A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies

BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib/II clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.

Start Date14 Jul 2026

Sponsor / Collaborator

Guangzhou Lupeng Pharmaceutical Co., Ltd.

NCT07570017

/ Not yet recruitingPhase 1

A Phase Ib Study to Evaluate the Safety and Efficacy of Rocbrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin (R-GemOx) in Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma

This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R/R non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic "3+3" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.

Start Date30 May 2026

Sponsor / Collaborator

Guangzhou Lupeng Pharmaceutical Co., Ltd.

NCT07342478

/ RecruitingPhase 3

A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects

This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 participants will be randomized 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Randomization will be stratified by presence of del(17p)/TP53 mutation (yes/no), reason for discontinuation of prior cBTKi therapy (toxicity vs disease progression), prior exposure to a BCL2 inhibitor (yes/no), and region (United States/China/rest of world). The primary endpoint is progression-free survival (PFS) assessed by an independent review committee (IRC) using iwCLL 2018 criteria for CLL and Lugano 2014 criteria for SLL. Key secondary objectives include overall survival, overall response rate, time-to-event outcomes, and safety/tolerability; exploratory objectives include health-related quality of life and biomarker assessments.

Start Date23 Apr 2026

Sponsor / Collaborator

Newave Pharmaceutical Inc.

100 Clinical Results associated with Rocbrutinib

100 Translational Medicine associated with Rocbrutinib

100 Patents (Medical) associated with Rocbrutinib

Literatures (Medical) associated with Rocbrutinib

06 Feb 2026·Cancer Discovery

New BTK Inhibitors May Combat Resistance in CLL

Article

Three trials report positive data for the noncovalent Bruton tyrosine kinase inhibitor pirtobrutinib and a potential successor, rocbrutinib, in chronic lymphocytic leukemia. One study of previously untreated patients found a 24-month progression-free survival of 93.4% for pirtobrutinib, versus 70.7% for bendamustine and rituximab. The second study suggests the drug is noninferior to the covalent inhibitor ibrutinib in previously untreated or relapsed or refractory patients. The third study found an overall response rate of 62.5% for rocbrutinib in previously treated patients.

Journal of Hematology & Oncology

Novel BTK inhibitors and degraders for relapsed/refractory CLL/SLL: latest updates from ASH 2025 annual meeting

Letter

Author: Liu, Delong ; Jiang, Heng ; Sharma, Pritika

Although covalent and non-covalent Bruton tyrosine kinase inhibitors (BTKi) have extended clinical benefit to relapsed/refractory (R/R) and BTKi-resistant chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), there remains an unmet need for additional B-cell receptor (BCR) pathway targeted therapies for highly refractory disease. This summary highlighted latest updates from the American Society of Hematology 2025 Annual Meeting on emerging BTK-directed agents in CLL/SLL, including next-generation non-covalent BTKi, dual-kinase inhibitors, and BTK degraders. Phase 1 studies of docirbrutinib and rocbrutinib demonstrated target engagement across wild-type and resistance-associated BTK mutations with encouraging safety profiles and preliminary efficacy signals in heavily pretreated populations. Birletinib, a dual LYN/BTK inhibitor, showed a high objective response rate in patients with prior exposure to BTKi, BCL-2 inhibitors, and BTK degraders. BTK degraders, including bexobrutideg and BGB-16673, demonstrated rapid and deep responses, activity in high-risk molecular subgroups, and manageable toxicity profiles, with recommended phase 2 doses established. Collectively, these latest updates support continued clinical development of novel agents to address resistance and disease progression in R/R CLL/SLL.

