HUTCHMED’s Post

Ascentage Pharma announced that updated results from three studies of olverembatinib, have been released in posters at the 2024 European Hematology Association Hybrid Congress, taking place in Madrid, Spain. Olverembatinib (HQP1351) is an oral, third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma for the treatment of chronic myeloid leukaemia (CML), acute myeloid leukaemia, acute lymphoblastic leukaemia (ALL) and solid tumours, including gastrointestinal stromal tumours (GIST). Olverembatinib is an ATP binding-site inhibitor of wild type BCR-ABL1 kinase and a broad spectrum of BCR-ABL1 mutants, including mutant T315I, which confers resistance against all first- and second-generation TKIs.  Chemenu has been working to develop more compounds for drug discovery. Here comes the building blocks we can provide: https://lnkd.in/gaVnBaRP #Olverembatinib #HQP1351 #GZD824 #TKI #CML #buildingblocks

Ascentage Pharma Group International (the “Company” or “Ascentage Pharma”) is pleased to announce that it has released updated results from three studies of olverembatinib (HQP1351), the first China-approved third-generation BCR-ABL inhibitor and updated data of lisaftoclax (APG-2575), one of its key drug candidates, combined with novel therapeutic regimens in patients with relapsed/refractory (R/R) multiple myeloma (MM) or immunoglobulin light-chain (AL) amyloidosis, in poster presentations at the 2024 European Hematology Association Hybrid Congress (EHA 2024), taking place in Madrid, Europe. Read More: https://lnkd.in/e6739D2g

iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease - https://lnkd.in/g6vekNF6 On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene Therapeutics targeting Parkinson’s Disease. This marks a significant milestone as NouvNeu001 becomes the world’s first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson’s disease in the US. Previously, the “Combined Phase I/II Clinical Study” of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson’s disease. Read more at: https://lnkd.in/g6vekNF6 #parkinsonsdisease #regenerativemedicine #stemcell

iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease - https://lnkd.in/gbKS7Z8M On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene Therapeutics targeting Parkinson’s Disease. This marks a significant milestone as NouvNeu001 becomes the world’s first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson’s disease in the US. Previously, the “Combined Phase I/II Clinical Study” of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson’s disease. Read more at: https://lnkd.in/gbKS7Z8M #parkinsonsdisease #regenerativemedicine #stemcell

𝐔𝐫𝐨𝐆𝐞𝐧 𝐏𝐡𝐚𝐫𝐦𝐚 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐅𝐃𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐍𝐃𝐀 𝐟𝐨𝐫 𝐔𝐆𝐍-𝟏𝟎𝟐 UroGen Pharma (Nasdaq: URGN) UroGen Pharma announced that the FDA has accepted the New Drug Application (NDA) for UGN-102 (mitomycin) intravesical solution. If approved, UGN-102 could become the first FDA-approved treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA set a PDUFA goal date of June 13, 2025. “We’re thrilled about this pivotal milestone,” said Liz Barrett Liz Barrett, CEO of UroGen. “UGN-102 offers a novel approach that could meet unmet needs for patients.” Chief Medical Officer Dr. Mark Schoenberg added, “The NDA is supported by strong data, including a 79.6% complete response rate at 3 months and an 82.3% 12-month duration of response in the ENVISION trial. If approved, UGN-102 could deliver lasting results and reduce recurrence rates, representing a significant advancement for LG-IR-NMIBC management.” #FDA #Biotech #BladderCancer #CancerTreatment #UGN102 #Pharma #HealthcareInnovation

The most recent ODAC meeting has personal significance for me - On Friday, March 15th, the FDA's Oncology Drugs Advisory Committee (ODAC) advised the FDA to approve the CAR-T therapies, Carvykti and Abecma, in earlier lines of therapy for Multiple Myeloma (MM). Last year, a dear family friend passed away from a particularly aggressive form of MM. She underwent 4 prior lines of therapy and an autologous stem cell transplant before finally becoming eligible for CAR-T. She did not survive long enough to receive the therapy. At the time of her death, the results of the CARTITUDE-4 study were just being released showing that anti-BCMA CAR-T was effective in increasing PFS and OS in patients in earlier lines of therapy. While CAR-T therapies are far from risk-free, there is a good chance that if my Aunt had received CAR-T after just 1 or 2 lines of therapy, when she was stronger and healthier, she might have survived for another year or more. Reflecting over the weekend on the ODAC discussion, I am thankful for the efforts of the panelists to weigh the front-loaded risk of early deaths, with the long-term benefits of prolonged disease-free survival with good quality of life. #fda #ODAC #Abecma #Carvykti #AdComm #Overallsurvival #multiplemyeloma #johnsonandjohnson #bms https://lnkd.in/gkh8djXW

The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has recommended the expansion of CAR-T #celltherapy Carvykti (developed by Johnson & Johnson and Legend Biotech) for earlier treatment in patients with multiple myeloma. The proposed change would see Carvykti move to a second-line treatment, opening the therapy up to all patients who have undergone at least one line of therapy. Currently only approved for treatment of patients who have been through three or more lines of treatment, the expansion would represent a key step forward for the cell therapy industry and would see the lifesaving therapy become accessible to tens of thousands of patients every year. Read more in BioSpace: https://bit.ly/4c00kYP

We are thrilled to be partnering with Gilead Sciences, Inc. for the distribution of a novel selective peroxisome proliferator-activated receptor delta (PPARδ) agonist to treat adults with primary biliary cholangitis (PBC). LIVDELZI® is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase. LIVDELZI is a first-in-class PPARδ agonist treatment option for patients with PBC. For more information: https://lnkd.in/eBdBPr2C

Congratulations to our friends at Hansa Biopharma (Hansa) on completing the recruitment and randomization phases of their US ConfldeStrial. ConfldeS is a Phase 3 open-label, randomized, controlled trial evaluating the efficacy of imlifidase in kidney transplantation. The data from this trial plays a pivotal role in supporting the Biologic License Application (BLA) submission to the FDA. We recognize Hansa’s dedication to addressing the unmet needs of highly sensitized kidney transplant patients. Read more about their milestone achievement in the article linked below! #MovingMedicineForward #AdvancingHealthcareSolutions #CRO #ThinkGlobalActLocal #ClinicalResearch #ProudFriends #Hansa

CymaBay to be acquired by Gilead Sciences for USD 4.3 billion An investment in CymaBay Therapeutics by both Arctic Aurora LifeScience and Biotech Select is bearing fruit today, as the liver disease specialist has agreed to be acquired by Gilead Sciences for USD 4.3 billion, or USD 32.5 per share, representing a 26.5% premium to last Friday's close, while the stock has returned 35.4% this year. CymaBay's main asset is seladelpar, a potentially best-in-class molecule for the treatment of primary biliary cholangitis (PBC), an autoimmune disease that causes excruciating itching, among other symptoms. In PBC, the patient's immune system attacks the bile duct, causing it to become inflamed and slowly destroyed, which can ultimately lead to liver failure. In a pivotal Phase 3 trial, seladelpar significantly improved patients' condition, with a particularly strong effect on pruritus, which has a positive impact on patients' quality of life. Based on these data, the company is awaiting the FDA's decision on the drug's approval, which is expected by 14 August this year. Gilead has a historic presence in hepatitis and has been active in other fibrotic and inflammatory liver diseases, so the acquisition strengthens its presence in this area and has been well received by the markets.