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Akeso Biopharma’s Cadonilimab Achieves National Delivery in China
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China-based biotech Akeso Biopharma (HKG: 9926) announced the national delivery of its cadonilimab (AK104), marking a commercial launch just six days after approval. The drug, conditionally approved in China on June 29th, is a self-discovered bispecific antibody (BsAb) indicated for the treatment of recurrent or metastatic cervical cancer that has…
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Sobi’s Anakinra (Kineret) Prioritized for Review in China for FMF Treatment
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The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV: SOBIN) market filing for its anakinra (trade name: Kineret) has been prioritized for review. The drug is indicated for autoinflammatory periodic fever syndrome (familial Mediterranean fever – FMF) in adults, adolescents, children, and infants eight…
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Arctic Vision Enrolls First Patient in ARVN003 Phase III Trial for Presbyopia
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China-based ophthalmic therapies developer Arctic Vision announced the first patient enrollment in a Phase III clinical study for its ARVN003, a proprietary pilocarpine formulation leveraging its micro-dosing platform Optejet. The study aims to evaluate the efficacy and safety of ARVN003 in temporarily improving vision in adults with presbyopia (long-sightedness) in…
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JW Therapeutics Initiates Phase I Study of JWATM204 for Hepatocellular Carcinoma
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China-based JW Therapeutics (HKG: 2126) announced the initiation of a Phase I clinical study for its JWATM204 in patients with advanced hepatocellular carcinoma (HCC). This first-in-human study aims to evaluate the safety, tolerability, dose-limiting toxicity, and pharmacokinetic profile of JWATM204 in adult subjects with advanced HCC. It will also explore…
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Brii Biosciences Exercises Option for VIR-3434 in Greater China
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China-based Brii Biosciences Limited (HKG: 2137) announced the exercise of its option to acquire exclusive development and commercialization rights for VIR-3434 (BRII-877) in Greater China as part of its broader collaboration with Vir Biotechnology, Inc. (NASDAQ: VIR). Drug ProfileVIR-3434, an investigational subcutaneously administered HBV-neutralizing monoclonal antibody, is designed to block…
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Innovent Biologics Doses First Patient in IBI112 Phase II Study for Ulcerative Colitis
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the successful first patient dosing in a Phase II clinical study (clinicaltrials.gov: NCT05377580) for its IBI112, a recombinant anti-interleukin 23p19 subunit antibody, in moderate-to-severe active ulcerative colitis (UC). The multi-center, randomized, double-blind, parallel, placebo-controlled Phase II clinical study aims to evaluate the efficacy,…
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Junshi Biosciences Receives FDA Approval for PI3K-α Inhibitor RP903 in Breast Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study of its PI3K-α inhibitor RP903 (JS105) in combination with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative, PIK3CA-mutated advanced or metastatic…
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InnoCare Pharma’s Guangzhou Plant Approved for Orelabrutinib Commercial Production
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Beijing InnoCare Pharma (HKG: 9969) announced that as of June 30, its manufacturing plant in Guangzhou has been approved for the commercial manufacturing of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The plant, located in Sino-Singapore Guangzhou Knowledge City, is compliant with Good Manufacturing Practice (GMP) standards in China, Japan,…
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Hengrui Medicine’s Generic Tacrolimus Wins NMPA Approval for Transplant Rejection Prevention
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Astellas’s tacrolimus. The drug is approved for use in the prevention of graft rejection after kidney transplantation, prevention of graft rejection in the…
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Abbisko Therapeutics Doses First Patient in ABSK061 Phase I Study for Solid Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the first patient dosing in a Phase I clinical study for its ABSK061, an oral highly selective FGFR2/3 inhibitor, in solid tumors. The molecule is described as the first of its kind globally to reach the clinical stages. Study DetailsThe study,…
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Ascletis Pharma Doses First Patient in ASC22 HIV Study with Chidamide
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China-based Ascletis Pharma Inc. (HKG: 1672) announced that the first patient has been dosed in a clinical study for its PD-L1 antibody ASC22 (envafolimab) in combination with chidamide for the functional cure of human immunodeficiency virus (HIV) infection. The study was initiated by the Shanghai Public Health Clinical Center. This…
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Bio-Thera Solutions’ BAT8010 Receives NMPA Approval for Solid Tumor Clinical Trials
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that it has received approval from the National Medical Products Administration (NMPA) for its BAT8010 to enter clinical trials for the treatment of general solid tumors. The drug, independently developed by Bio-Thera, is an HER2-targeted antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2…
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Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer…
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BeiGene’s Tislelizumab Shows Survival Benefit in Esophageal Cancer Study
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BeiGene (NASDAQ: BGNE) has released the latest results of the global Phase III RATIONALE 306 study, which evaluated the efficacy of its programmed death – 1 (PD – 1) inhibitor tislelizumab in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not previously…
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Huadong Medicine’s Biosimilar Ozempic (Semaglutide) Wins NMPA Clinical Trial Approval
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that a clinical trial filing for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide), submitted by subsidiaries Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd and Chongqing Peg-Bio Biopharma Co., Ltd, has been approved by the National Medical Products Administration (NMPA). Drug ProfileOriginally developed…
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Jixing Pharmaceuticals Enrolls First Patient in Etripamil Phase III Study for PSVT
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China-based Ji Xing Pharmaceuticals Ltd (Jixing) announced the first patient enrollment in a Phase III clinical study in China for etripamil, a drug candidate being assessed as a treatment for paroxysmal supraventricular tachycardia (PSVT). The multi-center, randomized, double-blind, placebo-controlled Phase III study will evaluate the efficacy and safety of self-administered…
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Takeda’s Obizur Prioritized for Review in Acquired Hemophilia A Treatment
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The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd’s Obizur (susoctocog alfa) has been prioritized for review for the on-demand treatment and control of bleeding events in adults with acquired hemophilia A. Drug Profile and MechanismAcquired hemophilia A is an acquired bleeding disorder characterized by reduced…
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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for First-Line NSCLC Treatment
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for furmonertinib. The third-generation epidermal growth factor receptor (EGFR) inhibitor is now approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR…
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Ascentage Pharma’s APG-5918 Receives FDA Approval for First-in-Human Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a first-in-human clinical study of its embryonic ectoderm development (EED) inhibitor APG-5918. The study will assess the safety, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced…
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Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged…
