Latest news with #AbbiskoTherapeutics
Yahoo
16-06-2025
- Health
- Yahoo
Abbisko Therapeutics Completes First Patient Dosing in Registrational Study of Irpagratinib for HCC
SHANGHAI, June 15, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) today announced that it has completed first patient dosing in a registrational study of irpagratinib, a self-developed and highly-selective small molecule FGFR4 inhibitor, for the treatment of Hepatocellular Carcinoma (HCC). In May, irpagratinib received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). It is the first therapeutic agent to utilize molecularly defined biomarkers for precision-targeted treatment of HCC. The vast majority of patients with advanced HCC treated with current standard-of-care therapies—including immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs)— experience disease progression within one year. Additionally, approximately 30% of HCC patients exhibit FGF19 overexpression, a biomarker associated with more aggressive tumor biology and poorer prognosis. The registrational study of irpagratinib (ABSK-011-205) is a multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of irpagratinib in combination with Best Supportive Care (BSC) versus placebo in combination with BSC, in patients with advanced or unresectable HCC who exhibit FGF19 overexpression and have previously been treated with ICIs and mTKIs. Eligible patients will be randomized in a 2:1 ratio to receive irpagratinib or placebo. About Irpagratinib (ABSK-011) Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC. To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of HCC patients with FGF19 overexpression. In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the previous 2024 ESMO GI Congress, Abbisko presented clinical data demonstrating 220mg irpagratinib BID in combination with atezolizumab achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously received immune checkpoint inhibition therapy. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit for more information. View original content: SOURCE Abbisko
Globe and Mail
13-06-2025
- Business
- Globe and Mail
Graft vs Host Disease Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Graft vs Host Disease pipeline constitutes 45+ key companies continuously working towards developing 50+ Graft vs Host Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. ' Graft vs Host Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Graft vs Host Disease Market. The Graft vs Host Disease Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details. Some of the key takeaways from the Graft vs Host Disease Pipeline Report: Companies across the globe are diligently working toward developing novel Graft vs Host Disease treatment therapies with a considerable amount of success over the years. Graft vs Host Disease companies working in the treatment market are Abbisko Therapeutics, Theriva Biologics, Seres Therapeutics, Cellestia Biotech, Pfizer, Chia Tai Tianqing Pharmaceutical, Regimmune Corporation, Syndax Pharmaceuticals, MaaT Pharma, Medac, Equillium, Xenikos, and others, are developing therapies for the Graft vs Host Disease treatment Emerging Graft vs Host Disease therapies in the different phases of clinical trials are- ABSK021, SYN-004, SER-155, CB103, Glasdegib, TQ 05105, RGI-2001, Axatilimab, MaaT013, MC 0518, Itolizumab, T-Guard, and others are expected to have a significant impact on the Graft vs Host Disease market in the coming years. In April 2025, The California Institute for Regenerative Medicine (CIRM) has granted $8 million to biotech firm Tr1X to advance its Phase I/IIa clinical trial of TRX103. This therapy aims to prevent graft-versus-host disease (GvHD) in blood cancer patients receiving mismatched stem cell transplants. TRX103 is an allogeneic, engineered type 1 regulatory (Tr1) Treg cell therapy designed to reduce transplant-related complications and improve patient outcomes. In March 2025, Orca Bio's investigational T-cell immunotherapy for blood cancers significantly improved outcomes, more than doubling the rate of patients who remained free from moderate-to-severe chronic graft-versus-host disease (GvHD). According to results from the Phase III Precision-T trial (NCT05316701), 78% of patients treated with Orca-T (TRGFT-201), the company's lead allogeneic T-cell therapy, were GvHD-free after one year, compared to only 38% in the group receiving standard allogeneic stem cell transplants. In January 2025, MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotech company specializing in Microbiome Ecosystem Therapies™ (MET) aimed at improving survival outcomes in cancer patients through immune system modulation, has announced positive topline results from its pivotal Phase 3 ARES trial. This single-arm, open-label, multicenter study conducted across Europe assessed the safety and efficacy of MaaT013 in patients with acute Graft-versus-Host Disease involving the gastrointestinal tract (GI-aGvHD) who are in third-line treatment — meaning they are resistant to steroids and either refractory or intolerant to ruxolitinib. The trial successfully achieved its primary endpoint, with a 28-day gastrointestinal overall response rate (GI-ORR) of 62%, significantly surpassing the expected rate of 38%. These outcomes, evaluated by an Independent Review Committee (IRC), exceeded the predefined efficacy threshold and underscore the strong clinical potential of MaaT013 in treating third-line GI-aGvHD. In December 2024, The FDA has granted approval to Mesoblast's allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, remestemcel-L, for treating steroid-refractory acute graft versus host disease (GvHD) in pediatric patients aged two months and older. Significantly, this marks the first FDA-approved MSC-based therapy. The treatment will be commercially available under the brand name Ryoncil. Graft vs Host Disease Overview Graft versus Host Disease (GvHD) is a medical condition that can occur after a stem cell or bone marrow