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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of Timdarpacept in CMML
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). IMM01 is an SIRPαFc fusion protein that is being studied for use in combination with…
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CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
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FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
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Eli Lilly Launches New Formula of Taltz in China with Reduced Injection Site Pain
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical company in the U.S., has announced the launch of a new formula for Taltz (ixekizumab) in China, following its approval in the country in November of the previous year. The new formula of the IL-17A monoclonal antibody (mAb) is free from…
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Hengrui Pharmaceuticals Advances Two Drug Candidates Following NMPA Clinical Trial Green Lights
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates: HRS-5346 tablets and SHR-9539 injection. HRS-5346, a small molecule drug developed in-house, is…
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JW Therapeutics Presents Positive Clinical Data for Carteyva in SLE at EULAR 2024
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JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has presented new clinical data for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), at the European Alliance of Associations for Rheumatology (EULAR) 2024 annual meeting. The data was for adult patients in China with active…
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Akeso Inc.’s Ivonescimab Shows Positive Interim Analysis in Phase III NSCLC Study
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with…
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Laekna Therapeutics Initiates Phase III Trial for Breast Cancer Candidate LAE002 in Combination with Fulvestrant
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
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Jiangsu QYuns Therapeutics Initiates Phase III Trial for Skin Disease Candidate QX005N
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a pivotal Phase III clinical study. The multi-center, randomized, double-blinded, placebo-controlled trial is designed to evaluate the efficacy of QX005N, a monoclonal antibody (mAb) targeting IL-4Rα for the…
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Wanbangde’s Huperzine A Earns Orphan Drug Status from FDA for Treating Neonatal Brain Injury
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Wanbangde New Building Materials Co., Ltd (SHE: 002082), a company operating in China, has announced that its drug candidate, huperzine A, has been granted an orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE). This designation is a significant…
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Zelgen Biopharmaceuticals Gets NMPA Approval for Jacktinib Vitiligo Trial in Adolescents and Adults
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II/III study for its Category 1 product candidate, jacktinib tablets. The study will focus on adolescent and adult patients suffering from non-segmental vitiligo.…
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Hengrui Pharmaceuticals’ Vitiligo Treatment SHR0302 and Diabetes Drug HRS9531 Get Green Light from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and HRS9531. SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, has…
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Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and…
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Full-Life Technologies Receives FDA Green Light for ²²⁵Ac-FL-020 Clinical Study in mCRPC
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its investigational drug ²²⁵Ac-FL-020 in patients with metastatic castration-resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA (prostate-specific…
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Alphamab Oncology’s KN046 Misses Primary Endpoint in Phase III Pancreatic Cancer Study
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in…
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Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, developed by Eli Lilly, a leading pharmaceutical…
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Hinova Pharmaceuticals to Present Phase I Data for PROTAC Drug HP518 at ASCO 2024
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, is poised to present data from the first-in-human, non-randomized, open-label, multi-center Phase I dosage escalation study of its drug candidate HP518 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. HP518 is an androgen receptor (AR)-targeted PROteolysis TArgeting…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, its biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Hotgen Biotech Receives FDA Approval to Begin Clinical Trials for Acute Myocardial Infarction Drug
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001, a monoclonal antibody (mAb) co-developed with Capital Medical University, is intended for the emergency…