News (Medical) associated with Rocbrutinib

04 Jun 2026

·www.prnewswire.com

Lupeng Pharmaceutical's Fourth-Generation BTK Inhibitor Rocbrutinib Approved in China for Relapsed or Refractory Mantle Cell Lymphoma

GUANGZHOU, China, June 4, 2026 /PRNewswire/ -- Lupeng Pharmaceutical today announced that the National Medical Products Administration (NMPA) has granted accelerated approval to rocbrutinib (development code: LP-168) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have received at least two prior systemic therapies, including BTK inhibitors. Rocbrutinib, independently developed by Lupeng Pharmaceutical, is the fourth-generation BTK inhibitor with dual covalent (irreversible) and non-covalent (reversible) mechanism. The approval of rocbrutinib will provide a new breakthrough treatment option for R/R MCL patients following failure of earlier-generation BTK inhibitor therapy. Dr. Tan Fenlai, co-founder and CEO of Lupeng Pharmaceutical, stated, "The successful approval of rocbrutinib is a major milestone in Lupeng Pharmaceutical's development. It will bring a new and effective treatment option to MCL patients who have experienced disease progression after earlier-generation BTK inhibitor therapy. Furthermore, it demonstrates Lupeng's global leadership in advancing BTK-targeted innovation. Going forward, we will continue to advance clinical studies of rocbrutinib in other indications such as diffuse large B-cell lymphoma (DLBCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), to help more patients with various hematologic malignancies." Dr. Chen Yi, co-founder and CSO of the company, said, "The market launch of rocbrutinib is a successful example of Lupeng's 'innovation methodology,' proving that the company's unique 'Beyond the Rule of 5' , BeyondX Oral MedChem Platform , can efficiently develop next-generation, globally best-in-class small molecule targeted drugs featuring novel mechanisms of action." The NMPA approval of rocbrutinib for the treatment of R/R MCL is primarily based on positive results from a nationwide, multi-center, open-label, single-arm Phase II registration clinical trial (the ROCK-1 study)[1-2], led by Professor Zhu Jun and Professor Song Yuqin from Peking University Cancer Hospital. Forty-one centers across China participated in the study, which was designed to evaluate the efficacy and safety of rocbrutinib monotherapy in MCL patients who had relapsed or were refractory after prior treatment with covalent BTK inhibitors. As of June 5, 2025, clinical trial data showed an objective response rate (ORR) of 63.9%, a complete response rate (CR) of 23%, and a median duration of response (mDOR) of 16.5 months. All enrolled patients had previously received at least a covalent BTK inhibitor; more than one-third of them had received two or more cBTK inhibitors. Baseline characteristics of the patient group were generally difficult to treat and had poor prognosis. In terms of safety, no atrial fibrillation/flutter or other cardiac events occurred, and no patient permanently discontinued treatment due to adverse events. The incidence of BTK inhibitor–associated toxicity was relatively low. In April 2026, rocbrutinib was included for the first time in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma , where it was listed as a Category II recommendation for the treatment of R/R MCL. Its inclusion in the guidelines prior to formal NMPA approval reflects the recognition by leading clinical experts of rocbrutinib's innovative mechanism and promising clinical