-
Bayer’s Gadoquatrane Shows Positive Results in Phase III QUANTI CNS Study
•
German pharmaceutical giant Bayer (ETR: BAYN) announced positive results from the Phase III QUANTI CNS study for its gadoquatrane, a gadolinium-based contrast agent (GBCA), in adults with known or suspected pathologies of the central nervous system undergoing contrast-enhanced magnetic resonance imaging (MRI). Study Details and ResultsIn the trials, gadoquatrane was…
-
Precigen’s RRP Therapy PRGN-2012 Gets FDA Review
•
US-based cell and gene therapy (CGT) specialist Precigen, Inc. (NASDAQ: PGEN) announced that the US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for its zopapogene imadenovec (PRGN-2012) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The agency is expected to act on the…
-
InnoCare Pharma’s Orelabrutinib Shows Efficacy in RRMS at ACTRIMS Forum
•
Beijing-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the presentation of Phase II study results for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib in relapsing-remitting multiple sclerosis (RRMS) at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. Study HighlightsThe data demonstrated significant efficacy of…
-
Jiangsu Hengrui’s HRS-1301 Receives NMPA Approval for Hyperlipidemia
•
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its Category 1 chemical drug HRS-1301 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of hyperlipidemia. Clinical Approval DetailsThe approval marks a significant milestone for HRS-1301, a novel drug designed to address hyperlipidemia.…
-
Hepalink Pharmaceutical’s Enoparin Receives Argentina Approval for Thromboembolic Diseases
•
China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow Pharmaceutical Co., Ltd, has received marketing approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) for its Enoparin (enoxaparin) product. The approved specifications include 0.2ml: 20mg, 0.4ml: 40mg, 0.6ml: 60mg, and 0.8ml:…
-
Fosun Pharma’s Tenapanor Approved in China for CKD Dialysis Patients
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tenapanor, an innovative phosphate absorption inhibitor, in China. The drug, commercially known as Wan Ti Le, is now available for controlling serum phosphorus levels…
-
J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment
•
Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval from China’s National Medical Products Administration (NMPA) for treating moderate to severe active Crohn’s disease (CD) in adults who have not responded adequately to traditional therapies or biologics. Drug ProfileTremfya, an interleukin-23 monoclonal antibody, was…
-
Sanofi’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
•
Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM). This marks the fourth treatment regimen approved for Sarclisa in…
-
YolTech Therapeutics’ YOLT-203 Shows Promise in Primary Hyperoxaluria Type 1 Trial
•
YolTech Therapeutics, a Shanghai-based startup specializing in lipid nanoparticle delivery and gene editing, announced positive results from an investigator-initiated trial (ITT) of YOLT-203 in patients with primary hyperoxaluria type 1 (PH1). The therapy marks the first in vivo gene-editing treatment to demonstrate positive clinical data for PH1, showing excellent safety…
-
Merck’s Keytruda sBLA for LA-HNSCC Accepted by FDA for Review
•
Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review. The application seeks approval for Keytruda’s use in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC)…
-
Eli Lilly Launches New Zepbound Doses with Lower Prices for Self-Pay Patients
•
Eli Lilly & Co. (NYSE: LLY) announced the launch of 7.5 mg and 10 mg single-dose vials of Zepbound (tirzepatide) for self-pay patients with obesity, priced at USD 499 under the new Zepbound Self Pay Journey Program. Dosing OptionsThe program offers self-pay patients a range of Zepbound doses: 2.5 mg,…
-
Suzhou Ribo Life Science’s RBD2080 siRNA Drug Receives Australian Clinical Trial Approval
•
China-based Suzhou Ribo Life Science Co., Ltd announced that its siRNA drug RBD2080 has received clinical trial approval from Australia’s Therapeutic Goods Administration (TGA). The drug, designed to treat autoimmune diseases, will soon enter a Phase I study in Australia. Trial DetailsThe upcoming trial is a randomized, double-blind, placebo-controlled study…
-
CANbridge Pharmaceuticals Doses First Patient in CAN108 Biliary Atresia Study
•
China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that the first patient has been dosed in the Phase II EMBARK study of CAN108 (maralixibat) for biliary atresia (BA). The global, multi-center, randomized, controlled trial aims to enroll 72 patients, including 20 in China, to evaluate the drug’s efficacy…
-
Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
•
Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) autoimmune drug Stelara (ustekinumab), in the US. The drug, developed by South Korea’s Samsung Bioepis Co., Ltd., is approved for the same chronic inflammatory disease indications as the originator. Licensing DealSandoz…
-
Xellsmart’s iPSC Therapy XS-228 Receives FDA Approval for ALS Study
•
Suzhou-based stem-cell startup Xellsmart announced that the U.S. FDA has approved its regulatory study of XS-228, an iPSC-derived neural precursor cell therapy, for amyotrophic lateral sclerosis (ALS). The therapy, designed to provide a universal cell treatment for ALS patients, received orphan drug designation (ODD) from the FDA in December 2023.…
-
Huadong Medicine’s HDM1005 Receives NMPA Approval for OSA Treatment
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its HDM1005, a long-acting GLP-1/GIP receptor agonist, has received clinical trial approval from the National Medical Products Administration (NMPA) for obstructive sleep apnea (OSA) combined with obesity or overweight. The drug previously received nods for type 2 diabetes, weight loss, and…
-
Pfizer’s Hympavzi (Marstacimab) Launched in China’s Boao Lecheng Pilot Zone for Hemophilia
•
Pfizer Inc. (NYSE: PFE) announced the implementation of its hemophilia therapy Hympavzi (marstacimab) in China’s Boao Lecheng Medical Tourism Pilot Zone. The drug, approved in the U.S. and European Union, is the first innovative therapy to be administered subcutaneously once weekly via a pre-filled injection pen for hemophilia A and…
-
Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer
•
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment for adult and pediatric patients (aged 12+) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA set…
-
CanSino Biologics Receives NMPA Approval for DTcP Hib MCV4 Combined Vaccine
•
China-based vaccine specialist CanSino Biologics Inc. (HKG: 6185) announced that its absorbed diphtheria, tetanus, acellular pertussis (DTcP), Haemophilus influenzae type b (Hib), and Group ACYW135 meningococcal (MCV4) combined vaccine has received clinical trial approval from the National Medical Products Administration (NMPA). The single-dose vaccine aims to provide comprehensive immune protection…
-
Boehringer Ingelheim’s Nerandomilast Receives NMPA Review for IPF Treatment
•
Boehringer Ingelheim announced that its investigational drug nerandomilast has been accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The German pharma giant seeks approval for the oral phosphodiesterase 4B (PDE4B) inhibitor to treat idiopathic pulmonary fibrosis (IPF) in adults. Clinical Trial…
