Recently, on May 25, 2026, the NMPA (National Medical Products Administration) released the latest drug notification letter delivery information, which included GlaxoSmithKline’s (GSK) investigational new drug Bepirovirsen injection (Bepirovirsen, GSK3228836, GSK836) for the treatment of chronic hepatitis B, with acceptance…
On June 4 local time, the ClinicalTrials website showed that Hengrui Medicine registered a Phase III clinical trial of HRS-7535 for the treatment of chronic kidney disease (CKD) . This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III study designed…
Roche’s Obinutuzumab Injection (Brand Name: Gazyvaro®/Gazyva®) has been granted priority review by the CDE for the treatment of primary membranous nephropathy (pMN). In February of this year, Roche announced that the study met its primary endpoint: the proportion of patients…
On June 4 local time, the ClinicalTrials website showed that SystImmune, a wholly-owned subsidiary of Baili Tianheng, registered a Phase III clinical trial of BL-M14D1 in combination with Tecentriq for the first-line treatment of extensive-stage small cell lung cancer. According…
This morning, Qihan Biotech reported preliminary positive clinical data for its in vivo CAR-T therapy. Qihan Biotech did not disclose specific information about its in vivo CAR-T pipeline. It is only known that the company’s first in vivo CAR-T program…
Lupeng Pharmaceutical’s BTK inhibitor Rocbrutinib granted priority review and conditional approval. Rocbrutinib is the world’s first fourth-generation BTK inhibitor with a dual covalent and non-covalent binding mechanism. It was developed by Lupeng Pharmaceutical using its proprietary BeyondX® platform and is…
The drug’s New Drug Application (NDA) was formally accepted and subsequently approved by the NMPA via priority review and conditional approval mechanisms. VC004 is the first approved Category 1 innovative chemical drug from Jiangsu Vcare PharmaTech. It is specifically designed…
The National Medical Products Administration (NMPA) recently granted conditional approval to Otsuka Pharmaceutical Co., Ltd. for Sibeprenlimab Injection (subcutaneous injection) (brand name: Voyxact) through a priority review and approval process. The drug is indicated for reducing proteinuria in adult patients…
The Category 1 new drug Bemiltenase Alfa for injection, developed by Staidson’s subsidiary Jiangsu Beijietai Biotechnology Co., Ltd., has been granted conditional marketing approval. Bemiltenase Alfa for injection is a global first-in-class coagulation Factor X activator (a domestic Category 1…
On June 4, according to the latest announcement on the official website of the CDE, the New Drug Application (NDA) for IBI343, a Class 1 novel drug independently developed by Innovent Biologics, has been formally accepted. The proposed indication is…