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Concord Healthcare Announces Approval Granted to the Application for the Proton Therapy Equipment Registration Certificate

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Concord Medical Services Holdings (NYSE: CCM) announced that China's National Medical Products Administration has approved the Registration Certificate for Medical Device for their proton therapy equipment on December 6, 2024. The company's Guangzhou Concord Cancer Center completed the proton equipment installation in September 2020, began clinical trials in November 2022, and obtained the large medical equipment procurement license in September 2024. With this final approval, the center plans to commence proton therapy treatment services soon.

The news was also announced by Concord Healthcare Group, CCM's subsidiary listed on the Hong Kong Stock Exchange (2453.HK) since January 9, 2024.

Concord Medical Services Holdings (NYSE: CCM) ha annunciato che l'Amministrazione Nazionale dei Prodotti Medici della Cina ha approvato il Certificato di Registrazione per Dispositivi Medici per la loro attrezzatura di terapia protonica il 6 dicembre 2024. Il Guangzhou Concord Cancer Center della società ha completato l'installazione dell'attrezzatura protonica nel settembre 2020, ha iniziato le prove cliniche nel novembre 2022 e ha ottenuto la licenza per l'acquisto di grandi apparecchiature medico-sanitarie nel settembre 2024. Con questa approvazione finale, il centro prevede di avviare presto i servizi di trattamento con terapia protonica.

La notizia è stata annunciata anche da Concord Healthcare Group, la sussidiaria di CCM quotata alla Borsa di Hong Kong (2453.HK) dal 9 gennaio 2024.

Concord Medical Services Holdings (NYSE: CCM) anunció que la Administración Nacional de Productos Médicos de China ha aprobado el Certificado de Registro para Dispositivos Médicos para su equipo de terapia de protones el 6 de diciembre de 2024. El Guangzhou Concord Cancer Center de la compañía completó la instalación del equipo de protones en septiembre de 2020, comenzó ensayos clínicos en noviembre de 2022 y obtuvo la licencia de adquisición de grandes equipos médicos en septiembre de 2024. Con esta aprobación final, el centro planea iniciar pronto los servicios de tratamiento con terapia de protones.

La noticia también fue anunciada por Concord Healthcare Group, la subsidiaria de CCM que cotiza en la Bolsa de Valores de Hong Kong (2453.HK) desde el 9 de enero de 2024.

Concord Medical Services Holdings (NYSE: CCM)은 중국 국가 의약품 관리국이 2024년 12월 6일에 그들의 양성자 치료 장비에 대한 의료기기 등록증을 승인했다고 발표했습니다. 회사의 광저우 콩코드 암 센터는 2020년 9월에 양성자 장비 설치를 완료하고 2022년 11월에 임상 시험을 시작했으며 2024년 9월에 대형 의료 장비 구매 라이센스를 취득했습니다. 이 최종 승인을 통해 센터는 곧 양성자 치료 서비스 를 시작할 예정입니다.

이 소식은 2024년 1월 9일부터 홍콩 증권 거래소 (2453.HK)에 상장된 CCM의 자회사인 Concord Healthcare Group에 의해 발표되었습니다.

Concord Medical Services Holdings (NYSE: CCM) a annoncé que l'Administration nationale des produits médicaux de Chine a approuvé le Certificat d'enregistrement pour dispositifs médicaux de son équipement de thérapie par protons le 6 décembre 2024. Le Guangzhou Concord Cancer Center de l'entreprise a terminé l'installation de l'équipement de protons en septembre 2020, a commencé des essais cliniques en novembre 2022 et a obtenu la licence d'achat de gros équipements médicaux en septembre 2024. Avec cette approbation finale, le centre prévoit de lancer bientôt des services de traitement par thérapie par protons.

La nouvelle a également été annoncée par Concord Healthcare Group, la filiale de CCM cotée à la Bourse de Hong Kong (2453.HK) depuis le 9 janvier 2024.

Concord Medical Services Holdings (NYSE: CCM) gab bekannt, dass die Nationale Arzneimittelbehörde Chinas am 6. Dezember 2024 das Registrierungszertifikat für Medizinprodukte für ihre Protonentherapiegeräte genehmigt hat. Das Guangzhou Concord Cancer Center des Unternehmens hat die Installation der Protonengeräte im September 2020 abgeschlossen, klinische Studien im November 2022 gestartet und die Lizenz für den Erwerb großer medizinischer Geräte im September 2024 erhalten. Mit dieser endgültigen Genehmigung plant das Zentrum, bald mit den Leistungen der Protonentherapie zu beginnen.

Die Nachricht wurde auch von Concord Healthcare Group angekündigt, der Tochtergesellschaft von CCM, die seit dem 9. Januar 2024 an der Börse in Hongkong (2453.HK) notiert ist.

Positive
  • Received regulatory approval for proton therapy equipment Registration Certificate
  • Completed all necessary regulatory requirements to begin proton therapy treatments
  • Ready to launch new revenue-generating treatment service
Negative
  • None.

