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Fosun Pharma Launches Online Registration for BioNTech COVID-19 Vaccine in Hong Kong
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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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Immunotech Biopharm’s CAR-T-19-D2 IND Filing Accepted by NMPA
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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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CanSino Biologics Updates Data from COVID-19 Vaccine Clinical Studies
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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’ Vaborem IND Filing Accepted by NMPA
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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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Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review
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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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InnoCare Pharma Receives Hong Kong Approval for Tafasitamab in DLBCL
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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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Simcere Receives NMPA Clearance for SIM0237 Clinical Study
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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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CStone Pharmaceuticals Publishes Ayvakit Study Results on Oncologist Website
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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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Elpiscience Receives IND Approval for ES014 in China
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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…
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InnoCare Pharma’s Orelabrutinib Placed on Partial Clinical Hold by FDA
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that the US FDA has placed orelabrutinib for use in multiple sclerosis (MS) on partial clinical hold. As a result, new enrollment of the Phase II study in the United States will not be initiated. Participants in the US who have…
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Hainan Poly Pharm Receives FDA Approval for Generic Lincomycin
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the US FDA for its generic version of US-based Upjohn’s lincomycin. This approval marks a significant milestone for Poly Pharm in expanding its presence in the US market. Drug Profile and IndicationsLincomycin, first approved in the…
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Innovent Biologics’ GFH925 Receives Breakthrough Therapy Designation
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China’s Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics (HKG: 1801) has received a breakthrough therapy designation (BTD) for its Category 1 chemical drug GFH925. The drug is intended for the treatment of KRASG12C mutant advanced non-small cell lung cancer (NSCLC) in patients who have previously received…
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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Faces FDA Review Delay
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Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that they have not received an action letter from the US FDA regarding the Biologics License Application (BLA) for the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The ongoing delay is attributed to the failure to inspect the manufacturing site. The…
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Huadong Medicine’s Lanluma V and X Approved for Use in Hainan
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval from the Hainan Medical Products Administration for its poly-l-lactic collagen stimulators Lanluma V and X as clinically urgent medical devices for designated use in the Arsmo (Hainan) Aesthetic Hospital in the Boao Lecheng Medical Tourism Pilot Zone. The product…
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Antengene and MSD Collaborate on Global Clinical Study for ATG-037
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China-based Antengene Corporation Limited (HKG: 6996) has announced a global clinical collaboration with Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to conduct a multicenter, open-label, Phase I dose-finding study for ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab). The targeted indication is locally advanced…
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IASO Biotherapeutics Receives FDA Approval for CT103A IND Application
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China-based IASO Biotherapeutics has announced approval from the US FDA for an Investigational New Drug (IND) application for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy CT103A (equecabtagene autoleucel). The therapy will be assessed in US-based clinical trials for relapsed/refractory multiple myeloma (r/r MM). Drug Profile and DevelopmentEquecabtagene autoleucel…
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CSPC’s NBL-020 Receives FDA IND Approval for Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. The targeted indication is advanced solid tumors, marking a significant step forward in the development of this innovative therapy. Drug Profile and Mechanism of ActionNBL-020 is an…
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Jiangsu Chia Tai Tianqing’s TQB2102m Gains NMPA Clinical Approval
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Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102m, an HER2 targeted antibody drug conjugate (ADC), has obtained clinical approval from the National Medical Products Administration (NMPA). The targeted indication is advanced malignant tumors, with no similar product currently approved for marketing anywhere in the world.…
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Hengrui Pharmaceuticals Receives New Approval for Remimazolam Tosylate
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced one new supplementary approval for its gamma-aminobutyric acid type A (GABAA) receptor antagonist remimazolam tosylate. The approval, with the indication being sedation and anesthesia during non-tracheal intubation surgery / operation, marks the drug’s fourth market approval. Previous Approvals and Clinical StudiesRemimazolam tosylate…
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Jing Medicine’s HJM-353 Gains Clinical Trial Approvals in US and China
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China-based Jing Medicine Technology (Shanghai) Co., Ltd’s HJM-353 has obtained clinical trial approvals in the US and China. The investigational embryonic ectoderm development (EED) inhibitor is expected to enter a Phase I clinical study for advanced blood cancer and solid tumors. Mechanism of Action and DevelopmentPolycomb repressive complex 2 (PRC2)…
