HUTCHMED Announces Continued Inclusion of ORPATHYS® (savolitinib) in the National Reimbursement Drug List in China at Current Terms
HUTCHMED announces that ORPATHYS® (savolitinib) will maintain its inclusion in China's National Reimbursement Drug List (NRDL) under the same terms, effective January 1, 2025. ORPATHYS®, an oral MET tyrosine kinase inhibitor, received conditional approval in China in 2021 for treating specific non-small cell lung cancer patients with MET exon 14 skipping alterations. The drug has been part of the NRDL since March 1, 2023. This continuation is significant as China represents over one-third of global lung cancer patients, with 2-3% of NSCLC cases showing MET exon 14 skipping alterations. The NRDL coverage extends to approximately 1.33 billion people in China, representing 95% of the population.
HUTCHMED annuncia che ORPATHYS® (savolitinib) manterrà la sua inclusione nella Lista Nazionale dei Farmaci Rimborsabili (NRDL) della Cina alle stesse condizioni, a partire dal 1 gennaio 2025. ORPATHYS®, un inibitore della tirosina chinasi MET orale, ha ricevuto approvazione condizionata in Cina nel 2021 per il trattamento di specifici pazienti affetti da carcinoma polmonare non a piccole cellule con alterazioni di skipping dell'esone 14 del MET. Il farmaco è parte della NRDL dal 1 marzo 2023. Questa continuazione è significativa poiché la Cina rappresenta oltre un terzo dei pazienti globali affetti da cancro ai polmoni, con il 2-3% dei casi di NSCLC che mostrano alterazioni di skipping dell'esone 14 del MET. La copertura NRDL si estende a circa 1,33 miliardi di persone in Cina, che rappresentano il 95% della popolazione.
HUTCHMED anuncia que ORPATHYS® (savolitinib) mantendrá su inclusión en la Lista Nacional de Medicamentos Reembolsables (NRDL) de China en las mismas condiciones, a partir del 1 de enero de 2025. ORPATHYS®, un inhibidor de la tirosina quinasa MET oral, recibió aprobación condicional en China en 2021 para tratar a pacientes específicos con cáncer de pulmón no microcítico que presentan alteraciones de skip del exón 14 de MET. El medicamento forma parte de la NRDL desde el 1 de marzo de 2023. Esta continuación es significativa, ya que China representa más de un tercio de los pacientes de cáncer de pulmón en todo el mundo, con un 2-3% de los casos de NSCLC mostrando alteraciones de skip del exón 14 de MET. La cobertura de la NRDL abarca aproximadamente a 1.33 mil millones de personas en China, lo que representa el 95% de la población.
HUTCHMED는 ORPATHYS® (savolitinib)가 2025년 1월 1일부터 동일한 조건으로 중국의 국가재정약품목록(NRDL)에 포함될 것이라고 발표했습니다. ORPATHYS®는 경구용 MET 티로신 키나제 억제제로, 2021년 MET 엑손 14 건너뛰기 변이를 가진 특정 비소세포 폐암 환자 치료를 위해 중국에서 조건부 승인을 받았습니다. 이 약물은 2023년 3월 1일부터 NRDL의 일부입니다. 이 지속은 중국이 전 세계 폐암 환자의 3분의 1 이상을 차지하고 있으며, NSCLC 사례의 2-3%가 MET 엑손 14 건너뛰기 변이가 나타나는 중요한 의미를 갖습니다. NRDL 보장은 약 13억 3천만 명의 중국 인구를 대상으로 하며, 이는 전체 인구의 95%에 해당합니다.
