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WinHealth’s Ravicti Receives Orphan Drug Designation in Taiwan
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China-based Hong Kong WinHealth Pharma Group Ltd announced that its Swiss partner Immedica Pharma AB’s Ravicti (glycerol phenylbutyrate) has received orphan drug designation (ODD) status in Taiwan. This rare disease drug, which is awaiting regulatory decisions in China with priority review status, can now be used as a long-term adjuvant…
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Lee’s Pharmaceutical’s NVK-002 Shows Strong Results in Phase III CHAMP Study
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its partner Vyluma Inc. has published the primary results of the Phase III CHAMP study. The results indicate that NVK-002, a potential treatment for myopia in children, has demonstrated strong safety and efficacy. NVK-002: Drug…
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CSPC’s Antibody-Drug Conjugate SYS6002 Gains CDE Approval for Clinical Study
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for SYS6002, an antibody-drug conjugate (ADC) developed in-house by its subsidiary CSPC Jushi Biopharmaceutical Co., Ltd. The intended indication for SYS6002 is advanced solid…
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Ausper Biopharma’s COVID-19 Nasal Spray Antibody Gets NMPA Approval
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Ausper Biopharma Inc., a Hangzhou-based developer of hepatitis B virus (HBV) drugs, announced that its joint venture Chongqing Mingdao Haoyue Biotechnology Co., Ltd has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its nasal spray COVID-19 neutralizing antibody MY-586. Drug Mechanism and AdvantagesMY-586 is described as…
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Ocumension Initiates Second Phase III Denali Study for OT-301 in US
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China-based Ocumension Therapeutics (HKG: 1477) announced the initiation of a second Phase III Denali study for its OT-301 (NCX 470) in the US, with the first patient enrolled on November 9. This marks a significant milestone in the clinical development of the drug, which is designed to lower intraocular pressure…
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BeiGene’s Brukinsa Receives Multiple Marketing Approvals in Latin America
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals in Latin America for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for various indications across several Latin American countries. Approvals and IndicationsBrukinsa has received approval to treat…
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Zhaoke Ophthalmology Completes Enrollment for Intrarosa Phase III Trial
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has completed patient enrollment in a Phase III clinical study for Intrarosa (prasterone). The drug is a vaginal non-estrogen treatment for moderate to severe painful sex due to menopause. Phase III Trial DesignThe multi-center, randomized Phase III…
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Ascletis Pharma Files IND for Monkeypox Antiviral ASC10 with FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the submission of an Investigational New Drug (IND) filing with the US FDA for its ASC10, an oral antiviral drug candidate targeting the viral polymerase of the monkeypox virus. This marks a significant step in the development of new treatments for monkeypox, a…
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Simcere Receives FDA Clearance for Clinical Study of SIM0237
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China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US FDA 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 intended for the treatment of locally advanced, unresectable metastatic…
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United Labs Gains NMPA Approval for Ozempic Biosimilar IND
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide). Ozempic is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a seven-day half-life, used to treat…
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OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
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Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). The therapy targets GPRC5D, a receptor highly expressed in multiple myeloma (MM) cells, and is being developed…
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Ascentage Pharma Files for Phase Ib/II Study of Bcl-2 Inhibitor in Systemic Lupus Erythematosus
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced the submission of a clinical filing with the Center for Drug Evaluation (CDE) to initiate a randomized, double-blind, placebo-controlled Phase Ib/II clinical study. The study will assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of its Bcl-2 inhibitor, lisaftoclax (APG-2575), in patients…
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Shanghai Henlius’ PD-1 Inhibitor Serplulimab Gains Australian Clearance for Phase III Study
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to conduct a Phase III clinical study evaluating the efficacy and safety of its programmed death-1 (PD-1) inhibitor, Serplulimab (HaiSiZhuang). The study will assess the drug in combination with chemotherapy (carboplatin/cisplatin-etoposide) in patients with limited stage…
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Covis Pharma’s COPD Therapies Show Positive Results in Phase III AVANT Trial
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Luxembourg-based Covis Pharma Group has released positive topline data from its Phase III AVANT trial, which assessed the efficacy of two chronic obstructive pulmonary disorder (COPD) therapies, Duaklir (aclidinium bromide 400µg/formoterol 12µg twice-daily) and Eklira/Tudorza (aclidinium bromide 400µg twice-daily), compared to placebo. The trial, which recruited 70% of patients from…
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CSPC Receives CDE Approval for Generic Version of Pfizer’s Xeljanz
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received market approval from the Center for Drug Evaluation (CDE) for its generic version of Pfizer’s Xeljanz (tofacitinib). This marks the second sustained-release tablet version of the drug (in 11mg dosage) to pass China’s generic quality consistency…
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Daiichi Sankyo Initiates Global Phase II Study of DS7300 for Small-Cell Lung Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced the first patient dosing in a global pivotal Phase II clinical study (S7300-127) assessing the efficacy and safety of its DS7300 (DS7300a), a potential first-in-class antibody drug conjugate (ADC), in patients with extensive small-cell lung cancer (SCLC) in China. DS7300 is an…
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Abbisko’s ABSK021 Gets CDE Approval for Phase III Study in Giant Cell Tumor of Tendon Sheath
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase III clinical study for its Category 1 drug, ABSK021. The randomized, double-blind, placebo-controlled, multi-center Phase III study is designed to assess the efficacy and…
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Livzon Launches National Rollout of COVID-19 Vaccine V-01 in China
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China-based Livzon Pharmaceutical Group (HKG: 1513) has announced the national promotion of its recombinant novel coronavirus fusion protein vaccine, V-01. The vaccine was first administered as a sequential booster shot in Guangdong on September 21. V-01 is being co-developed by Livzon subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology Co., Ltd and…
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Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a Phase Ib/II clinical study in China for its SHR-A1811 combined with SHR-1701 in patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). This approval marks a significant step forward in the development of…
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MicuRx Pharmaceuticals Concludes US Phase I Study for MRX-8
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Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the conclusion of Phase I of its first-in-human study for MRX-8, a new drug targeting gram-negative drug-resistant bacteria, in the United States. The results demonstrated that at the expected clinical dose, MRX-8 exhibited an acceptable safety and pharmacokinetic profile in…
