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Immorna’s JCXH-221 mRNA Vaccine Cleared by FDA for Phase I/II Study
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Immorna (Hangzhou) Biotechnology Co., Ltd has announced that the US FDA has cleared its investigational new drug (IND) application to conduct a Phase I/II multi-center study assessing the safety and immunogenicity of JCXH-221, a lipid nanoparticle (LNP) complex broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases, in healthy adult…
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Kanghong Pharma Receives FDA Approval for KH631 Gene Therapy Trial
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. KH631 ProfileKH631…
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Frontier Biotechnologies Gains CDE Approval for FB2001 COVID-19 Inhalant Study
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China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase II/III clinical study assessing its FB2001 atomized inhalant bofutrelvir in mild and common COVID-19 patients. This marks a significant step forward in the development of innovative treatments for COVID-19.…
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Alphamab Oncology and CSPC Announce Positive Phase II Data for KN026 in HER2-Positive Gastric Cancer
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The…
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Kexing Pharma Receives Ethical Approval for Phase II Study of SHEN26 COVID-19 Drug
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China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases. Study…
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Kintor Pharma’s GT20029 Shows Positive Results in Phase I Study for Androgenetic Alopecia and Acne
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive results from a Phase I clinical study in China for its GT20029, which is being developed to treat androgenetic alopecia and acne. The study demonstrated that GT20029 has a good safety, tolerability, and pharmacokinetics profile. Study DetailsThe randomized, double-blind, placebo-controlled Phase…
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FibroGen Sues Former Employees and Two Pharma Firms for Trade Secret Theft
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US-based FibroGen Inc. has filed a lawsuit against two former employees, Liu Dong and Deng Shaojiang, accusing them of trade secret theft. The case, filed with the US District Court for the Northern District of California, also names two pharmaceutical firms as co-defendants: US-based Kind Pharmaceuticals LLC and China-based Hangzhou…
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China’s First Gene Therapy for Deafness, RRG-003, Begins Clinical Study
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RRG-003, an adeno-associated virus (AAV) gene therapy co-developed by China’s Shanghai Dingxin Gene Technology Co., Ltd and the Eye & ENT Hospital of Fudan University, has initiated a clinical study targeting hearing loss in the country. This marks the first gene therapy trial for deafness, with the first patient expected…
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BeiGene to Present Final PFS Results for Brukinsa at ASH Meeting
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced plans to present the final progression-free survival (PFS) superiority analysis results of the Phase III ALPINE study for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) at the annual American Society of Hematology (ASH) meeting. The study assessed…
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Vcanbio’s VUM02 Accepted for Review by China’s Center for Drug Evaluation
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product, has been accepted for review by the Center for Drug Evaluation. This marks a significant step forward in…
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Fosun Pharma’s Human Interferon Gamma Approved for New Indication by NMPA
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its human interferon gamma for injection. The therapeutic biologic product can now be used to reduce the frequency and severity of severe infections associated with chronic granulomatosis, an indication…
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InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health Sciences Authority (HSA) of Singapore for its Bruton’s tyrosine kinase (BTK) inhibitor Hibruka (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). This marks a significant expansion of the drug’s…
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Salubris Pharmaceuticals’ SAL0119 Accepted for CDE Review in China
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that its clinical trial filing for the Category 1 drug candidate SAL0119 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant step forward in the development of SAL0119, an oral small-molecule immunosuppressant designed…
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Aosaikang’s ASKG915 Accepted for FDA Review, Targets Advanced Solid Tumors
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that its clinical trial filing for the Category 1 biologic product ASKG915 has been accepted for review by the US FDA. This marks a significant step forward in the development of ASKG915, a bifunctional fusion protein targeting programmed-death 1 (PD-1) and…
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Legend Biotech Receives IND Approval for LB2102 CAR-T Therapy
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced receiving Investigational New Drug (IND) approval for its LB2102, an autologous chimeric antigen receptor-T (CAR-T) therapy designed to treat adult patients with small cell lung cancer (SCLC) by targeting DLL3, a cell surface protein highly expressed in SCLC. Clinical Study DesignThe open-label…
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Sun-Novo Pharma Gains NMPA Approval for STC007 Clinical Study in CKD-aP
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007. The study will focus on moderate to severe chronic kidney disease-associated pruritus (CKD-aP) in adults receiving hemodialysis (HD).…
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Junshi Biosciences’ JunMaiKang Approved by NMPA for Multiple Indications
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been approved by the National Medical Products Administration (NMPA) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and…
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Hengrui Pharmaceuticals Receives FDA ANDA Approval for Gadobutrol Generic
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving Abbreviated New Drug Application (ANDA) status from the US FDA for its generic version of Bayer’s Gadovist (gadobutrol injection), marking the first generic approval of this kind in the United States. This approval positions Hengrui to expand its presence in the…
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Fosun Pharma’s Bivalent COVID-19 Vaccine Comirnaty Authorized in Hong Kong
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced obtaining emergency use authorization (EUA) in Hong Kong for its bivalent COVID-19 original strain/Omicron variant BA.4-5 vaccine Comirnaty (BNT162b2) as a booster shot for populations aged 12 and above. This marks a significant step in the company’s efforts to provide enhanced…
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IASO Biotherapeutics Reports Positive Phase I Results for CAR-T Therapy in NMOSD
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China-based IASO Biotherapeutics has announced the interim results of a Phase I investigator-initiated-trial (ITT) for its BCMA chimeric antigen receptor autologous T (CAR-T) cell therapy equecabtagene autoleucel (CT103A) in neuromyelitis optica spectrum disorder (NMOSD). The study (NCT04561557) is the world’s first to assess a CAR-T therapy in aquaporin 4 (AQP4)-mediated…