transplant, where the donor's immune cells (graft) recognize the recipient's body (host) as foreign and attack it. GvHD commonly affects the skin, liver, and gastrointestinal tract. It is classified into acute and chronic forms, with symptoms ranging from mild rashes and diarrhea to severe organ damage. Management typically involves immunosuppressive therapies to reduce the immune response. Emerging Graft vs Host Disease Drugs Under Different Phases of Clinical Development Include: ABSK021: Abbisko Therapeutics SYN-004: Theriva Biologics SER-155: Seres Therapeutics CB103: Cellestia Biotech Glasdegib: Pfizer TQ 05105: Chia Tai Tianqing Pharmaceutical RGI-2001: Regimmune Corporation Axatilimab: Syndax Pharmaceuticals MaaT013: MaaT Pharma MC 0518: Medac Itolizumab: Equillium Elranatamab: Pfizer Felzartamab: Janssen Pharmaceutical T-Guard: Xenikos MaaT013: MaaT Pharma Axatilimab: Syndax Pharmaceuticals TQ 05105: Chia Tai Tianqing Pharmaceutical Group Graft vs Host Disease Route of Administration Graft vs Host Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as Oral Intravenous Subcutaneous Graft vs Host Disease Molecule Type Graft vs Host Disease Products have been categorized under various Molecule types, such as Small molecule Cell Therapy Peptides Polymer Small molecule Gene therapy Graft vs Host Disease Pipeline Therapeutics Assessment Graft vs Host Disease Assessment by Product Type Graft vs Host Disease By Stage and Product Type Graft vs Host Disease Assessment by Route of Administration Graft vs Host Disease By Stage and Route of Administration Graft vs Host Disease Assessment by Molecule Type Graft vs Host Disease by Stage and Molecule Type DelveInsight's Graft vs Host Disease Report covers around 50+ products under different phases of clinical development like Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Further Graft vs Host Disease product details are provided in the report. Download the Graft vs Host Disease pipeline report to learn more about the emerging Graft vs Host Disease therapies Some of the key companies in the Graft vs Host Disease Therapeutics Market include: Key companies developing therapies for Graft vs Host Disease are - Biocon, medac GmbH, MaaT Pharma, ElsaLys Biotech, Glia, Syndax Pharmaceuticals, ASC Therapeutics, SCM Lifescience, REGiMMUNE, Roche, VectivBio, Chia Tai Tianqing Pharmaceutical Group, Amgen, Pfizer, Medsenic, Xenothera, Xenikos, AltruBio Inc., Biogen, OncoImmune, Inc., Cellect Biotechnology, AstraZeneca, Bristol-Myers Squibb, Dystrogen Therapeutics, CTI BioPharma, Ossium Health, Inc., Orca Biosystems, Inc., Synthetic Biologics Inc., Cellenkos, Corvus Pharmaceuticals, ImStem Biotechnology, Rheos Medicines, Equillium, Cellestia Biotech, Genentech, Humanigen, CSL Behring, ADIENNE, and others. Graft vs Host Disease Pipeline Analysis: The Graft vs Host Disease pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Graft vs Host Disease with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Graft vs Host Disease Treatment. Graft vs Host Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Graft vs Host Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Graft vs Host Disease market. The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc. Graft vs Host Disease Pipeline Market Drivers Increase in the number of patients suffering from chronic GvHD, robust Pipeline of GvHD are some of the important factors that are fueling the Graft vs Host Disease Market. Graft vs Host Disease Pipeline Market Barriers However, high cost of treatment, recognizing the limitations of currently available aGVHD therapies and other factors are creating obstacles in the Graft vs Host Disease Market growth. Scope of Graft vs Host Disease Pipeline Drug Insight Coverage: Global Key Graft vs Host Disease Companies: Abbisko Therapeutics, Theriva Biologics, Seres Therapeutics, Cellestia Biotech, Pfizer, Chia Tai Tianqing Pharmaceutical, Regimmune Corporation, Syndax Pharmaceuticals, MaaT Pharma, Medac, Equillium, Xenikos, and others Key Graft vs Host Disease Therapies: ABSK021, SYN-004, SER-155, CB103, Glasdegib, TQ 05105, RGI-2001, Axatilimab, MaaT013, MC 0518, Itolizumab, T-Guard, and others Graft vs Host Disease Therapeutic Assessment: Graft vs Host Disease current marketed and Graft vs Host Disease emerging therapies Graft vs Host Disease Market Dynamics: Graft vs Host Disease market drivers and Graft vs Host Disease market barriers Table of Contents 1. Graft vs Host Disease Report Introduction 2. Graft vs Host Disease Executive Summary 3. Graft vs Host Disease Overview 4. Graft vs Host Disease- Analytical Perspective In-depth Commercial Assessment 5. Graft vs Host Disease Pipeline Therapeutics 6. Graft vs Host Disease Late Stage Products (Phase II/III) 7. Graft vs Host Disease Mid Stage Products (Phase II) 8. Graft vs Host Disease Early Stage Products (Phase I) 9. Graft vs Host Disease Preclinical Stage Products 10. Graft vs Host Disease Therapeutics Assessment 11. Graft vs Host Disease Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Graft vs Host Disease Key Companies 14. Graft vs Host Disease Key Products 15. Graft vs Host Disease Unmet Needs 16 . Graft vs Host Disease Market Drivers and Barriers 17. Graft vs Host Disease Future Perspectives and Conclusion 18. Graft vs Host Disease Analyst Views 19. Appendix 20. About DelveInsight 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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Al Bawaba
11-06-2025
- Business
- Al Bawaba
China's Center for Drug Evaluation Accepts Merck's Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor
