-
Fosun Kite’s Yescarta Gains Priority Review Status for r/r LBCL
•
China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead subsidiary Kite Pharma, has revealed that Yescarta (axicabtagene ciloleucel) has obtained priority review status for adult large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has…
-
Genor Biopharma Initiates First Patient Dosing for GB263T in China
•
China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a Phase I/II clinical study for its pipeline candidate GB263T in advanced non-small cell lung cancer (NSCLC) and other solid tumors in China. The drug was first administered in a first-in-human trial in Australia in May…
-
Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
•
China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in combination with its anti-CD73 monoclonal antibody (mAb) AK119 for…
-
Innovent Biologics Publishes Mazdutide Phase Ib Study Results for Obesity
•
China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the results of the higher-dose cohorts in a Phase Ib study for mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in overweight or obese Chinese participants have been published online at eClinicalMedicine. Licensing Deal and Drug ProfileInnovent struck…
-
Sihuan Pharma to Acquire Additional Stake in Heilongjiang Duoduo Pharma
•
China-based Sihuan Pharmaceutical Holdings Group Ltd’s subsidiary, Beijing Centergate Technologies (Holding) Co., Ltd (SHE: 000931), has announced that Sihuan Pharma is set to acquire an additional 9.56% stake in Heilongjiang Duoduo Pharmaceutical Co., Ltd. Upon the deal’s closure, Sihuan will own a 78.82% stake in Duoduo Pharma, maintaining its position…
-
BeiGene’s Brukinsa Receives Positive CHMP Opinion for CLL Approval
•
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). This recommendation is…
-
Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
•
Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
-
RemeGen’s Telitacicept Gains EU, China Approvals for Global Phase III Study
•
China-based pharma firm RemeGen (HKG: 9995) has announced receiving approvals from authorities in the European Union (EU) and China to conduct a global multi-center Phase III clinical study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE). This marks a significant step forward in the development of innovative…
-
Zelgen’s Jacktinib Shows Strong Efficacy in Phase III Myelofibrosis Study
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has published major data from a Phase III clinical study for its Janus kinase (JAK) inhibitor, jacktinib, in patients with medium- to high-risk myelofibrosis (MF). The results indicate an excellent efficacy and safety profile for the drug. A New Drug Application (NDA) for…
-
Ningbo Menovo to Sell Zhejiang Liaoyuan Pharma Stake to Jemincare for RMB 512.58M
•
China-based Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has announced plans to transfer all of its ownership in Zhejiang Liaoyuan Pharmaceutical Co., Ltd (23,771,218 shares, or 84.5661% of the target company’s total shares) to Jiangxi Jemincare Group for a consideration of RMB 512.58 million (USD 71.2 million). The deal is…
-
Alioth Biotech Raises RMB 100M in Series A Financing for Pharma Processing Products
•
China-based Alioth Biotech (Shanghai) Co., Ltd has raised close to RMB 100 million (USD 13.9 million) in a Series A financing round. The round was led by Matrix Partners and Legend Capital, with participation from Shanghai Yishuishan Enterprise Consulting Partnership Limited. The proceeds will be used to construct a membrane…
-
HICOMP MicroTech Raises RMB 100M in Series B+ Financing for Microfluidics Expansion
•
China-based micro/nano technology developer HICOMP MicroTech (Suzhou) Co., Ltd has raised RMB 100 million (USD 13.9 million) in a Series B+ financing round. The round was led by Shunwei Capital, with contributions from IC Space’s industrial investment platform. The proceeds will be used to support microfluidics research and development (R&D),…
-
Kintor’s Dual c-Myc/GSPT1 Degradation Therapy GT19715 Shows Promise in Pre-Clinical Studies
•
China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published positive results from a pre-clinical study of its dual c-Myc/GSPT1 degrader GT19715 in acute myeloid leukemia (AML) and lymphomas. The findings highlight the potential of GT19715 as a targeted therapy for these challenging cancers. Pre-Clinical Study ResultsCell-free, cellular assays, and animal studies…
-
CARsgen’s BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China
•
The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd’s (HKG: 2171) B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy CT053 (zevor-cel) is set for priority review. This status relates to a market approval filing to treat adult patients with recurrent…
-
LianBio Cancels Phase III Trial for Truseltiq in China Amid Global Halt
•
China-based LianBio (OTCMKTS: LIANY) revealed in an SEC filing that it is canceling work on a Phase III trial in China for Truseltiq (infigratinib). The decision follows an announcement by BridgeBio Pharma Inc. (NASDAQ: BBIO), the drug’s discoverer, that the ongoing global Phase III PROOF-301 trial is being closed. This…
-
Accutar Biotechnology Initiates Phase I Trial for ERα Targeting Degradation Molecule AC0682
•
New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0682, an orally bioavailable chimeric degrader molecule targeting the ERα protein. The molecule, which previously entered a Phase I study in the US, is the firm’s…
-
RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
•
China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD) status from the US FDA for its fusion protein drug telitacicept in myasthenia gravis (MG). This designation highlights the potential of telitacicept in treating this rare and chronic autoimmune disease. The drug previously concluded a…
-
Jacobio Partners with Merck KGaA for KRAS G12C Inhibitor Clinical Study
•
China-based Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has announced a clinical study collaboration partnership with German giant Merck KGaA (ETR: MRK). The focus of the study is the combination of Jacobio’s KRAS G12C inhibitor JAB-21822 with Merck’s cetuximab in KRAS G12C mutant colorectal cancer (CRC). This partnership aims to…
-
Hotgen Biotech Gains Regulatory Approvals in Saudi Arabia and India
•
China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving one certificate from the Saudi Food & Drug Authority (SFDA) and six certificates from the Drugs Controller General of India (DCGI) for its in-house developed products. These approvals mark significant milestones in the company’s global expansion efforts. Saudi Arabia ApprovalSpecifically,…
