Innovent and Lilly Expand Collaboration Through Agreement on Commercialization Rights for Jaypirca® (pirtobrutinib) in Mainland China
Innovent Biologics and Eli Lilly have announced a Distribution and Promotion Agreement for Jaypirca® (pirtobrutinib) in Mainland China. Under the agreement, Innovent will handle importation, marketing, distribution, and promotion, while Lilly maintains responsibility for R&D and post-market medical affairs.
Jaypirca® is the first and only approved non-covalent BTK inhibitor, receiving FDA approval in January 2023 and NMPA approval in October 2024. It's indicated for adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor.
The collaboration aims to leverage Innovent's established hematology oncology commercial team and Lilly's expertise in drug development to improve cancer patient outcomes in Mainland China.
Innovent Biologics ed Eli Lilly hanno annunciato un Accordo di Distribuzione e Promozione per Jaypirca® (pirtobrutinib) nella Cina continentale. Secondo l'accordo, Innovent si occuperà dell'importazione, del marketing, della distribuzione e della promozione, mentre Lilly manterrà la responsabilità per la R&S e le questioni medicali post-marketing.
Jaypirca® è il primo e unico inibitore BTK non covalente approvato, avendo ricevuto l'approvazione dalla FDA nel gennaio 2023 e l'approvazione dalla NMPA nell'ottobre 2024. È indicato per i pazienti adulti con linfoma a cellule mantellari recidivante o refrattario dopo almeno due tipi di terapia sistemica, incluso un inibitore BTK.
La collaborazione mira a sfruttare il team commerciale consolidato di ematologia oncologica di Innovent e l'esperienza di Lilly nello sviluppo di farmaci per migliorare i risultati per i pazienti oncologici nella Cina continentale.
Innovent Biologics y Eli Lilly han anunciado un Acuerdo de Distribución y Promoción para Jaypirca® (pirtobrutinib) en la China continental. Según el acuerdo, Innovent se encargará de la importación, el marketing, la distribución y la promoción, mientras que Lilly mantendrá la responsabilidad de I+D y los asuntos médicos post-comercialización.
Jaypirca® es el primer y único inhibidor de BTK no covalente aprobado, recibiendo la aprobación de la FDA en enero de 2023 y la aprobación de la NMPA en octubre de 2024. Está indicado para pacientes adultos con linfoma de células de manto en recaída o refractario tras al menos dos tipos de terapia sistémica, incluyendo un inhibidor de BTK.
La colaboración tiene como objetivo aprovechar el equipo comercial establecido de oncología hematológica de Innovent y la experiencia de Lilly en el desarrollo de medicamentos para mejorar los resultados de los pacientes con cáncer en la China continental.
Innovent Biologics와 Eli Lilly가 중국 본토에서 Jaypirca® (pirtobrutinib) 유통 및 홍보 계약을 발표했습니다. 계약에 따라 Innovent는 수입, 마케팅, 유통 및 프로모션을 담당하고, Lilly는 연구개발 및 시판 후 의학 업무에 대한 책임을 유지합니다.
Jaypirca®는 FDA의 승인을 2023년 1월에, NMPA의 승인을 2024년 10월에 받은 최초이자 유일한 비공유 BTK 억제제입니다. 이는 최소 두 가지 유형의 전신 치료를 받은 재발성 또는 난치성 맨틀 세포 림프종의 성인 환자에게 적응증이 있습니다.
이 협력은 Innovent의 확립된 혈액종양 상업 팀과 Lilly의 약물 개발 전문성을 활용하여 중국 본토의 암 환자 결과를 개선하는 것을 목표로 합니다.
Innovent Biologics et Eli Lilly ont annoncé un Accord de Distribution et de Promotion pour Jaypirca® (pirtobrutinib) en Chine continentale. Selon l'accord, Innovent s'occupera de l'importation, du marketing, de la distribution et de la promotion, tandis que Lilly conservera la responsabilité de la R&D et des affaires médicales post-commercialisation.
Jaypirca® est le premier et unique inhibiteur de BTK non covalent approuvé, ayant reçu l'autorisation de la FDA en janvier 2023 et celle de la NMPA en octobre 2024. Il est indiqué pour les patients adultes atteints de lymphome à cellules du manteau en rechute ou réfractaire après au moins deux types de thérapie systémique, y compris un inhibiteur de BTK.
Cette collaboration vise à tirer parti de l'équipe commerciale établie en hématologie-oncologie d'Innovent et de l'expertise de Lilly en développement de médicaments pour améliorer les résultats des patients atteints de cancer en Chine continentale.
Innovent Biologics und Eli Lilly haben eine Vertriebs- und Werbevereinbarung für Jaypirca® (pirtobrutinib) im chinesischen Festland bekannt gegeben. Laut der Vereinbarung wird Innovent den Import, das Marketing, die Verteilung und die Promotion übernehmen, während Lilly die Verantwortung für Forschung und Entwicklung sowie für medizinische Angelegenheiten nach der Markteinführung behält.
Jaypirca® ist der erste und einzige zugelassene nicht-kovalente BTK-Hemmer und erhielt im Januar 2023 die Zulassung von der FDA sowie im Oktober 2024 die Zulassung von der NMPA. Es ist für erwachsene Patienten mit rezidiviertem oder refraktärem Mantelzelllymphom nach mindestens zwei Arten von Systemtherapien, einschließlich eines BTK-Hemmers, angezeigt.
