-
Lyvgen Biopharma Initiates Phase II Study for LVGN7409 in Advanced NSCLC
•
Shanghai-based immuno-oncology therapeutics specialist Lyvgen Biopharma has announced the initiation of an open-label, multi-center, randomized Phase II clinical study to assess the efficacy and safety of its LVGN7409 in combination with docetaxel or nivolumab for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC). The combination study is set to…
-
Everest Medicines’ Nefecon Gains Accelerated Approval in Taiwan and South Korea
•
China-based Everest Medicines (HKG: 1952) has announced receiving Accelerated Approval Designation (AAD) from the Taiwan Food and Drug Administration and Orphan Drug Designation (ODD) from the Ministry of Food and Drug Safety in South Korea for its lead product Nefecon (targeted-release budesonide). These designations are for the treatment of primary…
-
Jiangsu Hengrui Gets NMPA Approval for HR20031 Clinical Study in Type 2 Diabetes
•
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its HR20031 in patients with type 2 diabetes. This marks a significant step forward in the development of a novel treatment option for patients with poorly controlled…
-
Fosun Pharma’s Henlius Completes Clinical Trial Filing for HLX301 in Australia
•
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its subsidiary, Shanghai Henlius Biotech (HKG: 2696), has completed a clinical trial filing for HLX301 in Australia. Henlius will conduct a Phase I clinical study in the country for the bispecific antibody (BsAb) targeting programmed-death-ligand 1 (PD-L1)…
-
China Resources Double-Crane Gains Approval for Definity in China
•
China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving market approval from the National Medical Products Administration (NMPA) to act as the domestic agent for Definity (perflutren lipid microsphere injection). The contrast agent can now be used to enhance the recognition of the left ventricular endocardial boundary when…
-
Bliss Bio’s BB-1709 Accepted for Review by China’s CDE
•
Hangzhou-based oncology-focused clinical stage biotech Bliss Bio has announced that its clinical filing for the Category 1 therapeutic biologic product injectable BB-1709 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BB-1709, a potential first-in-class antibody drug conjugate…
-
Junshi Biosciences Files for UK Approval of PD-1 Inhibitor Tuoyi
•
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has filed for market approval with the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The filing seeks approval for the checkpoint inhibitor in combination with chemotherapy as a…
-
Immorna’s JCXH-221 mRNA Vaccine Cleared by FDA for Phase I/II Study
•
Immorna (Hangzhou) Biotechnology Co., Ltd has announced that the US FDA has cleared its investigational new drug (IND) application to conduct a Phase I/II multi-center study assessing the safety and immunogenicity of JCXH-221, a lipid nanoparticle (LNP) complex broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases, in healthy adult…
-
Kanghong Pharma Receives FDA Approval for KH631 Gene Therapy Trial
•
China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. KH631 ProfileKH631…
-
Frontier Biotechnologies Gains CDE Approval for FB2001 COVID-19 Inhalant Study
•
China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase II/III clinical study assessing its FB2001 atomized inhalant bofutrelvir in mild and common COVID-19 patients. This marks a significant step forward in the development of innovative treatments for COVID-19.…
-
Alphamab Oncology and CSPC Announce Positive Phase II Data for KN026 in HER2-Positive Gastric Cancer
•
China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The…
-
Kexing Pharma Receives Ethical Approval for Phase II Study of SHEN26 COVID-19 Drug
•
China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases. Study…
-
Kintor Pharma’s GT20029 Shows Positive Results in Phase I Study for Androgenetic Alopecia and Acne
•
China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive results from a Phase I clinical study in China for its GT20029, which is being developed to treat androgenetic alopecia and acne. The study demonstrated that GT20029 has a good safety, tolerability, and pharmacokinetics profile. Study DetailsThe randomized, double-blind, placebo-controlled Phase…
-
FibroGen Sues Former Employees and Two Pharma Firms for Trade Secret Theft
•
US-based FibroGen Inc. has filed a lawsuit against two former employees, Liu Dong and Deng Shaojiang, accusing them of trade secret theft. The case, filed with the US District Court for the Northern District of California, also names two pharmaceutical firms as co-defendants: US-based Kind Pharmaceuticals LLC and China-based Hangzhou…
-
China’s First Gene Therapy for Deafness, RRG-003, Begins Clinical Study
•
RRG-003, an adeno-associated virus (AAV) gene therapy co-developed by China’s Shanghai Dingxin Gene Technology Co., Ltd and the Eye & ENT Hospital of Fudan University, has initiated a clinical study targeting hearing loss in the country. This marks the first gene therapy trial for deafness, with the first patient expected…
-
BeiGene to Present Final PFS Results for Brukinsa at ASH Meeting
•
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced plans to present the final progression-free survival (PFS) superiority analysis results of the Phase III ALPINE study for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) at the annual American Society of Hematology (ASH) meeting. The study assessed…
-
Vcanbio’s VUM02 Accepted for Review by China’s Center for Drug Evaluation
•
China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product, has been accepted for review by the Center for Drug Evaluation. This marks a significant step forward in…
-
Fosun Pharma’s Human Interferon Gamma Approved for New Indication by NMPA
•
Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its human interferon gamma for injection. The therapeutic biologic product can now be used to reduce the frequency and severity of severe infections associated with chronic granulomatosis, an indication…
-
InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore
•
China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health Sciences Authority (HSA) of Singapore for its Bruton’s tyrosine kinase (BTK) inhibitor Hibruka (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). This marks a significant expansion of the drug’s…
-
Salubris Pharmaceuticals’ SAL0119 Accepted for CDE Review in China
•
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that its clinical trial filing for the Category 1 drug candidate SAL0119 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant step forward in the development of SAL0119, an oral small-molecule immunosuppressant designed…
