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Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
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Kangfang Biotech Presents Groundbreaking mCRC Treatment Data at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) debuted its independently developed PD-1/VEGF bispecific antibody, Yivoxi, in combination with or without the next-generation CD47 monoclonal antibody, Laifali, plus FOLFOXIRI as a first-line treatment for microsatellite stable (MSS) or proficient mismatch repair (pMMR) advanced metastatic…
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Kangfang Biotech’s Yivoxi Shows Promising Results in First-Line TNBC Treatment at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled for the first time the results of its independently developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). Preliminary data…
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Kangfang Biotech’s Yivoxi Shows Promising Results in Treating R/M HNSCC at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent…
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Shanghai Pharmaceuticals’ Dual-Targeting CAR-T Therapy Advances with IND Re-Acceptance
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Shanghai Pharmaceuticals Group Co., Ltd. (SHA: 601607)’s biotech subsidiary has announced that its investigational ‘CD19 and CD22 targeting chimeric antigen receptor T cell injection’ has received renewed acceptance for its Investigational New Drug (IND) application by the relevant authorities. Known under the development code B019, this cellular therapy candidate has…
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Novartis’ Cemiplimab Approved in China for Moderate-to-Severe Atopic Dermatitis
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Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
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Johnson & Johnson’s Tremfya Gains FDA Approval for Ulcerative Colitis Treatment
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Johnson & Johnson (NYSE: JNJ) announced today that the US Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya stands out as the sole fully-human, dual-acting monoclonal antibody that not only…
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Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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Lilly’s Once-Monthly Atopic Dermatitis Treatment Ebglyss Gets Green Light from FDA
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received market approval from the US Food and Drug Administration (FDA) for Ebglyss (lebrikizumab), a new treatment for adults and children aged 12 years and over suffering from moderate-to-severe atopic dermatitis (AD). Ebglyss is an interleukin-13 (IL-13) inhibitor that…
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Roche’s Ocrevus Zunovo Receives FDA Nod as First Twice-Yearly MS Treatment
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Roche Group (SWX: ROG; OTCMKTS: RHHBY) , a Swiss pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has granted approval for Ocrevus Zunovo (ocrelizumab, hyaluronidase), marking a significant advancement in the treatment of multiple sclerosis (MS). This new formulation is the first and only twice-per-year treatment…
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Ascentage Pharma’s Olverembatinib Shows Promise in SDH-Deficient GIST at ESMO Congress
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced the presentation of clinical study results for its drug olverembatinib (HQP1351) at the 2024 European Society of Medical Oncology (ESMO) Congress. The study focused on patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor (GIST), a rare and aggressive form…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
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Johnson & Johnson Submits Second NDA for Nipocalimab to Treat Generalized Myasthenia Gravis
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Johnson & Johnson (NYSE: JNJ), a leading healthcare company based in the U.S., has reported a second New Drug Application (NDA) filing for its FcRn blocker, nipocalimab. The company has submitted the application to the European Medicines Agency (EMA) for the treatment of adults with generalized myasthenia gravis (gMG) who…
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Keymed Biosciences’ IL-4Rα mAb Stapokibart Receives NMPA Approval for Atopic Dermatitis Treatment
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone…
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Sanofi’s Dupixent Shows Promise in Phase III Trials for Rare Skin Disease and Chronic Hives
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has announced positive results from two Phase III clinical trials for its drug Dupixent (dupilumab), indicating its potential for two distinct indications. The first trial, ADEPT, concentrated on the treatment of the rare skin condition bullous pemphigoid (BP), while the…
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Suzhou GenAssist Launches First-of-Its-Kind Base Editing Drug Trial for Duchenne Muscular Dystrophy
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Suzhou GenAssist Therapeutic Co., Ltd, a biopharmaceutical company based in China, has announced the commencement of an investigator-initiated-trial (ITT) for its base editing drug candidate, GEN6050X, in patients afflicted with Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder linked to the X-chromosome, typically caused by mutations in the…
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Innovent Biologics’ Mazdutide Outperforms Dulaglutide in Phase III T2D Study at EASD Meeting
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Innovent Biologics, Inc. (HKG: 1801), a biopharmaceutical company based in China, has presented significant findings from the Phase III DREAMS-2 study on its drug candidate mazdutide at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). Mazdutide, a dual agonist targeting the glucagon-like peptide-1 receptor…
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Qilu Pharmaceutical’s Iruplinalkib Shows Promising Results in Phase II Study for ALK+ NSCLC
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
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Nuance Pharma Completes Enrollment for Phase III COPD Trial of Ohtuvayre in China
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Nuance Pharma, a China-based pharmaceutical company, has announced the completion of patient enrollment for the Phase III ENHANCE-CHINA study (NCT05743075) for its drug Ohtuvayre (ensifentrine). This Phase III trial is a randomized, double-blind, placebo-controlled investigation assessing the efficacy and safety of Ohtuvayre over a 24-week period in adult patients diagnosed…
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Innovent Biologics Presents Promising Phase I Data for IBI363 in Advanced NSCLC at WCLC
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
