ATI-502

近日，艾伯维、强生、阿斯利康、礼来、诺和诺德荣登美国制药经理人杂志公布的2023全球制药企业TOP榜。全球经济下行、新药板块融资遇冷对创新药赛道的挤兑，导致国内创新药产业链进入泡沫出清阶段，众多Biotech公司在破产边缘苦苦挣扎。相比之下，这些MNC经历过多轮经济周期，在面对危机时布局的方向具有更强的前瞻性。本文笔者将对在医药寒冬中，MNC布局领域进行分析。01艾伯维2022年，艾伯维处方销售额561亿美元，仅次于辉瑞。自免领域是艾伯维第一大领域，销售额前三的药物有两款是自免药物（Humira和Skyrizi），肿瘤是其第二大版块；另外，在医美、神经科学、眼科等领域都有布局。2023年，艾伯维管线中约有50款新分子实体药物，240余项临床试验正在进行中。值得一提的是，Humira（修美乐）2022年全球销售额212.37亿美，接近艾伯维全年营收的四成。FDA已经批准多款Humira的生物类似药上市，Amgevita半年独占期即将结束接下来就是价格战。为了保持自己免疫领域的领先地位，Skyrizi和Rinvoq继续拓展适应症来应对，加上其丰富的在研创新管线，将充分消化在美国失去Humira市场独占权的负面影响，其业绩有望在2025年恢复增长。Rinvoq（Upadacitinib）Rinvoq是一款选择性JAK1抑制剂，属于第二代选择性JAK抑制剂。目前已经获批了特应性皮炎、类风湿关节炎、银屑病关节炎等多项适应症，克罗恩病的适应症即将在美国获批上市，而该适应症已经在今年四月份在欧洲获批，Rinvoq 2022实现销售额25.22亿美元。白癜风适应症的2期临床数据已经读出，而FDA批准的治疗白癜风治疗药物较少仅2022年获批的Opzelura（涂抹型JAK抑制剂）。目前处于临床阶段的JAK药物有：Ifidancitinib、Ritlecitinib、Brepocitinib、Cerdulatinib，其中进展最快的是辉瑞的Ritlecitinib，目前在临床3期。Skyrizi（Risankizumab）Skyrizi是一款IL-23抑制剂，已经获批了银屑病、银屑病关节炎和克罗恩病3项适应症。今年3月份艾伯维公布了Skyrizi治疗中重度活动性结肠炎成人患者的3期诱导研究的积极顶线结果，在12周达到了主要终点和所有次要终点。该适应症已经提交上市。Skyrizi 2022年销售额为51.65亿美元，艾伯维预测，Skyrizi和Rinvoq两款产品的销售额将超过修乐美210亿美元的峰值收入。EpcoritamabEpcoritamab是一种双特异性单抗（CD3/CD20），由艾伯维与Genmab联合开发。5月份，Epcoritamab被FDA加速批准用于治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL），EPCORE NHL-1研究结果显示ORR为61%，其中38%的患者得到完全缓解。目前FDA批准的CD20双抗仅罗氏的Lunsumnio。Venclexta 3线及以上治疗多发性骨髓瘤提交上市申请；Navitoclax 1线治疗骨髓纤维化症提交上市申请。而ABBV-951（24小时持续皮下注射剂）治疗晚期帕金森获批被推迟。另外，艾伯维还布局了多款早期肿瘤管线寻求突破。02强生2022年，强生处方药销售额501亿美元，研发费用创新高，达141亿美元，仅次于罗氏148亿美元。根据其披露的管线资料显示，目前正在进行的研究有102项，10项处于上市申报阶段，45项研究进入3期临床阶段，24项处于2期临床，另外还有23项1期临床研究，涉及的适应症包括肿瘤、心血管和代谢、免疫学、神经科学、肺动脉高压等领域。近年来，强生利用Talquetamab和Carvykti继续强化血液瘤布局，Aprocitentan和Rybrevant力求在高血压和肺癌等治疗领域寻求突破。AprocitentanAprocitentan是强生和Idorsia合作研发用于治疗难治性高血压的药物。难治性高血压是指在服用了至少三种不同药理学类别的抗高血压药物（包括利尿剂）仍无法有效控制血压。Aprocitentan是一种新型口服双重内皮素受体拮抗剂，是首款将ETRa/b（内皮素受体A和B）抑制剂运用于高血压的药物，有望成为30年来首个高血压创新药物。早期试验显示Aprocitentan具有更高的安全性和耐受性，3期临床研究结果显示Aprocitentan的降压效果显著优于安慰剂，可以显著降低患者血压，降压效果可维持一年。去年12月份强生已经向FDA提交上市申请。在美国大约有2000万耐药性高血压患者；在我国《中国高血压临床实践指南》更新版本发布后，我国的高血压患者数量将由2.45亿增长至近5亿，难治性高血压将占到10~20%。TalquetamabTalquetamab是一种首创（FIC）、即用型（off-the-shelf）T细胞重定向双特异性抗体，用于治疗复发难治性多发性骨髓瘤（R/R MM）。Talquetamab同时靶向GPRC5D（多发性骨髓瘤上的新颖靶标）和CD3（抗癌T细胞上的表面受体）。Talquetamab通过招募和激活CD3阳性T细胞，诱导T细胞介导的GPRC5D阳性多发性骨髓瘤细胞的杀伤，抑制肿瘤的形成和生长。根据MonumenTAL-1临床数据显示Talquetamab14.9m随访ORR为74%，优于已上市的Teclistamab。基于MonumenTAL-1的临床数据，强生已经向FDA提交了上市申请，预计今年将会在美国和欧洲获批。同靶点的在研药物目前只有罗氏的forimtamig，目前处于临床1期。CarvyktiCarvykti原本计划于今年在EHA大会上公布的CARTITUDE-4数据提前泄露，CARTITUDE-4研究旨在评估在接受过1-3线治疗的R/R MM患者中CARVYKTI与标准疗法（PVd或DPd）相比的疗效与安全性，数据显示Carvykti较标准疗法可降低74%的复发风险（HR=0.26），此前市场乐观的预期是60~70%，这效果显著超出预期，BMS的Abecma HR为0.49，Carvykti有望成为MM治疗领域BIC产品。强生曾预计CARVYKTI产品销售峰值有望达到50亿美元。除此之外，Darzalex治疗不可接受骨髓移植的MM临床3期SYMPATICO研究数据读出。Rybrevant（Amivantamab）今年3月底，强生公布了Rybrevant CHRYSALIS研究的新长期数据，并在2023年欧洲肺癌大会(ELCC)的口头报告中进行了介绍中位OS为23个月，两年OS率为47%。Nipocalimab（FcRn IgG1抗体）Nipocalimab AnaptysBio开发后被强生收购，该药物有9项适应症在临床中后期阶段，其中慢性脱髓鞘性神经炎（CIDP）、重症肌无力（MG），以及抗体型自身免疫性溶血性贫血（wAIHA）在临床3期。03阿斯利康2022年，阿斯利康处方药销售额为430亿美元，根据其披露的在研管线显示，有178项研究正在进行，涉及肿瘤学、心血管与代谢、呼吸与免疫学、罕见病、疫苗和免疫疗法。其中，30余项研究处于临床3期，有14款新分子实体处于临床研究后期，有2款新分子实体处于审查阶段。2022年，其研发费用为95亿美元，与强生相比阿斯利康的研发更像是广撒网多捞鱼。Beyfortus（Nirsevimab）Nirsevimab是由阿斯利康和赛诺菲共同开发的一种单剂量长效抗体，基于MEDLOFY/MEDLEY研究，今年1月份获得FDA批准旨在为新生儿和婴儿（这是RSV的易感人群）提供直接的RSV保护，保护率为80%。