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Cellbri Bio Secures Nearly RMB 200 Million in Series B Financing to Boost CGT Commercialization
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Shenzhen Cellbri Bio-Innovation Technology Co., Ltd, a prominent player in China’s cell and gene therapy (CGT) sector, has reportedly secured nearly RMB 200 million in a Series B financing round. The round was led by 3E Bioventures, with participation from HongSheng Capital and existing investors including Beijing Shuimu Guoding Investment,…
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Apeloa Pharmaceutical Partners with Beijing Highthink for CRO Services on Semaglutide Generic
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Apeloa Pharmaceutical Co., Ltd (SHE: 000739), a China-based pharmaceutical company, has forged a strategic partnership with Beijing Highthink Pharmaceutical Technology Service Co., Ltd. The collaboration is aimed at providing Contract Research Organization (CRO) services, specifically to support a clinical study for Apeloa’s generic version of semaglutide. Under the terms of…
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Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Misses Late-Stage Trial Endpoints
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Pfizer Inc. (NYSE: PFE) has announced that a late-stage clinical trial for its investigational gene therapy, fordadistrogene movaparvovec, in children aged 4 to 7 with Duchenne muscular dystrophy (DMD) failed to meet its primary endpoint of improving motor function. Additionally, secondary endpoints related to motor function showed no significant improvement…
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AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients. The FDA’s decision was…
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Amgen’s Prolia Secures NMPA Approval for Treating Glucocorticoid-Induced Osteoporosis in High-Risk Patients
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Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Prolia (denosumab) to treat glucocorticoid-induced osteoporosis (GIOP) in patients at high risk of fractures. This approval marks a significant expansion of Prolia’s indication in China, where it is already approved to treat osteoporosis…
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Eli Lilly’s Baqsimi Gains NMPA Approval for Diabetes Hypoglycemia Treatment
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The National Medical Products Administration (NMPA) in China has granted approval to Eli Lilly & Co. (NYSE: LLY) for its Baqsimi (glucagon nasal powder spray), marking a significant advancement in the treatment of severe hypoglycemia in diabetic patients aged four and above. Hypoglycemia, a common and potentially dangerous complication of…
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Boehringer Ingelheim’s Survodutide Earns Breakthrough Designation for MASH Treatment in China
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Boehringer Ingelheim (BI), the German pharmaceutical colossus, has declared that it has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) for its experimental drug candidate, survodutide (BI 456906). This designation underscores the drug’s promising therapeutic potential for patients suffering from metabolic dysfunction-associated steatohepatitis (MASH). Derived…
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Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
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Zelgen Biopharmaceuticals’ Jacktinib Meets Primary Endpoint in Severe Alopecia Areata Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that its Phase III clinical trial for jacktinib tablets, a Category 1 product candidate for severe alopecia areata, has successfully met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial was conducted to evaluate the…
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Joincare Pharmaceutical Receives NMPA Approval for Generic Seretide
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a leading pharmaceutical company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its generic version of GlaxoSmithKline’s (GSK) Seretide (salmeterol, fluticasone). This compound inhalable preparation is now approved for use as…
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Eli Lilly’s Tirzepatide Hits Primary Endpoint in MASH Trial, Outperforming Placebo
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Eli Lilly and Company (NYSE: LLY), a global healthcare conglomerate, has announced positive outcomes from a Phase II clinical trial of tirzepatide, a novel GIP/GLP-1 receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. The study successfully achieved its primary endpoint, demonstrating resolution of MASH without exacerbation of…
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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,…
