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FDA Approves Phase Ib Study for Jiangsu Yahong’s APL1401 in Ulcerative Colitis
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that it has received approval from the US FDA to conduct a Phase Ib clinical study for its drug candidate APL1401. The trial will evaluate APL1401 as a treatment for moderate to severe active ulcerative colitis…
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CDE Prioritizes Review for Jiedi Pharma’s Mitotane and Other Key Drugs
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The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs, including Jiedi Pharma’s mitotane, Pfizer’s ritlecitinib, Northrop Grumman’s trientine, and Ark Bio’s ziresovir, have been prioritized for review. This move highlights the CDE’s efforts to expedite the approval process for drugs with significant therapeutic potential.…
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CanSino Biologics’ Inhalable COVID-19 Vaccine Authorized in Morocco
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Morocco. This marks a significant milestone in the global deployment of innovative COVID-19 vaccines. Convidecia ProfileConvidecia, the recombinant novel coronavirus vaccine…
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Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of…
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Lundbeck’s Eptinezumab Launches in Boao Lecheng for Migraine Treatment
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Lundbeck’s (FRA: LDBB) Eptinezumab has been launched in the Boao Lecheng International Medical Tourism Zone, marking it as the first innovative drug available in the region for migraine treatment. This milestone was announced on November 10, 2022, at a joint press conference held by the Hainan Boao Lecheng International Medical…
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RemeGen’s Telitacicept Set for Breakthrough Therapy Designation in Myasthenia Gravis
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The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995, SHA: 688331) novel fusion protein telitacicept is set to receive breakthrough therapy designation (BTD) status for the treatment of myasthenia gravis (MG). This marks a significant step forward in addressing a rare and challenging autoimmune…
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CStone’s PD-L1 Inhibitor Sugemalimab Achieves Primary Endpoint in Gastric Cancer Study
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that its GEMSTONE-303 study for the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab, combined with chemotherapy as a first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with PD-L1 expression ≥ 5%, has reached the primary endpoint of progression-free survival (PFS). This…
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BeiGene’s Brukinsa Receives Marketing Approval in Brazil
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL)…
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Sinocelltech’s SCTV01E Vaccine Receives NMPA Approval for Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein…
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3SBio’s Thrombopoietin Study in Pediatric ITP Reaches Primary Endpoint
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China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group’s superiority…
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LianBio Initiates Phase I Study of SHP2 Inhibitor BBP-398 in China
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Sino-US biotech LianBio has announced the first patient dosing in a Phase I clinical study for its SHP2 inhibitor BBP-398 in Chinese patients with advanced solid tumors. This marks a significant step forward in the development of BBP-398, which targets the SHP2 protein-tyrosine phosphatase. SHP2 links growth factor, cytokine, and…
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Ascentage Pharma Gains CDE Approval for Phase I Study of APG-5918
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a multi-center, open-label, dose escalation and expansion Phase I study. The study will assess the safety, pharmacokinetics, and efficacy of its embryonic ectoderm development (EED) inhibitor APG-5918. The drug…
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3SBio Receives NMPA Review for Pediatric ITP Thrombopoietin Filing
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China-based 3SBio Inc. (HKG: 1530) has announced that the National Medical Products Administration (NMPA) has accepted another market filing for its recombinant thrombopoietin for the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children or adolescents. This marks a significant step forward in expanding the therapeutic indications for…
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Betta Pharmaceuticals’ BPI-D0316 Shows Promise in Phase II/III Lung Cancer Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced the summary report of a Phase II/III study for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316. The study evaluated the drug as a first-line treatment for naïve locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR…
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Haisco’s HSK16149 Accepted for Review by NMPA for Diabetic Neuropathic Pain
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that a market approval filing for its drug candidate HSK16149, intended for the treatment of diabetic peripheral neuropathic pain (DPNP), has been accepted for review by the National Medical Products Administration (NMPA). HSK16149 is an in-house Category 1 drug being…
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Liaoning Chengda’s ACYW135 Meningococcal Vaccine Receives NMPA Clearance
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China’s Liaoning Chengda Biotechnology Co., Ltd (SHA: 688739) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its ACYW135 meningococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent epidemic cerebrospinal meningitis caused by Neisseria meningitidis of groups A, C, Y, and W135.…
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Zhaoke Ophthalmology Enrolls First Patients for ZKY001 in Phase II Trials
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) has announced the enrollment of the first patients for its ZKY001 in a Phase II clinical study in transepithelial photorefractive keratectomy (TPRK). The study will enroll 120 patients across 10 centers. Additionally, a separate Phase II clinical…
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MicuRx Pharmaceuticals Doses First Patient in China for MRX-8 Trial
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Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the first patient dosing in a Phase I clinical study in China for its MRX-8, a new drug against gram-negative drug-resistant bacteria. This marks a significant milestone in the development of MRX-8, which aims to address the growing challenge of…
