Bupivacaine liposome

-- Veteran Executive Brings More Than 25 Years of Clinical Development and Industry Expertise -- BRISBANE, Calif., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced the appointment of Samit Hirawat, M.D., to its Board of Directors. This appointment increases the size of the company’s Board of Directors to 10 members. “Samit is an accomplished and widely respected leader in the biopharmaceutical industry, and we are pleased to welcome him to our Board of Directors,” said Laura Brege, independent board chair of Pacira. “We believe his deep clinical development expertise and longstanding commitment to advancing innovative, patient‑centric therapies will make him an invaluable addition to our organization. We look forward to drawing on his insight and leadership as we accelerate the growth of our robust portfolio and pipeline of non‑opioid pain solutions and continue to elevate the standard of care for patients.” “I’m excited to be joining Pacira’s Board during this pivotal time in the Company’s evolution,” said Dr. Hirawat. “Pacira stands at the forefront of non‑opioid pain management, driven by an industry‑leading commercial portfolio and an exceptionally promising pipeline of innovative pain solutions, including next‑generation gene therapies. I look forward to collaborating with this talented leadership team and contributing my experience to help advance Pacira’s mission to fundamentally transform how pain is treated for patients around the world.” Most recently, Dr. Hirawat served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol Myers Squibb, where he oversaw the worldwide clinical development portfolio and advanced multiple transformative therapies across therapeutic areas. Prior to that, he spent more than a decade at Novartis Pharmaceuticals in roles of increasing strategic and operational responsibility, culminating in his position as Executive Vice President and Head of Oncology Development. Dr. Hirawat earned his Bachelor of Medicine and Bachelor of Surgery (MBBS) from Sawai Man Singh Medical College, where he also trained as a Resident in General Surgery. He conducted his Internal Medicine