Die Zusammenarbeit zielt darauf ab, das etablierte kommerzielle Team für Hämatologie-Onkologie von Innovent und die Expertise von Lilly in der Arzneimittelentwicklung zu nutzen, um die Behandlungsergebnisse für Krebspatienten im chinesischen Festland zu verbessern.
- First and only approved non-covalent BTK inhibitor in the market
- Recent NMPA approval in October 2024 for the Chinese market
- Expands Innovent's hematological malignancy portfolio
- Strategic partnership leveraging both companies' strengths
- to second-line or later therapy, requiring prior treatment failure
- Restricted to Mainland China market only
Insights
The Innovent-Lilly collaboration for Jaypirca® represents a significant development in China's hematological oncology market. As the first and only approved non-covalent BTK inhibitor, Jaypirca® addresses a critical unmet need for MCL patients who have developed resistance to traditional BTK inhibitors. The drug's novel reversible binding mechanism provides a important second-line option, potentially extending survival for patients who have exhausted other treatment options.
The ongoing Phase 3 trials exploring Jaypirca®'s efficacy in CLL/SLL and BTK inhibitor-naïve MCL patients could substantially expand its market potential. The drug's unique mechanism of action and proven efficacy in resistant cases position it favorably in the competitive landscape of BTK inhibitors.
This distribution agreement significantly strengthens Innovent's position in China's hematological oncology market. The company's existing portfolio, including TYVYT®, HALPRYZA® and FUCASO®, will be complemented by Jaypirca®, creating a comprehensive offering in blood cancers. Innovent's established commercial infrastructure and market presence in hematology will likely accelerate Jaypirca®'s market penetration.
The partnership leverages each company's strengths - Innovent's commercial capabilities and Lilly's R&D expertise. With China's growing focus on innovative therapies and the "Healthy China 2030" initiative, this collaboration could capture significant market share in the expanding BTK inhibitor market, particularly in the second-line setting where options are
- Innovent will be responsible for the importation, marketing, distribution and promotion of Jaypirca®;
- Lilly will be responsible for the R&D and post-market medical affairs of Jaypirca®.
Jaypirca®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma (MCL) patients previously treated with a covalent BTK inhibitor (approved including ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) and extend the benefit of targeting the BTK pathway, thus effectively addressing the unmet clinical needs for these patients. Approved by the
Lilly is conducting comprehensive global Phase 3 development programs (including in
Under the agreement, Innovent holds the sole commercialization rights for Jaypirca® in Mainland China, overseeing importation, marketing, distribution and promotion. Lilly will be responsible for R&D and post-market medical affairs. Leveraging Innovent's established hematology oncology commercial team and Lilly's deep expertise in drug development and scientific insights in the therapeutic area, the partnership is committed to broadening access to innovative treatments and improving outcomes for cancer patients in Mainland China.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Building on our long-term strategic collaboration with Lilly, we are proud to expand our collaboration through this agreement. Jaypirca®, the world's first and only approved non-covalent (reversible) BTK inhibitor, represents a breakthrough treatment option for patients who have previously received BTK inhibitors. Innovent has built a robust and leading portfolio in the hematological malignancy field, consisting of TYVYT® (sintilimab injection), HALPRYZA® (rituximab injection), olverembatinib, FUCASO® (Equecabtagene Autoleucel Injection), and Jaypirca®. By fully leveraging our commercialization capabilities and extensive coverage in this field, we aim to bring forward innovative medicines to benefit cancer patients and further enhance our leading position in oncology. We remain steadfast in our commitment to advancing the biopharmaceutical industry through collaborative efforts so that first-rate pharmaceutical drugs can become widely accessible."
Huzur Devletsah, President and General Manager of Lilly China, states, "Lilly is thrilled to appoint Innovent for the distribution and promotion of Jaypirca® marking a pivotal moment in hematologic cancer treatment for Lilly. This agreement allows to rapidly increase patient access in Mainland China by drawing on Innovent's robust market presence and our extensive R&D expertise. Together, we are poised to deliver innovative therapies and support the 'Healthy China 2030' initiative, continuing our commitment: 'In
About Jaypirca® (pirtobrutinib)
Jaypirca® (pirtobrutinib, formerly known as LOXO-305) is a highly selective (300 times more selective for BTK versus
About Innovent's strategic cooperation with Lilly
Innovent and Lilly have established a comprehensive level of cooperation, setting an example of partnership between a Chinese innovative pharmaceutical company and a global leading medicine company in the field of R&D, CMC, clinical development and commercialization, aiming to accelerate the access of innovative medicines to benefit more patients worldwide.
In March 2015, Innovent entered into a strategic partnership with Lilly focused on biological medicine. Under the initial agreement, Lilly and Innovent co-developed and co-commercialized oncology medicines, including Tyvyt® (sintilimab injection) in
About Innovent Biologics
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 12 products in the market. It has 5 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.
Statement:
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza), Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.
About Eli Lilly and Company
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit www.lilly.com.
Forward-Looking Statements of Innovent Biologics
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 Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.
The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
References
[i] Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5 |
[ii] Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1 |
[iii] Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7 |
View original content:https://www.prnewswire.com/news-releases/innovent-and-lilly-expand-collaboration-through-agreement-on-commercialization-rights-for-jaypirca-pirtobrutinib-in-mainland-china-302331967.html
SOURCE Innovent Biologics
FAQ
What are the terms of the Innovent-Lilly agreement for Jaypirca® distribution in China?
When did Jaypirca® receive NMPA approval in China?
What is the approved indication for Jaypirca® in China?
What makes Jaypirca® unique in the BTK inhibitor market?
What other products are in Innovent's hematological malignancy portfolio?
