-
Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
•
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing for its tyrosine kinase inhibitor (TKI) pyrotinib has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is for use in combination with trastuzumab plus docetaxel in advanced, recurrent or…
-
NMPA Approves JW Therapeutics’ Carteyva for Recurrent Follicular Lymphoma
•
The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’ (HKG: 2126) Carteyva (relmacabtagene autoleucel injection). The anti-CD19 autologous chimeric antigen receptor (CAR) T-cell immunotherapy product can now be used to treat recurrent or refractory (r/r) follicular lymphoma (FL) in adults after second-line or above…
-
Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
•
Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for its anti-tumor drug Cyramza (ramucirumab) in hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). The indication focuses on patients with alpha fetoprotein (AFP) ≥ 400 ng/mL who have previously been…
-
Sciwind Biosciences Initiates US Phase I Study for GLP-1 Agonist XW014
•
China-based Sciwind Biosciences Co., Ltd has announced the initiation and first patient dosing of a Phase I clinical study for its XW014 in the United States. The double-blind, randomized, placebo-controlled, single and multiple ascending dose study is designed to assess the safety, tolerability, food effects, pharmacokinetics, pharmacodynamics, and early treatment…
-
Fujian Cosunter Doses First Patient in Phase I Study of COVID-19 Drug GST-HG171
•
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese…
-
Salubris Pharmaceuticals’ First-in-Class Anti-Tumor Drug SAL008 Accepted by NMPA
•
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing for its first-in-class anti-tumor biologic drug SAL008 has been accepted for review by the National Medical Products Administration (NMPA). The drug, indicated for advanced solid tumors, has previously entered Phase I clinical trials in Europe.…
-
Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer
•
Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China for the treatment of early and metastatic HER2-positive breast cancer in combination with chemotherapy. This approval marks a significant advancement in the treatment options available for patients with HER2-positive breast cancer, offering a more convenient…
-
Merck’s Keytruda Gains 9th Indication Approval in China for Hepatocellular Carcinoma
•
US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 9th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used as a monotherapy to treat hepatocellular carcinoma (HCC) previously treated with sorafenib or oxaliplatin. Approval Based…
-
Eli Lilly’s Retevmo Wins First China Approvals for RET-Driven Cancers
•
Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo (selpercatinib), a RET kinase inhibitor, across three indications. The drug is now approved for the treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-mutated advanced or metastatic medullary thyroid…
-
Ark Biosciences’ Ziresovir Shows Positive Results in Phase III AIRFLO Study for RSV Infection
•
China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its novel antiviral drug ziresovir (AK0529). The study evaluated the efficacy and safety of ziresovir in hospitalized infants with respiratory syncytial virus (RSV) infection. The drug achieved its primary endpoint of a significant reduction in symptom…
-
Pfizer’s Talzenna Shows Positive Results in Phase III TALAPRO-2 Study for mCRPC
•
US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced positive results from the Phase III TALAPRO-2 study for its oral poly ADP ribose polymerase (PARP) inhibitor, Talzenna (talazoparib). The study evaluated the drug in combination with Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with or without homologous…
-
Hua Medicine’s Dorzagliatin Approved in China for Type 2 Diabetes
•
China-based Hua Medicine (HKG: 2552) has announced that its Category 1 drug dorzagliatin has been approved by the National Medical Products Administration (NMPA) for improving blood glucose control in adults with type 2 diabetes. The first-in-class oral hypoglycemic drug represents an innovative treatment option for patients in China. Approval Based…
-
Allergan Aesthetics Launches Juvederm Volite in China’s Boao Lecheng
•
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has announced the commercial launch of Juvederm Volite at the Arsmo (Hainan) Aesthetic Hospital in Boao Lecheng, China. The product follows the successful introduction of Juvederm Volux into the region under the “first pilot, first trial” policy, further expanding the company’s aesthetic portfolio…
-
Junshi Biosciences Launches PD-1 Inhibitor Tuoyi for Advanced NSCLC in China
•
Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has held a national market launch meeting for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in China. The drug received its sixth indication approval last month for treating…
-
Everest Medicines’ Xerava Approved in Hong Kong for Complicated Intra-Abdominal Infections
•
Everest Medicines Limited (HKG: 1952), a China-based biopharmaceutical company, has announced that it has received market approval from the Department of Health of the Hong Kong Special Administrative Region for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in the…
-
Ascletis Pharma Doses First Patient in Phase II Study of ASC41 for NASH
•
Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient has been dosed in a 52-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41. The study is targeting patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). Phase II Clinical Trial DesignThe…
-
Transcenta’s TST004 Receives FDA IND Clearance for IgAN Treatment
•
China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for TST004, a best-in-class, humanized monoclonal antibody targeting MASP2. The drug is set to be evaluated as a potential treatment for immunoglobulin A nephropathy (IgAN).…
-
Connect Biopharma’s CBP-201 Shows Positive Results in Atopic Dermatitis Study
•
China-based Connect Biopharmaceuticals Ltd has announced the topline results of a pivotal clinical study for its monoclonal antibody (mAb) candidate, CBP-201, targeting allergic inflammation in moderate-to-severe atopic dermatitis (AD). The study was conducted across multiple centers in China and evaluated the efficacy and safety of CBP-201, as well as the…
-
Kira Pharmaceuticals Gets FDA Green Light for Phase II Study of KP104 in SLE-TMA
•
Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study of KP104. The study will assess the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with systemic lupus…
-
Humanwell Healthcare’s Remimazolam Receives NMPA Approval for Bronchoscopy Use
•
China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its remimazolam (benzenesulfonate), a Category 1 chemical injectable. The drug is now approved for use as a sedative in support of bronchoscopy procedures. Drug Overview…
