-
Fosun Pharma’s Comirnaty Bivalent Vaccine Approved in Macau for Booster Shots
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its Comirnaty bivalent vaccine has been approved as a normal import vaccine in Macau. The vaccine is authorized for use as a booster shot in individuals aged 12 and above. Partnership and DevelopmentFosun Pharma is partnered with…
-
HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004
•
China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the US FDA for its ophthalmology gene therapy HG004. The company plans to initiate a global, multi-center clinical study for the drug, a single-administered, non-adeno-associated virus serotype 2 (non-AAV2) gene replacement therapy, targeting retinopathy associated…
-
Ascletis Receives IND Approval for ASC10 in Monkeypox Treatment
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its ASC10, an oral double prodrug antiviral, to evaluate its potential as a treatment for monkeypox. This approval marks a significant step in expanding the therapeutic applications of…
-
Legend Biotech’s Carvykti Meets Primary Endpoint in CARTITUDE-4 Phase III Study
•
Legend Biotech (NASDAQ: LEGN) has released positive data from the CARTITUDE-4 Phase III study, evaluating Carvykti (ciltacabtagene autoleucel; cilta-cel) as a treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM). The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard…
-
CSPC’s Octreotide Long-Acting Injection Approved for Acromegaly Clinical Study
•
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 Category 2.2 chemical octreotide long-acting injection in acromegaly. This marks a significant step forward in developing more convenient treatment options for patients with this rare…
-
BeiGene’s Brukinsa Approved by FDA for Chronic Lymphocytic Leukemia
•
China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the US FDA has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In a separate announcement, BeiGene also noted that the Medicines…
-
CNBG-Virogin’s Omicron-Targeted mRNA Vaccine Approved for Clinical Trials
•
CNBG-Virogin Biotech (Shanghai) Co., Ltd has announced obtaining clinical trial approval from the National Medical Products Administration (NMPA) for its Omicron variant-targeted mRNA vaccine. This marks a significant milestone in the development of COVID-19 vaccines tailored to emerging variants. Vaccine Development and InnovationThe product, China’s first COVID-19 mRNA vaccine encoding…
-
Hepagene’s FXR Agonist HPG1860 Shows Positive Phase IIa Data in NASH Study
•
China-based liver disease specialist Hepagene Therapeutics (HK) Limited has revealed positive data from the Phase IIa clinical study of its in-house developed FXR agonist HPG1860 in non-alcoholic steatohepatitis (NASH). The results highlight the drug’s potential in addressing this metabolic liver disease. Phase IIa RISE Study ResultsThe multi-center, randomized, double-blind, placebo-controlled…
-
BMS’s Opdivo Approved in China for Neoadjuvant Therapy in Urothelial Carcinoma
•
US-based Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another new indication approval in China for its programmed death-1 (PD-1) inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use as a neoadjuvant therapy for patients with urothelial carcinoma (UC) at high risk of recurrence after radical resection. This marks the…
-
Harbour BioMed Receives FDA Approval for HBM1007 Clinical Study
•
China-based Harbour BioMed (HKG: 2142) has announced receiving approval from the US FDA to initiate a clinical study of its monoclonal antibody (mAb) HBM1007, a fully-human antibody targeting CD73. This marks a significant step forward in the development of innovative therapies targeting this key biomarker. HBM1007: Mechanism and DevelopmentHBM1007 is…
-
Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
•
China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology Co. Ltd has received marketing approval in China for its biosimilar version of Roche Holding AG’s (OTCMKTS: RHHBY) Actemra/RoActemra (tocilizumab). This approval marks a significant milestone in expanding treatment options for…
-
CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
•
China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase II part of the ongoing CAN103 Phase I/II study. The trial is focused on treatment-naïve patients with Gaucher disease (GD) Types I and III in China. This milestone marks a significant step forward in the…
-
CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
•
The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s rilonacept, and Zai Lab’s sulbactam/durlobactam (SUL-DUR) are set to obtain priority review statuses. These designations highlight the significance of these therapies in addressing critical medical needs. Vonicog Alfa: Vascular Hemophilia TreatmentVonicog alfa is a recombinant…
-
Immunofoco’s CLDN18.2-Targeted CAR-T Therapy IMC002 Accepted for CDE Review
•
China’s Center for Drug Evaluation (CDE) has accepted a clinical trial filing for IMC002, an in-house developed CLDN18.2-targeted chimeric antigen receptor (CAR)-T therapy by Suzhou Immunofoco. This marks a significant milestone for the Chinese firm, which aims to develop the drug for treating advanced digestive system tumors with CLDN18.2 expression,…
-
Keymed Biosciences’ CMG901 Shows Promising Results in Phase Ia Study for Solid Tumors
•
China-based Keymed Biosciences Inc. (HKG: 2162) has revealed the latest data update from a Phase Ia dosage escalation study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of its CMG901. The study focuses on CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) for advanced solid tumors. The data…
-
Staidson’s STSP-0601 Begins Phase II Study for Hemophilia Treatment
•
China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced the first subject dosing in a Phase II clinical study for its Category 1 biologic STSP-0601. The study aims to evaluate the drug as an on-demand treatment for bleeding in patients with hemophilia A or B without inhibitors. This marks…
-
Everest Medicines’ EVER206 Shows Positive Phase I Results in China
•
China-based Everest Medicines (HKG: 1952) has announced top-line results from a Phase I study in China, demonstrating that EVER206 (also known as SPR206), a novel intravenous polymyxin derivative, is well-tolerated with no evidence of acute kidney injury or new safety signals. The study supports Everest’s plans to initiate next-phase clinical…
-
Junshi Biosciences’ Neotorch Study Achieves Superiority in Lung Cancer Trial
•
Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its randomized, double-blind, placebo-controlled, multi-center Phase III Neotorch study has completed the pre-set interim analysis. The study assessed the efficacy and safety of its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with chemotherapy as a perioperative treatment for patients…
-
Hengrui’s EZH2 Inhibitor SHR2554 Nears Breakthrough Therapy Designation
•
China-based Jiangsu Hengrui Pharmamceuticals (SHA: 600276) has announced that its enhancer for the zeste homolog 2 (EZH2) inhibitor, SHR2554, is set to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. The designation is for use in relapsed/refractory (r/r) peripheral T-cell lymphoma, marking a…
-
Hansoh’s HS-10517 Greenlit for COVID-19 Clinical Study by NMPA
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its HS-10517, a Category 1 anti-COVID-19 drug co-developed by the Global Health Drug Discovery Institute (GHDDI). The study will focus on mild to moderate COVID-19…
