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HeNan Genuine Biotech Sets Azvudine Price at RMB300 per Bottle for COVID-19 Therapy
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China-based HeNan Genuine Biotech Co., Ltd has set the price of its COVID-19 therapy azvudine at no more than RMB300 (USD44.41) per bottle, according to Henan Daily, a local media outlet. Each bottle contains 35 pieces, with each tablet weighing 1mg. Drug BackgroundAzvudine is a Category 1 anti-HIV/AIDS drug targeting…
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Dizal Pharma’s Sunvozertinib Shows Promise in NSCLC with EGFR Exon 20 Insertion
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has unveiled the latest positive data for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008). The drug is in late-stage global studies for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (Exon20ins) mutation, both in the second-line stage following…
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HutchMed’s FRESCO-2 Study for Elunate in Colorectal Cancer Meets Primary Endpoint
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) has met the primary overall survival (OS) endpoint. The multi-center study, initiated in July 2020, recruited 691 patients…
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Innovent Biologics Doses First Subject in IBI324 Phase I Study for DME
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China-based biotech Innovent Biologics Inc. (HKG: 1801) announced that the first subject has been dosed in a Phase I clinical study for its IBI324, a bispecific antibody (BsAb) targeting vascular endothelial growth factor A (VEGF-A) and angiopoietin2 (Ang-2) in diabetic macular edema (DME). Study DetailsThe Phase I dosage escalation study…
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Immvira’s Oncolytic Virus MVR-C5252 Receives FDA Orphan Drug Designation for Glioma
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Shenzhen-based Immvira Co., Ltd, a biotech company focused on oncolytic viruses, announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its herpetic oncolytic virus MVR-C5252. The designation is for the drug’s use in treating malignant glioma. Drug DetailsMVR-C5252, developed in-house…
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Merck Launches Prevymis, a Non-Nucleoside CMV Inhibitor, in China
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US pharmaceutical giant Merck Sharp & Dohme (MSD, NYSE: MRK) announced the commercial launch of its non-nucleoside cytomegalovirus (CMV) inhibitor Prevymis (letermovir) in China. The drug received market approval in December 2021 for the prevention of CMV infection and CMV disease in adult recipients with CMV seropositive [R+] undergoing allogeneic…
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Zhongsheng Pharmaceutical Completes Phase I Study of RAY1216 for COVID-19 Treatment
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced the completion of subject enrollment and clinical observation for the Phase I clinical study of RAY1216, an innovative oral therapy for the novel coronavirus developed by its subsidiary Guangdong Raynovent Biotech Co., Ltd. The study results demonstrated good safety and pharmacokinetic…
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CSPC Pharmaceutical’s rhTNK-tPA Meets Primary Endpoint in Stroke Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the Phase III clinical study for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) in acute ischemic stroke has reached the pre-set primary endpoint. Study DetailsThe multi-center, prospective, randomized, open, blinded, non-inferiority Phase III clinical study was designed to…
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Hybio Pharmaceutical’s HY3000 Nasal Spray for COVID-19 Enters NMPA Review
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its clinical trial filing for HY3000 nasal spray, a Category 1 chemical drug targeting COVID-19, has been accepted for review by the National Medical Products Administration (NMPA). Drug DetailsHY3000 is a novel polypeptide membrane fusion inhibitor that binds to the HR1…
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Boehringer Ingelheim Wins Patent Infringement Ruling Against HEC Over Trajenta
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The China National Intellectual Property Administration (CNIPA) has ruled in favor of German pharmaceutical giant Boehringer Ingelheim (BI) in a patent infringement dispute with HEC and its affiliate Yichang HEC Changjiang Pharmaceutical Co., Ltd. The ruling centers on BI’s patent protecting the linagliptin compound used in its Trajenta diabetes drug.…
