-
RemeGen and Allist Partner to Assess ADC and EGFR Inhibitor Combination in NSCLC
•
China-based RemeGen Ltd (HKG: 9995) and Allist Pharmaceuticals Inc. (SHA: 688578) have announced a clinical cooperation agreement to evaluate the safety, tolerability, efficacy, and pharmacokinetics of RemeGen’s antibody drug conjugate (ADC) RC108 in combination with Allist’s epidermal growth factor receptor (EGFR) inhibitor furmonertinib. The collaboration aims to assess the potential…
-
HealZen Therapeutics Gains NMPA Approval for HZ-A-018 Clinical Study in Autoimmune Diseases
•
Hangzhou-based HealZen Therapeutics has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate HZ-A-018 in recurrent multiple sclerosis (RMS) and neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step forward in exploring new treatment options for these…
-
Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
•
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316 has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for BPI-D0316 in first-line treatment of locally advanced…
-
Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE
•
China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its zorifertinib, an oral tyrosine kinase inhibitor targeting epidermal growth factor receptor (EGFR) mutations (L858R and Exon 19Del), has been accepted for review by the Center for Drug Evaluation (CDE). Zorifertinib is indicated for the treatment…
-
Grand Pharma’s Jext Auto-Injector Approved for Import into Greater Bay Area
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced receiving official approval from the Guangdong provincial Medical Products Administration bureau for its Jext pre-filled adrenaline auto-injector pen. The product is now permitted to be imported into the Greater Bay Area (GBA) as a clinically urgently needed product. Product Details and…
-
Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
•
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib…
-
CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment
•
The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to obtain priority review status, with the drug in line for conditional approval. HL-085 is being developed to treat advanced melanoma with NRAS mutations in patients previously treated with immunotherapy. The investigational MEK inhibitor is undergoing…
-
NMPA Approves Two China-Developed COVID-19 Small-Molecule Therapies
•
The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered COVID-19 small-molecule therapies: SIM0417 from Hainan Simcere Pharmaceutical Co., Ltd, and VV116 from Shanghai JunTop Biosciences Co., Ltd. JunTop is a joint venture (JV) between Junshi Biosciences and Vigonvita Life Sciences Co., Ltd. SIM0417: Next-Generation…
-
China’s NHC Issues Guidelines to Improve Pediatric Medication Management
•
The National Health Commission (NHC) has released a notification aimed at refining management measures for pediatric clinical medication. The goal is to drive improvements in pediatric healthcare quality and ensure the safe use of pediatric drugs. Management of Drug Selection and AllocationThe notice proposes that medical institutions strengthen the management…
-
China’s Multi-Bureau Plan Aims to Eradicate Cervical Cancer by 2030
•
The National Health Commission (NHC), Ministry of Education, Ministry of Civil Affairs, and six other bureaus have released the “Accelerating the Eradication of Cervical Cancer Action Plan.” The initiative seeks to establish a multi-bureau network focused on driving cervical cancer prevention and control mechanisms with the goal of eradicating the…
-
JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911
•
Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by its US subsidiary VITRAC Therapeutics, LLC for its small molecule aurora A kinase (AURKA) inhibitor VIC-1911. The molecule is being assessed both as a monotherapy and in combination with sotorasib for the treatment of KRAS…
-
Akeso Receives First $300M Installment from Summit for Bispecific Antibody Ivonescimab
•
Akeso Inc. (HKG: 9926) has announced receiving the first installment of USD 300 million as part of an upfront fee paid by US-based Summit Therapeutics Inc. (NASDAQ: SMMT) under the firms’ December 2022 licensing deal for the bispecific antibody (BsAb) ivonescimab. The initial payment includes USD 274.9 million in cash…
-
NMPA Proposes Emergency Use Management Measures for Medical Devices
•
The National Medical Products Administration (NMPA) has released the “Medical Device Emergency Use Management Measures” for public consultation. The draft proposals are open for feedback until February 15, 2023. These measures aim to streamline the emergency use of medical devices, particularly during public health emergencies. Emergency Use CriteriaEmergency use will…
-
InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023
•
Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune diseases, has announced the latest data for its pan-fibroblast growth factor receptor (FGFR) inhibitor gunagratinib (ICP-192) in cholangiocarcinoma at the ASCO-GI 2023 meeting. The findings highlight the drug’s potential in treating this challenging form of…
-
Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD
•
Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US FDA to conduct a Phase I clinical study for its EXG102-031. The study will assess the safety, tolerability, and vision improvement potential of this once-administered gene therapy in patients with wet age-related macular degeneration (wAMD).…
-
Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition
•
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for its Cosela (trilaciclib) at the Jilin Cancer Hospital. This milestone marks the official clinical application of the first-in-class CDK4/6 inhibitor in China. Drug Background and DevelopmentTrilaciclib, discovered by US biotech G1 Therapeutics Inc., was in-licensed…
-
China Updates Export Controls on Technologies, Adds Gene Editing to List
•
The Ministry of Finance (MOF) has released an updated notification regarding technologies banned and restricted from export from China. The update includes the removal of 32 items, revision of 36 items, and the addition of 7 new items. The list now comprises 24 technologies prohibited from export and 115 with…
-
Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive,…
-
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…