residency and Medical Oncology fellowship at North Shore University Hospital. Dr. Hirawat has published more than 150 peer-reviewed manuscripts and abstracts across therapeutic areas. About Pacira Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing a pipeline of clinical-stage assets for musculoskeletal pain and adjacencies, its most advanced product candidate, PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy in Phase 2 clinical development for osteoarthritis of the knee. To learn more about Pacira, visit www.pacira.com. Forward-Looking Statements Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: the contributions of new directors; '5x30', our growth and business strategy, our future outlook, the strength and efficacy of our intellectual property protection and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company and the anticipated funding or benefits of our share repurchase program. and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC. Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Sara Marino, (973) 370-5430 sara.marino@pacira.com

2025年上半年，恒瑞医药宣布其创新药收入占比突破60%。若剔除对外授权部分，创新药销售收入占其药品总收入的55.28%。这标志着，驱动公司增长的核心动能已完成切换，恒瑞实现了从“仿制为主”到“创新为主”的时代性跨越。然而，数字的背后并非偶然，而是一场深植于行业变局中的彻底重构。这一轮中国医药产业的结构性变革，并非选择题，而是生存题。随着集采常态化以及全球医药创新门槛持续抬升，依赖仿制药规模扩张的增长模式迅速触顶，行业被迫进入以研发能力和创新效率为核心的深水区。对头部企业而言，转型不仅意味着加大投入，更意味着在短期利润承压中重塑研发体系、组织能力与长期战略定力——这是一次关于方向判断、耐力与决心的集体考验。回望过去十余年，恒瑞医药在行业剧变中完成的这场转型，也成为了中国医药产业从“仿制大国”迈向“创新高地”的十年崛起之路上最生动的注脚。近期，南都健闻“生物医药创新力调研团”走进江苏连云港，解码这家成立55年的“医药大象”的承“重”转“新”之路。 南都健闻“生物医药创新力调研团”参观恒瑞连云港生物医药生产基地。01/前瞻布局洞察趋势，一步一脚印叩开创新之门恒瑞医药（下简称“恒瑞“）的成功转型，常被简单归“因”为押中了创新药赛道。然而，回溯其创新历程，这不是一场豪赌，也不是仅凭既有体量的顺水推舟，其核心在于对行业趋势的深刻洞察与强大执行力所构筑的“护城河”。可以说，恒瑞的创新源于一场静悄悄的、极具中国特色的“攀登”。本世纪初的中国医药市场，仍以仿制为主流。主打肿瘤化疗药的恒瑞，却率先开启了创新药布局。2000年，恒瑞成功在上海证券交易所上市，用上市募集的大部分资金在上海闵行设立上海恒瑞研发中心，自此正式走上了创新研发之路。真正的考验始于 2018 年。随着国家药品集中采购试点启动，中国医药行业进入一轮深刻调整期。“以价换量”的集采机制在降低患者负担的同时，也对企业的收入结构和增长模式带来直接冲击。在创新药竞争加速、部分赛道同质化加剧的背景下，行业整体承压。长期稳居行业前列的恒瑞同样未能置身事外。从恒瑞医药近十年的营收与利润走势可以清晰看到，公司在行业剧变中经历了“触底-反弹”的“V形”反转。调研中，恒瑞表示：“真正让管理层意识到转型必要性的关键节点，是当我们看到传统仿制药利润空间持续收窄，而同时同类靶点竞争日益激烈的时候。那一刻我们明白，唯有转向真正具有临床差异化的创新，才能在全球制药格局中占据一席之地。”2011年，恒瑞首款创新药艾瑞昔布获批上市；2014年，历时10年研发、拥有自主知识产权的1类创新药阿帕替尼上市。