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Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials
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Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced that its drug candidate soticlestat did not meet the primary endpoints in two Phase III trials. The drug is currently under development for the treatment of two rare forms of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome—and…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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MSD’s Keytruda Secures FDA Approval for Advanced or Recurrent Endometrial Carcinoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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Takeda Secures Global Rights to Ascentage Pharma’s Olverembatinib Outside of China and Select Territories
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Takeda Pharmaceuticals, a leading biopharmaceutical company based in Japan (TYO: 4502), has entered into an option agreement with China-based Ascentage Pharma (HKG: 6855), securing exclusive development and commercialization rights for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), in markets outside of China, Hong Kong, Macau, Taiwan, and Russia. The…
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CARsgen Therapeutics’ Saikaize and CT071 Show Strong Results in EHA Clinical Trials
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CARsgen Therapeutics, a biopharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 2171), has announced promising results from two pivotal clinical trials at the 29th European Hematology Association Annual Meeting. The data presented highlights the potential of two CAR-T therapies: Saikaize (zevorcabtagene autoleucel), an autologous BCMA-targeted therapy for multiple…
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RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
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CStone Pharmaceuticals Gets NMPA Green Light for Local Production of Gavreto
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to begin local manufacturing of Gavreto (pralsetinib tablets, 300mg), moving away from overseas supply. The company anticipates that domestic production will start by the end…
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Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
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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…
