•
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has obtained another indication approval in China for its generic version of BI/Eli Lilly’s Jardiance (empagliflozin). The hypoglycemic agent can now be used to reduce the risk of hospitalization due to heart failure in adult patients with symptomatic chronic heart failure. Jardiance:…
•
The National Medical Products Administration (NMPA) has granted approval to Jiangsu Carephar Pharmaceutical Co., Ltd’s Category 1 drug, keverprazan, for the treatment of duodenal ulcers and reflux esophagitis in China. This approval marks a significant advancement in the treatment options available for these gastrointestinal conditions. Keverprazan: A New Potassium Competitive…
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving separate approvals in Pakistan to initiate a Phase I clinical study for its mRNA vaccine against COVID-19 variants and a Phase III study for its mRNA vaccine against the COVID-19 prototype as a sequential booster. This marks a significant step…
•
China-based Innovent Biologics (HKG: 1801) has announced the first subject dosing in the Phase III CLEAR study for its picankibart (IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection, in moderate-to-severe plaque psoriasis. This marks a significant advancement in the development of innovative treatments for this chronic skin condition. Phase…
•
Sino-US gene therapy specialist Frontera Therapeutics has announced the first patient dosing in a clinical study for its in-house developed gene therapy FT-002. This marks a significant milestone in the development of treatments for X-linked retinitis pigmentosa (XLRP), a genetic disorder affecting vision. FT-002: First-in-Class Gene TherapyFT-002 is a recombinant…
•
China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving an Orphan Drug Designation (ODD) from the US FDA for its Category 1 drug candidate KH617 in glioblastoma. This designation is a significant milestone in the development of KH617, which is aimed at treating advanced solid tumors and…
•
China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its Category 1 product BA2101. This marks it as the first long-acting anti-IL-4Rα monoclonal antibody to enter the clinical trial stage in China. BA2101 is being developed to treat allergic diseases…
•
The Center for Drug Evaluation (CDE) website indicates that a clinical trial filing for RNK05047, a potential first-in-class small-molecule degrader targeting BRD4, by Hangzhou-based Ranok Therapeutics Co., Ltd, has been accepted for review. This marks a significant step forward in the development of innovative cancer treatments. Discovery and Mechanism of…
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) and its US partner Coherus BioSciences Inc., (NASDAQ: CHRS) have announced positive findings from the final analysis of overall survival (OS) in the pivotal Phase III JUPITER-02 (NCT03581786) clinical study. The study assessed the programmed death-1 inhibitor Tuoyi (toripalimab) as a…
•
Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921 combined with adebrelimab (SHR-1316) in advanced solid tumors. This marks a significant step in the development of…
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that separate clinical trial filings for its Category 1 product candidates ZG2001 and ZG0895 have both been accepted for review by the National Medical Products Administration (NMPA) in China. This marks a significant milestone in the development of these innovative drug…
•
China-based Innovent Biologics Inc., (HKG: 1801) has announced the first patient dosing in a Phase II clinical study for its IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in thyroid-associated ophthalmopathy (TAO). IBI311 is an IGF-1R-targeting monoclonal antibody independently developed by Innovent, marking a significant step in the…
•
China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the first subject enrollment in a Phase I clinical study for its tetravalent influenza virus split vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against influenza, particularly for individuals aged…
•
China-based Jiangsu Recbio Technology Co., Ltd has announced the completion of the first tranche of subject enrollment in a clinical study for its novel adjuvanted recombinant shingles vaccine, REC610. This milestone marks a significant step in the development of a vaccine designed to provide enhanced protection against shingles, particularly for…
•
China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced the initiation and first subject enrollment in a Phase I clinical study for its 20-valent pneumonia vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against pneumonia. Vaccine Development and…
•
Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step in the development…
•
China-based RemeGen Ltd (HKG: 9995) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate an open, single-center Phase Ib/II clinical study. The study will assess the safety, efficacy, and pharmacokinetics of its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin) combined with Hengrui pharmamceuticals’ pyrotinib, a…
•
China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has announced the first jab of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in Zhejiang. This recombinant protein vaccine is recommended by the national second dosage (fourth shot) booster immunization plan and is suitable for use in the elderly, immune-compromised individuals, and populations with complications.…
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced a licensing agreement with Massachusetts-based Corbus Pharmaceuticals Inc. The deal pertains to CSPC’s anti-nectin-4 antibody drug conjugate (ADC) SYS6002. Under the terms of the agreement, Corbus obtains development and commercialization rights to SYS6002 in the United States, EU, United Kingdom, Canada,…
•
China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its BA1106, an in-house developed CD25 monoclonal antibody (mAb). The study, filed by subsidiary Shandong BoAn Biotechnology Co., Ltd, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of…