-
Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
•
Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
-
BlissBio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
•
BlissBio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors, signifying…
-
Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
-
Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
-
China’s NMPA Approves Pilot Plan to Streamline Clinical Trial Reviews for Innovative Drugs
•
In a meeting chaired by Party Secretary and Director of the National Medical Products Administration (NMPA) Li Li on July 30, 2024, the “Pilot Work Plan for Optimizing Clinical Trial Review and Approval of Innovative Drugs” was given the green light. The initiative aims to enhance the quality and efficiency…
-
Sichuan Huiyu’s HY07121 Antifungal Protein Earns NMPA Review for Clinical Trials
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for HY07121, an innovative antibody fusion protein targeting PD-1, TIGIT, and IL-15 for the treatment of advanced solid tumors. The drug candidate, classified as…
-
Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
-
Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
•
Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
-
AIM Vaccine Submits Pre-IND Applications for mRNA Vaccines Targeting RSV and Herpes Zoster to NMPA
•
AIM Vaccine Co., Ltd (HKG: 6660), a biopharmaceutical company based in China, has announced the submission of pre-Investigational New Drug (pre-IND) filings to China’s National Medical Products Administration (NMPA) for two of its mRNA vaccine candidates. These candidates target the respiratory syncytial virus (RSV) and herpes zoster, respectively. RSV infection…
-
Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
-
InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
•
InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s…
-
Sino-US Laekna’s LAE102 Clinical Trial Filing Accepted for Review in Obesity and Metabolic Disorders
•
Sino-US Laekna (HKG: 2105) has announced that its clinical trial application for LAE102, an antibody targeting adult obesity and metabolic disorders, has been accepted for review by the Center for Drug Evaluation (CDE). LAE102 is a potent and selective monoclonal antibody against ActRIIA, known for its regulatory roles in tumor…
-
Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
•
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
-
Everest Medicines Secures IND Review for Zetomipzomib in China
•
Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for zetomipzomib has been accepted for review by China’s National Medical Products Administration (NMPA). Zetomipzomib is a first-in-class selective immunoproteasome inhibitor currently under development for a variety of autoimmune diseases, including lupus nephritis and systemic lupus erythematosus…
-
Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter
•
Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance. The…
-
SinoMab BioScience’s Suciraslimab IND Accepted for Review by China’s NMPA
•
SinoMab BioScience Ltd (HKG: 3681), a Hong Kong-based biotechnology company, has announced that the National Medical Products Administration (NMPA) in China has accepted its Investigational New Drug (IND) filing for suciraslimab for review. The company anticipates initiating a Phase I clinical study for the drug in the treatment of early…
-
Sirius Therapeutics Pursues First-in-Human Trial for SRSD107 in Australia
•
Sino-US biotech Sirius Therapeutics has announced its pursuit of Investigational New Drug (IND) approval in Australia to conduct a first-in-human clinical trial for its pipeline candidate, SRSD107. This next-generation small interfering RNA (siRNA) therapeutic is under development for the treatment of thromboembolic disorders and targets coagulation factor XI (FXI). Notably,…
-
Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
•
Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment…
-
Jiangsu Aidea’s HIV-1 Drug ACC017 Accepted for NMPA Review in China
•
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 drug, ACC017, for the treatment of HIV-1 infection in combination with other antiretroviral drugs. Mechanism and Pre-Clinical FindingsACC017 is a human immunodeficiency virus…
-
Shanghai Fudan-Zhangjiang’s ADC FZ-AD005 Accepted for NMPA Review in Advanced Solid Tumors
•
China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National Medical Products Administration (NMPA) has accepted a Phase I clinical trial filing for its investigational drug FZ-AD005 in advanced solid tumors. This marks a significant step forward in the development of novel cancer therapies in…
-
Haisco Pharmaceutical’s HSK21542 Accepted for NMPA Review in Postoperative Pain Management
•
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing for HSK21542, a Category 1 drug, in postoperative analgesia for abdominal surgery has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of HSK21542,…
-
Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
•
China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational New Drug (IND) filing for its novel injectable PL002 has been accepted for review by the US Food and Drug Administration (FDA). The drug is indicated for preoperative diagnosis and intraoperative navigation in patients with…
-
Healthstar Medical’s KC1036 Pediatric Indication Accepted for NMPA Review
•
Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 chemical drug, KC1036, for a pediatric indication. This development signifies a significant step forward in the exploration of new treatment options for pediatric…
-
Sino Biopharmaceutical Submits IND Application for AT2R Antagonist TRD205 to FDA
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biotech company, has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its AT2R antagonist, TRD205. The drug is intended to address neuropathic pain, a common and debilitating chronic condition that significantly…
-
Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
-
Hybio Pharmaceutical’s Semaglutide Clinical Trial Filing Accepted by China’s NMPA
•
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for semaglutide, a Category 2.2 product. Category 2.2 products in China are new formulations of known drugs that aim to offer a demonstrable clinical benefit over the originator…