Insights

This regulatory milestone marks a significant advancement for Concord Medical's cancer treatment capabilities. The approval of the proton therapy equipment registration certificate, following the successful installation and clinical trials at Guangzhou Hospital, positions CCM to begin offering advanced proton therapy services.

Proton therapy represents a cutting-edge cancer treatment modality that offers more precise tumor targeting with potentially fewer side effects compared to conventional radiation therapy. The completion of this regulatory process, combined with the previously obtained large medical equipment procurement license, creates a clear path for service commencement.

This development could significantly enhance CCM's competitive position in China's specialized cancer treatment market, particularly as proton therapy services often command premium pricing and attract patients seeking advanced treatment options.

The approval of the proton therapy equipment registration certificate represents a important revenue catalyst for CCM. With all regulatory requirements now met, including the procurement license obtained in September 2024, the company can proceed with commercializing its proton therapy services.

For context, proton therapy treatments typically generate higher margins compared to conventional radiation therapy, with potential revenue per patient ranging from $30,000 to $120,000. The Guangzhou facility's ability to offer these services could materially impact CCM's financial performance.

Additionally, the dual listing structure with Concord Healthcare (2453.HK) on HKSE provides enhanced visibility and potential access to capital markets, which could support future expansion plans.

BEIJING, Dec. 9, 2024 /PRNewswire/ -- Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a healthcare provider specialized in cancer treatment, research, education and prevention in China, today announced that the National Medical Products Administration of the People's Republic of China has granted approval to the application for the Registration Certificate for Medical Device for the proton therapy equipment (the "Registration Certificate") made by the Company's equipment supplier on December 6, 2024.

As previously disclosed in the Company's annual report for the fiscal year ended December 31, 2023, Guangzhou Concord Cancer Center ("Guangzhou Hospital"), a PRC subsidiary of the Company offering comprehensive cancer care services, has completed the installment of the proton equipment in September 2020 and commenced its clinical trial in November 2022. Guangzhou Hospital has also subsequently obtained the large medical equipment procurement license for its proton equipment in September 2024. Upon obtaining the approval for the Registration Certificate, Guangzhou Hospital plans to start its proton therapy treatment services at its earliest convenience after necessary preparations.

Concord Healthcare Group Co., Ltd. ("Concord Healthcare"), a subsidiary of the Company listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "HKSE") under the stock code 2453.HK, also announced on December 9, 2024 that the approval for Registration Certificate was granted. The Company previously announced the listing of Concord Healthcare's H shares on the HKSE on January 9, 2024. The information related to Concord Healthcare's Transactions on the HKSE is accessible through the HKSE's website at www.hkexnews.hk.

About Concord Medical

Concord Medical Services Holdings Limited is a healthcare provider featuring a full cycle of premium oncology services including cancer diagnosis, treatment, education and prevention. The Company focuses on providing multidisciplinary cancer care in all aspects of oncology healthcare services in its cancer hospitals and equipping them with technologically advanced equipment such as the state-of-the-art proton therapy system. The Company is striving to improve the quality and accessibility of cancer care through its network of self-owned cancer hospitals and clinics as well as partnered hospitals across China. For more information, please see http://ir.ccm.cn.

About Concord Healthcare

Concord Healthcare is an oncology healthcare provider in China. Concord Healthcare serves both cancer patients through self-owned medical institutions and third-party medical institutions through medical equipment, software and related services. In its self-owned medical institutions, Concord Healthcare provides a full spectrum of oncology healthcare services to cancer patients across the entire care continuum, leveraging its multidisciplinary team specialists and diagnosis and treatment capabilities featuring precision radiation therapy. Through its medical equipment, software and related services, Concord Healthcare serves a widespread network of enterprise customers, primarily hospitals, with integrated oncology-related services, including primarily sales and installing of medical equipment and software, management and technical support, and operating lease.

Safe Harbor Statement

This announcement contains forward-looking statements. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar expressions. Forward-looking statements are inherently subject to uncertainties and contingencies beyond the Company's control and based upon premises with respect to future business decisions, which are subject to change. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. The Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Cision View original content:https://www.prnewswire.com/news-releases/concord-healthcare-announces-approval-granted-to-the-application-for-the-proton-therapy-equipment-registration-certificate-302326028.html

SOURCE Concord Medical Services Holdings Limited

FAQ

When did Concord Medical (CCM) receive approval for its proton therapy equipment in China?

Concord Medical received approval for its proton therapy equipment Registration Certificate from China's National Medical Products Administration on December 6, 2024.

What major milestones has CCM's Guangzhou Hospital achieved for its proton therapy program?

The Guangzhou Hospital completed equipment installation in September 2020, started clinical trials in November 2022, obtained the procurement license in September 2024, and received the Registration Certificate in December 2024.

When can Concord Medical (CCM) begin offering proton therapy treatments at Guangzhou Hospital?

Following the Registration Certificate approval, Guangzhou Hospital plans to start offering proton therapy treatment services after completing necessary preparations.

Concord Medical Services Holding Limited

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