value in addressing the significant unmet need in R/R MCL. Professor Weiping Liu of Peking University Cancer Hospital noted that, based on key evidence from clinical studies, rocbrutinib has become an important recommended treatment option for MCL and provides support for standardized clinical practice. Professor Jun Ma of Harbin Institute of Hematology & Oncology further emphasized that patients with R/R MCL have long lacked effective standard treatment options, representing a major challenge in clinical practice. As the first fourth-generation BTK inhibitor to reach the marketing application stage, rocbrutinib's dual covalent and non-covalent mechanism enables it to target C481-site and other resistance mutations such as T474I and L528W, providing a scientific basis for overcoming acquired resistance. The recommendation provides authoritative and standardized clinical guidance for physicians and offers a new treatment opportunity for patients with R/R MCL. More importantly, rocbrutinib's anti-tumor activity is not limited to MCL; it has demonstrated positive therapeutic potential in various B-cell malignancies, including DLBCL, CLL/SLL and Marginal zone lymphoma (MZL). The guidelines also include a note indicating rocbrutinib's efficacy as monotherapy or in combination therapy for patients with R/R DLBCL. Based on preliminary study results in adult patients with non-GCB DLBCL who had received at least two prior lines of treatment, rocbrutinib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in May 2024. The corresponding pivotal Phase II registration study (ROCK-2) had already been initiated by the end of 2025. Results from a Phase I study conducted in the United States showed that rocbrutinib achieved an ORR of 78.3% at doses of 200–300 mg/day in CLL patients previously treated with BTK inhibitors, with an estimated median progression-free survival (PFS) of 28.1 months in the 100–300 mg/day dose range[3]. In January 2026, the global Phase III head-to-head clinical trial comparing rocbrutinib with the third-generation non-covalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL/SLL (the ROCKET-CLL study, NCT07342478) was launched, marking a new stage in rocbrutinib's global development. About Lupeng Pharmaceutical Lupeng Pharmaceutical is a clinical-stage company dedicated to the discovery and development of innovative medicines for the treatment of hematological malignancies and autoimmune diseases. In pursuit of cutting-edge science, we are mainly focusing on clinically validated targets such as BTK, Bcl-2 and Bcl-xL and promoting international and domestic multi-center clinical development and commercialization. Our investigational drugs LP-168 (rocbrutinib), LP-108 (lacutoclax) and LP-118 have demonstrated promising efficacy with a favorable safety profile, positioning them as potential Best-in-Class (BIC) medicines. Rocbrutinib was already granted accelerated approval for relapsed or refractory mantle cell lymphoma (R/R MCL) by the National Medical Products Administration (NMPA) in China and was included in the Lymphoid Diagnosis and Treatment Guidelines of Chinese Society of Clinical Oncology (CSCO) 2026. Lacutoclax have been granted regulatory approval by CDE for pivotal registration trials. At Lupeng Pharmaceutical, we are committed to building a multinational pharmaceutical company and delivering innovative medicines to address unmet medical needs for the improvements of patient's lives. SOURCE Lupeng Pharmaceutical Ltd 21% more press release views with Request a Demo

