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Fosun Pharma Gains NMPA Approval for Phase I Trial of XS-03 in Advanced Solid Tumors
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, XS-03. This study will focus on evaluating the drug’s efficacy in…
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Cutia Therapeutics’ CU-20401 Completes Phase I Study for Obesity Treatment
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China-based dermatology specialist Cutia Therapeutics (HKG: 2487) has announced the last subject out (LSO) in a Phase I study for its potential Category 1 drug, CU-20401. This recombinant mutant collagenase is being developed for the treatment of obesity and other metabolic diseases related to local fat accumulation, marking a significant…
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China Grand Pharma Initiates Phase III Trial for GPN00833 in Cataract Surgery Recovery
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced a significant milestone in the clinical development of GPN00833, with the first patient enrolled and dosed in a Phase III study. This multi-center, randomized, double-blinded, placebo-controlled, parallel group study is designed to assess the efficacy and safety of…
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Sihuan Pharmaceutical Gains NMPA Approval for Innovative Type 2 Diabetes Treatment
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its insulin degludec, liraglutide to treat type 2 diabetes. This marks a significant step forward in the development of novel treatments for diabetes in China.…
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Jiangsu Aidea’s HIV-1 Drug ACC017 Accepted for NMPA Review in China
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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…
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Shandong Luoxin’s LX-039 Demonstrates Promise in Phase I Oncology Study at ESMO
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Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a China-based pharmaceutical innovator, has published data from a Phase I clinical study for its novel anti-tumor drug, LX-039. This oral selective estrogen receptor modulator (SERD) was in the spotlight at the European Society for Medical Oncology (ESMO) Congress 2023, where…
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Kintor’s Proxalutamide Shows Promise in Metastatic Breast Cancer Study at ESMO
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published the latest data from a Phase Ic clinical study evaluating its proxalutamide in combination with endocrine therapies (ETs) for metastatic breast cancer. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023, shedding light on the drug’s potential…
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Walvax Biotechnology Secures BPOM Approval for Weuphoria Pneumococcal Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received market approval from the Indonesian Food and Drug Control Agency (BPOM) for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval is a significant milestone for Walvax as it expands its reach into the Indonesian…
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Ascentage Pharma’s Pelcitoclax Shows Promise in ESMO Study for NSCLC
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Suzhou-based pharmaceutical company Ascentage Pharma (HKG: 6855) has published the latest results from a Phase Ib study of its pelcitoclax (APG-1252), a dual inhibitor of BCL-2 and BCL-xL proteins, in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The findings were presented at…
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Changchun BCHT Biotechnology Invests in Influenza Vaccine Production Expansion
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China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced plans to invest RMB 805 million (USD 110 million) in the production of 10 million annual doses of its influenza virus split vaccine (BK-01 adjuvant). This substantial investment includes RMB 659 million for industrialization and RMB 146 million for operational…
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Yiling Pharmaceutical Gains NMPA Approval for XY0206 in AML Trial
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, XY0206. The drug is intended for use in treating acute myeloid leukemia (AML) with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal…
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Chengdu Kanghong Receives FDA Nod for Clinical Trial of Novel Depression Therapy KH607
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced that it has received approval from the US FDA for a clinical trial of its novel depression therapy, KH607. This marks a significant milestone for the company as it advances its innovative treatment through the regulatory pipeline in the…
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Transcenta Holdings Unveils Updated Osemitamab Data in Advanced Gastric Cancer at ESMO
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) has presented updated efficacy data from the expansion cohort of the TranStar102 trial at the ESMO Congress 2023 in Madrid, Spain. The trial assessed osemitamab (TST001), a high affinity humanized anti-CLDN18.2 monoclonal antibody (mAb) with enhanced antibody-dependent cellular cytotoxicity (ADCC), in combination with…
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Vcanbio Receives NMPA Approval for Clinical Study of VUM02 in SR-aGvHD Treatment
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China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its VUM02, a Category 1 therapeutic biologic product. This human umbilical cord-derived mesenchymal stem cell therapy is intended…
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Alphamab Oncology Presents Promising Data for KN046 and KN026 at ESMO 2023
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China-based Alphamab Oncology (HKG: 9966) has released data snapshots from clinical studies for two of its pipeline candidates, KN046 and KN026, at the European Society for Medical Oncology (ESMO) Congress 2023. These bispecific antibodies (BsAbs) are being evaluated for their efficacy and safety in treating various types of cancers, with…
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Janssen’s TAR-200 Shows High Complete Response Rate in Bladder Cancer Study
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has published data from a Phase IIb study demonstrating the efficacy of its intravesical gemcitabine delivery system, TAR-200, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) carcinoma in situ-positive. The study results are a significant step forward in the…
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Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
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Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III study evaluating the CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy for stage II and III HR+/HER2- early breast cancer (EBC). The findings confirm that the combination therapy significantly improves invasive disease-free survival (iDFS)…
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Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
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Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal vaccine, Penbraya, with the US Food and Drug Administration (FDA). The vaccine is designed for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged…
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Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
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Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials. Previous…
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Shanghai Fudan-Zhangjiang’s ADC FZ-AD005 Accepted for NMPA Review in Advanced Solid Tumors
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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…
