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2026年9月CDMO机会与威胁报告：FDA与EMA适应症扩展及NICE批准事件影响分析
September 2026 — CDMO Opportunities And Threats Report
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GlobalData旗下PharmSource发布2026年9月CMOT报告，列出可能受客户关键事件影响的CDMO，事件涵盖企业收购、产品收购与许可、产品批准、晚期临床终止及FDA拒绝。
正文 · 原文
By GlobalData
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
| Contractor | BioPharma Company | Event | Product | Relationship |
POTENTIALLY POSITIVE |
||||
| Alcami Corp | Otsuka Pharmaceutical Europe Ltd | NICE approval | Dawnzera | Parenteral manufacture |
| Almac Group Ltd | Jazz Pharmaceuticals Inc | FDA expanded indications | Ziihera | Parenteral packaging |
| Astrea Pharma | Moderna Inc | FDA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Bachem Americas Inc | Amylyx Pharmaceuticals Inc | Phase III top-line results | avexitide acetate | Small-molecule API |
| Biogen Inc | Janssen-Cilag International NV | EMA expanded indications | Tecvayli | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca UK Ltd | NICE approval | Imfinzi | Biologic API |
| BSP Pharmaceuticals SpA | Eli Lilly and Co | FDA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| BSP Pharmaceuticals SpA | Gilead Sciences Europe Ltd | EMA expanded indications | Trodelvy | Parenteral manufacture |
| BSP Pharmaceuticals SpA | Gilead Sciences Europe Ltd | EMA expanded indications | Trodelvy | Biologic API |
| Cambrex Corp | Neopharmed Gentili SpA | EMA expanded indications | Orladeyo | Small-molecule API |
| Catalent CTS LLC | Neopharmed Gentili SpA | EMA expanded indications | Orladeyo | Solid-dose manufacture |
| Catalent Inc | Neopharmed Gentili SpA | EMA expanded indications | Orladeyo | Solid-dose packaging |
| Catalent Inc | IVERIC bio Inc | Phase I/II top-line results | OPGx-BEST1 | Biologic API |
| Catalent Micron Technologies Ltd | ViiV Healthcare Company | FDA expanded indications | Tivicay | Small-molecule API |
| Catalent U.K. Swindon Zydis Ltd | ALK-Abello Ltd | NICE approval | Acarizax | Solid-dose manufacture & packaging |
| Chemspec-API Inc | Can-Fite BioPharma Ltd | Phase III interim results | namodenoson | Small-molecule API |
| Corden Pharma International GmbH | Eli Lilly and Co | FDA expanded indications | Mounjaro | Small-molecule API |
| Delpharm SAS | ViiV Healthcare Company | FDA expanded indications | Tivicay | Solid-dose manufacture & packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca UK Ltd | NICE approval | Calquence | Small-molecule API |
| Esteve Quimica SA | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
| Evonik Industries AG | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
| Ferndale Pharma Group Inc | Quoin Pharmaceuticals Ltd | Phase II/III interim results | QRX-003 | Solid-dose manufacture |
| Flamma SpA | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
| Fritz Keller Holding AG | Biofrontera Inc | FDA expanded indications | Ameluz | Liquid non-sterile manufacture & Packaging |
| Fujifilm Diosynth Biotechnologies UK Ltd | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Biologic API |
| Fujimoto Chemicals Co Ltd | ViiV Healthcare Company | FDA expanded indications | Tivicay | Small-molecule API |
| Gilead Alberta ULC | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
| GSK plc | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Parenteral manufacture & packaging |
| Just Evotec Biologics Inc | Alpine Immune Sciences Inc | Trial planned - Phase III | povetacicept | Biologic API |
| Lentigen Technology Inc | AbClon Inc | Trial planned - Phase II | nespecabtagene autoleucel | Biologic API |
| Lonza Group Ltd | Daiichi Sankyo Co Ltd | EMA expanded indications | Enhertu | Biologic API |
| Lonza Group Ltd | Moderna Inc | FDA expanded indications | Spikevax XFG | Biologic API |
| Mabion SA | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Biologic API |
| Par Sterile Products LLC | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Parenteral manufacture & packaging |
| Parabolic Drugs Ltd | Biofrontera Inc | FDA expanded indications | Ameluz | Small-molecule API |
| Patheon Biologics LLC | Janssen Biotech Inc | FDA expanded indications | Stelara | Biologic API |
| Patheon Italia SpA | Moderna Inc | FDA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Patheon NV | Neopharmed Gentili SpA | EMA expanded indications | Orladeyo | Solid-dose manufacture |
| Patheon NV | Moderna Inc | FDA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Patheon NV | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Solid-dose manufacture |
| Patheon NV | Janssen-Cilag International NV | EMA expanded indications | Tecvayli | Parenteral manufacture & packaging |
| PCI Pharma Services | GlaxoSmithKline UK Ltd | NICE approval | Jemperli | Parenteral manufacture & packaging |
| PCI Pharma Services | Eli Lilly and Co | FDA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| PCI Pharma Services | Neopharmed Gentili SpA | EMA expanded indications | Orladeyo | Solid-dose packaging |
