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Yantai Dongcheng Pharmaceutical Gets Singapore HSA Nod for Phase I Study of 177Lu-LNC1003
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical study for its investigational drug, 177Lu-LNC1003. 177Lu-LNC1003: A Radiopharmaceutical for Advanced Prostate Cancer177Lu-LNC1003 is a radioactive in vivo therapeutic drug that targets prostate…
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Abbisko Therapeutics’ CD73 Inhibitor ABSK051 Clears for Phase I Clinical Trial in China
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD),…
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Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors. Objectives of the Phase I…
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Chengdu Kanghong Pharmaceutical’s KH629 Receives FDA Approval for NASH Clinical Trial
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, KH629, which is intended for the treatment of non-alcoholic steatohepatitis (NASH). KH629’s Profile and Previous…
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RinuaGene Receives US FDA IND Approval for HPV-Associated Tumor mRNA Vaccine RG002
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RinuaGene, a leading mRNA specialist headquartered in Suzhou, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) associated tumor therapeutic mRNA vaccine, RG002. This marks a significant step forward in the development of the vaccine,…
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MicuRx Pharmaceuticals Secures Clinical Trial Approvals for MRX-4 and Contezolid in Multiple Countries
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received clinical trial approvals for its novel anti-microbial agent MRX-4 in combination with contezolid (MRX-I) as a sequential treatment for diabetic foot infections. The approvals span several countries, including the United Kingdom, Turkey, Georgia, Argentina, and Chile. Both…
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Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
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IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6011 Biologic Drug Clinical Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic drug candidate, SYS6011. The study will be focused on general solid tumors, marking a significant step…
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Shanghai Pharmaceuticals Gets NMPA Approval for Phase I Clinical Study of B019 CAR-T Cell Injection
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for its proprietary B019 injection. B019 is a chimeric antigen receptor (CAR) autologous T cell injection that targets CD19…
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Hinova Pharmaceuticals’ HP518 Receives NMPA Approval for mCRPC Clinical Trial
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China-based biopharmaceutical company Hinova Pharmaceuticals (SHA: 688302) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) in China for its drug candidate HP518, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC). The androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug…
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Sino Biopharmaceutical’s TQG3902 Injection Receives NMPA Approval for Septic Shock Clinical Trial
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biotech company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its TQG3902 injection, which is under development to increase blood pressure in adults with septic shock or other distributed shock. This…
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Hainan Poly Pharm Receives FDA Approval for PL002 in Primary Liver Cancer Surgery
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received clinical trial approval from the US FDA for its novel injection candidate PL002. This innovative product is indicated for preoperative diagnosis and intraoperative navigation in patients with primary liver cancer. PL002 is an in-house developed bimodal…
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Changchun BCHT Biotechnology Receives NMPA Approval for Anti-Tetanus Monoclonal Antibody Injection
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China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its human anti-tetanus toxin monoclonal antibody (mAb) A82/B86 injection combination preparation. This innovative treatment is designed as a prophylactic against tetanus. Tetanus, a serious bacterial…
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Shenzhen Chipscreen Biosciences Gets NMPA Approval for Phase I Study of CS32582 in Psoriasis
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its investigational drug CS32582 in patients with psoriasis. This approval marks a significant step forward in the…
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Staidson Receives NMPA Approval for Clinical Trial of STSA-1301 in Primary Immune Thrombocytopenia
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its STSA-1301 subcutaneous injection. The drug is targeted for the treatment of primary immune thrombocytopenia (ITP), a condition characterized by a low…
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Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in…
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CSPC Pharmaceutical Group Gains NMPA Approval for Bivalent COVID-19 mRNA Vaccine Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bivalent COVID-19 mRNA vaccine SYS6006.32, targeting the XBB.1.5 and BQ.1 variants. Vaccine Development and ImmunogenicitySYS6006.32 is…
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Alphamab Oncology and 3D Medicines Gain FDA Approval for Envafolimab Phase III Trial
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Partners Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244) have announced that they have received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for envafolimab (KN035) in proficient mismatch repair (fMMR) advanced or recurrent endometrial cancer combined with lenvatinib. This approval…
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Fosun Pharma Gains NMPA Approval for Clinical Trials of HLX42 and HLX43 ADCs
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG:…
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TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.…
