年3月，自主研发的冻干人用狂犬病疫苗（Vero细胞）于中国境内获批上市，相关产线亦已通过GMP符合性检查。 02 多项在研管线快速推进，创新发展再添动能 围绕未被满足的临床需求，复星医药通过自主研发、合作开发、许可引进、产业投资等多元化、多层次的合作模式，持续丰富创新产品管线，并不断聚焦差异化、高技术壁垒的产品研发，持续提升管线价值。2024年上半年，复星医药研发投入27.37亿元；其中，研发费用为18.62亿元。制药业务研发投入24.06亿元，占制药业务收入的16.39%；其中，研发费用为15.72亿元，占制药业务收入的10.71%。 2024年上半年，复星医药自主研发、合作开发及许可引进的4个创新药/生物类似药共9项适应症进入上市前审批/关键临床阶段。制药板块专利申请达124项，其中包括美国专利申请2项、PCT申请8项，获得发明专利授权37项。 报告期内，复星医药自主研发的MEK1/2选择性抑制剂复迈替尼片（项目代号：FCN-159）两项适应症的上市注册申请先后于2024年5月、6月获国家药监局受理，且均被纳入优先审评程序；自主研发的地舒单抗生物类似药HLX14（重组抗RANKL全人单克隆抗体注射液）5项适应症的上市许可申请（MAAs）获欧洲药品管理局（EMA）受理。 此外，报告期内，复星医药自主研发的汉斯状®（斯鲁利单抗注射液）联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者于中国境内启动III期临床研究；与明治制果药业共同开发的OP0595与头孢吡肟或氨曲南联合给药，针对治疗方案有限的成人需氧革兰氏阴性菌感染于中国境内启动III期临床研究。 报告期内，复星医药亦有多项在研产品及已上市产品的临床数据在美国临床肿瘤学会（ASCO）、美国癌症协会年会（AACR）、欧洲血液学协会大会（EHA）等全球行业学术会议上发布，创新研发实力获国际认可。 在自研投入的同时，复星医药充分践行开放式研发模式，通过发起设立、管理产业基金等方式开展研发项目的孵化和投入，确保创新研发的可持续性；报告期内，完成50亿元深圳生物医药产业基金的设立和备案。 03 全球化运营能力进一步加强，创新产品出海获国际认可 复星医药持续在创新研发、许可引进、生产运营及商业化等多维度践行国际化战略，提升运营效率，强化全球市场布局，海外商业化团队近1,000人，主要覆盖美国、欧洲、非洲等海外市场。2024年上半年，复星医药实现海外收入55.1亿元，同比提升15.13%，海外营收占比26.93%。 报告期内，复星医药自主研发的汉曲优®（注射用曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）有3项适应症获美国FDA批准上市，涵盖乳腺癌及胃癌领域，成为在中国、欧盟、美国三地获批的国产生物类似药。同时，通过与国际知名药企许可合作全面布局欧洲、美国、加拿大等地和众多新兴国家市场，汉曲优®迄今已在48个国家和地区获批上市，累计惠及超20万全球患者，为全球乳腺癌和胃癌患者带去可负担、高品质的治疗选择。 复星医药自主研发的创新生物药斯鲁利单抗注射液（PD-1抑制剂，中国境内商品名：汉斯状®）已于2024年1月完成首批海外发货，成为首个在东南亚国家获批上市的国产PD-1单抗，其于欧盟的上市许可申请（MAA）亦已于2023年3月获得欧洲药品管理局（EMA）受理，于美国启动的桥接试验亦在有序开展中。同时，复星医药也已组建美国创新药团队，开展斯鲁利单抗注射液的商业化筹备工作。 在积极推动自研创新产品出海的同时，复星医药还积极将国际领先技术和产品引入中国市场，惠及更多患者、客户。报告期内，联营公司直观复星总部产业基地于2024年6月在上海张江国际医学园区落成启用，该基地集研发、生产和培训于一体，该基地的启用将进一步加速达芬奇手术系统的国产化进程。截至2024年6月末，于中国境内和港澳地区，达芬奇手术机器人已为超54万名患者提供治疗、在300多家医院落户、累计装机量超过380台。报告期内，复星医药与Insightec于中国成立的合资公司复星医视特就“磁波刀”脑部治疗系统在中国境内及港澳市场临床推广和商业化工作稳步进行。 作为一家全球布局的药企，复星医药持续推进生产体系的国际质量标准认证，质量管理体系和生产能力获国际权威认证机构的认可，进一步夯实制剂出海基础。截至报告期末，复星医药制药板块国内控股子公司所有商业化生产线均已通过国内GMP认证，并有10条生产线通过美国、欧盟等主流法规市场GMP认证。 吴以芳 复星医药董事长 “ 在4IN战略（创新、国际化、智能化、整合）的指导下，复星医药始终围绕未被满足的临床需求，聚焦创新研发，坚持科技驱动和产品驱动，持续夯实全球化运营能力，保持公司稳健可持续发展。展望未来，复星医药内部运营将进一步提质增效，继续巩固在血液瘤、乳腺癌、肺癌等肿瘤领域的优势地位，拓展免疫炎症、慢病和中枢神经领域的布局机会，加大与国际一流高校、科研院所开展产学研合作，在早期阶段捕获源头创新产品。同时，积极推动优质产品出海，推进全球同步开发，致力于成为全球领先的医疗创新整合者。 ” 关于复星医药 上海复星医药（集团）股份有限公司（“复星医药”，股票代码：600196.SH，02196.HK）成立于1994 年，是一家植根中国、创新驱动的全球化医药健康产业集团，直接运营的业务包括制药、医疗器械、医学诊断、医疗健康服务，并通过参股国药控股覆盖到医药商业领域。 复星医药以患者为中心、围绕未被满足的临床需求，通过自主研发、合作开发、许可引进、产业投资等多元化、多层次的合作模式，持续丰富创新产品管线，并不断聚焦差异化、高技术壁垒的产品研发，持续提升管线价值。复星医药的创新产品聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域，并重点强化抗体/ADC、细胞治疗、小分子等核心技术平台。 在“4IN”（创新 Innovation、国际化 Internationalization、智能化 Intelligentization、整合 Integration）的战略指导下，复星医药秉持“持续创新、乐享健康”的经营理念，持续推进创新转型，积极布局国际化，强化业务的分线聚焦，推动整合式运营和效率提升，致力于成为全球领先的医疗创新整合者。 欲了解公司更多资讯，可登录官网：www.fosunpharma.com。

