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春节特辑 2025年是“十四五”规划最后一年，或有诸多挑战，但渡过低点，恢复可期。医保控费仍为大方向，药价治理持续深化，新一轮国谈、国采蓄势待发，商保有望成为支付端重要新增量；医药反腐向纵深推进，覆盖面、精准性有望再度升级；创新药开启“真创新”的新“十年”，BIC、FIC等高价值产品数量增多，并购热潮持续涌动，出海模式走向多元化。本期推出2025年重磅首仿获批预测，以飨读者。 表1：2025年有望获批的重磅首仿药注：按即时汇率统一换算为美元来源：米内网综合数据库 阿贝西利：$30亿重磅抗肿瘤药 礼来的阿贝西利是全球首个获批用于治疗早期乳腺癌的CDK4/6抑制剂，2023年该产品的全球销售额超过38亿美元。原研的阿贝西利片在2020年获批进入中国市场，2021年谈判成功进入国家医保目录。 图1：阿贝西利的国内销售情况（单位：万元）来源：米内网格局数据库 在中国三大终端六大市场（统计范围见文末），礼来的阿贝西利片销售额快速增长，2023年已超过9.6亿元，2024上半年的增长率为3.05%，全年有望向10亿元级别冲刺。从渠道来看，2024上半年城市公立医院占比升至70%以上，城市实体药店占比降至24%。 齐鲁制药在2024年12月首家提交阿贝西利片的4类仿制上市申请，江西科睿药业在2025年1月第二家报产，目前仅有两家药企竞争国内首仿。 布地奈德福莫特罗：30亿热销吸入剂 阿斯利康的布地奈德福莫特罗用于需要联合应用吸入皮质激素和长效β2-受体激动剂的哮喘病人的常规治疗，2023年该产品的全球销售额超过23亿美元。目前在国内市场上的原研产品有布地奈德福莫特罗吸入粉雾剂(Ⅰ)、布地奈德福莫特罗吸入粉雾剂(Ⅱ)和布地奈德福莫特罗吸入气雾剂(Ⅲ)，已全部进入国家医保常规目录。 图2：布地奈德福莫特罗的国内销售情况（单位：万元）来源：米内网格局数据库 在中国三大终端六大市场，阿斯利康的布地奈德福莫特罗吸入粉雾剂(Ⅰ)和布地奈德福莫特罗吸入粉雾剂(Ⅱ)合计销售额在2023年达到了33亿元，2024上半年的增长率为3.63%。从渠道来看，2024上半年城市公立医院占半壁江山，县级公立医院、城市实体药店分别占了19%、14%。 倍特药业旗下四川普锐特药业在2017年首家提交布地奈德福莫特罗吸入气雾剂的3类仿制上市申请随后在2018年获批临床，公司在2023年再次出击，目前相关受理号正在审评审批中，仅1家药企争夺国内首仿。 诺西那生钠：$10亿“救命药” 渤健的诺西那生钠注射液是全球首个SMA（脊髓性肌肉萎缩症）精准靶向治疗药物，2023年该产品的全球销售额超过17亿美元。原研的诺西那生钠注射液在2019年进入中国市场，2021年谈判成功进入国家医保目录，“天价救命药成功进医保”曾一度刷屏网络，备受市场瞩目。 图3：诺西那生钠的国内渠道格局来源：米内网格局数据库 2020-2022年在中国三大终端六大市场，渤健的诺西那生钠注射液销售额增长率均达三位数，2022年销售额峰值为6.2亿元，近两年有下滑态势。从渠道来看，近三年城市公立医院占比保持在90%以上。 重庆药友制药在2024年9月首家提交诺西那生钠注射液的4类仿制上市申请，齐鲁制药在2025年1月第二家报产，目前仅2家药企参与国内首仿争夺。 卡非佐米：遭10多家国内药企围攻 卡非佐米是一种蛋白酶体抑制剂，是针对多发性骨髓瘤（MM）的靶向治疗药物，2023年该产品的全球销售额超过了14亿美元。原研的注射用卡非佐米在2021年进入中国市场，2022年谈判成功进入国家医保目录。 图4：卡非佐米的国内销售情况（单位：万元） 来源：米内网格局数据库 在中国三大终端六大市场，原研的注射用卡非佐米销售额保持快速增长，2023年接近1.5亿元，2024上半年增长率为116.35%。从渠道来看，2024上半年城市公立医院占比在75%以上，城市实体药店的占比在22%左右。 早在2020年就有国内药企申报注射用卡非佐米3类仿制上市，目前在审评审批中的企业超过10家，四川汇宇制药、扬子江药业集团、正大天晴药业集团等明星药企均已入局，最终国内首仿属谁，我们拭目以待。 氘丁苯那嗪：中国首个氘代药物 2020年5月，梯瓦宣布其创新药氘丁苯那嗪片经国家药监局优先审评审批后批准用于治疗与亨廷顿病（HD）有关的舞蹈病及成人迟发性运动障碍（TD），这是中国首个获批上市的氘代药物，获批当年便谈判成功进入国家医保目录。在中国三大终端六大市场，原研的氘丁苯那嗪片2022-2024上半年的销售额增长率分别为207.38%、80.80%、62.35%，潜力可期。从渠道来看，2024上半年城市公立医院占比下滑至56%，而城市实体药店占比上升至40%。 图5：氘丁苯那嗪的全球销售情况（单位：百万美元） 来源：米内网跨国上市公司数据库 梯瓦制药的氘丁苯那嗪在全球的销售额不断刷新记录，2023年成为了新的全球超10亿美元重磅品种，未来可期。 南京正大天晴制药在2024年5月首家提交氘丁苯那嗪片的4类仿制上市申请，目前仅1家药企报产。 利那洛肽：全球首个鸟苷酸环化酶激动剂 利那洛肽是全球首个鸟苷酸环化酶激动剂，可显著缓解便秘型肠易激综合征患者便秘及腹痛、腹胀等症状，2023年该产品的全球销售额超过11亿美元。原研的利那洛肽胶囊在2019年进入中国市场，2020年谈判成功进入国家医保目录，2024年转入国家医保常规目录。 2020-2022年在中国三大终端六大市场，原研的利那洛肽胶囊销售额快速增长，2022-2023年保持在1亿元以上，2024上半年有12%的降幅。从渠道来看，2024上半年城市公立医院占比在59%，县级公立医院占比在19%，网上药店的占比在13%。 早在2021年就有国内药企申报利那洛肽胶囊的4类仿制上市，国内首仿一直悬而未定，目前齐鲁制药(海南)、四川国为制药、双鹤药业(海南)等6家企业仍在审评审批中。 西尼莫德：罕见病重磅新药 图6：原研的西尼莫德片审评情况 来源：米内网中国申报进度（MED）数据库 诺华的西尼莫德片在2019年按进口1类新药申报上市并于2020年获批进入中国市场，是全球首个用于治疗活动性继发进展型多发性硬化的口服疾病修正治疗药物，获批当年便谈判成功进入国家医保目录，2024年转入国家医保常规目录。2021-2022年在中国三大终端六大市场，原研的西尼莫德片销售额暴涨10498.66%、104.07%，近两年有下滑态势。从渠道来看，2024上半年城市公立医院占比保持在七成左右，城市实体药店占比超过22%。 图7：西尼莫德的全球销售情况（单位：百万美元） 来源：米内网跨国上市公司数据库 在全球市场上，诺华的西尼莫德销售额则一路攀升，2023年升至3.9亿美元。 湖南科伦制药在2023年2月首家申报西尼莫德片4类仿制上市，齐鲁制药在2024年1月第二家报产，目前仅2家药企争夺国内首仿。 非奈利酮：中药明星企业也来搅局 图8：原研的非奈利酮审评情况 来源：米内网中国申报进度（MED）数据库 拜耳的非奈利酮片在2021年按进口1类新药申报上市并于2022年获批进入中国市场，该产品是一种非甾体类选择性盐皮质激素受体（MR）拮抗剂，2022年谈判成功进入国家医保目录。