产品销售由赛诺菲负责，定价预计在600美元，不具备价格优势，但是目前上市两款疫苗分别是GSK的Arexvy和辉瑞的ABRYSVO主要针对60岁以上的人群。Nirsevimab也已经在中国提交了上市申请。Lynparza（Olaparib）Lynparza是一种聚腺苷二磷酸核糖聚合酶抑制剂(PARP抑制剂)，于2014年12月首次获FDA批准，目前已经获批用于治疗乳腺癌和卵巢癌等多项癌症。今年3月份，FDA批准Lynparza用于高危早期乳腺癌的辅助治疗；5月31日FDA批准Lynparza联合阿比特龙和泼尼松（或泼尼松龙）治疗BRCA突变转移性去势抵抗性前列腺癌(mCRPC)的成年患者。同样是5月份Beyfortus 1线治疗子宫内膜癌临床3期DUO-E研究数据读出。Tagrisso(Osimertinib)Tagrisso是第三代EGFR-TKI，用于二线治疗非小细胞肺癌，今年5月份根据阿斯利康公布的FLAURA2 III期试验结果显示，Tagrisso加化疗显著改善了EGFR突变的晚期肺癌患者的无进展生存期，基于该项研究Tagrisso一线治疗非小细胞肺癌的适应症提交了上市申请。今年不可切除的非小细胞肺癌适应症也提交了上市申请。Tagrisso在用于早期EGFR突变肺癌患者辅助治疗的ADAURA III期试验中显示出强大的总体生存获益，其具体的细节数据将在ASCO会议上展示。公司业绩会上表示2030年拿下肺癌一半市场。EnhertuEnhertu是阿斯利康和第一三共联合开发的一款靶向HER2的抗体药物偶联物，通过一种4肽链接子将曲妥珠单抗与Dxd连接在一起，靶向送至癌细胞内。Enhertu将乳腺癌的治疗带到了一个很高的门槛，此外Enhertu还获批胃癌、非小细胞肺癌。最近其2线治疗HER2-Low乳腺癌临床3期DB06研究数据读出，今年2月份，Enhertu首次在中国获批上市。2022年Enhertu销售额达到了12.34亿美元同比增长189%，成为销售额最快突破10亿美元的ADC药物。Imfinzi（Durvalumab，PD-L1）Imfinzi治疗不可切除非小细胞肺癌3期临床研究PACIFIC-2数据读出，该适应症已经向FDA提交上市申请，AEGEAN III期试验显示Imfinzi显著提高了可切除非小细胞肺癌患者无事件生存期；基于NILE、NIAGARA两项临床3期研究数据Imfinz膀胱癌的适应症也提交了上市申请。肝癌等多项3期临床研究数据读出。另外，阿斯利康的TROP2 ADC Dato-DXd在肺癌、Capivasertib在乳腺癌治疗中均展现了显著的效果。04礼来近来，礼来市值超4000亿美元登顶全球最贵药企被广泛报道，其主要原因是礼来业绩确定性较强，糖尿病、减重、阿尔兹海默症3大领域齐开花。与其他美国MNC不同，礼来的研发特点更像是“集中力量干大事”，2022年礼来研发费用为71.91亿美元，目前有30余项研究处于3期临床，主要涉及糖尿病、肿瘤、免疫、神精系统四大领域。未来，礼来的四大重磅品种获批预计将会带动企业在2024年进入业绩快速成长期，分别是Tirzepatide减重适应症；Donanemab治疗阿尔兹海默症，Mirikizumab治疗溃疡性结肠炎；Lebrikizumab用于治疗特应性皮炎。Tirzepatide替尔泊肽是一种每周注射一次的葡萄糖依赖性GIP和GLP-1受体双重激动剂，目前虽然只获批用于治疗2型糖尿病，但是上市不到一年已经斩获了5.7亿美元销售额。根据先前公布的SURMOUNT-1研究数据，Tirzepatide治疗组的患者在72周时平均减重最高达22.5%，优于司美格鲁肽。今年4月份，礼来登记了SURMOUNT-5研究，在减重适应症与司美格鲁肽进行头对头研究。肥胖或超重的2型糖尿病成人患者的SURMOUNT-2研究数据在今年4月27日公布，高剂量减重15.7%，低剂量减重13.4%。今年4月份减重的适应症在美国已经提交申请，有望于今年获批。Tirzepatide放量速度显著高于同类的度拉糖肽和司美格鲁肽，市场预测Tirzepatide峰值销售额有望达520亿美元。DonanemabDonanemab是一款靶向N3pG修饰的Aβ蛋白的抗体药物，旨在靶向并破坏阿尔茨海默症患者大脑中形成的淀粉样蛋白斑块。这与Biogen的ADUHELM和卫材的LEQEMBI属于同一疗法。今年1月份，FDA拒绝批准了礼来加速批准上市的申请，原因是12个月药物暴露量数据的患者数量有限，要求至少提供100例。5月3日礼来宣布Donanemab的3期临床研究TRAILBLAZER-ALZ 2达到所有主要终点和关键次要终点。iADRS评分变化相较于安慰剂18个月内患者的认知和功能下降进程减缓35%。次要终点CDR-SB评分上，Donanemab可以减缓病程36%，高于LEQEMBI的27%。另外礼来的另外一款治疗阿尔兹海默症的药物Remternetug也已经启动了3期临床。MirikizumabMirikizumab是一种人源化IgG4单克隆抗体，可与IL-23的p19亚基结合，阻断IL-23介导的炎症反应。目前，用于治疗免疫性疾病，如银屑病、溃疡性结肠炎和克罗恩病。今年4月，因为生产制造有关问题，FDA拒绝批准Mirikizumab治疗溃疡性结肠炎，但是药物临床数据、安全性以及标签没有问题。克罗恩病CD临床3期数据已经读出，有望成为治疗克罗恩病的第三种药物。LebrikizumabLebrikizumab是一种在研的高亲和力强效IL-13抑制剂，正在进行12岁及以上患有中度至重度AD的成人和青少年患者的研究，也是一种新型的单克隆抗体，与IL-13具有高亲和力，特异性阻断IL-13Rα1/IL-4Rα异二聚体复合物的形成和信号传导。IL-13是特应性皮炎的中心致病介质。基于ADvocate 1和ADvocate 2研究以及ADhere研究的16周诱导期数据的事后分析显示，服用Lebrikizumab的特应性皮炎患者中，58%-73%的面部或者手部皮肤得到改善或者清除，与赛诺菲的dupilumab相比，Lebrikizumab只靶向IL-13，靶点更加精确，理论上lebrikizumab的副作用应该较小，但是目前缺少头对头的数据。根据最新公布的数据显示，lebrikizumab最常报告的AE是结膜炎、感冒和头痛，这些不良反应不会导致治疗中断。Dupixent 2022年销售额为83亿欧元，同比增长43.8%，预计今年将突破百亿欧元。另外礼来的Retatrutide预计今年启动减重的3期临床，Orforglipron成为首个启动临床3期减重、糖尿病研究的GLP-1R小分子，预计3期临床将在2025年初步完成。05诺和诺德2022年，诺和诺德处方药营收为253亿美元，大部分为GLP-1产品收入。目前，根据一季报显示诺和诺德有17项研究处于临床3期，涉及糖尿病、肥胖、罕见病领域；同样为全球糖尿病和肥胖领域领导者的诺和诺德，比礼来更加专注，其管线的布局聚焦于自家的重磅产品Semaglutide，最大的看点为是否会对肥胖（非糖尿病）患者带来心血管获益。心脑血管是公司在代谢和罕见病之外新的研发重点。SemaglutideSemaglutide是一种GLP-1类似物促胰岛素分泌并抑制胰高血糖素分泌，用于治疗2型糖尿病，2022年司美格鲁肽降糖针（Ozempic）、司美格鲁肽片（Rybelsus）、司美格鲁肽减肥针（Wegovy）的销售额分别为597.50亿丹麦克朗（84.39亿美元）、112.99亿丹麦克朗（15.69亿美元）和61.88亿丹麦克朗（8.74亿美元）。其未来主要的竞争对手将会是礼来的Tirzepatide。目前Semaglutide正在开发口服减重的剂型。