-
Huadong Medicine’s Arcalyst Receives NMPA Approval for Cryopyrin-Associated Periodic Syndromes
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Arcalyst (rilonacept), indicated for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs), including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). Understanding CAPS and Its SubtypesCAPS is a…
-
Huadong Medicine’s Elahere (Mirvetuximab Soravtansine) Approved by NMPA for Ovarian Cancer Treatment
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), for the treatment of FRα positive platinum-resistant ovarian cancer (PROC) in patients who have…
-
MicuRx Pharmaceuticals’ MRX-4 Combo Shows Positive Results in Phase III Study
•
Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced positive results from a Phase III study for its drug MRX-4 in combination with contezolid as sequential therapy for complex skin and soft tissue infections. The study successfully met its primary efficacy endpoint, demonstrating good clinical and microbiological efficacy. The regimen’s…
-
Jiangsu Kanion Pharmaceutical Secures NMPA Approvals for KYHY2302 and KYHY2303
•
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
-
BeiGene’s Tevimbra Receives EC Approval for First-Line ESCC and G/GEJ Adenocarcinoma Treatments
•
China-based biotech company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has received a marketing approval from the European Commission (EC) for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The drug is now approved for use in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC)…
-
Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Cervical Muscle Tone Disorders
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has approved another indication for its product Daxxify (daxibotulinumtoxin, RT002). The type A botulinum toxin is now approved for the treatment of adult cervical muscle tone disorders in China. Background on…
-
Phil Rivers Technology Secures IND Approval for PR00012 from NMPA’s CDE
•
Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
-
Hansoh Pharmaceutical’s Ameile Receives NMPA Review for Fifth Indication in NSCLC Treatment
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing for Ameile (almonertinib) has been accepted for review by the National Medical Products Administration (NMPA). The epidermal growth factor receptor (EGFR) inhibitor is now under review for the first-line treatment of locally advanced or metastatic…
-
China Medical System Holdings Gets NMPA Approval to Test Obesity Treatment CMS-D005
•
China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study in China. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D005 in healthy and overweight and obese adult subjects. Dual…
-
GSK plc Receives EC Approval for Single-Vial Menveo Vaccine for Meningococcal Disease
•
GSK plc (NYSE: GSK) has announced that it has received marketing approval from the European Commission (EC) for its Menveo vaccine, a Meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY vaccine), in a single-vial, fully liquid presentation. This formulation is designed for the prevention of invasive meningococcal disease…
-
Immunochina Pharmaceuticals’ IM19 CAR-T Therapy Accepted for Review by NMPA
•
Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its chimeric antigen receptor T cell (CAR-T) product, IM19. The therapy is being sought for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r…
-
Thederma’s TAP-1503 Cream Approved by China’s NMPA for Atopic Dermatitis Treatment
•
China-based Thederma has announced that its TAP-1503 cream has been granted approval by the National Medical Products Administration (NMPA) with priority review status. The drug, containing 1% tapinarof as a small molecule chemical drug, is now approved for the treatment of atopic dermatitis (eczema) in children over two years old…
-
Novartis’s Kisqali Approved by EC for Adjuvant Treatment of High-Risk Early Breast Cancer
•
Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early…
-
Chia Tai Tianqing’s Benmelstobart Combo Approved by NMPA for Endometrial Cancer Treatment
•
China-based Chia Tai Tianqing has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is now approved in combination with the multi-target kinase inhibitor anlotinib to treat patients with non-Microsatellite Instability-High (non MSI-H)…
-
Sichuan Kelun-Biotech’s SKB264/MK-2870 Approved by NMPA for Triple Negative Breast Cancer
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a China-based biopharmaceutical company, has received market approval from the National Medical Products Administration (NMPA) for its drug sacituzumab tirumotecan (SKB264/MK-2870). This drug is intended to treat adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously…
-
CORXEL’s Varenicline Nasal Spray Approved by NMPA for Dry Eye Treatment
•
Shanghai-based CORXEL, formerly known as Ji Xing Pharmaceuticals, supported by RTW Investments, has received approval from China’s National Medical Products Administration (NMPA) for its varenicline nasal spray, which is indicated for increasing tear secretion in patients diagnosed with xerophthalmia. Clinical Studies Support NMPA ApprovalThe NMPA’s approval was grounded in data…
-
Pfizer Partners with CR Pharma to Expand Cancer Drug Access in China
•
US pharmaceutical giant Pfizer Inc. (NYSE: PFE) has entered into a strategic agreement with China Resources Pharmaceutical Group Co., Ltd (HKG: 3320) to leverage their respective strengths in promoting the commercial operations of Pfizer’s established oncology drugs in China. The focus will be on drugs Aromasin (exemestane), Ibrance (palbociclib), Pharmorubicin…
-
CanSino Biologics’ Menhycia Vaccine Aims to Expand Age Range with NMPA Filing
•
CanSino Biologics (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted its supplementary market filing for the ACYW135 Meningococcal Conjugate Vaccine (CRM197), trade named Menhycia. The Chinese biotechnology company is looking to extend the vaccine’s approved age range to include children from 3 months to 6…
-
Jiangsu Hengrui Medicine’s SHR-1819 Receives NMPA Approval for Atopic Dermatitis Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel monoclonal antibody, SHR-1819. This injectable treatment can now proceed to Phase Ib/II studies, focusing on atopic dermatitis (AD) in children and adolescents aged 6-17…
-
AstraZeneca’s Truqap Meets Primary Endpoint in Phase III Prostate Cancer Study
•
UK-based pharmaceutical giant AstraZeneca Inc., (AZ, NASDAQ: AZN) has announced that its Phase III CAPItello-281 study has successfully met its primary endpoint of radiographic progression-free survival (rPFS). The study evaluated the efficacy of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient de novo…
