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AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
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The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by AbbVie Inc. (NYSE: ABBV) and Calico Life Sciences, into its Rare Disease Therapy Pilot Program. The investigational eIF2B activator is currently undergoing a Phase Ib/II clinical trial for the treatment of vanishing white matter (VWM)…
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Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
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Kyowa Kirin’s Evocalcet Wins NMPA Nod for Chronic Kidney Disease Treatment
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Kyowa Kirin Co. (TYO: 4151), a Japanese pharmaceutical firm, has secured marketing approval from China’s National Medical Products Administration (NMPA) for its novel drug evocalcet. The drug is indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing maintenance dialysis due to chronic kidney disease (CKD). Evocalcet, classified as…
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Sperogenix Launches Early Access Program for DMD Therapy Agamgree in Hainan
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Switzerland-based Santhera Pharmaceuticals (SWX: SANN) has announced that its Chinese partner Sperogenix Therapeutics has initiated an early access program (EAP) for the rare disease therapy Agamgree (vamorolone) in Hainan’s Bo’ao Lecheng Pilot Zone, with the first patients now receiving treatment for Duchenne muscular dystrophy (DMD). Sperogenix secured the rights to…
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Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
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Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed…
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FDA Committee Backs Eli Lilly’s Donanemab for Early Symptomatic Alzheimer’s Disease
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This week, a US Food and Drug Administration (FDA) advisory committee endorsed the safety and efficacy of Eli Lilly and Co.’s (NYSE: LLY) donanemab, a biologic therapy that targets amyloid plaques, for its use in treating early symptomatic Alzheimer’s disease (AD). The recommendation follows a request from the regulator earlier…
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Luye Pharma’s Paliperidone Palmitate Injection Wins NMPA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its paliperidone palmitate injection. This second-generation antipsychotic long-acting injection is now approved for the treatment of schizophrenia during both the acute and…
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Junshi Biosciences’ Toripalimab-Bevacizumab Combo Meets Primary Endpoints in HCC Phase III Trial
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival…
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SinoMab BioScience’s SM17 Atopic Dermatitis Drug Reaches First Patient Milestone in Phase Ib Trial
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SinoMab BioScience Ltd (HKG: 3681), a biotech firm based in Hong Kong, has announced the first patient dosing in a Phase Ib clinical study for SM17, a pioneering drug for atopic dermatitis (AD). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of SM17, along with preliminary efficacy,…
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CGP’s GPN00884 Myopia Drug Enters Phase I Clinical Trial with First Patient Dosed
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the commencement of a Phase I clinical study for GPN00884, an innovative ophthalmic drug aimed at arresting the progression of childhood myopia, with the first patient now dosed. This randomized, double-blind, placebo-controlled, dose-escalation study is designed to evaluate…
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Sino Biopharmaceutical’s KRAS Inhibitor Garsorasib Earns Breakthrough Designation in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its candidate garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation covers two indications: the treatment of…
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Ascentage Pharma Gets Green Light for Global Phase III Trial of Olverembatinib in SDH-Deficient GIST
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a global regulatory Phase III study for its Category 1 drug olverembatinib. The study aims to evaluate the efficacy of olverembatinib in…
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Bayer’s HER2 Targeting Drug BAY 2927088 Earns Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to German pharmaceutical giant Bayer (ETR: BAYN)’s drug candidate BAY 2927088 for the treatment of HER2 mutant non-small cell lung cancer (NSCLC), as indicated on the CDE’s official website. This marks a significant regulatory milestone for…
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InnoCare Pharma’s TYK2 Inhibitor ICP-332 Receives FDA IND Approval for Atopic Dermatitis
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InnoCare Pharma (HKG: 9969, SHA: 688428), a biopharmaceutical company based in China has announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its TYK2 inhibitor, ICP-332. This development marks a significant step forward for the company as it seeks to expand its…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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Biosion’s Bosakitug Shows Positive Results in Atopic Dermatitis Phase II POC Study
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Biosion, a clinical-stage biotechnology company with operations in Delaware, U.S., and China, has announced key findings from its Phase II proof-of-concept (POC) ADAMANT study for bosakitug, a candidate in its pipeline for the treatment of atopic dermatitis (AD). Bosakitug is a monoclonal antibody (mAb) that targets thymic stromal lymphopoietin (TSLP),…
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Ascletis Pharma’s ASC41 Shows Promise in Phase II Study for Metabolic Dysfunction-Associated Steatohepatitis
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Ascletis Pharma Inc. (HKG: 1672), a biopharmaceutical company based in China, has announced positive interim results from a 12-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41, in patients with metabolic dysfunction-associated steatohepatitis (MSAH). The randomized, double-blinded, placebo-controlled, and multi-center Phase II trial demonstrated significant…
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Shanghai Pharmaceuticals Halts Development of B001 and I022 for Selected Indications
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced the discontinuation of clinical studies and further development for its drug candidates B001, B001-A, I022, and I022-K. B001, a monoclonal antibody (mAb) intended for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma (B-NHL), has been suspended following the completion of Phase I,…
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AI-Powered Biotech Insilico Medicine Initiates Phase I Clinical Trial for Inflammatory Bowel Disease Drug
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Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that the first patient has been dosed in a Phase I clinical study for its candidate drug ISM5411. This follows the drug’s initial entry into clinical studies in Australia. ISM5411 is an orally administered…