5月22日诺和诺德公布了口服Semaglutide（50mg）OASIS 1减重研究数据，参与者平均基线体重为105.4kg，在68周后平均减重17.4%，而安慰剂组减重为1.8%，达到了主要终点。CagriSema是卡瑞林肽和Semaglutide的复方，前期的研究显示有更好减重效果和安全性，目前已启动临床3期预计今年将有阶段性数据读出。Semaglutide治疗NASH、AD的两项研究也已经进入三期临床。另外诺和诺德在超长效胰岛素Icodec的基础上开发了胰岛素复方周制剂Icosema（Icodec胰岛素+司美格鲁肽），目前也已经进入3期临床，预计将在2024年完成。口服疗法Amycretin能够同时激活GLP-1受体和长效胰淀素受体，给药方式更为便捷，目前正在进行1期临床。PYY1875为NPYRs激动剂，目前正在美国进行肥胖适应症的II期临床。罕见病领域Somapacitan（商品名Sogroya）能够将给药频率从每日注射变为每周注射，预计今年上半年能够在美国、欧盟、日本获批上市。全球首创新药Concizumab单抗已获得FDA突破性疗法认定，目前也已在美国、欧盟和日本提交上市申请。与阿斯利康合作的IL6抑制剂Ziltivekimab治疗ASCVD的研究也进入三期临床。小结可以看到，上述MNC一家一个或者多个重磅产品，成为支撑其发展的重要条件。重磅产品的持续开发及在重磅产品专利到期之后，仍有产品接棒填补空白，是MNC长胜不败的秘诀。在治疗领域上，抗肿瘤、自免疾病仍是必争之地，礼来和诺和诺德正是凭借降糖和减重差异化风景独好，礼来市值更是一度突破4000亿美元，超越强生成为市值最高药企。你如何看待MNC布局管线？欢迎在评论区留言讨论。如果大家感兴趣，笔者未来会对其他MNC的重点布局进行盘点。参考资料：1.德邦证券、各公司官网以及FDA官网.2.Positive Phase 3 study with aprocitentan demonstrates significant antihypertensive efficacy in patients with resistant hypertension.3.New RYBREVANT®(amivantamab-vmjw)Data Showed Long-Term Clinical Response and Safety in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Who Have Failed Prior Platinum-Based Chemotherapy.4.FDA rejects Eli Lilly's ulcerative colitis prospect mirikizumab,citing manufacturing shortfalls.5.Press Release:FDA accepts nirsevimab application as first protective option against RSV disease for all infants.6.Imfinzi significantly improved event-free survival in AEGEAN Phase III trial for patients with resectable non-small cell lung cancer.声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八角转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信） 阅读原文，是受欢迎的文章哦

→ Zymeworks used a poison pill maneuver a couple weeks ago as the counterpunch to a $773 million takeover bid by All Blue Falcons , and new CEO Kenneth Galbraith isn’t done piecing the staff together either. Paul Moore will end his 14-year association with MacroGenics , where he was VP, cell biology, and immunology, and step up to the plate as CSO of Zymeworks on July 18. Tony Polverino , the chief scientist who preceded Moore, didn’t escape the sweeping changes that were enacted by Galbraith in January, when half the C-suite and 25% of the staff overall received pink slips. Neil Klompas and Neil Josephson were named COO and CMO, respectively, and Chris Astle took over as CFO a month later. → Pearl Huang — one of our Women in Biopharma R&D honorees from 2020 — is a CEO again, this time at Cambridge, UK, protein degradation biotech Dunad Therapeutics . Huang was Roche ’s head of therapeutic modalities until 2018 and became CEO of Flagship ’s exoneural biology company Cygnal Therapeutics a short time later. When Flagship combined Inzen and Cygnal to form Sonata Therapeutics in mid-May, Volker Herrmann was named chief executive, leaving Huang to explore other options. She lands at Dunad after Novartis inked a $1.3+ billion deal with the startup in November 2021. → Hoping to revitalize a pipeline that has yet to see an FDA approval in its 20-plus year history, Inovio has tapped Michael Sumner as CMO, joining new chief executive Jacqueline Shea . For the last nine years, Sumner was medical chief for Swedish biotech Orexo , and he’s worked in medical affairs for Shire and Novo Nordisk . A month ago, Shea took over for Joseph Kim after