Merck, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company's application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The submission follows the granting of Priority Review to pimicotinib by the CDE in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., also has been granted breakthrough therapy designation (BTD) by the NMPA. 'With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country,' said Hong Chow, Head of China and International, Healthcare business of Merck. 'Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets.' TGCT is a locally aggressive and often recurring tumor of the joints that can cause high morbidity associated with swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting daily activities and quality of life in the primarily working-age population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. This highlights the need for well-tolerated and effective systemic treatments that can impact tumor growth while relieving the symptoms of the disease. The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO Annual Meeting.
Yahoo
10-06-2025
- Business
- Yahoo
China's Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany's Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor
First global filing for potentially best-in-class TGCT treatment based on strong positive data from Phase 3 MANEUVER study Potential for pimicotinib to be first systemic TGCT therapy approved in China, following recent granting of Priority Review by CDE Additional applications planned in the US and other markets around the world Not intended for UK-based media DARMSTADT, Germany, June 10, 2025--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company's application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The submission follows the granting of Priority Review to pimicotinib by the CDE in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., also has been granted breakthrough therapy designation (BTD) by the NMPA. "With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country," said Hong Chow, Head of China and International, Healthcare business of Merck KGaA, Darmstadt, Germany. "Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets." TGCT is a locally aggressive and often recurring tumor of the joints that can cause high morbidity associated with swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting daily activities and quality of life in the primarily working-age population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. This highlights the need for well-tolerated and effective systemic treatments that can impact tumor growth while relieving the symptoms of the disease. The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO Annual Meeting. About MANEUVERThe pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21). In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS). After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up. About Pimicotinib (ABSK021)Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy. Pimicotinib has been granted breakthrough therapy designation (BTD) by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck KGaA, Darmstadt, Germany, holds worldwide commercialization rights for pimicotinib. Advancing the Future of Cancer CareAt Merck KGaA, Darmstadt, Germany, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer's deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors. Learn more at About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck KGaA, Darmstadt, Germany, generated sales of € 21.2 billion in 65 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to to register for your online, change your selection or discontinue this service. View source version on Contacts Media Relations Phone: +1 (781) 427-4351 Investor Relations Phone: +49 6151 72-3321 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-06-2025
- Business
- Yahoo
Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT
SHANGHAI, June 10, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ( today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT). Pimicotinib is the first internally discovered and self-developed program from Abbisko Therapeutics to enter the NDA approval process, and has the potential to provide patients with a best-in-class therapy to treat TGCT given its exceptional clinical efficacy, safety, and tolerability as demonstrated in multiple clinical trials. "TGCT grows in and around the joints, primarily affecting young and middle-aged adults in their working years. The swelling, pain, stiffness and limited mobility caused by the disease can have a significant impact on the ability to perform daily activities, limiting patients' work and social lives," said Professor Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "Based on these new data from the MANEUVER study, pimicotinib has the potential to establish a new treatment paradigm for patients with TGCT." The submission follows the granting of Priority Review to pimicotinib by the Center for Drug Evaluation (CDE) of the NMPA in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib also has been granted breakthrough therapy designation (BTD) by the NMPA. In December 2023, Abbisko entered into an agreement with Merck pertaining to the commercial rights to pimicotinib, pursuant to which Merck is responsible for the commercialization of pimicotinib globally. Yao-Chang Xu, Chairman and CEO of Abbisko Therapeutics, said: "The acceptance of the New Drug Application for pimicotinib marks a significant milestone in the development journey of Abbisko Therapeutics. Pimicotinib demonstrates a meaningful clinical efficacy and safety profile that positions it to be an innovative treatment option for TGCT patients and clinicians. It will reinforce our strength and determination in innovative drug development. " "With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country," said Hong Chow, Head of China and International, Healthcare business of Merck. "Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets." The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO Annual Meeting. Outside of China, pimicotinib has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and PRIME Designation by the European Medicines Agency (EMA). About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit for more information. View original content: SOURCE Abbisko Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