HUTCHMED annonce que ORPATHYS® (savolitinib) maintiendra son inclusion dans la Liste Nationale des Médicaments Remboursables (NRDL) de la Chine dans les mêmes conditions, à compter du 1er janvier 2025. ORPATHYS®, un inhibiteur oral de la tyrosine kinase MET, a reçu une approbation conditionnelle en Chine en 2021 pour le traitement de patients spécifiques atteints de cancer du poumon non à petites cellules présentant des altérations de saut de l'exon 14 de MET. Le médicament fait partie de la NRDL depuis le 1er mars 2023. Cette continuation est significative car la Chine représente plus d'un tiers des patients de cancer du poumon dans le monde, avec 2 à 3 % des cas de NSCLC montrant des altérations de saut de l'exon 14 de MET. La couverture NRDL s'étend à environ 1,33 milliard de personnes en Chine, représentant 95 % de la population.
HUTCHMED gibt bekannt, dass ORPATHYS® (savolitinib) weiterhin unter denselben Bedingungen in Chinas Nationales Erstattungsliste (NRDL) enthalten sein wird, und zwar ab dem 1. Januar 2025. ORPATHYS®, ein oraler MET-Tyrosinkinase-Inhibitor, erhielt 2021 in China eine bedingte Zulassung zur Behandlung bestimmter Patienten mit nicht-kleinzelligem Lungenkrebs, die MET-Exon-14-Auslassungsänderungen aufweisen. Das Medikament ist seit dem 1. März 2023 Teil der NRDL. Diese Fortsetzung ist bedeutend, da China mehr als ein Drittel der globalen Lungenkrebspatienten ausmacht, wobei 2-3% der NSCLC-Fälle MET-Exon-14-Auslassungsänderungen zeigen. Die NRDL-Abdeckung erstreckt sich auf etwa 1,33 Milliarden Menschen in China, was 95% der Bevölkerung entspricht.
- Maintained NRDL inclusion at current terms, ensuring continued market access
- Access to large patient pool with 95% of China's population covered by basic medical insurance
- Targets significant market with China representing over one-third of global lung cancer patients
- Requires patient copayment as a Category B medicine
- NRDL inclusion subject to renewal every two years
Insights
The continued inclusion of ORPATHYS® in China's NRDL at current terms represents significant market stability for HUTCHMED. The drug addresses a critical unmet need in NSCLC treatment, targeting the 2-3% of patients with MET exon 14 skipping alterations. With 1.33 billion people covered under China's basic medical insurance, representing 95% of the population, the reimbursement status ensures broad market access and affordability.
The renewal without price adjustments maintains the commercial potential established since its March 2023 NRDL inclusion. This stability is particularly valuable in China's oncology market, where pricing pressures during NRDL negotiations can significantly impact revenue potential. The continuation of current terms suggests strong market acceptance and clinical value recognition.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement.
ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”). It received conditional approval in China in June 2021 for the treatment of certain patients with non-small cell lung cancer (“NSCLC”) with MET exon 14 skipping alterations. More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2
ORPATHYS® was first included in the NRDL on March 1, 2023. The government in China has placed great importance on improving the affordability of drug treatments for the public. As of end of 2023, 1.33 billion people in China had basic medical insurance coverage, representing around
About ORPATHYS®
ORPATHYS® (savolitinib) is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.
ORPATHYS® is jointly developed by HUTCHMED and AstraZeneca and commercialized by AstraZeneca. It is approved in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is the first selective MET inhibitor approved in China and the first in the NRDL. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations for the commercialization of savolitinib in China, the potential benefits and further clinical development of savolitinib, its expectations as to whether further studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the commercial acceptance of savolitinib, the impact of the inclusion of savolitinib on the NRDL on sales of the drug and its pricing, clinical trial enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of savolitinib to obtain regulatory approval for a targeted indication in different jurisdictions and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum | +44 (20) 7886 2500 |
FAQ
When will ORPATHYS® continue its inclusion in China's NRDL?
What percentage of NSCLC patients globally have MET exon 14 skipping alterations that ORPATHYS® treats?
What is the current medical insurance coverage for ORPATHYS® in China?
When did HUTCHMED's ORPATHYS® first receive NRDL inclusion in China?