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Zelgen’s Jacktinib Hits Phase IIb Endpoint in Myelofibrosis Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a pivotal Phase IIb clinical trial (ZGJAK006) for its in-house Janus kinase (JAK) inhibitor, jacktinib, in patients with ruxolitinib-intolerant, medium- to high-risk myelofibrosis. The study met its primary endpoint, with 43.2% of subjects achieving ≥35% spleen volume reduction…
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Ascletis Pharma’s ASC10 Receives IND Approval for COVID-19 Treatment in US and China
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China-based Ascletis Pharma Inc. (HKG: 1672) has provided updates on the clinical progress of ASC10, its oral RNA-dependent RNA polymerase (RdRp) drug therapy for COVID-19. The National Medical Products Administration (NMPA) has accepted an Investigational New Drug (IND) filing for review, and the US Food and Drug Administration (FDA) has…
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ProfoundBio Receives FDA Approval for PRO1184, Appoints New CMO
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China-based macromolecular targeted therapy developer ProfoundBio (Suzhou) Co., Ltd announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) PRO1184 in advanced tumors. The announcement was made alongside the appointment of Dr. Naomi Hunder as the company’s chief…
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Lee’s Pharma Completes Enrollment for NVK-002 Myopia Trials in China
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced the completion of patient enrollment in two Phase III trials for NVK-002, its core product for controlling myopia progression in children and adolescents. The studies, known as China CHAMP and Small CHAMP, mark a key milestone in…
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Lynk Pharma Gets NMPA Green Light for LNK01004 Atopic Dermatitis Study
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Hangzhou-based Lynk Pharmaceuticals Co., Ltd announced it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its drug LNK01004 for atopic dermatitis (AD). The drug was previously approved for a clinical trial in mild to moderate plaque psoriasis, with the first patient dosed…
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Sciwind Biosciences’ XW003 Hits Phase II Trial Goals in Type 2 Diabetes Treatment
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Hangzhou-based biopharma Sciwind Biosciences Co., Ltd announced positive results from a 20-week Phase II trial of its XW003 (ecnoglutide) in Chinese adults with type 2 diabetes (T2D). The study demonstrated the drug’s safety, tolerability, and significant HbA1c reductions, meeting primary endpoints. Study DetailsThe multi-center, randomized, placebo-controlled trial involved 145 patients…
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Eli Lilly Files for Baqsimi Approval in China to Treat Severe Hypoglycemia
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Eli Lilly & Co. (NYSE: LLY) has submitted a market approval application to China’s Center for Drug Evaluation (CDE) for Baqsimi, its glucagon nasal powder spray designed to treat severe hypoglycemia in diabetes patients aged four and older. Drug DetailsHypoglycemia, a common complication during diabetes treatment, can be life-threatening and…
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Aosaikang’s ASKG315 Receives Ethics Approval for Phase I Cancer Trial in Australia
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced it has received ethical approval from Australia’s Bellberry Human Research Ethics Committee (HREC) to initiate a Phase I clinical trial for ASKG315, its recombinant human interleukin-15 (IL-15) prodrug Fc fusion protein. The trial will assess the molecule in patients with advanced malignant…
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Eli Lilly’s Taltz Wins Second NMPA Approval for Ankylosing Spondylitis
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U.S. pharmaceutical giant Eli Lilly announced it has received a second marketing approval from the National Medical Products Administration (NMPA) for Taltz (ixekizumab). The IL-17A monoclonal antibody (mAb) is now approved to treat active ankylosing spondylitis (AS) in patients with a poor response to conventional therapy. Drug BackgroundTaltz was first…
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Hengrui Medicine’s Pyrotinib Combo Meets Endpoints in HER2+ Breast Cancer Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its tyrosine kinase inhibitor (TKI) pyrotinib, combined with trastuzumab and docetaxel, met endpoints in a Phase III clinical trial as a first-line treatment for HER2-positive recurrent/metastatic breast cancer. The company plans to hold pre-market approval filing discussions with regulators soon. Study…