2023年在中国三大终端六大市场，原研的非奈利酮片暴涨20625%，销售额冲破1.7亿元，2024上半年增长率为319.99%，销售额已达1.9亿元，全年有望再创新高。从渠道来看，2024上半年城市公立医院占比在65%，城市实体药店占比超过21%。 在全球市场上，拜耳的非奈利酮销售额2022年为1.07亿欧元，2023年涨至2.7亿欧元，增长率也超过150%。 湖南明瑞制药在2024年9月首家申报非奈利酮片的4类仿制上市，同年山东朗诺制药、天地恒一制药、湖南慧泽生物医药陆续加入战局，中药明星企业康恩贝在2025年1月报产，江苏德源药业、重庆华邦制药也在近期报产，该产品的国内首仿之争也是十分火热。 结语 上述14个重磅产品分布在抗肿瘤和免疫调节剂、呼吸系统用药、全身用抗感染药物、神经系统药物、肌肉-骨骼系统、消化系统及代谢药、杂类、心脑血管系统药物8个大类市场。米内网数据显示，这8个大类市场（化+生）2023年在中国三大终端六大市场的合计规模超过10000亿元，新一轮市场洗牌来袭，2025年最终能有多少个首仿药获批，米内网将继续跟踪报道，敬请留意。 资料来源：米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至1月28日。 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。 投稿及报料请发邮件到872470254@qq.com 稿件要求详询米内微信首页菜单栏 商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

Leiden, the Netherlands, January 21, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces today that the Board of Directors has nominated Fabrice Chouraqui to become Pharming’s new Executive Director and Chief Executive Officer, succeeding Sijmen de Vries. Pharming will nominate Mr. Chouraqui for the appointment as Executive Director and Chief Executive Officer for a term of four years at an upcoming Extraordinary General Meeting of Shareholders (EGM). Information regarding the EGM, including the notice to convene, will be shared shortly in a separate press release. Upon the appointment of Mr. Chouraqui, Sijmen de Vries will resign from the Board of Directors. To ensure a smooth hand-over of tasks and responsibilities, Mr. de Vries will remain a strategic advisor to the new CEO until December 31, 2025. Dr. Richard Peters, Chairman of the Board of Directors, commented:“After an extensive search, the Board and I are confident that Fabrice Chouraqui is the right candidate to lead Pharming and continue to implement our growth strategy, shaping Pharming into the rare disease company of choice. Fabrice is a deeply experienced global pharmaceutical and biotechnology executive, who brings a wealth of profound global expertise and experience, across the entire biopharmaceutical value chain, to Pharming. On behalf of the entire Board of Directors, I would like to thank Sijmen de Vries for his great commitment to Pharming over the past 16 years and for creating the company that it is today, serving patients and paving the way for delivery on the company’s strategy for growth. We are grateful that Sijmen will continue to be available through the end of the year to ensure a smooth hand-over with Fabrice.” Sijmen de Vries, Chief Executive Officer, commented:“I am very pleased with the nomination of Fabrice Chouraqui as my successor. Fabrice brings strong leadership experience with global pharmaceutical companies and highly innovative biotechnology companies to Pharming. To make way for Fabrice to take over the executive leadership of the Company, I will resign from the Board of Directors upon the appointment of Fabrice by our shareholders. I look forward to supporting Fabrice, working closely together through the remainder of the year, and ensuring a smooth hand-over.” Fabrice Chouraqui commented:“I am honored to have