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NMPA Releases 67th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 67th batch of reference drugs for generic quality consistency evaluation (GQCE) work, further expanding the list of drugs under evaluation. This batch includes 50 new specifications, with 11 injectables and 29 specifications undergoing modifications. Details of the 67th Batch of Reference…
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Jiangsu Hengrui Pharmaceuticals Advances SHR-1819, SHR-2002, and Adebrelimab into New Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced receiving clinical trial approvals for its drug candidates SHR-1819, SHR-2002, and adebrelimab (SHR-1316). SHR-1819 is now cleared to enter Phase II clinical trials for chronic sinusitis with nasal polyps, and SHR-2002 will proceed to a Phase I clinical study in advanced…
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Ascletis Pharma Receives Approval for Phase IIa Study of ASC10 for RSV Infection
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the green light to conduct a Phase IIa study for its ASC10 in the treatment of respiratory syncytial virus (RSV) infection. This follows the company’s previous approval from the US FDA in January 2023 to carry out a similar Phase IIa…
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AstraZeneca’s MEK Inhibitor Koselugo Approved in China for Pediatric NF1-Related PN
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UK major AstraZeneca (AZ, NASDAQ: AZN) has announced that its mitogen-activated protein kinase (MEK) inhibitor, Koselugo (selumetinib), has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromatosis (PN) in pediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. This marks a significant advancement in…
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BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China’s National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-naïve…
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Shanghai Junshi Biosciences’ Tuoyi Shows Promise in Phase III Study for ES-SCLC
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced encouraging results from the Phase III EXTENTORCH study, which assessed the company’s programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in combination with chemotherapy for first-line extensive stage small cell lung cancer (ES-SCLC). The trial has successfully reached its pre-set primary…
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Suzhou GenAssist’s GEN6050 Receives US FDA Pre-IND Acceptance for Duchenne Muscular Dystrophy Treatment
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China-based Suzhou GenAssist Therapeutic Co., Ltd has announced that the US Food and Drug Administration (FDA) has accepted a pre-Investigational New Drug (pre-IND) application for the company’s first pipeline candidate, GEN6050. This in vivo base editing drug targets exon 50 skipping in the Duchenne muscular dystrophy (DMD) gene, with the…
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Reistone Biopharma’s Edralbrutinib Earns Orphan Drug Designation for NMOSD from US FDA
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Medicine with an investment of USD 100 million in 2018, has announced the receipt of orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, edralbrutinib. The designation is awarded for the…
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Henlius Biotech’s HLX26 and HaiSiZhuang Combo for NSCLC Gets NMPA Phase II Approval
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will evaluate the combination of HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, with Henlius’s programmed-death 1…
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Huadong Medicine’s Mefatinib Poised for Breakthrough Therapy Designation by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Huadong Medicine Co., Ltd (SHE: 000963) is on course to obtain breakthrough therapy designation (BTD) for its mefatinib. This second-generation irreversible EGFR/HER2 inhibitor is targeted for the treatment of first-line advanced non-small cell lung cancer (NSCLC) with rare mutations in…
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Yantai Dongcheng Pharma’s 177Lu-LNC1003 Cleared for US FDA Phase I Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its drug 177Lu-LNC1003. This marks a significant milestone for the company as it advances its innovative treatment…
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ABM Therapeutics’ ABM-168 Begins Phase I Dosing in the US for Advanced Solid Tumors
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Shanghai-based ABM Therapeutics, Inc. has announced the commencement of the first patient enrollment and dosing in a Phase I clinical study for its investigational drug ABM-168 in the United States. This open, dosage escalation, dosage expansion study, which received approval in the country in October 2022, is designed to assess…
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Innovent Biologics’ GFH925 Earns Breakthrough Therapy Designation for KRASG12C CRC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category 1 chemical drug GFH925 has been awarded a breakthrough therapy designation (BTD) for the treatment of KRASG12C mutant advanced colorectal cancer (CRC). This designation highlights the potential of GFH925 in addressing a significant unmet medical…
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CARsgen Therapeutics’ AB011 and Tecentriq Combo Gets NMPA Approval for Gastric Cancer Treatment
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China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 combined with Roche’s programmed death-ligand 1 (PD-L1) therapy Tecentriq (atezolizumab) alongside standard chemotherapy. This treatment is…
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Fujian Cosunter Pharmaceutical Completes Enrollment in Phase II/III Trial for GST-HG171/Ritonavir
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the completion of 1,200 patient enrollment in a Phase II/III clinical study for its Category 1 product, GST-HG171/ritonavir. This multi-center, randomized, double-blind, controlled trial is designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients.…
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Ascletis Pharma’s ASC40 Meets Acne Treatment Goals in Phase II Trial
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, ASC40 (senifanstat), has successfully met primary and key secondary endpoints in a Phase II clinical trial for acne vulgaris. ASC40’s Mechanism of Action and Trial DesignASC40 is an oral, selective small-molecule inhibitor…
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BDgene Technology’s BD111 Receives Tacit Approval for HSV-1 Keratitis Trial
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Shanghai BDgene Technology Co., Ltd has announced that it has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its innovative therapy, BD111. This CRISPR-Cas9 in vivo-based therapy is designed for the treatment of recurrent type 1 herpes simplex virus (HSV-1)-related keratitis (HSK) and is being…
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SanReno Therapeutics Completes Dosing in Kidney Disease Trial for BION-1301
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SanReno Therapeutics, a China-based joint venture (JV) specializing in nephropathy treatments, has announced the completion of dosing in 36 patients for its new kidney disease drug, BION-1301, in a trial conducted in Shanghai. The JV is a collaboration between Chinook Therapeutics Inc., a US-based biopharmaceutical company listed on Nasdaq (KDNY),…
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Qilu Pharmaceutical Launches First Generic Iressa in the US Market
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China-based Qilu Pharmaceutical has announced the market launch of its generic version of AstraZeneca’s (AZ, NASDAQ: AZN) first-generation epidermal growth factor receptor (EGFR) inhibitor, Iressa (gefitinib), in the United States. This marks the debut of the first generic version of Iressa in the country, expanding access to this crucial medication…
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Transcenta’s Osemitamab Achieves Full Enrollment in Phase II Gastric Cancer Study
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Transcenta Holding Limited (HKG: 6628), a China-based biopharmaceutical company, has announced the completion of enrollment in two patient cohorts for its Phase II study of osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. The study, known as Transtar-102 (NCT04495296), focuses on patients with CLDN18.2 expressing gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma in China. A…