作为全球第一个在晚期胃癌被证实安全有效的小分子抗血管生成靶向药物，阿帕替尼也成为恒瑞创新能力的重要标志。时至2020年，恒瑞的创新版图与节奏在年报中清晰可见：累计承担 57项“国家重大新药创制”专项项目，7款1类创新药先后获批上市，已基本形成了每年都有创新药申请临床，每1-2年都有创新药上市的良性发展态势。可以说，在行业风暴来临前，恒瑞已为自己筑起了一道至关重要的早期创新防线。02/内核重构火力全开，“人才+平台”锻造创新引擎转型并非简单加减法。恒瑞在压缩部分仿制药管线的同时，还开启了一场深刻的“肌体”重塑：一边持续优化销售运营管理，一边向研发“大脑”做战略性投入。2020年至2024年间，这一策略体现为一场极致的资源再分配：一方面，优化组织结构，促进运营提效。坚持学术市场引领，增强医学及市场专业化人才团队力量，加速销售模式转型。另一方面是研发投入的持续加码与团队的壮大。仅2021至2024四年间，公司研发投入累计近300亿元，研发投入占比持续维持在23.95%至29.40%的高位上。截至2025年底，恒瑞研发投入累计超500亿元。恒瑞持续的高强度的研发投入，驱动了公司增长动能的彻底切换。持续的大幅增加的研发投入，为恒瑞构建起了全球化的研发体系。截至目前，公司在连云港、上海、美国和欧洲等地设立了15个功能互补的研发中心，组建起一支超过5600人、占总员工比例近28%的全球研发团队，为恒瑞面向未来的创新引擎注入了强劲持久的动力。伴随着一场持续十余年、波澜壮阔的研发人才的回流潮，恒瑞始终坚持“人才是第一资源”的理念，以开放的心态，大力引进高层次人才，从而系统性地重构了其创新研发体系。如2010年，恒瑞从跨国药企引进了多位核心科学家，为其创新药的自主研发注入火种。邀请在美国多家知名药企从业的张连山博士回国加盟恒瑞主导创新研发；2023年，邀请兼具国际视野与中国经验的江宁军博士出任恒瑞首席战略官，进一步推动公司的创新药国际化、全球临床研发和商务拓展。近年来，随着恒瑞采取资源调配策略，聚焦肿瘤、代谢和心血管疾病、免疫和呼吸系统疾病以及神经科学等多个领域，恒瑞高层人才的引进更是进一步提速。2025年4月，恒瑞邀请兼具本土化运营与全球化视野的冯佶出任公司总裁兼首席运营官，全面负责公司运营管理。冯佶拥有超过30年的医药行业经验，曾任职于诺华、阿斯利康等跨国药企，历经包括销售和营销管理、全球产品组合战略及国际业务运营和拓展等重要业务管理工作；同年，来自礼来的朱国新博士等多位拥有跨国药企背景的国际化精英相继加盟。这些覆盖研发、临床、商业运营等全链条的顶尖人才，不仅带来了先进的技术与管理经验，更直接将恒瑞置于全球竞争的坐标中进行思考和布局。人才汇聚，旨在加强源头创新。恒瑞不再满足于单个靶点的跟随，而是全面布局覆盖ADC、双/多抗、蛋白降解剂、小核酸药物、口服多肽等技术平台，同步开拓新平台领域。在人工智能时代，AI驱动的药物研发（AIDD）也已成为恒瑞重要创新引擎，为创新研发提供强大基础保障。平台化研发的优势在于，它能够像“乐高”一样组合不同的技术模块，高效、系统性地孵化出具有差异化的产品管线，从而摆脱对单一偶然性发现的依赖。值得一提的是，ADC平台已成为恒瑞的“创新引擎”。该平台已有10余个新型、具有差异化的ADC分子成功获批临床，其中注射用瑞康曲妥珠单抗已获批上市，9项适应症被CDE（国家药品监督管理局药品审评中心）纳入突破性治疗品种名单。在新技术平台的加持和研发团队的努力下，以肿瘤和特药起家的恒瑞，不仅开创了创新研发的新格局，还不断生产出差异化、具有创新竞争力的产品。如在抗肿瘤领域的布局，从传统的化疗药物到靶向治疗药物，再到免疫治疗药物，抗肿瘤药物发展的每一个重要阶段恒瑞几乎都有参与，并在某些领域实现了领先。截至目前，恒瑞已有 24款1类创新药、5款2类新药在国内获批上市，其中1类创新药比5年前多了17款。2025年的医保国谈结果，更是折射出恒瑞创新药的成色——共有20款产品/适应症通过新版国家医保目录调整，其中10款首次纳入医保，覆盖肿瘤、代谢、心血管疾病、免疫系统疾病及眼科等多个领域。 来源：第44届摩根大通年度健康医疗大会——恒瑞医药演讲PPT。03/出海进阶双轮驱动，从产品输出到能力输出当创新成果在中国市场得到验证后，广阔的全球市场成为必然的下一站。早在2020年年报中，恒瑞就提出了“国际化”的方向。尽管一路走来并非一帆风顺，但从近年来的表现看，恒瑞显然选择了一条更符合自身特点的国际化路径，并从“单个产品出海”向“体系能力出海”进阶。自2023年至今，恒瑞BD交易爆发式增长，累计完成了12笔对外授权交易，潜在总交易额超270亿美元，合作方包括GSK、MSD、Merck等跨国药企。其中，2025年7月与GSK达成的合作具有里程碑意义：将共同开发至多12款涵盖呼吸、自免和炎症、肿瘤治疗领域的创新药物（含PDE3/4抑制剂HRS9821大中华区以外授权）。GSK向恒瑞医药支付5亿美元的首付款，潜在总金额约120亿美元的选择权行使费和里程碑付款，以及相应的分梯度的销售提成。这种“核心产品+管线选择权”的合作模式，使恒瑞得以与跨国巨头深度绑定在早研。