PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀
PolyPid (Nasdaq: PYPD) has successfully completed its fourth consecutive Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health for its manufacturing facility. The inspection, operating under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA), validates the facility's compliance with European market standards.
This milestone strengthens PolyPid's position as it prepares for its planned New Drug Application (NDA) submission for D-PLEX₁₀₀ in early 2026. The successful inspection serves as preparation for the upcoming FDA facility inspection and confirms the company's readiness for commercial production following the positive Phase 3 SHIELD II trial results.
PolyPid (Nasdaq: PYPD) ha completato con successo la sua quarta ispezione consecutiva Good Manufacturing Practice (GMP) da parte del Ministero della Salute israeliano per il suo stabilimento di produzione. L'ispezione, operante nell'ambito dell'Accordo UE-Israele sull'Accertamento della Conformità e sull'Accettazione (ACAA), attesta la conformità dello stabilimento agli standard del mercato europeo.
Questo traguardo rafforza la posizione di PolyPid mentre si prepara alla presentazione pianificata della Domanda di Nuovo Farmaco (NDA) per D-PLEX100 all'inizio del 2026. L'ispezione riuscita serve da preparazione per la futura ispezione della FDA e conferma la prontezza dell'azienda per la produzione commerciale a seguito dei risultati positivi dello studio di fase 3 SHIELD II.
PolyPid (Nasdaq: PYPD) ha completado con éxito su cuarta inspección consecutiva de Buenas Prácticas de Manufactura (GMP) por parte del Ministerio de Salud de Israel para su instalación de fabricación. La inspección, que opera bajo el Atrato EU-Israel sobre Evaluación de Conformidad y Aceptación (ACAA), valida el cumplimiento de la instalación con los estándares del mercado europeo.
Este hito fortalece la posición de PolyPid mientras se prepara para su presentación planificada de la Solicitud de Nuevo Fármaco (NDA) para D-PLEX100 a principios de 2026. La inspección exitosa sirve de preparación para la próxima inspección de la FDA y confirma la disposición de la empresa para la producción comercial tras los resultados positivos de la fase 3 SHIELD II.
PolyPid (나스닥: PYPD)가 이스라엘 보건부의 제조시설에 대한 네 번째 연속 GMP(우수의약품 제조) 점검을 성공적으로 완료했습니다. 이 점검은 EU-이스라엘 적합성 평가 및 수용 협정(ACAA) 하에서 운영되며, 시설의 유럽 시장 표준 준수를 확인합니다.
이 이정표는 PolyPid의 위치를 강화하며 2026년 초 D-PLEX100에 대한 신약승인(NDA) 신청 예정 준비를 돕습니다. 이 성공적인 점검은 다가오는 FDA 시설 점검에 대한 준비로 작용하며, 3상 SHIELD II 시험 결과 이후 상업 생산 준비를 확인합니다.
PolyPid (Nasdaq: PYPD) a réussi sa quatrième inspection GMP consécutive par le ministère israélien de la Santé pour son unité de fabrication. L'inspection, opérant dans le cadre de l'Accord UE-Israël sur l'évaluation de la conformité et l'acceptation (ACAA), confirme la conformité de l'installation aux normes du marché européen.
Cette étape renforce la position de PolyPid alors qu'elle se prépare à la présentation prévue de la demande de médicament nouveau (NDA) pour D-PLEX100 début 2026. L'inspection réussie sert de préparation à la prochaine inspection de la FDA et confirme la préparation de l'entreprise à la production commerciale à la suite des résultats positifs de l'essai de phase 3 SHIELD II.
PolyPid (Nasdaq: PYPD) hat erfolgreich seine vierte aufeinanderfolgende GMP-Inspektion durch das israelische Ministry of Health für seine Produktionsstätte abgeschlossen. Die Inspektion, die im Rahmen des EU-Israel-Abkommens über Konformitätsbewertung und Annahme (ACAA) durchgeführt wird, bestätigt die Einhaltung der Einrichtung mit den europäischen Marktstandards.
Dieser Meilenstein stärkt die Position von PolyPid, während das Unternehmen sich auf die geplante Einreichung eines New Drug Application (NDA) für D-PLEX100 Anfang 2026 vorbereitet. Die erfolgreiche Inspektion dient als Vorbereitung auf die kommende FDA-Inspektion und bestätigt die Bereitschaft des Unternehmens zur kommerziellen Produktion nach den positiven Phase-3-Ergebnissen von SHIELD II.
PolyPid (ناسداك: PYPD) أكملت بنجاح تفتيش GMP المتتالي الرابع من قبل وزارة الصحة الإسرائيلية لمرفق التصنيع الخاص بها. تُشغّل التفتيش بموجب اتفاقية الاتحاد الأوروبي-إسرائيل بشأن تقييم المطابقة والقبول (ACAA)، وتؤكد امتثال المرفق لمعايير السوق الأوروبية.