Inovio hit multiple potholes with its Covid-19 vaccine, leading to a different approach with INO-4800 as a heterologous booster. → There’s a lot to sift through at the US-Danish cancer biotech Allarity Therapeutics , starting with CEO Steve Carchedi , who has yielded the top spot to CBO James Cullem on an interim basis. Cullem had been SVP of corporate development for seven years before ascending to the role of business chief in December. CFO Jens Knudsen is also out, and Allarity has lined up director of financial reporting Joan Brown to pinch-hit. Meanwhile, Thomas Jensen — who co-founded the company in 2004 — will now be SVP of investor relations after two years as SVP, information technology. Allarity’s board “expects to name a permanent CEO and CFO in H1 2023,” according to the press release. → The unrelenting job cuts in the industry haven’t spared hit eye disease-focused Oyster Point Pharma , which will scrap about 50 employees as part of its new “ streamlining plan .” Changes have filtered into the senior leadership too as Genentech alum John Snisarenko — the chief commercial officer since 2019 — heads into retirement, while sales and commercial operations VP Michael Campbell becomes head of commercial. Elsewhere at Oyster Point, Daniel Lochner will also tackle the role of CBO in addition to his CFO duties. → In October 2021, The Carlyle Group jumped on the AI bandwagon alongside the investment arms of Pfizer , Merck , Amgen and McKesson with the $430 million buyout of cloud-based Saama Technologies . Saama’s founding CEO Suresh Katta has now stepped aside after 25 years and will transition to the role of chairman emeritus as Vivek Sharma takes control at the California AI player. Sharma has been a chief executive before with Decision Resources Group , Piramal Pharma Solutions and more recently, Adare Pharma Solutions . In addition to his new title at Saama, Katta will also be an advisor for Carlyle. → Firing back at the FDA with a formal dispute resolution request for its epidermolysis bullosa drug Filsuvez , Amryt Pharma has promoted Tracy Cunningham to CMO. Cunningham is a Sanofi alum who had been clinical lead for selumetinib — now marketed as Koselugo — with AstraZeneca before making her way to Amryt as head of development in 2020. Earlier, Cunningham held medical affairs roles at Novartis and GSK . → As for Cunningham’s predecessor, he only has to switch out a few letters: Mark Sumeray has left Amryt to become CMO at Amolyt Pharma , a French-American endocrine disease biotech that filled the piggy bank with an $80 million Series B round in September 2021. Before his six years as CMO at Amryt, Sumeray was the medical chief for Aegerion Pharmaceuticals and VP, US cardiovascular and metabolic medical affairs with Bristol Myers Squibb . → To accommodate its entry into the clinical trial business, as reported from Cannes last week, Walgreens has lined up a string of hires, with chief clinical trials officer Ramita Tandon batting leadoff. Other appointments include: Kendal Whitlock (head of digital optimization, real world evidence clinical trials), John Campbell (head of decentralized clinical trials), Liam Wood (head of product, clinical trials) and Adam Samson (head