Tafasitamab-Cxix

BEIJING, Aug. 03, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that orelabrutinib, in combination with mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy. Orelabrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy. Mesutoclax is a novel, oral BCL2 inhibitor developed by InnoCare that can exert anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax is the first BCL2 inhibitor granted BTD recognition in China for the treatment of mantle cell lymphoma (MCL) in patients previously treated with a BTK inhibitor. This is the second BTD granted to the novel BCL2 inhibitor. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We are pleased that orelabrutinib in combination with mesutoclax has been granted BTD, which will help accelerate clinical trials to provide better treatment options for more patients.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated that orelabrutinib in combination with mesutoclax achieved excellent efficacy and safety in patients with MZL who had received at least one prior therapy, with an overall response rate (ORR) of 100%. MZL is an indolent B-cell non-Hodgkin's lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with relapsed or refractor MZL lack effective treatment options. The BTD aims to accelerate the clinical development and approval of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials. About InnoCare Pharma InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit and follow us on LinkedIn. Contact Media Investors Chunhua Lu 86-10-66609879 86-10-66609999 chunhua.lu@innocarepharma.com ir@innocarepharma.com

Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen listed on the Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1],[2] In the pivotal Phase 3 inMIND clinical trial, patients with R/R FL receiving the Minjuvi combination regimen experienced a significant improvement in progression-free survival, with a 57% reduction in the risk of disease progression, relapse or death, compared with placebo plus lenalidomide and rituximab.[3] Follicular lymphoma is the second most common non-Hodgkin lymphoma (NHL), with over 10,000 Australians living with the disease and approximately 1,500 Australians diagnosed each year.[4],[5] SINGAPORE, Aug. 2, 2026 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the listing of Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1] This milestone follows the Australian registration of Minjuvi for R/R FL by the Therapeutic Goods Administration (TGA) in April 2026, via the Project Orbis process.[6] The PBS listing of Minjuvi marks the availability of the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this group of patients.[1],[2] Effective 1 August 2026, eligible patients with FL who have experienced relapses or disease progression on existing therapies will now have equitable access to a new treatment option for this difficult-to-treat condition.[1] "As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia," said Carlo Montagner, ST Chief Executive Officer. "After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay." ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore. Minjuvi is a CD19 targeting immunotherapy that works within a patient's immune system to help find and eliminate malignant B-cells.[7] In combination with rituximab and lenalidomide, Minjuvi delivers a complementary immune-mediated approach that helps control disease progression and supports improved long-term outcomes for patients with follicular lymphoma.[7] The PBS reimbursement underscores the growing recognition of innovative immunotherapy-based treatment strategies in follicular lymphoma and reinforces ST's commitment to improving access to life-changing therapies for patients across the Asia-Pacific region. "While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment," said Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne. "Today's PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for R/R FL." Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting.[7] Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.[7] "Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community," said Sharon Winton, Chief Executive Officer of Lymphoma Australia. "As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families." The PBS listing of Minjuvi for R/R FL means these patients will now have equitable access to a new targeted immunotherapy combination treatment when they need it. It is important that patients with R/R FL speak with their doctor to understand the most suitable treatment option available for them. For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website. PBS Information: This medicine is listed on the Pharmaceutical Benefits Scheme (PBS) — AUTHORITY REQUIRED. Refer to the PBS Schedule for full authority information. Important Safety Information on Minjuvi [7] Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops. Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded. In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%). Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle. Ends. About Minjuvi ® (tafasitamab) Minjuvi® (tafasitamab) is a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody. Minjuvi incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).[7] Incyte licenses exclusive worldwide rights to develop and commercialise Minjuvi from Xencor, Inc. In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorisation from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy. In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory DLBCL. Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory FL (2L+ FL). In Australia, Minjuvi® (tafasitamab) is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).[7] ▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA.[7] XmAb® is a registered trademark of Xencor, Inc. Monjuvi and Minjuvi are registered trademarks of Incyte. About the inMIND Study[ 3] A global, double-blind, randomised, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years), including 548 participants with R/R FL. 54 Australians participated in the study across 12 local trial sites around the country. The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. The clinical trial met its primary endpoint, with the data demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56]. Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of Minjuvi to lenalidomide in combination with rituximab. The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. Additional information can be found at . REFERENCES: SOURCE Specialised Therapeutics 21% more press release views with Request a Demo