•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) former subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a significant milestone. The company’s generic version of AbbVie’s (NYSE: ABBV) bimatoprost and timolol maleate eye drops has been granted approval in China. This approval is for use in lowering the intraocular pressure of patients…
•
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug limaprost. This therapeutic drug targets analgesia and microcirculation, addressing a significant health issue among the country’s population. Lumbar Spinal Stenosis: A Prevalent ConditionTubular stenosis, particularly lumbar spinal…
•
Cell and gene therapy (CGT) specialist Biosyngen Pte Ltd has announced receiving approval from the US FDA to initiate a Phase I/II clinical study for its BRG01, an autologous T cell therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC). This marks a significant milestone in the development of innovative…
•
Shanghai-based BRL Medicine Inc. has announced a significant breakthrough in the treatment of thalassemia major. The company reported the first cure in a multi-center Phase clinical study assessing the safety and efficacy of its BRL-101, an autologous hematopoietic stem progenitor cell therapy. This marks a major milestone in the development…
•
China-based Immuno Cure BioTech has announced the initiation of a Phase I clinical study for its ICVAX, a therapeutic vaccine against HIV/AIDS, in Shenzhen. This marks a significant step forward in the development of innovative treatments for HIV/AIDS, a condition that affects millions of people globally. Study Design and ObjectivesThe…
•
Zhejiang’s Provincial Center for Drug & Medical Device Procurement has issued a notification suspending the online trading qualifications for generic versions of Takeda’s (TYO: 4502) Nesina (alogliptin). The notice specifically targets products manufactured by Jiangsu Zhongtian Pharmaceutical Co., Ltd and Sinopharm Guorui Pharmaceutical Co. Ltd. This suspension is part of…
•
The Center for Drug Evaluation (CDE) website indicates that China-based Wuhan Binhui Biotechnology Co., Ltd’s GM-CSF oncolytic herpes simplex virus type II (OH2) for injection (Vero cells) has been awarded breakthrough therapy designation (BTD) status. This designation is for the treatment of patients with unresectable or metastatic melanoma who have…
•
The Center for Drug Evaluation (CDE) website indicates that Japan-based Eisai’s (TYO: 4523) lecanemab has been awarded priority review status. The drug falls under the category of “clinically urgent shortage drugs and innovative and modified drugs for the prevention and treatment of major infectious diseases and rare diseases.” This designation…
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate a clinical study for the antibody drug NBL-020. This marks a significant step forward in the development of new treatments for advanced solid tumors. NBL-020: Anti-Tumor Necrosis Factor Type…
•
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…