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CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
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CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
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GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
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Ipsen’s Somatuline Receives First Prescription in China for GEP-NETs Treatment
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French biopharmaceutical company Ipsen (EPA: IPN; OTCMKTS: IPSEY) has announced that the first prescription of its Somatuline (lanreotide) sustained-release injection has been issued in China for the treatment of gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). Somatuline, the only somatostatin analogue (SSA) for deep subcutaneous self-injection, received approval in China in December…
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Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
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Hengrui Pharmaceuticals Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company 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, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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GSK’s Gepotidacin Shows Non-Inferior Efficacy in Phase III Gonorrhoea Tria
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GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK), a leading UK pharmaceutical company, last week announced positive results from a Phase III clinical trial for gepotidacin, a first-in-class triazaacenaphthylene antibiotic, in the treatment of uncomplicated urogenital gonorrhoea (GC). The study demonstrated non-inferiority to the standard azithromycin-based treatment, with a microbiological response rate…
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Joincare Pharmaceutical’s TG-1000 Shows Promise in Phase III Flu Treatment Trial
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Joincare Pharmaceutical Group Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has reportedly completed the unblinding of a Phase III trial for TG-1000, an investigational influenza antiviral drug. The trial has shown positive preliminary data, indicating that the company is now preparing to file a New Drug Application (NDA) in…
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Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
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Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
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Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
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The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active…
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China’s Health Authorities Investigate Alleged Price Manipulation in Pharma Procurement Tenders
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Chinese health regulators are delving into allegations of irregular pricing practices during the national volume-based procurement (VBP) tenders for several pharmaceutical products. A joint statement issued by the National Drug Alliance Procurement Office and the Shanghai Pharmaceutical Centralized Bidding Procurement Management Office cited public complaints regarding the bidding and pricing…
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Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
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Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
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Kintor Pharmaceutical’s GT20029 Meets Primary Endpoint in Phase II AGA Trial
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Kintor Pharmaceutical Ltd (HKG: 9939), a clinical-stage biotechnology company, has announced that its Phase II clinical study for GT20029, a first-in-class proteolysis targeting chimera (PROTAC) compound, has met its primary endpoint in the treatment of male androgenetic alopecia (AGA) in China. The multi-center, randomized, double-blind, placebo-controlled study aimed to evaluate…
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GSK’s Shingrix Vaccine Maintains High Efficacy for Over a Decade, Phase III Data Show
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GlaxoSmithKline (GSK, LON: GSK, NYSE: GSK), the UK-based pharmaceutical giant, has this week released long-term data from a follow-up Phase III trial of its recombinant herpes zoster vaccine, Shingrix. The vaccine demonstrated robust efficacy in adults aged 50 and above, with a 79.7% efficacy rate sustained from year 6 to…
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AbbVie’s Rinvoq Meets Main Goal in Late-Stage Giant Cell Arteritis Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
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Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
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Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
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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…
