Orelabrutinib

SAN FRANCISCO and SUZHOU, China, Dec. 15, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Eli Lilly and Company (NYSE: LLY) today jointly announced a Distribution and Promotion Agreement in Mainland China regarding Lilly's non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets). The agreement highlights the following aspects: 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 U.S. FDA in January 2023, Jaypirca® (pirtobrutinib) became the first and only approved non-covalent (reversible) BTK inhibitor. In October 2024, Jaypirca® (pirtobrutinib) received approval from China's National Medical Products Administration (NMPA) as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two types of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor (Link). Lilly is conducting comprehensive global Phase 3 development programs (including in China), in first-line and relapse or refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and BTK inhibitor-naïve relapse or refractory MCL, to explore monotherapy or combination therapy. 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 China, For China." About Jaypirca® (pirtobrutinib) Jaypirca® (pirtobrutinib, formerly known as LOXO-305) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[i] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.[ii],[iii] 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 China. In October 2015, the two parties announced the extension of collaboration to include the co-development of three additional antibodies in oncology. In August 2019, the cooperation extended with a licensing agreement for the development and commercialization of a potentially global best-in-class investigational GCG/GLP-1 medicine in China. In August 2020, Innovent and Lilly announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened their engagement in oncology, granting Innovent sole commercialization rights for Cyramza® (ramucirumab) and Retsevmo® (selpercatinib), and a right of first negotiation for potential future commercialization of Jaypirca® (pirtobrutinib) in Mainland China. In December 2024, the agreement of the commercialization of Jaypirca® (pirtobrutinib) in Mainland China officially achieved. 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 , 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 . 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 SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BEIJING--( BUSINESS WIRE )--Latest data of InnoCare’s (HKEX: 09969; SSE: 688428) orelabrutinib were presented at the ongoing 66th American Society of Hematology (ASH) Annual Meeting. Poster Presentation 1. Orelabrutinib in Patients with Indolent Non-Hodgkin Lymphoma (iNHL) Who Are Intolerant to Prior Bruton Tyrosine Kinase Inhibitors (BTKi): Updated Results from a Phase 2 Study (Abstract No.: 4399) Orelabrutinib improved outcomes of prior BTKi-intolerant adverse events (AEs), particularly the off-target toxicities. Patients who switched experienced minimal and low levels of intolerance recurrences and all achieved disease control. These updated results show promising efficacy and safety data of orelabrutinib in prior BTKi-intolerant iNHL patients. As data cutoff (July 9, 2024), 66 patients were enrolled and 64 patients were available for AE and efficacy analysis. At a median follow-up of 6.8 months, the median progression-free survival (PFS) and overall survival (OS) were not reached. Both PFS and OS rates remained 100%. 2. Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study) (Abstract No.: 3244) This is a multicenter, open-label, non-randomized phase II study for previously untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) without restriction by del(17p)/TP53 aberrations and/or immunoglobulin heavy⁃chain variable region gene (IGHV) mutation status. The Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab regimen leads to a rapid and deep molecular remission with a manageable safety profile in previously untreated CLL patients including those with unfavorable characteristics. After cycle 6, the rates of peripheral blood (PB) undetectable minimal residual disease (uMRD) and bone marrow (BM) uMRD by flow cytometry (FCM) were 95% and 86%, respectively, and the rate of complete response (CR)/CR with incomplete hematologic recovery (CRi ) was 59%. After cycle 12, the rates of PB-uMRD by FCM, BM-uMRD by FCM, and CR/CRi were 95%, 91% and 77% respectively. 3. A Prospective, Multicenter, Single-Arm Study on the Combination of Orelabrutinib and Rituximab in the Second-Line Treatment of Relapsed/Refractory Marginal Zone Lymphoma (Abstract No.: 4391) This is a prospective, multicenter, single-arm, phase II clinical trial, aiming to evaluate the efficacy and safety of orelabrutinib in combination with rituximab in patients with relapsed or refractory Marginal Zone Lymphoma (MZL). The preliminary results of this study suggest that the combination therapy of orelabrutinib and rituximab is effective in patients with rrMZL and has manageable safety, with tolerable maintenance therapy. Of the 12 enrolled patients, 6 have completed the interim efficacy assessment, achieving an overall response rate (ORR) of 100%. 3 patients completed the combination therapy and entered the maintenance phase, keeping the ORR at 100%. All patients chose orelabrutinib for maintenance therapy. 