هذا الإنجاز يعزز موقع PolyPid بينما تستعد لتقديم طلب دواء جديد (NDA) مخطط لـ D-PLEX100 في أوائل 2026. ويُعد التفتيش الناجح بمثابة استعداد للفحص القادم لمرفق الـ FDA ويؤكد جاهزية الشركة للإنتاج التجاري عقب نتائج تجربة SHIELD II للمرحلة الثالثة بإيجابية.
PolyPid（纳斯达克：PYPD） 已成功完成以色列卫生部对其制造设施的第四次连续GMP检查。该检查在欧盟-以色列合格评定与接受协定（ACAA）框架下进行，验证该设施符合欧洲市场标准。
这一里程碑在PolyPid为2026年初的D-PLEX100新药申请（NDA）提交做好准备的同时，进一步巩固其地位。此次成功的检查为即将到来的FDA设施检查做准备，并在SHIELD II III期试验结果呈阳性后，确认公司具备商业生产的能力。
- Fourth consecutive successful GMP inspection validates manufacturing quality standards
- Manufacturing facility meets EU commercial production requirements through ACAA framework
- Company on track for NDA submission of D-PLEX₁₀₀ in early 2026
- Successful Phase 3 SHIELD II trial results support commercialization pathway
- None.
Insights
PolyPid's successful GMP inspection strengthens commercialization prospects for D-PLEX₁₀₀ following positive Phase 3 results.
The successful completion of PolyPid's fourth consecutive GMP inspection represents a significant regulatory milestone that substantiates the company's manufacturing readiness for commercial production. This inspection carries particular weight because it was conducted under the EU-Israel Agreement on Conformity Assessment and Acceptance framework, essentially providing regulatory equivalence for European market standards. For a company with a lead product advancing through late-stage development, manufacturing validation is often an underappreciated yet critical hurdle in the commercialization process.
The timing of this inspection is strategically important as PolyPid prepares for its planned NDA submission in early 2026. Pharmaceutical companies typically face heightened regulatory scrutiny during pre-approval inspections, and this successful routine inspection serves as a valuable preparation for the more rigorous FDA facility inspection that will follow the NDA filing. Manufacturing deficiencies identified during pre-approval inspections can lead to Complete Response Letters and significant commercialization delays, so this positive outcome substantially de-risks PolyPid's regulatory pathway.
With the combination of positive Phase 3 SHIELD II trial results and validated manufacturing capabilities, PolyPid has now cleared two of the three major hurdles in bringing D-PLEX₁₀₀ to market – clinical efficacy/safety and manufacturing compliance. The remaining challenge will be navigating the regulatory review process. This inspection success increases confidence in PolyPid's operational readiness to support commercial production following potential approvals in both U.S. and European markets, strengthening their position as they transition from a development-stage to a commercial-stage organization.
Key Manufacturing Milestone Strengthens PolyPid’s Position as it Advances Towards Global Commercialization of D-PLEX₁₀₀ Following Successful SHIELD II Phase 3 Trial
PETACH TIKVA, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of a routine Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health. The inspection, concluded earlier this week, marks the fourth consecutive successful GMP inspection of PolyPid's manufacturing facility.
The Israeli Ministry of Health operates under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA) framework, whereby European regulatory authorities rely on these inspections for EU GMP compliance certification. This regulatory equivalence confirms that PolyPid's manufacturing facility meets the standards required for commercial production in the European market.
"Successfully completing this inspection demonstrates our consistent adherence to international GMP standards and validates our quality systems for commercial-scale manufacturing," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "As we advance toward our planned New Drug Application (“NDA”) submission for D-PLEX₁₀₀ in early 2026, this inspection serves as crucial real-world preparation for the U.S. Food and Drug Administration (“FDA”) facility inspection that will follow. With positive Phase 3 SHIELD II results in hand, confirming our manufacturing readiness represents another step toward bringing D-PLEX₁₀₀ to patients."
The inspection comprehensively evaluated PolyPid's quality systems, manufacturing processes, and facility operations, confirming the Company's readiness to support commercial production of D-PLEX₁₀₀ following regulatory approvals. We believe that this milestone further reinforces our path to commercialization as PolyPid prepares for potential market entry in both U.S. and European markets.
About D-PLEX₁₀₀
D-PLEX₁₀₀, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX₁₀₀ into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX₁₀₀ recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. Following positive phase 3 results, New Drug Application (NDA) submission of D-PLEX₁₀₀, PolyPid's lead product candidate, for the prevention of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology, obesity and diabetes.
For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the manufacturing facility's readiness for commercial production, the planned NDA submission for D-PLEX₁₀₀ and timing thereof, preparation for FDA facility inspection, the Company’s belief that this milestone further reinforces its path to commercialization and the potential for market entry in U.S. and European markets. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on February 26, 2025. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.
Company Contact:
PolyPid Ltd.
Ori Warshavsky
908-858-5995
IR@Polypid.com
Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com
FAQ
What was the outcome of PolyPid's (PYPD) recent GMP inspection?
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What is the significance of the SHIELD II trial for PolyPid's D-PLEX₁₀₀?
