-
Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
•
China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) vaccine, has been cleared by the US Food and Drug Administration (FDA). This milestone marks a significant advancement for the company’s innovative oncology pipeline. EVM14’s Mechanism and Pre-Clinical SuccessEVM14 is…
-
CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational antibody-drug conjugate (ADC) SYS6040. The trial will focus on evaluating the safety and efficacy of SYS6040 in patients with advanced solid tumors. Promising Pre-Clinical…
-
Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
•
Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan. The drug is approved for treating adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer who have undergone prior chemotherapy. First TROP2-Directed Therapy…
-
Triastek’s 3D-Printed T20G Receives US Clinical Approval for NOAC Treatment
•
China-based Triastek Inc., a pharmaceutical-focused 3D printing company, has announced receiving clinical approval in the US for its T20G. This 3D-printed non-vitamin K antagonist oral anticoagulant (NOAC) was previously cleared for trials in China in January of last year. T20G’s Technological AdvantagesT20G leverages Triastek’s patented 3D Microstructure for Gastric Retention…
-
Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
•
US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the US Food and Drug Administration (FDA) to market its Tremfya (guselkumab) as a treatment for moderately to severely active Crohn’s disease (CD). This IL-23 inhibitor now offers both subcutaneous (SC) and intravenous (IV) induction options…
-
Elevation Oncology Halts EO-3021 Development After Poor Phase 1 Data
•
US-based Elevation Oncology, Inc. (NASDAQ: ELEV) has announced the decision to terminate development of EO-3021 following disappointing Phase 1 data, which caused its stock price to plummet 41% before trading. EO-3021’s Background and Licensing DealEO-3021, a Claudin 18.2-targeted antibody drug conjugate (ADC) originated by China’s CSPC Pharmaceutical Group Ltd (HKG:…
-
Changchun High & New Technology Industries Receives US Trial Approval for GenSci120 in Rheumatoid Arthritis
•
China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced its subsidiary GenScipt Biotech Corp. receiving approval to initiate a clinical study for its GenSci120 in rheumatoid arthritis (RA) in the United States. This marks a significant step forward in the development of this innovative biologic product for…
-
Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
•
Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the US Food and Drug Administration (FDA) for the treatment of adults with C3 glomerulopathy (C3G). This marks the first and only approved therapy specifically targeting this rare kidney disease, which is characterized by a poor…
-
Arcutis Biotherapeutics’ Zoryve Cream Nears FDA Approval for Pediatric Atopic Dermatitis
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has filed a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast) 0.05% with the US Food and Drug Administration (FDA). The application seeks approval for the topical use of Zoryve in children…
-
Kintor Pharmaceutical’s KX-826 Shows Promising Results in Alopecia Phase III Trial
•
China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced positive topline results from the long-term safety Phase III study for its KX-826 (pyrilutamide) in alopecia. The trial met the primary endpoint with statistical significance and demonstrated the drug’s outstanding safety and efficacy. Clinical Trial ResultsAt week 52, patients showed significant improvements in…
-
Junshi Biosciences Receives NMPA Approval for JS212 in Advanced Solid Tumors
•
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its JS212, a bispecific antibody drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). This marks a…
-
Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
•
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
-
Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
•
On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). This designation marks a significant milestone in the development of…
-
Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
•
On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class 1 new drug, the PI3Kα inhibitor JYP0035 capsule, received clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of targeted therapies for breast cancer patients…
-
Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
•
China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its insulin degludec and liraglutide combination drug, administering the first dose to a patient in China. This marks a significant step forward in the development of this biosimilar version of Novo Nordisk’s Xultophy. Drug Profile and…
-
AccurEdit Therapeutics Receives FDA Orphan Drug Designation for ATTR Treatment
•
China-based AccurEdit Therapeutics (Suzhou) Co., Ltd announced receiving Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug ART001, targeting transthyretin amyloidosis (ATTR). This marks a significant milestone in the development of this innovative gene-editing therapy. Drug Profile and MechanismART001 is the first non-viral…
-
Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sjögren’s Disease
•
US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sjögren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year. Mechanism…
-
AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
•
UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for its PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Clinical Need and Approval SignificanceSCLC is a highly…
-
HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
•
Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with…
-
Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction
•
German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for its Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The targeted indication is adult patients with heart failure (HF)…