Drug ApprovalPhase 2Clinical ResultPhase 3Breakthrough Therapy

21 May 2026

·www.prnewswire.com

Guangzhou Lupeng/Newave Pharmaceutical Inc. Enrolled the First Patient in the Global Phase 3 ROCKET-CLL Trial Evaluating Rocbrutinib (LP-168) vs. Pirtobrutinib in R/R CLL/SLL

Head-to-Head Study Highlights Rocbrutinib as the World's First Fourth-Generation Dual Covalent and Non-Covalent BTK Inhibitor Designed to Overcome Resistance Mutations GUANGZHOU, China and SAN FRANCISCO, May 21, 2026 /PRNewswire/ -- Lupeng Pharmaceutical Ltd, a global clinical-stage biopharmaceutical company, announced the enrollment of the first patient in its global Phase 3 ROCKET-CLL trial (NCT07342478). Newave Pharmaceutical Inc. (hereinafter referred to as "Newave") and Guangzhou Lupeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Guangzhou Lupeng") are both wholly-owned subsidiaries of Lupeng Pharmaceutical Ltd. This head-to-head study evaluates the efficacy and safety of rocbrutinib (LP-168), a novel oral fourth-generation BTK inhibitor, against pirtobrutinib in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) who have received prior therapy with a covalent BTK inhibitor (cBTKi). Existing BTK inhibitors face resistance challenges, underscoring the need for next-generation therapies that can overcome resistance. The first study site of the ROCKET-CLL Phase 3 trial (LP-168-US-CLL301; NCT07342478) was activated on April 28, 2026, at OptumCare Cancer Care Center in Las Vegas, Nevada, under the leadership of Dr. Russell Gollard. On May 20, 2026, Dr. Gollard and his team enrolled the first patient, marking a key milestone in the global development of rocbrutinib (LP-168), an investigational BTK inhibitor being evaluated in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have progressed after prior covalent BTK inhibitor therapy. ROCKET-CLL is a randomized, open-label, multicenter Phase 3 study expected to enroll approximately 306 adult patients worldwide. The study is co-led by Drs. Jennifer Woyach at Ohio State University and John Byrd at the University of Pittsburgh Medical Center, with participation by leading academic centers in the US, EU, China, and Australia. Participants are randomized 1:1 to receive once-daily oral rocbrutinib (200 mg) or pirtobrutinib (200 mg). The primary endpoint is progression-free survival (PFS), and secondary endpoints include overall survival (OS, key secondary endpoint), overall response rate (ORR), and duration of response (DOR), time to next treatment (TTNT), event-free survival (EFS), safety and tolerability. Exploratory endpoints include patient-reported outcomes, health-related quality of life, and biomarker analyses to further characterize treatment response and resistance mechanisms. Enrollment is expected to be completed by early Q4 2027, with an interim analysis planned for 2029. "ROCKET-CLL marks an important step in validating rocbrutinib's differentiated dual covalent and non-covalent mechanism," said Jennifer Woyach, MD, Bertha Bouroncle MD and Andrew Pereny Chair of Medicine at The Ohio State University College of Medicine. "Based on clinical findings from the US Phase 1 study, among CLL patients previously treated with cBTKi and/or ncBTKi, patients treated at dose levels of 200 mg/day or higher, the overall response rate was 78.3%, with an estimated median progression-free survival of 28.1 months for doses of at least 100 mg/daily" [1]. About Rocbrutinib (LP-168) Rocbrutinib (LP-168) is a novel, orally available, highly selective fourth-generation Bruton's tyrosine kinase (BTK) inhibitor developed on Lupeng's proprietary BeyondX platform. It is engineered to combine covalent (irreversible) and non-covalent (reversible) binding, enabling inhibition of both wild-type and C481-mutant BTK and overcoming multiple resistance mutations, including C481X, T474X, and L528W. This differentiated mechanism positions rocbrutinib as a potential best-in-class BTK inhibitor in the post-BTKi setting. Rocbrutinib has demonstrated a favorable safety profile and durable clinical responses across multiple B-cell malignancies. In China, rocbrutinib's New Drug Application (NDA) for relapsed or refractory mantle cell lymphoma (R/R MCL) has been accepted and is under Priority Review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Additionally, rocbrutinib has received Breakthrough Therapy Designation (BTD) in China for adult patients with relapsed or refractory non-germinal center B-cell-like diffuse large B-cell lymphoma (R/R non-GCB DLBCL) who have received at least two prior lines of therapy, making it the first BTK inhibitor in China—and the only one globally—to receive such designation in this indication. About Lupeng Pharmaceutical Ltd Newave Pharmaceutical Inc. (hereinafter referred to as "Newave") and Guangzhou Lupeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Guangzhou Lupeng") are both wholly-owned subsidiaries of Lupeng Pharmaceutical Ltd. Lupeng Pharmaceutical Ltd is a global clinical-stage biopharmaceutical company dedicated to discovering and developing next-generation therapies for hematological malignancies and autoimmune diseases. Leveraging its proprietary BeyondX medicinal chemistry platform, the company is advancing a robust pipeline targeting clinically validated pathways, including BTK, Bcl-2, and Bcl-xL. With a strong commitment to innovation and global development, Lupeng aims to deliver transformative therapies that address unmet medical needs worldwide. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements, including those regarding clinical development timelines, regulatory progress, and the potential therapeutic benefits of rocbrutinib. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Reference: 1. Updates of R/R CLL with prior exposure to Bruton's tyrosine kinase (BTK) inhibitor and/or bcl-2 inhibitor in the Phase 1 trial of LP-168 (rocbrutinib), a novel COVALENT and non-COVALENT BTK inhibitor. ASH 2025. abs25-2620 SOURCE Lupeng Pharmaceutical Ltd 21% more press release views with Request a Demo

Phase 3Phase 1Breakthrough TherapyExecutive ChangeClinical Result

28 Nov 2024

·www.prnewswire.com

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. 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Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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ImmunotherapyLicense out/inPhase 3VaccineCell Therapy

