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Innovent Biologics Initiates Phase II Study for IBI311 in Thyroid-Associated Ophthalmopathy
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China-based Innovent Biologics Inc., (HKG: 1801) has announced the first patient dosing in a Phase II clinical study for its IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in thyroid-associated ophthalmopathy (TAO). IBI311 is an IGF-1R-targeting monoclonal antibody independently developed by Innovent, marking a significant step in the…
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Kangtai Biological Begins Phase I Trial for Tetravalent Influenza Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the first subject enrollment in a Phase I clinical study for its tetravalent influenza virus split vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against influenza, particularly for individuals aged…
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Jiangsu Recbio Completes First Tranche Enrollment for Shingles Vaccine REC610
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China-based Jiangsu Recbio Technology Co., Ltd has announced the completion of the first tranche of subject enrollment in a clinical study for its novel adjuvanted recombinant shingles vaccine, REC610. This milestone marks a significant step in the development of a vaccine designed to provide enhanced protection against shingles, particularly for…
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Beijing Wantai Initiates Phase I Study for 20-Valent Pneumonia Vaccine
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China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced the initiation and first subject enrollment in a Phase I clinical study for its 20-valent pneumonia vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against pneumonia. Vaccine Development and…
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Gracell Biotechnologies Gains IND Approval for GC012F in China
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Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step in the development…
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RemeGen Gains NMPA Approval for RC48 and Pyrotinib Clinical Study
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China-based RemeGen Ltd (HKG: 9995) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate an open, single-center Phase Ib/II clinical study. The study will assess the safety, efficacy, and pharmacokinetics of its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin) combined with Hengrui pharmamceuticals’ pyrotinib, a…
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Clover Biopharmaceuticals Administers First Dose of COVID-19 Vaccine SCB-2019 in Zhejiang
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China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has announced the first jab of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in Zhejiang. This recombinant protein vaccine is recommended by the national second dosage (fourth shot) booster immunization plan and is suitable for use in the elderly, immune-compromised individuals, and populations with complications.…
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CSPC Pharmaceutical Licenses ADC SYS6002 to Corbus Pharmaceuticals
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced a licensing agreement with Massachusetts-based Corbus Pharmaceuticals Inc. The deal pertains to CSPC’s anti-nectin-4 antibody drug conjugate (ADC) SYS6002. Under the terms of the agreement, Corbus obtains development and commercialization rights to SYS6002 in the United States, EU, United Kingdom, Canada,…
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Luye Pharma Initiates Phase I Study for BA1106, a CD25 Monoclonal Antibody
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China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its BA1106, an in-house developed CD25 monoclonal antibody (mAb). The study, filed by subsidiary Shandong BoAn Biotechnology Co., Ltd, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of…
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Zelgen’s ZGGS15 Accepted for NMPA Review as First Global BsAb Filing
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that a clinical trial filing for its ZGGS15, a bispecific antibody (BsAb) targeting LAG-3 and TIGIT in advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone as ZGGS15 is touted…
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Kintor’s GT20029 Shows Positive Results in US Phase I Study for AGA and Acne
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive topline data from a Phase I clinical study in the United States for its GT20029, a treatment for androgenetic alopecia (AGA) and acne. This marks a significant step in the development of a novel treatment option for these common conditions. Phase…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug conjugate (ADC), is on course to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of unresectable or metastatic breast cancer with low…
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EOC Pharma’s CDK7 Inhibitor EOC237 Accepted for CDE Review
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EOC Pharma, a biotech operating out of the US and China, has announced that a clinical trial filing for its CDK7 inhibitor EOC237 has been accepted for review by the Center for Drug Evaluation (CDE) in China. This marks a significant milestone in the development of EOC237, which is expected…
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Joincare’s Generic Seretide Accepted for NMPA Review
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China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that the market filing for its generic version of GlaxoSmithKline’s (GSK, NYSE: GSK) Seretide (salmeterol, fluticasone) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for Joincare, which holds the first-mover…
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Everest Medicines’ Nefecon Included in South Korea’s GIFT Program
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China-based Everest Medicines (HKG: 1952) has announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has included the firm’s Nefecon (targeted-release formulation-budesonide) in the Global Innovative Fast Track (GIFT) program for the treatment of primary immunoglobulin A nephropathy (IgAN). This designation is a significant step in the development…
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Hinova’s HP530S Accepted for NMPA Review as FAK Inhibitor for Solid Tumors
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China-based biopharma Hinova Pharmaceuticals (SHA: 688302) has announced that a clinical trial filing for its HP530S, a highly active and selective focal adhesion kinase (FAK) inhibitor against solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of…
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Qilu Pharmaceutical’s QLS12004 Gains Tacit Clinical Trial Approval
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The Center for Drug Evaluation (CDE) website indicates that China-based Qilu Pharmaceutical’s Category 1 chemical drug candidate QLS12004 has obtained tacit clinical trial approval. This marks a significant step forward in the development of new treatments for solid tumors, including advanced breast cancer, which is the leading malignant cancer affecting…
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ImmVira’s MVR-T3011 IT Shows Efficacy in Melanoma Treatment
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Shenzhen-based biopharma ImmVira has revealed that its first intra-tumoral injection oncolytic virus (OV) product, MVR-T3011 IT, has produced positive signs of efficacy as a treatment for melanoma in late-stage patients who have failed previous immunotherapy. In a Phase II clinical study conducted in China and the United States, monotherapy treatment…
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Grand Pharma Completes Patient Enrollment for STC3141 Sepsis Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that all patients have completed enrollment and dosing in the Phase Ib REFINE study for its drug candidate STC3141 in sepsis in Australia and Belgium. The first data readout is expected in four months’ time, marking a significant milestone in the…
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SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has announced that a market approval filing has been made in Hong Kong for its Danyelza (naxitamab) in recurrent or refractory high-risk neuroblastoma. This marks a significant step in the global expansion of this innovative…