of clinical delivery operations, clinical trials). → Thierry Guillaudeux has been promoted to CSO of Seattle-based Kineta , which merged with Tony Coles ’ Parkinson’s play Yumanity in early June. A longtime professor at the University of Rennes 1 in France, Guillaudeux came to Kineta as SVP, immuno-oncology in 2019 and has helped develop its immunotherapy candidate KVA12.1 , an IgG1 monoclonal antibody. → Cambridge, MA-based GV20 Therapeutics is locking in Shirley Liu as CEO and bringing in duo Steven Landau and Ying Gong as CMO and CBO, respectively. Liu co-founded GV20 in 2016, having previously served as professor of biostatistics and computational biology at the Dana-Farber Cancer Institute and Harvard TH Chan School of Public Health. Meanwhile, Landau formerly ran operations as CMO at Shape Pharmaceuticals and Tensha Therapeutics , while Gong most recently served as project team leader for oncology at Genentech. → Eric Sullivan has been appointed CFO at next-gen T cell outfit TCR² Therapeutics . Sullivan, a bluebird and Merrimack vet, served as president, CFO and COO at Triplet Therapeutics , and has also served as SVP at Gemini Therapeutics and Oncorus prior to joining TCR², which is developing its lead program gavo-cel in several indications. → Hematologic disease biotech Forma Therapeutics will gain two execs on July 11: Agustín Melián (head of R&D) left AlloVir at the end of 2021 and was the Diana Brainard -led biotech’s first CMO. Prior to this, he spent 13 years at Merck and was SVP in global clinical development and medical sciences. Linea Aspesi (chief human resources officer) is a Sanofi Genzyme alum who held the same position at Saniona and led HR at Sobi . → Paradigm Biopharmaceuticals has handed over the CEO hat to Marco Polizzi . Prior to his new role, Polizzi was the founder and CEO of Oakrum Pharma . Polizzi has had a long career spanning roles at Casper Pharma (EVP commercial operations and business development), Sandoz (head of sales and marketing institutional), Mallinckrodt (VP/GM) and Teva . → San Diego-based RNA player DTx Pharma has locked in Peter Condon as CBO. From 2018-21, Condon was head of business development and alliance management at Gossamer Bio , and after 10 years at Genentech, he held the role of executive director, business development at Alexion and Google ’s anti-aging upstart Calico . → Sosei Heptares CBO James Taylor has left to fill the same position at Achilles Therapeutics , a T cell player that went public on the strength of a $175.5 million IPO in the spring of 2021. (Remember those?) Taylor was also a senior director of business development at GSK and held posts at AstraZeneca , Summit Therapeutics and Cellzome . Achilles has also added Cassian Yee, a professor at the University of Texas MD Anderson Cancer Center, to its scientific advisory board. → We told you about Jotin Marango leaving Aptose for Ikena Oncology in April, and this week Fletcher Payne has replaced Marango as CFO. Payne heads to Aptose after nearly three years as finance chief at Syapse , and he’s also been CFO at Plexxikon , CytomX and the now-shuttered Catalyst Biosciences . Aptose’s lead asset, HM43239 , is in a Phase I/II trial for relapsed or refractory