Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products Administration
Innovent Biologics (HKEX: 01801) has received NMPA approval for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor, for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
The approval is based on the Phase 2 TRUST-I trial results, which demonstrated significant therapeutic effects on brain lesions and efficacy in crizotinib-resistant patients. DOVBLERON® becomes Innovent's 13th commercial product, addressing a critical need as approximately 2.6% of NSCLC patients in China are ROS1-positive, with up to 55% developing brain metastases after initial treatment.
A second NDA for DOVBLERON® was accepted and granted Priority Review Designation in March 2024 for first-line treatment of ROS1-positive NSCLC patients.
Innovent Biologics (HKEX: 01801) ha ricevuto l'approvazione della NMPA per DOVBLERON® (capsule di taletrectinib adipato), un inibitore della tirosina chinasi di nuova generazione ROS1, per il trattamento di pazienti adulti con carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato o metastatico, che sono stati precedentemente trattati con inibitori della tirosina chinasi ROS1.
L'approvazione si basa sui risultati della fase 2 dello studio TRUST-I, che ha dimostrato effetti terapeutici significativi sulle lesioni cerebrali e efficacia nei pazienti resistenti a crizotinib. DOVBLERON® diventa il 13° prodotto commerciale di Innovent, rispondendo a un bisogno critico, poiché circa il 2,6% dei pazienti NSCLC in Cina è ROS1-positivo, con fino al 55% che sviluppa metastasi cerebrali dopo il trattamento iniziale.
Una seconda NDA per DOVBLERON® è stata accettata e ha ottenuto la Designazione di Revisione Prioritaria a marzo 2024 per il trattamento di prima linea dei pazienti NSCLC ROS1-positivi.
Innovent Biologics (HKEX: 01801) ha recibido la aprobación de la NMPA para DOVBLERON® (cápsula de taletrectinib adipato), un inhibidor de la tirosina quinasa de próxima generación ROS1, para tratar a pacientes adultos con cáncer de pulmón no microcítico (NSCLC) localmente avanzado o metastásico que han sido tratados previamente con TKI ROS1.
La aprobación se basa en los resultados del estudio de Fase 2 TRUST-I, que demostraron efectos terapéuticos significativos en lesiones cerebrales y eficacia en pacientes resistentes a crizotinib. DOVBLERON® se convierte en el 13° producto comercial de Innovent, abordando una necesidad crítica, ya que aproximadamente el 2.6% de los pacientes con NSCLC en China son ROS1-positivos, y hasta el 55% desarrolla metástasis cerebrales después del tratamiento inicial.
Una segunda NDA para DOVBLERON® fue aceptada y se le otorgó la Designación de Revisión Prioritaria en marzo de 2024 para el tratamiento de primera línea de pacientes con NSCLC ROS1-positivos.
Innovent Biologics (HKEX: 01801)은 DOVBLERON® (탈레트렉티닙 아디페이트 캡슐)에 대한 NMPA 승인을 받았습니다. 이는 성인 환자의 진행성 또는 전이성 ROS1 양성 비소세포 폐암(NSCLC) 치료를 위한 차세대 ROS1 티로신 키나제 억제제입니다. 이 환자들은 이전에 ROS1 TKI로 치료를 받았습니다.
승인은 뇌 병변에 대한 유의미한 치료 효과와 크리조티닙에 저항성을 보이는 환자들에 대한 효능을 입증한 2상 TRUST-I 임상 시험 결과를 기반으로 하고 있습니다. DOVBLERON®은 Innovent의 13번째 상업적 제품이 되어, 중국의 NSCLC 환자 중 약 2.6%가 ROS1 양성으로, 초기 치료 후 최대 55%가 뇌 전이를 개발하는 중요한 필요를 충족합니다.
DOVBLERON®에 대한 두 번째 NDA가 수락되었고, 2024년 3월에 ROS1 양성 NSCLC 환자를 위한 1차 치료에 대해 우선 심사 지정이 부여되었습니다.
Innovent Biologics (HKEX: 01801) a reçu l'approbation de la NMPA pour DOVBLERON® (capsule d'adipate de taletrectinib), un inhibiteur de kinase à tyrosine de nouvelle génération ROS1, destiné à traiter des patients adultes atteints d'un cancer du poumon non à petites cellules (NSCLC) localement avancé ou métastatique, qui ont été précédemment traités par des inhibiteurs de kinase à tyrosine ROS1.
L'approbation est basée sur les résultats de l'essai TRUST-I de phase 2, qui ont montré des effets thérapeutiques significatifs sur les lésions cérébrales et une efficacité chez les patients résistants au crizotinib. DOVBLERON® devient le 13e produit commercial d'Innovent, répondant à un besoin crucial, car environ 2,6 % des patients atteints de NSCLC en Chine sont positifs pour ROS1, avec jusqu'à 55 % développant des métastases cérébrales après un traitement initial.
