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Zhejiang Huahai’s HB0056 Approved for US Phase I Asthma Trial
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its HB0056. This injectable bispecific antibody (BsAb) targets thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11) and is now cleared to enter Phase I clinical study in asthma.…
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Hengrui’s HER2-Targeted ADC and Antibody Drug Combo Approved for Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer. SHR-A1811:…
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CSPC’s SYS 6043 Receives FDA Approval for Clinical Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its in-house developed SYS 6043 has obtained clinical trial approval from the US Food and Drug Administration (FDA). This approval marks a significant step forward in the development of innovative treatments for advanced/metastatic solid tumors. Clinical Trial Scope and ObjectivesThe…
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Innovent’s Limertinib Wins NMPA Approval for NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its limertinib. This third-generation EGFR TKI has been approved for use in adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer…
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HutchMed’s Orpathys Approved for Expanded NSCLC Indication in China
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration (NMPA) has approved another indication for its Orpathys (savolitinib). This approval means that the MET inhibitor can now be used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with…
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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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Wepon Medical’s WP107 Receives FDA Approval for gMG Clinical Trial
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China-based Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed WP107 (huperzine A). The acetylcholinesterase inhibitor is slated to enter a clinical study for the treatment of generalized myasthenia gravis (gMG). WP107: Preclinical…
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Fosun Pharma Initiates Phase II Study for Glomerular Disease Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II study for its Category I chemical drug, XH-S003, in glomerular diseases related to abnormal complement activation, such as IgA nephropathy in China. This marks a significant step forward in the development of…
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Hengrui’s SHR-9839 Receives NMPA Clearance for Advanced Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its SHR-9839 subcutaneous (SC) injection in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced malignant tumors. SHR-9839:…
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Chongqing Genrix’s Silevimig NDA Accepted for Rabies Immunization Review
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) has announced that a New Drug Application (NDA) filing for its silevimig (GR1801) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is intended for passive immunization in adults…
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Hengrui and Kailera Announce Positive Phase II Results for HRS9531 in Weight Loss
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) and its US partner Kailera Therapeutics, Inc. have jointly announced positive results from a Phase II weight loss study for HRS9531, a GLP-1/GIP receptor dual agonist. The study evaluated the drug at an 8 mg dose, which achieved significant weight loss and…
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Leqembi Autoinjector Advances with FDA Review for Alzheimer’s Treatment
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) for review. The application seeks approval for the treatment of Alzheimer’s disease (AD) in patients with…
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Novo Nordisk Launches Rybelsus in China, World’s First Oral GLP-1RA
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has announced the commercial launch of its innovative diabetes treatment, Rybelsus (semaglutide), in China. This marks a significant milestone for the company as it expands its presence in the Chinese market. Rybelsus: A First-in-Class TherapyRybelsus holds the distinction of being the world’s first…
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Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or…
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Huadong Medicine Gets FDA Nod for Phase I Study of HDM2006 in Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its Category 1 chemical drug, HDM2006, in patients with advanced solid tumors. This marks a significant step forward in…
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Zhaoke Ophthalmology Partners with AFT for Brimochol PF Distribution in ANZ
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China-based Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a strategic distribution and supply agreement with New Zealand-headquartered AFT Pharmaceuticals Limited, a leading healthcare product manufacturer and distributor. The agreement pertains to Brimochol PF, a fixed dose of carbachol and bromonidine tartrate that is preservative free, co-developed by Tenpoint Therapeutics Ltd.…
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Tonghua Dongbao Begins Phase II Trial for GLP-1/GIP Agonist THDBH120 in Weight Loss
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced a significant milestone in its clinical development program with the first patient dosing in the Phase II clinical study of THDBH120. This study is designed to assess the efficacy and safety of the GLP-1/GIP dual-targeted receptor agonist in weight loss applications. THDBH120…
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CSPC’s Prusogliptin Approved in China for Type 2 Diabetes Treatment
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China’s National Medical Products Administration (NMPA) has granted marketing approval to CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) for its drug prusogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The approval is for the drug’s use in improving blood sugar control among adult patients with type 2 diabetes (T2D). Mechanism of ActionPrusogliptin…
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JW Therapeutics’ Carteyva Granted Breakthrough Therapy Designation by CDE
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China-based JW Therapeutics (HKG: 2126) has announced that its Carteyva (relmacabtagene autoleucel injection) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation recognizes the potential of Carteyva as a second-line treatment for adults with relapsed or refractory…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
