-
Takeda’s Exkivity Receives First Prescription in China with Innovative Payment Solutions
•
Takeda Pharmaceutical Co., Ltd has announced the first prescription of its lung cancer therapy Exkivity (mobocertinib) in China. The Japanese pharmaceutical giant will partner with China-based health platform MediTrust Health to launch innovative payment solutions for the drug in China, making this advanced therapy more accessible to patients. Clinical Need…
-
Harbour BioMed’s Batoclimab Shows Positive Results in gMG Phase III Trial
•
Harbour BioMed (HKG: 2142), a biotech company operating out of the United States, the Netherlands, and Suzhou (China), has announced positive topline results from its phase III clinical trial of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). The pivotal clinical study, designed to confirm the efficacy and…
-
Sanofi’s Dupixent Receives Priority Review for Prurigo Nodosa Treatment
•
French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that it has received priority review status from the Center for Drug Evaluation (CDE) for its Dupixent (dupilumab) to treat prurigo nodosa (PN) in adults. This marks another significant breakthrough in the type 2 inflammation field, following the drug’s indication approval for…
-
Eli Lilly’s Retevmo Launched in China by Innovent Biologics
•
Eli Lilly & Co’s (NYSE: LLY) Retevmo (selpercatinib) has been officially launched in the Chinese market. The drug is being commercialized by domestic firm Innovent Biologics Inc. (HKEX: 01801) under a partnership deal signed between the two companies in March last year. This collaboration aims to bring innovative treatments to…
-
Huahai Pharma’s HB0025 Receives NMPA Approval for Clinical Trials
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for HB0025, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF). The BsAb will be assessed in combination…
-
Hengrui’s Adebrelimab Receives NMPA Approval for Lung Cancer Treatment
•
Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its adebrelimab (SHR-1316), a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb). The molecule is now approved for use in combination with chemotherapy to treat first-line extensive stage small-cell lung…
-
Sino Biopharmaceutical’s Bevacizumab Biosimilar Approved by NMPA
•
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. The approved indications for the biosimilar include the treatment of metastatic colorectal cancer (CRC), recurrent glioblastoma, and advanced metastatic or recurrent non-small cell lung cancer (NSCLC).…
-
Mabwell’s 9MW3911 Monoclonal Antibody Accepted for NMPA Review
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its 9MW3911, a non-IL-2 blocking CD25 monoclonal antibody (mAb) developed via the high-efficiency B lymphocyte screening platform, has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for this…
-
Venus Medtech Completes Patient Enrollment for Liwen RF Ablation System Study
•
China-based Venus Medtech (Hangzhou) Inc. (HKG: 2500) has announced that all patients have been successfully enrolled in a confirmatory study in China for its Liwen RF ablation system, designed for the treatment of hypertrophic cardiomyopathy (HCM). This marks a significant step forward in the clinical development of this innovative device.…
-
Atom Bioscience’s ABP-671 Shows Positive Phase IIa Results in Gout Treatment
•
China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced positive results from a Phase IIa clinical study for its lead product, ABP-671. The randomized, double-blind, placebo-controlled trial enrolled 54 patients with gout or hyperuricemia across six cohorts, with 7 randomized to ABP-671 and 2 to placebo per…
-
CSPC Pharmaceutical Initiates Phase III Study for Mitoxantrone Liposome in Nasopharyngeal Carcinoma
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the first patient dosing in a randomized, open, positive controlled, multi-center Phase III study. The study is designed to assess the efficacy and safety of its mitoxantrone hydrochloride liposome in patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) when combined with…
-
OcuMension Therapeutics Initiates Phase II Study for Dry Eye Treatment OT-202
•
Chinese ophthalmology specialist OcuMension Therapeutics (HKG: 1477) has announced the initiation of a randomized, double-blind, placebo-controlled Phase II clinical study. The study is designed to assess the safety and efficacy of its Category 1 drug OT-202, a tyrosine kinase inhibitor (TKI) intended for the treatment of dry eyes. This marks…
-
Merck Reports 12.9% Sales Growth in 2022 Annual Report
•
German major Merck (NYSE: MRK) released its 2022 annual report this week, showing a robust expansion in global net sales. The company reported a 12.9% year-on-year (YOY) increase to EUR 22.2 billion (USD 23.6 billion), driven by growth across all business sectors. This performance underscores Merck’s continued strength in the…
-
Zhejiang Medicine’s ARX788 Shows Positive Results in Breast Cancer Study
•
China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has announced positive results from a Phase II/III clinical study for its sARX788, an anti-HER2 monoclonal antibody-AS269 conjugate, in the treatment of breast cancer. The study, which assessed the drug’s efficacy and safety in HER2-positive local advanced or metastatic breast cancer, reached its…
-
CanSino Biologics’ Inhalable COVID-19 Vaccine Gets EUA in Indonesia
•
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 Indonesia. This marks a significant milestone in the global fight against COVID-19, as the company expands its vaccine’s availability to another…
-
3SBio’s Nalfurafine Tablets Accepted for Review by NMPA for Chronic Liver Disease
•
China-based 3SBio Inc. (HKG: 1530) has announced that a clinical trial filing for its nalfurafine oral disintegrating tablets (TRK-820) for the improvement of pruritus in patients with chronic liver disease has been accepted for review by the National Medical Products Administration (NMPA). This follows the previous acceptance for review of…
-
JW Therapeutics Initiates Clinical Study for JWATM214 in Advanced Hepatocellular Carcinoma
•
China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its pipeline candidate JWATM214 in patients with advanced hepatocellular carcinoma (HCC). This first-in-human study is designed to evaluate the safety and tolerability, determine the recommended Phase II dose (RP2D), and evaluate the pharmacokinetic profile and preliminary…
-
Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
•
The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria…
-
Sanofi’s Sarclisa Approved for Import in Shenzhen via Greater Bay Area Scheme
•
French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater Bay Area special drug entry scheme for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab). The approval covers Sarclisa in combination with pomalidomide plus dexamethasone for the treatment of multiple myeloma (MM) in patients who have…
-
Innovent Biologics Begins Phase I Trial for IBI333 in Neovascular AMD
•
China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study assessing the safety and tolerability of intravitreal injection of IBI333. This recombinant anti-VEGF-A and anti-VEGF-C bispecific antibody (BsAb) was independently developed by Innovent and is being evaluated for the treatment of neovascular…