100 Deals associated with Rocbrutinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	03 Jun 2026
Mantle cell lymphoma refractory	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	03 Jun 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mantle-Cell Lymphoma	NDA/BLA	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	28 May 2025
Chronic lymphocytic leukaemia refractory	Phase 3	United States	Newave Pharmaceutical Inc.	23 Apr 2026
Recurrent Chronic Lymphoid Leukemia	Phase 3	United States	Newave Pharmaceutical Inc.	23 Apr 2026
Small Lymphocytic Lymphoma	Phase 3	United States	Newave Pharmaceutical Inc.	23 Apr 2026
Chronic Lymphocytic Leukemia	Phase 2	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	14 Jul 2026
Follicular Lymphoma	Phase 2	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	14 Jul 2026
Waldenstrom Macroglobulinemia	Phase 2	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	14 Jul 2026
Mature B-Cell Neoplasm	Phase 2	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	29 Jun 2026
Multiple Sclerosis, Relapsing-Remitting	Phase 2	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	08 Feb 2026
Diffuse large B-cell lymphoma recurrent	Phase 2	China	Guangzhou Lupeng Pharmaceutical Co., Ltd.	27 Nov 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07342478 (ROCKET-CLL, ASCO2026)	Phase 3	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	306	Rocbrutinib 200 mg QD	vxistjmkbf(vkmgpidtpb) = rznfkkcqmu dixjifgxef (mematvtats )	Positive	29 May 2026
				Pirtobrutinib 200 mg QD	vxistjmkbf(vkmgpidtpb) = fwzpxqxnhv dixjifgxef (mematvtats )
NCT05716087 (ROCK-1, EHA2026)	Phase 2	Mantle cell lymphoma refractory	61	Rocbrutinib 150 mg once daily	drfbkfbfkl(ghkxbwtlvc) = hbojdjxvkj jfpbqccpzg (zctzawpzqt, 50.6 - 75.8) View more	Positive	12 May 2026
NCT07342478 (ROCKET-CLL, EHA2026)	Phase 3	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	306	Rocbrutinib	wvvcqhtwwv(publljtflt) = dtukxfjeuw skhinzonpg (ewjdtsgsuc ) View more	Positive	12 May 2026
				Pirtobrutinib	wvvcqhtwwv(publljtflt) = sfwgiawwdp skhinzonpg (ewjdtsgsuc ) View more
NCT04993690 (LP-168-CN101, ASH2025)	Phase 1	Mantle-Cell Lymphoma	28	Rocbrutinib 100 mg	jufhkcqruw(muhnvfnoay) = Dose interruption due to TRAEs occurred in 6 (21.4%) patients, but only 1 patient underwent dose reduction. No drug discontinuation or death due to TRAEs has occurred. oadjwswzlk (xmynuesdjp ) View more	Positive	06 Dec 2025
NCT05716087 (ROCK-1, ASH2025)	Phase 2	-	61	Rocbrutinib 150 mg QD	twxtnnupee(desewbdqcp) = uaslsnbchn pbxqjnfmhp (givxnllqul, 50.6 - 75.8) View more	Positive	06 Dec 2025
NCT04993690 (LP-168-CN101, ASH2025)	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line	41	Rocbrutinib (1L)	qoqdoxraqy(lovgbjpfzl) = qrhkvjtwca qdxasiuvbx (tdiiatemxo )	Positive	06 Dec 2025
				Rocbrutinib (R/R BTKi-naïve)	exhpptweax(owqlttbhdj) = xnwshsfwdz fjwhecuuau (tjwmnaxxrk ) View more
NCT04775745 (ASH2024) Manual	Phase 1	Chronic Lymphocytic Leukemia second-site T474 gatekeeper mutations	10	Rocbrutinib	tfarnmpamm(kqdeznjoxb) = None lpnbkukdiy (kvikgezmst ) View more	Positive	09 Dec 2024
				Rocbrutinib (second-site T474 gatekeeper mutations)
NCT04993690 (ASH2024) Manual	Phase 1	Diffuse Large B-Cell Lymphoma Last line \| Third line	33	Rocbrutinib	drstkzxwpl(buusjofnmf) = ehyrnhdqoe rwrhdczzpe (gmspisbsre ) View more	Positive	08 Dec 2024
NCT04993690 (ASH2024) Manual	Phase 1	Refractory Marginal Zone Lymphoma Second line	30	Rocbrutinib 100mg	jqbqqsdosj(yhpjxeqahp) = qfxsmqtjwp aylljvajqq (vcsjvtgxzo ) View more	Positive	07 Dec 2024
				Rocbrutinib 150mg	mmzbdanair(btsgviretq) = nfwdbtaptu dqvhcfocdl (pjxxqxvdym )
NCT04993690 (ASH2023)	Phase 1	B-cell lymphoma refractory	68	LP-168 100 mg	iyqawmvgqp(kfclybhkrl) = yfjfgvxjis goplqoiixy (nyxywicact )	-	11 Dec 2023

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