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The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend Biotech Corporation (NASDAQ: LEGN) for its BCMA-directed chimeric antigen receptor (CAR) T cell therapy Carvykti (ciltacabtagene autoleucel) has been accepted for review. This makes Carvykti the third BCMA CAR-T therapy to be filed for marketing…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate ALMB-0168 in osteoarthritis. ALMB-0168, a connexin 43-targeted monoclonal antibody developed in-house by subsidiary AlaMab Therapeutics Inc., is under development to treat acute…
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced receiving approval from the US FDA to initiate a Phase I clinical study for its antibody drug conjugate (ADC) RC108 in c-Met positive advanced solid tumors. This marks a significant step forward in the global development of RC108, building on its existing…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0348, a bispecific antibody (BsAb) targeting TIGIT and PVRIG in advanced malignant solid tumors. Mechanism of Action and DesignSIM0348 is designed to block the interaction between…
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China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review status for the New Drug Application (NDA) of Nefecon (targeted-release formulation-budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk…
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its BGM0504, a dual agonist targeting GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin-stimulating polypeptide). The targeted indications for BGM0504 are weight loss and type…
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China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human growth hormone Fc fusion protein injection AK2017. The drug will be assessed for treating children with growth deficiencies due to endogenous…
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UK-based pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Nexium (esomeprazole) to treat gastroesophageal reflux disease (GERD) in adolescents. This marks the proton pump inhibitor’s (PPI) first approval for a pediatric indication in China. Incidence and Treatment of GERD…
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The results of a Phase III clinical study for China-based Junshi Biosciences’ (HKG: 1877, SHA: 688180) oral nucleoside analog drug JT001 (VV116) have been published in the New England Journal of Medicine. The study compared VV116 with Pfizer’s Paxlovid (nirmatrelvir + ritonavir) as an early treatment for mild to moderate…
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China’s Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) has announced a Paragraph IV patent declaration in relation to the Abbreviated New Drug Application (ANDA) for its Paclitaxel, albumin-bound. This declaration indicates that Shuangcheng believes its drug does not infringe on the rights of Bristol-Myers Squibb’s (BMS, NYSE: BMY) originator drug…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its clinical study for the oral small molecule COVID-19 therapy GS221, a 3CLpro inhibitor, has delivered a good safety and tolerability profile. The study, approved in late September, observed no serious adverse events or adverse events leading to discontinuation. Efficacy…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced a new initiative allowing mainland China consumers to register online for vaccinations using BioNTech’s (NASDAQ: BNTX) (DE: 22Uay) mRNA COVID-19 vaccine in Hong Kong. Interested individuals are required to arrange their own travel to Hong Kong once their…
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that an Investigational New Drug (IND) filing for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is recurrent and refractory diffuse large B-cell lymphoma…
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China-based CanSino Biologics (HKG: 6185) has provided data updates from three clinical studies for its adenovirus type-5 vector-based COVID-19 vaccines. The studies assess the safety and immunogenicity of CanSino’s vaccines in various age groups and vaccination scenarios. Study 1: Bivalent Inhaled Vaccine for AdultsThe first study focused on CanSino’s bivalent…
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that an Investigational New Drug (IND) filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been accepted for review by the National Medical Products Administration (NMPA). The IND application covers a Phase III clinical study to evaluate the efficacy and safety…
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China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for…
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China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Department of Health in Hong Kong for its tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0237, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and interleukin-15 (IL-15). The molecule is set for development against locally advanced, unresectable, metastatic…
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China-based CStone Pharmaceuticals (HKG: 2616) has published the results of the China-based bridging NAVIGATOR study for its Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), on the Oncologist website. The open-label, multi-center Phase I/II study was designed to assess the safety, pharmacokinetics, and anti-tumor efficacy…
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Shanghai-based Elpiscience Biopharmaceuticals Inc. has announced receiving Investigational New Drug (IND) approval in China to initiate a Phase I clinical trial for its bispecific antibody (BsAb) ES014 in patients with advanced solid tumors. ES014 is a potential first-in-class anti-CD39 x TGF-beta immunotherapeutic designed to activate T cells and overcome resistance…