| PCI Pharma Services | Janssen-Cilag International NV | EMA expanded indications | Tecvayli | Parenteral packaging |
| PharmaKorell GmbH | Acadia Pharmaceuticals Inc | EMA approval | Daybu | Liquid non-sterile manufacture & Packaging |
| ROVI Pharma Industrial Services SAU | Moderna Inc | FDA expanded indications | Spikevax XFG | Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | AstraZeneca UK Ltd | NICE approval | Imfinzi | Biologic API |
| Samsung Biologics Co Ltd | Gilead Sciences Europe Ltd | EMA expanded indications | Trodelvy | Biologic API |
| Sharp Packaging Services LLC | Bayer HealthCare Pharmaceuticals Inc | FDA expanded indications | Hyrnuo | Solid-dose packaging |
| Sharp Packaging Services LLC | Regeneron Pharmaceuticals Inc | FDA approval | Pasatru | Parenteral packaging |
| Sharp Packaging Services LLC | Beigene USA Inc | FDA expanded indications | Tevimbra | Parenteral packaging |
| Siegfried Holding AG | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Parenteral manufacture & packaging |
| Simtra US LLC | Daiichi Sankyo Co Ltd | EMA expanded indications | Enhertu | Parenteral manufacture & packaging |
| Simtra US LLC | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Parenteral manufacture |
| Simtra US LLC | Regeneron Pharmaceuticals Inc | FDA approval | Pasatru | Parenteral manufacture |
| Simtra US LLC | Janssen Biotech Inc | FDA expanded indications | Stelara | Parenteral manufacture |
| SK Bioscience Ltd | Novavax Inc | FDA expanded indications | Nuvaxovid XFG | Biologic API |
| SK Pharmteco Inc | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
| Skyepharma Production SAS | Pharming Healthcare, Inc | FDA expanded indications | Joenja | Solid-dose manufacture & packaging |
| TopChem Pharmaceuticals Ltd | Quoin Pharmaceuticals Ltd | Phase II/III interim results | QRX-003 | Biologic API |
| Uquifa SA | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca UK Ltd | NICE approval | Imfinzi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | PharmaEssentia Corp | FDA expanded indications | Besremi | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen Biotech Inc | FDA expanded indications | Imaavy | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Eli Lilly and Co | FDA expanded indications | Mounjaro | Parenteral manufacture & packaging |
| WuXi Biologics Cayman Inc | Hbm Holdings Ltd | Trial planned - Phase II | porustobart | Parenteral manufacture |
| WuXi Biologics Cayman Inc | Spyre Therapeutics Inc | Phase II top-line results | SPY-001 | Biologic API |
| WuXi Biologics Co Ltd | GlaxoSmithKline UK Ltd | NICE approval | Jemperli | Biologic API |
| WuXi Biologics Co Ltd | Janssen Biotech Inc | FDA expanded indications | Imaavy | Biologic API |
| WuXi Biologics Co Ltd | Jazz Pharmaceuticals Inc | FDA expanded indications | Ziihera | Biologic API |
| WuXi Biologics Co Ltd | Jazz Pharmaceuticals Inc | FDA expanded indications | Ziihera | Parenteral manufacture |
| WuXi XDC Cayman Inc | Janssen Biotech Inc | FDA expanded indications | Imaavy | Biologic API |
| Yuhan Chemical Inc | Janssen-Cilag International NV | EMA expanded indications | Symtuza | Small-molecule API |
POTENTIALLY NEGATIVE |
||||
| Ajinomoto Bio-Pharma Services | MacroGenics Inc | Trial Suspended - Phase I | MGD-014 | Parenteral manufacture |
| Baxter International Inc | MacroGenics Inc | Trial Suspended - Phase I | MGD-014 | Parenteral manufacture |
| Hovione FarmaCiencia SA | Vifor Pharma UK Ltd | Withdrawn (UK) | Tavneos | Small-molecule API |
| Patheon NV | Vifor Pharma UK Ltd | Withdrawn (UK) | Tavneos | Solid-dose manufacture & packaging |
| Chime Biologics Ltd | EOC Pharma Ltd | Trial Terminated – Phase III | eftilagimod alfa | Parenteral manufacture |
| Chime Biologics Ltd | EOC Pharma Ltd | Trial Terminated – Phase I/II | eftilagimod alfa | Parenteral manufacture |
| ElevateBio LLC | Kyverna Therapeutics Inc | Trial Terminated – Phase I/II | mivocabtagene autoleucel | Biologic API |
| Samsung Biologics Co Ltd | LigaChem Biosciences Inc | Trial Suspended – Phase I/II | LCB-71 | Biologic API |
| WuXi Advanced Therapies Inc | Kyverna Therapeutics Inc | Trial Terminated – Phase I/II | mivocabtagene autoleucel | Parenteral manufacture |
| WuXi AppTec Co Ltd | Immutep Ltd | Trial Terminated – Phase I/II | eftilagimod alfa | Parenteral manufacture |
| WuXi AppTec Co Ltd | Immutep Ltd | Trial Terminated – Phase III | eftilagimod alfa | Parenteral manufacture |
| WuXi Biologics Cayman Inc | Immutep Ltd | Trial Terminated – Phase III | eftilagimod alfa | Biologic API |
| WuXi Biologics Cayman Inc | Immutep Ltd | Trial Terminated – Phase I/II | eftilagimod alfa | Biologic API |
Notes:
Source: GlobalData, Pharma Intelligence Center ©GlobalData
NICE = National Institute for Health and Care Excellence
*New molecular entities are in bold.
来源：Outsourced Pharma · outsourcedpharma.com