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Novartis’s Kesimpta Shows Sustained Efficacy in 6-Year Relapsing MS Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has this week unveiled six-year efficacy data for its anti-CD20 drug Kesimpta (ofatumumab) in the treatment of recently diagnosed relapsing multiple sclerosis (MS) in treatment-naive patients. The data shows that first-line continuous Kesimpta treatment, as compared to a teriflunomide regimen switched to Kesimpta, resulted…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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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). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
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Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
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Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
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Shionogi’s Xofluza Gains Approval in Taiwan for Pediatric Influenza Treatment and Prophylaxis
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Shionogi & Co., Ltd, a leading Japanese pharmaceutical company, has announced that it has received approval for a supplemental new drug application (sNDA) in Taiwan for its influenza treatment and prophylaxis drug, Xofluza (baloxavir marboxil). This first-in-class, oral anti-viral medication is now approved for use in children aged between 5…
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Kangtai Biological Receives NMPA Approval for 20-Valent Pneumococcal Vaccine Clinical Trial
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a leading biopharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its 20-valent pneumococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent infectious diseases caused by…
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KPC Pharmaceuticals Gets NMPA Green Light for Clinical Trial on Familial Mediterranean Fever Treatment
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Yunnan-based KPC Pharmaceuticals Inc., (SHA: 600422) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 product KPC-149, which is intended for the treatment of familial Mediterranean fever (FMF). FMF is an autosomal recessive autoimmune disease associated with mutations in…
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Carvykti CAR-T Therapy Sales Reach $157 Million in Q1 2024, Reports GenScript Subsidiary Legend Biotech
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GenScript Biotech Corporation (HKG: 1548), a leading Contract Research Organization (CRO) based in China, has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 157 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in the first quarter of 2024, which…
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China’s NMPA Releases 79th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) in China has released the 79th batch of reference drugs for Generic Quality Consistency Evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs in the country. This batch includes 64 new specifications and 34 modified specifications for…
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AstraZeneca’s Imfinzi Shows Sustained Survival Benefit in Advanced Biliary Tract Cancer Trial
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has this week announced 3-year results from a Phase III clinical trial of its anti-PD-L1 therapy Imfinzi (durvalumab) in combination with chemotherapy for the treatment of advanced biliary tract cancer (BTC). The trial, after a median follow-up of 41.3 months,…
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Sirnaomics Receives FDA Feedback on STP705 Development Plan for isSCC Treatment
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Sirnaomics Ltd (HKG: 2257), a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics, has announced receiving a written response from the U.S. Food and Drug Administration (FDA) regarding the required Class C meeting for STP705, a treatment for in situ squamous cell carcinoma (isSCC). The Class…
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China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face. Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S.…
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Easton Pharmaceutical Gets NMPA Nod for Generic Version of Merck KGaA’s Concor
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Concor, which contains bisoprolol and amlodipine, a compound preparation used as an alternative therapy for hypertension. The approval signifies that Easton’s…
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Sanofi Advances Phase I/II Trial of Trifunctional NK Cell Engager in Blood Cancers
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, has administered the first dose to a patient in the second part of a Phase I/II clinical trial for the trifunctional NK cell engager SAR443579, targeting blood cancers. The announcement was made by fellow French biotechnology company Innate Pharma (NASDAQ: IPHA) this…
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Roche’s Columvi Meets Overall Survival Endpoint in Diffuse Large B-Cell Lymphoma Trial
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Roche (SWX: RO), a leading Swiss pharmaceutical company, has announced that a late-stage clinical trial for its bispecific antibody Columvi (glofitamab) has successfully met its primary endpoint of overall survival (OS) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The trial involved patients who had received…
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Novartis’s Fabhalta Shows Promise in Phase III IgA Nephropathy Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive preliminary results from a Phase III clinical trial of its complement inhibitor Fabhalta (iptacopan) for the treatment of IgA nephropathy (IgAN). The trial data showed that after a nine-month treatment period, the Factor B inhibitor Fabhalta reduced proteinuria by 38.3% when…
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Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
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Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced the completion of the first dosing in a global multi-center Phase III study for its Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) CMG901 (AZD0901). The ADC is being evaluated as a treatment for advanced solid tumors in the…
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Hengrui Pharmaceuticals Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