4. Orelabrutinib, Rituximab, and Thiotepa (ORT) in Combination with or without High-Dose Methotrexate in Untreated Primary Central Nervous System Lymphoma (Abstract No.: 4487) The orelabrutinib, rituximab, and thiotepa (ORT) regimen, with or without high-dose methotrexate (HD-MTX), has shown initial efficacy and a manageable safety profile in treating Primary Central Nervous System Lymphoma (PCNSL), particularly in elderly patients with MCD subtypes. Autologous stem cell transplantation (ASCT) following ORT with or without HD-MTX induction therapy further improves patient response. Patients with complete response (CR) did not relapse and were well-tolerated on orelabrutinib maintenance therapy. The median follow-up was 8.27 months. The best CR rate was 85.71%, and the longest CR duration was 22.53 months. The objective response rate (ORR) was 85.71%. 5. Preliminary Data of a Single-Arm, Phase II Study of Orelabrutinib with/without Rituximab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma after BTK Inhibitor Therapy (Abstract No.: 3240) Despite the currently limited follow-up period, orelabrutinib combined with or without rituximab, demonstrated favorable efficacy in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with detectable MRD post-BTK inhibitor treatment, and MRD decreased significantly after 9 months. This treatment holds the potential to emerge as a new therapeutic option for CLL/SLL patients. At 9 months, 66.7% achieved undetectable peripheral blood MRD, with a 9-month complete response rate (CRR) of 77.8% and a 1-year overall survival (OS) of 100%, and no patient has progressed thus far. 6. Preliminary Data on the Efficacy and Safety of Orelabrutinib Combined with Rituximab and Methotrexate (ORM Regimen) As First-Line Treatment for Primary Central Nervous System Lymphoma, and the Exploration of Cerebrospinal Fluid ctDNA Dynamic Monitoring (Abstract No.: 4500) The Orelabrutinib Combined with Rituximab and Methotrexate regimen demonstrates high overall response rate (ORR) and complete response (CR) in the treatment of Primary Central Nervous System Lymphoma (PCNSL), with acceptable safety. Our results suggest that dynamic monitoring of cerebrospinal fluid circulating tumor DNA (ctDNA) is of significant importance for the early evaluation of therapeutic efficacy and prognosis prediction in PCNSL. During treatment the best response evaluation showed an ORR of 86.4% and a disease control rate (DCR) of 100%; Among the 21 patients who completed all induction therapies, the ORR was 85.71% with a CR rate of 76.19%. Among 19 patients with detectable ctDNA in baseline CSF, 13 patients had undetectable ctDNA in C5D1 CSF, of which 12 patients achieved CR. Patients with undetectable CSF ctDNA at C5D1 showed longer progression-free survival (PFS), indicating that early clearance of CSF ctDNA can predict favorable prognosis. 7. Preliminary Efficacy of Orelabrutinib Targeted Therapy in Induction Therapy of Primary Central Nervous System Diffuse B-Cell Lymphoma (Abstract No.: 4496) The Orelabrutinib, Rituximab and High-dose MTX regimen is an effective and safe induction therapy for primary central nervous system diffuse B-cell lymphoma, with a total response rate of 83.3% and a median onset time of 1 course for partial response (PR) and 2 courses for complete response (CR). It is a promising induction therapy for primary central nervous system diffuse B-cell lymphoma. 8. The Primary Results of R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) As the First-Line Induction Therapy Followed By Autologous Stem Cell Transplantation in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: 1742) This is a prospective designed, ongoing, single-center, single-arm, open-label study. The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib induction treatment has demonstrated notable efficacy in achieving higher response rates among patients with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL), and a tolerable safety profile. A total of 26 patients with newly diagnosed PCNSL were enrolled in this study. The overall response rate (ORR) was 96.15%, and the complete response (CR) rate was 92.30% after 4 cycles of treatment. Among ten patients who underwent autologous hematopoietic stem cell transplantation (HSCT), all of them (100%) remained in CR. The progression-free survival (PFS) and overall survival (OS) rate at 12 months were 82.24%, and 87.00% respectively. 9. Efficacy and Safety of Orelabrutinib in Relapsed/Refractory Idiopathic Multicentric Castleman Disease: A Single-Center, Retrospective Study (Abstract No.: 1656) Orelabrutinib, with its high response rate, durable response time, and improved safety profile can be a viable alternative for the treatment of patients with relapsed/refractory (r/r) idiopathic multicentric Castleman disease (iMCD). Ten patients with r/r iMCD were included in the study, Seven patients (70%) were assessed as responders, two of whom achieved complete response. The median time to remission for responders was 9.8 months (range: 5.9–20.5 months). In the non-responder group, despite not achieving response criteria, these patients still showed a continuous improvement in median hemoglobin, albumin, C-reactive protein (CRP) and creatine levels with treatment at month 12. No grade 3 or above adverse reactions occurred. Except poster presentation, more than 10 studies were also selected as online publications at the meeting. For more detailed clinical data, please refer to ASH website. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.