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US Lugano, Switzerland – June 24, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, is pleased to announce that AKYNZEO® (fosnetupitant/palonosetron) injection is now available in the US in a ready-to-use vial. AKYNZEO injection (Ready-to-Use) is a new method of administration and contains the same formulation as the prior AKYNZEO Injection (To-be-Diluted). The features of the new ready-to-use presentation of AKYNZEO injection include: No reconstitution or dilution required; infuse directly from the vial using a built-in hanging strapNo refrigeration required at any point during distribution, storage, or preparationAccessible via automated dispensing machine, allowing the product to be stored and available near the location of patient care AKYNZEO injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. It has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection does not contain polysorbate 80 or allergenic excipients such as soy or egg lecithin. It can be administered simultaneously with intravenous dexamethasone sodium phosphate. Dr. Melanie Rolli, Helsinn Group CEO, commented: “As a pioneer in cancer supportive care, Helsinn continues to be unwavering in our pursuit to help patients and clinicians in cancer care. We are very pleased to launch the new AKYNZEO Ready-to-Use vial, building on our legacy of innovation.” Ordering information Clinicians wishing to order the new vial should contact their GPO or distributor. The National Drug Code (NDC) number for AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]). About AKYNZEO® AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs. Adverse Reactions Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules. Drug Interactions Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days Dexamethasone doses should be reduced when given with AKYNZEO. A more than two- fold increase in the systemic exposure of dexamethasone was observed 4 days after a single infusion of fosnetupitant.Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO. Use in Specific Populations Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease.Advise women of potential risk to fetus; limited data are available; may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com