acute myeloid leukemia. → Now focused on indications like rheumatoid arthritis and hidradenitis suppurativa with zunsemetinib after misfiring in alopecia areata with ATI-502 , Aclaris Therapeutics has selected Gail Cawkwell as CMO. Cawkwell, the ex-CMO and special advisor to the board of directors at Purdue Pharma , spent the last four years as the SVP, medical affairs, safety & pharmacovigilance for Intercept , and she also worked on Xeljanz in her 14 years with Pfizer. Cawkwell’s predecessor, David Gordon , stepped aside at Aclaris on Jan. 7. → Cellino ’s “GMP-in-a-box” idea made a believer out of Leaps by Bayer , leading the $80 million Series A in January. Fast forward to this week, where Cellino has named Abhijit Kulkarni as COO and Paulette Dillon as CBO. Kulkarni had led the Neuromodulation Technology Development Center at Medtronic , while Dillon co-founded and was SVP of corporate development at recently downsized Atreca . “Their vision is to be a cell manufacturing foundry, where you can produce targeted cells at a fraction of the cost,” Jürgen Eckhardt , the head of Leaps by Bayer, said of Cellino. → NGM Biopharmaceuticals — which has collaborated with Merck — has announced that its CFO Siobhan Nolan Mangini will be taking over as president on top of her current duties. Mangini joined NGM in July 2016 and hailed from Castlight Health , where she was president and CFO. Additionally, William Rieflin , NGM’s executive chairman and former CEO, is transitioning to the role of chairman on NGM’s board of directors. → Peer Review has learned that 64x Bio , the George Church gene therapy manufacturing startup run by a 20 under 40 honoree from this year ( Lex Rovner ), has installed Christopher Hoppe as head of operations. Hoppe joins from Nektar , where he was clinical, operational, and strategic advancement lead for the biotech’s cytokine portfolio. → Scott Batty has joined autoimmune disease biotech Artax Biopharma as CMO. Batty, the ex-global director of medical affairs for the belatacept immunosuppression program at Bristol Myers, had previously been VP of regulatory and scientific affairs for CTI . He has also served as VP of global medical affairs for Genzyme’s transplant and oncology group. → Launa Aspeslet is settling in as COO of Hepion Pharmaceuticals , a New Jersey biotech using AI to develop therapies for NASH and hepatocellular carcinoma. Aspeslet had helmed Translational Research in Oncology , a clinical research organization out of Edmonton with offices in Paris and Montevideo, Uruguay, since 2015. She vaulted to COO of another Edmonton-based company, Isotechnika Pharma , before it was sold to Aurinia nine years ago. In other Hepion news, corporate strategy execs Anand Reddi ( Adverum ) and Kaouthar Lbiati ( Cytovia ) have earned their seats on the board of directors. → Dermira vet Luis Peña and his crew at Evommune have welcomed Greg Moss as chief corporate strategy and legal officer; he’ll also juggle the roles of corporate secretary and chief compliance officer at the inflammatory disease biotech. Moss comes to Evommune after a decade at Sanofi subsidiary Kadmon , where he was general counsel & corporate secretary, chief compliance officer. This isn’t the