the opportunity to take over the leadership of Pharming, building on the strong foundation and joining at a time when I can help propel the company through its next stage of growth in the rare disease space. I am impressed by Pharming’s growing portfolio of products and commercial opportunities which will pave the way for us to become the rare disease company of choice.” ProfileMr. Fabrice Chouraqui (date of birth: August 1, 1970, French national, U.S. citizen) is a global pharmaceutical executive with a record of value creation at Flagship Pioneering, Novartis and Bristol-Myers Squibb. A purpose-driven leader with a passion for bringing innovative treatments to patients, Mr. Chouraqui has a reputation for building strong followership in organizations. He is scientifically minded, with a deep understanding across the business spectrum, from research and development to access and commercialization, including strong expertise in investor management and business development. Across his career, Mr. Chouraqui has led the launch of treatments in many therapeutic areas, including highly targeted specialty care drugs and large primary care medicines. He consistently demonstrates strategic and innovative thinking to achieve long-lasting results and has a strong record of developing next generation talents and highly diverse teams. Until recently, Mr. Chouraqui was a CEO-Partner at Flagship Pioneering, one of the largest Biotech Venture Capital firms in the US. Mr. Chouraqui also served as CEO of Cellarity, Inc., one of the companies created by Flagship Pioneering. In his CEO capacity, Mr. Chouraqui was leading the development of Cellarity, a company which is driving a radically new approach to drug discovery by working at the intersection of AI and biology. Mr. Chouraqui raised over $250M and attracted world-renowned investors. He initiated a collaboration with Novo Nordisk and had Cellarity recognized as a top biotech to watch by several sources. Today, Mr. Chouraqui holds the position of Executive Chairman at Cellarity. Prior to joining Flagship Pioneering, Mr. Chouraqui spent 10 years at Novartis. He was President of Novartis Pharmaceuticals USA from 2016 to 2019, during which he delivered strong growth despite negative price impact and significantly improved profitability. Promoted to turn around performance after the business suffered issues with recent launches, Mr. Chouraqui developed sophisticated commercial and access capabilities to meet the new market environment. He achieved strong market positions for two significant growth drivers (Cosentyx and Entresto), drove the uptake of the rare disease drug Ilaris, initiated the landmark PIONEER clinical trial in heart failure, and championed several business development initiatives. Mr. Chouraqui moved the organization’s culture from “consensus building, conservative and siloed” to “questioning, experimenting and collaborative.” He also served as Novartis representative on the board of BIO. Before leading the US organization, Mr. Chouraqui was