Une seconde NDA pour DOVBLERON® a été acceptée et a reçu la désignation de révision prioritaire en mars 2024 pour le traitement de première ligne des patients NSCLC positifs pour ROS1.
Innovent Biologics (HKEX: 01801) hat die Genehmigung der NMPA für DOVBLERON® (Taletrectinib-Adipat-Kapsel) erhalten, einen neuartigen ROS1-Tyrosinkinase-Inhibitor zur Behandlung von erwachsenen Patienten mit lokal fortgeschrittenem oder metastasierenden ROS1-positiven nicht-kleinzelligem Lungenkrebs (NSCLC), die zuvor mit ROS1-TKIs behandelt wurden.
Die Genehmigung basiert auf den Ergebnissen der Phase-2-Studie TRUST-I, die erhebliche therapeutische Effekte auf Hirnmetastasen und Wirksamkeit bei crizotinib-resistenten Patienten nachwiesen. DOVBLERON® wird das 13. kommerzielle Produkt von Innovent und deckt einen kritischen Bedarf ab, da etwa 2,6 % der NSCLC-Patienten in China ROS1-positiv sind und bis zu 55 % nach der Erstbehandlung Hirnmetastasen entwickeln.
Ein zweites NDA für DOVBLERON® wurde akzeptiert und erhielt im März 2024 die Prioritätsbewertung für die Erstlinientherapie von ROS1-positiven NSCLC-Patienten.
- Received NMPA approval for DOVBLERON®, expanding commercial portfolio to 13 products
- Demonstrated efficacy in treating brain metastases and crizotinib-resistant patients
- Second NDA granted Priority Review Designation for first-line treatment
- Favorable safety profile with low rates of dose reduction and treatment discontinuation
- None.
Insights
The NMPA approval of DOVBLERON® represents a significant advancement in ROS1-positive NSCLC treatment. The drug addresses critical unmet needs, particularly for patients who have developed resistance to first-line ROS1 TKIs and those with brain metastases. Clinical data showing efficacy in crizotinib-resistant patients and against brain lesions positions this as a potentially superior second-line treatment option.
The market opportunity is substantial - with
For investors, this approval strengthens Innovent's oncology portfolio and competitive position in the precision medicine space. The company now has 13 commercialized products, with DOVBLERON® complementing existing TKI offerings like RETSEMOV®, PEMAZYRE® and DUPERT®.
This regulatory milestone enhances Innovent's commercial prospects in China's targeted therapy market. The approval timing and Priority Review status for first-line treatment indicate strong clinical data and regulatory confidence. The drug's differentiated profile in addressing resistance mutations and brain metastases could drive rapid market adoption and potentially command premium pricing.
Innovent's expanding TKI franchise demonstrates successful execution of its precision oncology strategy. The company's market cap of
Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about
The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated the potential of DOVBLERON® to address unmet needs, particularly in patients with limited therapeutic options after treatment with prior ROS1-targeted therapies. [Link]
In addition, a second NDA for DOVBLERON® was accepted and granted Priority Review Designation by
Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "The treatment landscape for advanced ROS1-positive NSCLC remains challenging, especially for patients with brain metastases, who account for more than half of patients who have progressed following initial treatment with a ROS1 TKI, as well as those patients who develop resistance mutations. DOVBLERON® demonstrated significant therapeutic effects on brain lesions, as well as efficacy in crizotinib-resistant patients. Moreover, DOVBLERON® has a favorable safety profile and tolerability with low rates of dose reduction and treatment discontinuation due to adverse events. The efficacy and safety profile of DOVBLERON® offers a new hope for patients and I look forward to its benefit in the ROS1-positive NSCLC patients in
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The approval of DOVBLERON® is a reflection of its potential best-in-class efficacy and safety profile, as demonstrated in the TRUST-I trial. We are delighted about the approval of DOVBLERON® and will bring this precision therapy to NSCLC patients who need novel treatment options. Innovent's robust TKI product pipeline—including RETSEMOV®, PEMAZYRE®, DUPERT® and DOVBLERON®—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients' quality of life."
About ROS1-positive Non-small Cell Lung Cancer
Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about
About DOVBLERON® (Taletrectinib Adipate Capsule)
DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib, the active ingredient in DOVBLERON® is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in
In December 2024, DOVBLERON® was approved by
Taletrectinib has been granted Orphan Drug Designation by the
In June 2021, Innovent and AnHeart Therapeutics (
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
References
[i] Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. Thorac Cancer. 2019 Jan;10(1):47-53. |
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SOURCE Innovent Biologics
FAQ
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