first Kadmon alum to become part of Evommune’s leadership: Ex-chief accounting officer Kyle Carver has been CFO at Evommune since March. → Person to Person: Natalie Holles is gradually fleshing out her team at Third Harmonic Bio with a new CFO ( Robert Ho ), CSO ( Adrian Ray ) and CMO ( Edward Conner ). This week Julie Person , who comes from ARCH ’s “Really Big Neuroscience Company” named Neumora , is on board as chief administrative officer. Person spent a year as VP of human resources at Sangamo after her time as global head of talent management at Shire, and then had a brief run at Holles’ former company, Audentes , prior to her appointment as Neumora’s chief people officer. → Peter Leddy has made his way to San Diego-based Maravai LifeSciences as chief administrative officer. Prior to joining Maravai, Leddy had such roles as chief human resources officer at Berkeley Lights , chief people officer at dosist and EVP, global human resources and corporate integrity at Nuvasive . → The leadership changes at Zentalis haven’t decelerated as the Pfizer partner brings in Andrea Paul as general counsel and corporate secretary on Aug. 1. Paul, who filled legal roles at Momenta and Akebia Therapeutics , had recently been general counsel and corporate secretary for a year at LogicBio . Back in May, Kimberly Blackwell succeeded Anthony Sun as Zentalis’ CEO, while co-founder Cam Gallagher was elevated to president. → Synthetic biology player and Roche IBD partner Synlogic has promoted Brendan St. Amant to general counsel and corporate secretary. Named VP, head of legal at Synlogic in July 2021, St. Amant was senior counsel at Vertex before moving to the now-defunct Flagship company Ohana Biosciences as VP of legal in 2019. → What’s new at NeuBase ? COO William Mann is tacking on the title of president to his current duties. Prior to his current stint, Mann was CEO and president of Helsinn Therapeutics and held roles at Sapphire Therapeutics and Novartis. → London-based Resolution Therapeutics is bringing aboard Amol Ketkar as chief development officer. Ketkar had a 21-year gig at GSK, most recently serving as VP, product development and supply for the company’s cell and gene therapy CMC group. → Elevar Therapeutics out of Salt Lake City is bringing in some new faces with the appointments of Jan Van Tornout as CMO and Gordon Schooley as chief regulatory officer. Van Tornout previously served as CMO of Tyme Technologies while Schooley jumps aboard after a seven-year run with BeyondSpring . → Peer Review has been informed that Cambridge, MA medtech Cognito Therapeutics has enlisted Steven Maxim as director of manufacturing. Maxim owned the same title at Avedro (purchased by Glaukos in 2019) and has further manufacturing experience from IPG Medical and Palomar Medical Technologies . → Gossamer Bio founder, CEO and chairman Faheem Hasnain is adding another board appointment to his résumé with his latest chairman stint at Sling Therapeutics . Currently, Hasnain sits on the board of Kura Oncology and serves as chairman of the board for Aspen Neuroscience , Mirati Therapeutics and SENTÉ . → With its NDA for vamorolone getting shelved for four to six months because of contract manufacturing