-
Shanghai Escugen Receives NMPA Approval for Second Phase III Trial of ESG401 in TNBC
•
Shanghai Escugen, a China-based biopharmaceutical company, has announced receiving the green light from the National Medical Products Administration (NMPA) to proceed with a second Phase III study for its antibody drug conjugate (ADC), ESG401. The study will focus on unresectable locally advanced, recurrent, or metastatic PD-L1 negative triple negative breast…
-
Haisco Pharmaceutical’s HSK46575 Receives NMPA Approval for Prostate Cancer Clinical Trial
•
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK46575, which is intended for the treatment of prostate cancer. HSK46575: A Promising Oral Small Molecule InhibitorHSK46575 has demonstrated significant therapeutic…
-
Sichuan Kelun-Biotech’s SKB500 Receives NMPA Clinical Clearance for Solid Tumor Treatment
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, (HKG: 6990), a leading biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its novel drug candidate, SKB500. This development marks a significant step forward in the advancement of the company’s pipeline. SKB500:…
-
Shanghai Henlius Biotech’s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study
•
Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase…
-
Guangzhou Virotech’s Oncolytic Virus M1 Receives Tacit Clinical Approval from NMPA
•
Guangzhou Virotech Pharmaceutical Co., Ltd., a China-based pharmaceutical company, has announced receiving tacit clinical approval from the National Medical Products Administration (NMPA) for its oncolytic virus therapy, M1 (VRT106). This approval paves the way for an imminent Phase I clinical study in China, which will assess the safety, tolerability, pharmacokinetics,…
-
OncoC4, Inc. Receives FDA Clearance for AI-081, a PD-1 and VEGF Bispecific Antibody
•
US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its innovative bispecific antibody, AI-081, which targets both PD-1 and VEGF pathways. Composition and Mechanism of AI-081AI-081 is composed of proprietary high-affinity clinical-stage anti-PD-1 (AI-025) and anti-VEGF (AI-011) antibodies. This…
-
Abbisko Therapeutics Gets FDA Green Light for Phase I Study of ABSK131 Inhibitor
•
Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
-
Zhejiang Huahai Pharmaceutical Initiates Clinical Study for HB0056 in New Zealand
•
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521), through its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd., has announced the first subject dosing in a clinical study for its potential first-in-class drug, HB0056, in New Zealand. This marks a significant step forward in the development of this innovative therapy. HB0056: A Bispecific…
-
Ocumen Therapeutics’ OT-301 Phase III Denali Study Surpasses 140 Patient Enrollment in China
•
Chinese ophthalmology specialist Ocumen Therapeutics (HKG: 1477) has announced the enrollment of more than 140 patients in the second Phase III Denali study for its OT-301 (NCX470) in China. This follows the commencement of the first Phase III MontBlanc study for the drug in the United States in June 2020,…
-
Simcere Zaiming Launches Phase III Trial for SERD Inhibitor SIM0270 in Breast Cancer
•
Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the initiation of a Phase III study for SIM0270 (SCR-6852), an oral brain-penetrating selective estrogen receptor down-regulator (SERD) inhibitor. The study includes the first patient dosing and is designed to assess the anti-tumor effect and safety of SIM0270 in…
-
ImmuneOnco Biopharmaceuticals Receives NMPA Approval for Lupus Nephritis Phase II Study
•
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for its dual-target macromolecular drug, amulirafusp alfa (IMM0306), in lupus nephritis (LN). Dual-Targeting Therapy with IMM0306IMM0306 is a bispecific antibody (BsAb) that targets…
-
Jiangsu Kanion Pharmaceutical Gets NMPA Clearance for Oncolytic Virus Product KYS202003A
•
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational product, KYS202003A. The Chinese company is set to initiate a clinical study assessing this Category 1 biologic product for the treatment of advanced solid tumors.…
-
Sichuan Biokin Pharmaceutical’s BL-M08D1 ADC Receives NMPA Approval for Clinical Trials
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
-
Huadong Medicine Receives FDA Clearance for HDM1005 Clinical Study in Obstructive Sleep Apnea
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a clinical study assessing its HDM1005 in patients with obstructive sleep apnea (OSA) who are overweight or obese. HDM1005: A Dual GLP-1 and GIP Receptor AgonistHDM1005…
-
Huadong Medicine’s Arcalyst Receives NMPA Approval for Cryopyrin-Associated Periodic Syndromes
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Arcalyst (rilonacept), indicated for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs), including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). Understanding CAPS and Its SubtypesCAPS is a…
-
Jiangsu Kanion Pharmaceutical Secures NMPA Approvals for KYHY2302 and KYHY2303
•
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
-
Phil Rivers Technology Secures IND Approval for PR00012 from NMPA’s CDE
•
Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
-
Jiangsu Hengrui Medicine’s SHR-1819 Receives NMPA Approval for Atopic Dermatitis Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel monoclonal antibody, SHR-1819. This injectable treatment can now proceed to Phase Ib/II studies, focusing on atopic dermatitis (AD) in children and adolescents aged 6-17…
-
Sichuan Huiyu Pharmaceutical’s HY-2003 Approved for Clinical Trials by China’s NMPA
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 modified drug, HY-2003. This drug is designed to improve moderate to severe contour protrusion caused by subcutaneous fat accumulation…
-
Nasal-Phyto Pharmaceutical Receives FDA Clearance for First-Ever Olfactory Drug-Device Combo
•
China-based Nasal-Phyto Pharmaceutical Technology Group Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its NPRD003, the world’s first precision olfactory area constant flow drip drug-device combination product. The product is indicated for the treatment of cerebral vasospasm secondary to subarachnoid hemorrhage (SAH).…
