-
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…
-
QYuns Therapeutics’ QX002N Meets Primary Endpoint in AS Phase III Study
•
China-based Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) announced that its Phase III study of QX002N, an anti-IL-17A monoclonal antibody, in ankylosing spondylitis (AS) has met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial enrolled 641 patients with moderate to severe AS. Study Results
-
Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
•
Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved a label extension for Takhzyro (lanadelumab) for subcutaneous administration in adolescents aged 12 and above and adult patients with Hereditary Angioedema (HAE) using a 2 mL pre-filled pen. Drug ProfileTakhzyro is now approved in the…
-
Meyer FSMP Hong Kong Secures NMPA Approval for First FSMP in Greater China
•
Hong Kong-based Meyer FSMP Hong Kong Limited, an oncology-focused foods for special medical purpose (FSMP) company, announced it has received marketing approval from China’s National Medical Products Administration (NMPA) for its carbohydrate component formula. The product is the first FSMP approved in the Hong Kong, Macao, and Taiwan regions. Product…
-
Pfizer Halts Global Development of Hemophilia B Gene Therapy Beqvez Amid Limited Demand
•
Pfizer Inc. (NYSE: PFE) has terminated the development and commercialization of Beqvez (fidanacogene elaparvovec), its hemophilia B gene therapy, globally, citing “limited interest” from patients and physicians, according to reports in Nikkei Asia and Reuters. The move marks the U.S. pharma giant’s exit from virally delivered gene replacement treatments. Decision…
-
CSPC Pharmaceutical Initiates Phase III Trial for Ammuxetine in Depression Treatment
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced the start of a Phase III clinical trial for its Category 1 chemical drug ammuxetine at the Shanghai Mental Health Center, a top-tier Class 3A mental hospital. Drug ProfileAmmuxetine, a small molecule SNR inhibitor discovered by the Chinese Academy of Military Medical…
-
Innorna’s IN013 Receives FDA Rare Pediatric Designation for Wilson’s Disease Treatment
•
Shenzhen-based Innorna Co., Ltd, a platform company leveraging mRNA and lipid nanoparticle (LNP) delivery technologies, announced that its IN013 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA). The mRNA drug is designed to treat hepatolenticular degeneration (HLD), also known as Wilson’s disease, a…
-
Joyo Pharma’s JYP0015 Receives CDE Approval for RAS Mutation Cancer Trials
•
China’s Center for Drug Evaluation (CDE) has tacitly approved Joyo Pharma’s Category 1 drug JYP0015, a molecular glue product, for clinical studies in hematological and solid tumors with RAS mutations. The approval follows positive preclinical data and a strategic licensing deal with U.S.-based Erasca, Inc. Drug ProfileJYP0015, a novel pan-RAS…
-
Zhejiang Huahai Pharma’s HB0056 Receives NMPA Approval for Asthma Trials
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its bispecific antibody HB0056 has received clinical trial approval from China’s National Medical Products Administration (NMPA) for asthma. The approval follows similar clearances in New Zealand (October 2024) and the U.S. (January 2025), positioning the drug for global development. Clinical…