hurdles, Swiss biotech Santhera has named Thomas Meier chairman of the board, replacing Elmar Schnee on Thursday. Meier, the chief executive at Santhera from 2011-19, has been a board member since 2017 and is managing partner at Viopas Venture Consulting in Zurich. → Former HHS Secretary and Wisconsin Gov. Tommy Thompson has been named Covid-19 special consultant to CEO Henry Ji at Sorrento Therapeutics . The 80-year-old Thompson was recently at his alma mater as interim president of the University of Wisconsin System from July 2020 to March 2022. → Striking a $1.25 billion Gavreto deal with Royalty Pharma and a separate pact with Sixth Street, Blueprint Medicines has reserved space for Habib Dable on to the board of directors. Dable had a 22-year career at Bayer before his CEO stint at Acceleron , which was sold to Merck last fall for $11.5 billion. → Meenu Karson has succeeded Kenneth Fong as chair of the board at Apexigen , which is merging with Brookline Capital Acquisition Corp. despite a battered market. The ex- Proteostasis Therapeutics chief is also on the board of directors at Fore Biotherapeutics . → Surface Oncology is welcoming Carsten Brunn to its ranks by pulling out a seat for the former Selecta CEO and president on its board of directors. Brunn formerly served in leadership roles at Bayer (president of pharmaceuticals for the Americas region), Eli Lilly, Novartis, Basilea and Bausch and Lomb . Brunn currently sits on the board of BIO. → Led by GSK alum Jack Bailey , Cosela maker G1 Therapeutics has added Jacks Lee to the board of directors. After 19 years at Sanofi, Lee has been with Merck since 2007 and is the pharma giant’s SVP, manufacturing & supply. → Chaired by former HHS Secretary and ex-Kansas Gov. Kathleen Sebelius , Laura Niklason -led Humacyte has added Biopharma Excellence co-founder and former CEO Diane Seimetz to the board of directors. Seimetz also serves on the board at Cumulus Oncology . → Axel-Sven Malkomes and Donald Bergstrom are the newest additions to the board of directors at Cellectis . Malkomes, a Barclays vet, was CFO and CBO of Medigene from 2019 until the end of March. Bergstorm has been a board observer at Cellectis since November and is head of R&D at Relay Therapeutics , which took the cover off its interim data for RLY-4008 in patients with bile duct cancer this week. → UK-based Genflow Biosciences is swapping out some of its board members and trading them in for Tamara Joseph (chief legal officer at Spero Therapeutics ) and Guy-Charles Fanneau de la Horie (former chief executive at Euronext Growth ). Joseph and Fanneau de la Horie succeed Gabrielle Silver and Andrew Scott , who are stepping down. → Aytu BioPharma is pulling Vivian Liu onto its board of directors. Liu currently serves as head of corporate affairs for PREMIA Holdings and previously held the titles of president, CEO and CFO of Innovus Pharmaceuticals . Earlier in her career, Liu was president and CEO of FasTrack Pharmaceuticals and NexMed . → Calidi Biotherapeutics has brought on WK Alfred Yung to its medical advisory board. Yung is a professor, neuro-oncology at the University of Texas MD Anderson Cancer Center and advised President Biden’s Cancer Moonshot initiative.