-
Huahai Pharmaceutical’s HB0028 and HB002.1T Cleared for Clinical Study by NMPA
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clearance from the National Medical Products Administration (NMPA) for its investigational drugs HB0028 and HB002.1T. The drugs are set to enter clinical studies, either in combination with or without standard chemotherapy, for the treatment of advanced…
-
Hengrui Pharmaceuticals Receives NMPA Approval for HRS-6768 Clinical Trial
•
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HRS-6768. This approval allows the company to proceed with testing the drug in patients with advanced solid tumors. Innovative Radiation Therapy for…
-
Thederma’s TAN-118 Receives Tacit Clinical Approval from China’s CDE for Global Trials
•
Shanghai-based Thederma has announced that its drug candidate TAN-118 has obtained tacit clinical approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This follows the clearance received from the US FDA in October of the previous year, indicating that TAN-118, an AhR…
-
Grand Pharmaceutical Initiates Study on GPN00289 for Liver Cancer Treatment
•
China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the first patient enrollment in a regulatory study designed to assess the safety and efficacy of GPN00289. This innovative temperature sensitive embolic product is intended for use in arterial chemoembolization of primary liver cancer. GPN00289: An Innovative Medical Device for…
-
SCG Cell Therapy’s SCG142 Receives NMPA Approval for HPV-Related Solid Tumor Clinical Trial
•
SCG Cell Therapy Pte. Ltd, a Singapore-based company with a presence in Shanghai, has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SCG142. This human papillomavirus (HPV) specific T cell receptor (TCR) therapy is set to be tested in a range of HPV-related…
-
Huadong Medicine’s HDM1005 Receives NMPA Approval for MAFLD/MASH Clinical Trial
•
Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 receptor and GIP receptor and will be tested in metabolic associated fatty liver disease (MAFLD) and…
-
Alphamab Oncology’s JSKN033 Advances to Phase III Trial for Platinum Resistant Ovarian Cancer
•
China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III study for its drug candidate JSKN033. The study will compare JSKN033 against the investigator’s choice of chemotherapy in…
-
Frontera Therapeutics Advances to Phase II with FT-003 for Diabetic Macular Edema
•
Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). This follows previous clearance for a Phase II…
-
Novartis Announces Positive Results from Phase III STEER Study on SMA Treatment
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive topline results from the Phase III STEER study, which was designed to assess the efficacy and safety of its intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2. The study focused on patients aged two…
-
Jiangxi Jemincare Group Gets NMPA Approval for Prostate Cancer Drug JMX-2006
•
China-based Jiangxi Jemincare Group has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) to test its Category 2.2 modified drug, JMX-2006, in prostate cancer. JMX-2006: An Innovative Sustain-Released Preparation for Prostate CancerJMX-2006 is an innovative sustain-released preparation designed to offer less frequent dosages,…
-
CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2219 in China
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of an investigator-initiated-trial (ITT) for its chimeric antigen receptor (CAR)-T therapy candidate product, KJ-C2219, in China. The trial is aimed at treating recurrent/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). KJ-C2219: A Universal CAR-T Therapy Targeting CD19 and CD20KJ-C2219 is a…
-
Hinova Pharmaceuticals’ HP568 Earns FDA Clinical Trial Approval for ER+/HER2- Breast Cancer
•
Chengdu-based biotech Hinova Pharmaceuticals Inc., (SHA: 688302) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, HP568. The Chinese firm plans to test HP568 in patients with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative…
-
CSPC Pharmaceutical Group Receives NMPA Approval for SYH9016 Clinical Study in Solid Tumors
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its GnRH receptor agonist, SYH9016, in the treatment of solid tumors. SYH9016: A Modified Leuprorelin Product for Solid TumorsSYH9016 is a novel modified…
-
HitGen Inc. Initiates Phase II Clinical Trial for HG146 in Adenoid Cystic Carcinoma
•
China-based HitGen Inc. (SHA: 688222) has announced the commencement of the first patient enrollment in a Phase II clinical study for its Category 1.1 anti-tumor drug, HG146. This study focuses on the treatment of recurrent or metastatic adenoid cystic carcinoma, a rare and aggressive form of cancer. HG146: A Promising…
-
Hinova Pharmaceuticals Enrolls First Patient in Phase II Study for HP518 in mCRPC
•
China-based biopharma Hinova Pharmaceuticals has announced the enrollment of the first patient in an open, multi-center Phase II study assessing the safety, pharmacokinetics, and anti-tumor activity of its Category 1 chemical drug, HP518, in patients with metastatic castration resistant prostate cancer (mCRPC). Innovative Mechanism of Action for HP518HP518 is an…
-
![China Isotope & Radiation Corporation’s [18F] Piramide Receives NMPA Clinical Trial Approval](https://flcube.com/wp-content/uploads/2024/12/122701.png)
China Isotope & Radiation Corporation’s [18F] Piramide Receives NMPA Clinical Trial Approval
•
On December 24, 2024, China Isotope & Radiation Corporation (HKG: 1763) announced that its subsidiary, HTA Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for their Class 1 innovative drug, [18F] Piramide Injection. [18F] Piramide: A PET Imaging Agent for Enhanced Melanoma…
-
Shanxi C&Y Pharmaceutical Initiates Clinical Study for Generic Ferric Maltol with NMPA Approval
•
China’s Shanxi C&Y Pharmaceutical Group Co., Ltd (SHE: 300254) has announced the initiation of a clinical study for its generic version of UK firm Shield TX（UK）Limited’s iron supplement ferric maltol, following approval from the National Medical Products Administration (NMPA). The study aims to evaluate the drug’s efficacy in treating iron…
-
Boji Medical Technology Receives NMPA Approval for TBA Clinical Study in Drug-Resistant Tuberculosis
•
China-based Clinical Research Organization (CRO) Boji Medical Technology Co., Ltd. (SHE: 300404) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for TBA, a novel treatment for drug-resistant pulmonary tuberculosis. TBA: A New Approach to Combating Drug-Resistant TuberculosisThe Category 1 chemical drug, co-developed…
-
Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for Prostate Cancer and Solid Tumor Clinical Trials
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA). One trial will test the combination of HRS-4357 with ADT and a novel androgen receptor pathway inhibitor for prostate cancer. The other trial will assess SHR-4602 in combination with…
-
Zelgen Biopharmaceuticals’ ZG005 Gets NMPA Green Light for Solid Tumor and Lymphoma Clinical Trial
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical approval from the National Medical Products Administration (NMPA) to test its Category 1 biologic product, ZG005, in combination with gecaicitinib for the treatment of advanced solid tumors and recurrent refractory lymphomas in China. ZG005: A Pioneering Bispecific Antibody for…