President, Latin America & Canada (2014-2016) for Novartis Pharmaceuticals, responsible for leading a portfolio shift from established primary care medicines to innovative specialty care drugs. He also served as Global Head, Business Franchise Neuroscience (2012-2014). In this role, he relaunched Gilenya (Multiple Sclerosis) following a post-launch regulatory review and made Gilenya the largest growth contributor in the Novartis five-year strategic plan. Mr. Chouraqui also addressed late-stage pipeline gaps with the start of the siponimod program in Secondary Progressive Multiple Sclerosis (approved in 2019) and the identification of business development opportunities, which led to the in-licensing of ofatumumab in MS from GSK (launched as Kesimpta) and a partnership with Amgen on erenumab for migraine (launched as Aymovig). From 2000 to 2010, Mr. Chouraqui held multiple international roles at Bristol-Myers Squibb, ultimately serving as Vice President, Commercial Operations, Asia-Pacific and General Manager, Southeast Asia (2008-2010). He began his career in R&D roles at Roussel Uclaf and Hoechst Marion Roussel, pharmaceutical companies that were predecessors to today’s Sanofi. Mr. Chouraqui earned a MBA from INSEAD and a Doctorate in Pharmacy, a Post-Graduate Degree in Quality Assurance of Medicines, and a MSc in Biological and Medicinal Sciences from University of Paris V. Mr. Chouraqui shall have stepped down as Executive Chairman of Cellarity, Inc., a non-listed company, no later than upon his appointment as the new Executive Director and Chief Executive Officer of Pharming. Thereafter, Mr. Chouraqui intends to serve as a non-executive Board member of Cellarity. Mr. Chouraqui also holds the position of independent Board member of OranoMed, a non-listed (and therefore private) subsidiary of Orano Group. OranoMed is a company specialized in the research and development of Pb-212 based radioligand alpha therapies for the treatment of various types of cancers. The resume of Mr. Chouraqui is available on our website. For further public information, contact:Pharming Group, Leiden, the NetherlandsMichael Levitan, VP Investor Relations & Corporate CommunicationsT: +1 (908) 705 1696E: investor@pharming.com FTI Consulting, London, UKVictoria Foster Mitchell/Alex Shaw/Amy ByrneT: +44 203 727 1000 LifeSpring Life Sciences Communication, Amsterdam, the NetherlandsLeon MelensT: +31 6 53 81 64 27E: pharming@lifespring.nl About Pharming Group N.V. Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific. For more information, visit www.pharming.com and find us on LinkedIn. Forward-Looking Statements   This press release may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, and Pharming's expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2023 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information. Inside InformationThis press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Attachments Fabrice Chouraqui Pharming to nominate new Executive Director and Chief Executive Officer_EN_21JAN25