此类 “风险共担、经验共享”的深度绑定，既体现了GSK对恒瑞早期研发能力的高度认可，更为恒瑞的创新产出提供了持续商业化通道，开创了本土药企与跨国巨头规模化合作的新范式。与此同时，恒瑞也在坚定地“造船出海”，海外临床布局加速。目前，恒瑞已获得4项FDA快速通道、5项FDA/EMA孤儿药认定。2025年，有5项创新药资产启动首个海外临床试验，新开设波士顿办公室；成功登陆港交所实现“A+H”上市，募资超百亿港元，为国际化提供了坚实的资本后盾。在高端制剂出海方面，目前公司产品已进入超40个国家，在欧美日获得包括注射剂、口服制剂和吸入性麻醉剂在内的20余个注册批件。2024年，有三款首仿药品在美国获批，分别为：他克莫司缓释胶囊、布比卡因脂质体注射液、注射用紫杉醇（白蛋白结合型），其中布比卡因脂质体注射液是该品种全球首仿药。04/未来之战穿越周期，迈向源头创新的“无人区”时至今日，这家成立55年的龙头药企，创新转型已进入了“成熟期”。据国际知名咨询机构Citeline发布的《2025年医药研发年度回顾》中，目前恒瑞在研管线规模全球排第13位、中国第1位,自研管线数量在全球范围内仅次于辉瑞位居第2。恒瑞的管线构建遵循三个原则：一是“一站式”解决方案，在关键疾病领域或关键作用机制上实现全面覆盖；二是协同效应，致力于持续探索改善患者预后；三是迭代创新，解决新出现的未满足需求。值得关注的是，在庞大且具竞争力的管线中，恒瑞聚焦研发同类首创（FIC）/同类最佳（BIC）的创新疗法：一是对“高难度靶点”的突破能力。在被称为“不可成药”的RAS通路上，恒瑞建立了全面且持续迭代的管线组合。KRAS G12D抑制剂HRS-4642在胰腺癌一线治疗1b/II期临床试验中显示出63.3%的客观缓解率，成为全球首个进入III期的KRAS G12D抑制剂。这是恒瑞在前沿靶点上具备“抢跑能力”的直接证明。二是围绕全球最大增量市场的卡位能力。在代谢疾病领域，恒瑞聚焦千亿美元规模的肥胖市场，形成领先且差异化的GLP-1资产组合及丰富的下一代创新管线。GLP-1/GIP双激动剂HRS9531（瑞普泊肽）已在中国递交新药上市申请并获受理。此前已公布的Ⅱ期临床试验结果中，治疗36周后，HRS9531 8mg组平均减重达23.6%，且未达平台期。2026年1月，海外合作伙伴Kailera已启动全球III期临床试验。三是在免疫和呼吸系统领域探索同类首创疗法。比如全球首款超长效制剂IL-23p19/IL-36R双抗，每年或每半年一次给药用于PsO（斑块状银屑病）、UC（溃疡性结肠炎）、PG（坏疽性脓皮病），具备同类最佳潜力；针对膜性肾病的潜在同类首创药物IFNAR1/TACI，协同双靶点作用机制，具备覆盖广泛适应症的潜力。来源：第44届摩根大通年度健康医疗大会——恒瑞医药演讲PPT。不过，恒瑞面临的挑战依然严峻。全球生物医药资本市场的波动、地缘政治的不确定性等现实问题要求这家转型中的巨头必须具备超越以往的定力与韧性。对此，作为根植中国，面向全球的恒瑞在稳步推进国际化的同时，提出了“赢在中国范式”夯实中国市场，强调采用“三大研发策略”，从研发立项就紧扣中国疾病负担最重的几大领域，积极迈向 “肿瘤+慢病” 的广阔疆域，以多技术平台模块组合+平台赋能打造差异化创新产品。在心血管代谢领域，过去五年，恒瑞上市6个创新产品，在糖尿病领域实现突破性进展并崭露头角；自身免疫领域，产品覆盖核心适应症与潜力市场，安达静®和艾速达®均已进入2025年国家医保药品目录。2025年8月，恒瑞成立生物制药事业部，旨在集中资源深耕慢病市场，打造真正适合中国患者的产品矩阵。与之并行的，则是持续优化渠道布局，加大对下沉市场和新兴渠道的拓展，提高药物可及。国际化的稳步推进与研发管线的持续“造血”，共同构成了恒瑞的发展从量变站上质变节点。2026年，恒瑞将站在成果丰硕的当下，迎来一个催化剂空前密集、增长路径高度清晰的全新爆发点。研发端：2026年预计将有超过10个创新药物或适应症获批，提交超过20项NDA/BLA申请，读出25项III期研究数据。管线中诸如HER2 ADC、KRAS G12D抑制剂、口服GLP-1等多个重磅资产的关键数据即将揭晓。来源：第44届摩根大通年度健康医疗大会——恒瑞医药演讲PPT。商业化端：随着10款新产品纳入新版国家医保目录，公司创新药收入有望实现超过25%的同比增长，进入加速放量通道。全球化端：公司将推动建立更多灵活模式的全球合作伙伴关系，启动更多全球临床试验，并加快特定产品中国以外的上市许可申请。同时，持续推进内生国际化团队建设与运营能力提升。可以说，恒瑞的创新转型之路，是一部中国传统产业巨头在时代剧变中“承重转身”的缩影。它承载着半个世纪积累的庞大身躯与路径依赖之“重”，通过战略上的果断抉择、组织上的不断进化、研发上的持之以“恒“，最终转向了创新驱动的新生之“瑞”。这条路并非坦途，充满了业绩阵痛与自我挑战。但正如其最新财报所揭示的，当创新药收入超越仿制药的那一刻，这头“医药大象”不仅完成了转身，更已然踏上了通往全球制药深海的新征程。它的故事，远未结束，而是正在为中国乃至全球医药创新的未来，书写新的篇章。策划：王卫国 李阳 尹来 统筹：王道斌采写：南都健闻“生物医药创新力”调研团南都制图：何欣（除注明外）