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Belief BioMed Group Initiates Clinical Study for Hemophilia A Gene Therapy BBM-H803 in China
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Belief BioMed Group, a Shanghai-based gene therapy specialist, has announced the first subject dosing in a regulatory clinical study for its in-house developed adeno-associated virus (AAV) gene therapy, BBM-H803, for the treatment of hemophilia A in China. This marks a significant step forward in addressing the unmet medical need for…
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ImmunoTech Biopharm Commences Patient Enrollment in Phase II Study for CAR-T-19 Injection
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ImmunoTech Biopharm Ltd, a China-based specialist in chimeric antigen receptor T-cell (CAR-T) therapies (HKG: 6978), has announced the enrollment of the first patient in a Phase II clinical study for its CAR-T-19 injection. The treatment is under development for children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).…
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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity Treatment
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Innovent Biologics Inc., a biopharmaceutical company based in China (HKG: 1801), has announced the first patient dosing in the Phase III GLORY-2 study, which is assessing the higher dose 9mg version of mazdutide (IBI362) for the treatment of obesity in Chinese adults. Mazdutide is a dual agonist drug candidate targeting…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its novel injectable PLAT001, intended for the treatment of advanced or metastatic solid tumors, including pancreatic cancer. PLAT001, a groundbreaking nanomedicine,…
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Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject enrollment in its Phase IIb clinical study for MRG003, its flagship product targeting recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The randomized, open-label, multi-center pivotal study aims to evaluate the efficacy and safety of this epidermal growth…
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Konruns Pharmaceutical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for KC1036 in combination with a programmed-death 1 (PD-1) inhibitor as first-line maintenance therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). KC1036, a…
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Simcere Affiliate Shanghai Simnova Biotech Gets China Nod for CAR-T Therapy SNC109
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Shanghai Simnova Biotech Co., Ltd, known as Simnova outside of China and an affiliate of Simcere Investment Group, has received tacit clinical trial approval from Chinese authorities for its SNC109, an in-house developed treatment for recurrent glioblastoma. SNC109 is a dual chimeric antigen receptor (CAR)-T cell therapy designed on Simnova…
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Shouyao Holdings Receives Ethical Approval for Phase III Study of ALK Inhibitor SY-3505
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received ethical approval to conduct a pivotal Phase III clinical study for its third-generation anaplastic lymphoma kinase (ALK) inhibitor, SY-3505. The study is a randomized, controlled, multi-center trial designed to assess the efficacy and safety of SY-3505…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
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China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of its Category 1 chemical drugs in China and the United States, with indications spanning cancer, kidney diseases, and infectious diseases. JMKX003801, approved for study in China for severe infections caused by Gram-negative bacteria, has demonstrated…
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Asieris Pharmaceuticals Gets Australian Greenlight for Acinetobacter Infection Drug Trial
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has received approval in Australia to commence a Phase I clinical study for its drug candidate APL-2301 (MET-102, formerly ASN-1733), which targets Acinetobacter baumannii infections. The study will evaluate the safety, tolerability, and pharmacokinetics of APL-2301 in healthy subjects…
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Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai…
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Jiangsu Nhwa Pharmaceutical Gets NMPA Green Light for Schizophrenia Drug Trial
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Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, NH300231, which is intended for the treatment of schizophrenia. This next-generation atypical antipsychotic drug is characterized as…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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RemeGen’s Telitacicept Secures FDA Approval for Global Phase III Study in Primary Sjogren’s Syndrome
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to proceed with a global multi-center Phase III clinical study for its fusion protein drug telitacicept in the treatment of active primary Sjogren’s syndrome (pSS). This 48-week, multi-center, randomized, double-blinded, placebo-controlled Phase…
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RemeGen Ltd Receives FDA Clearance for MSLN-Targeting ADC RC88 in Gynecological Tumors
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) RC88, which targets mesothelin (MSLN) in gynecological tumors. This approval paves the way for global multi-center Phase II clinical trials to…
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Konruns Pharmaceutical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate KC1036 in advanced Juventus sarcoma for adolescents aged 12 and above. KC1036, a tyrosine kinase inhibitor (TKI) that targets AXL, VEGFR2, and FLT3, is…
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3SBio Subsidiary Gets Green Light for SSGJ-608 Ankylosing Spondylitis Study
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has received approval from the US Food and Drug Administration (FDA) to conduct separate Phase II clinical studies for its drug candidate SSGJ-608. The molecule is set to be evaluated as a treatment for ankylosing spondylitis (AS)…
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Lynk Pharmaceuticals Initiates Phase III Clinical Trial for Rheumatoid Arthritis Drug in China
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China-based Lynk Pharmaceuticals Co., Ltd has announced that the first patient has been dosed in a Phase III clinical study for its drug candidate LNK01001, which is being developed to treat rheumatoid arthritis (RA). The trial is supported by Lynk’s commercialization partner, Simcere Pharmaceutical Group (HKG: 2096), and is being…
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Sirnaomics Ltd Granted FDA Approval for Phase I RSV mRNA Vaccine Study
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Sirnaomics Ltd (HKG: 2257) has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its mRNA vaccine candidate RV-1770, targeting the respiratory syncytial virus (RSV) to prevent infections in adults. The study will involve the administration of three different doses (50mg,…
