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Sinocelltech Group Receives NMPA Approval for COVID-19 Vaccine Bridging Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study. The study will assess the safety and immunogenicity of SCTV01E-2, an S trimer protein vaccine developed to combat COVID-19. This vaccine is designed for individuals…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase III Studies of Gallium Edotreotide Injection
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with Phase III clinical studies for its gallium [68Ga] edotreotide injection and gallium [68Ga] edotreotide injection preparation kit. Gallium [68Ga]…
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Jacobio Pharma Reports Promising Clinical Results for KRAS G12C Inhibitor Gecirasib in CRC
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China-based Jacobio Pharma (HKG: 1167) has announced clinical results for its novel KRAS G12C inhibitor, glecirasib, in the treatment of KRAS G12C mutant advanced colorectal cancer (CRC). The findings were presented at the Second JCA-AACR Precision Medicine International Conference, showcasing the potential of glecirasib as both a monotherapy and in…
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Harbour BioMed’s Batoclimab for Generalized Myasthenia Gravis Accepted for NMPA Review
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Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands, and Suzhou, China, has announced that the National Medical Products Administration (NMPA) has accepted a biological license application for its batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). This development follows the positive…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-10518 Clinical Study in Endometriosis Pain
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HS-10518 (TU2670). The study will focus on the treatment of moderate to severe pain associated with endometriosis and menorrhagia associated with…
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Qilu Pharmaceutical’s Iruplinalkib Receives NMPA Approval for ALK+ NSCLC Treatment
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China-based Qilu Pharmaceutical has announced that its Category 1 chemical drug, iruplinalkib, an ALK inhibitor, has obtained marketing approval from the National Medical Products Administration (NMPA). This approval allows the use of iruplinalkib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor anaplastic lymphoma…
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Jiangsu Hengrui’s Oteseconazole (SHR8008) Approved by NMPA for Severe Vulvovaginal Candidiasis
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The National Medical Products Administration (NMPA) has granted approval to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) for its drug oteseconazole (SHR8008), which will be used to treat severe vulvovaginal candidiasis (VVC). This marks a significant advancement in the treatment options for patients suffering from VVC. Oteseconazole: A Selective…
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EOC Pharma’s Lusutrombopag Receives NMPA Approval for Chronic Liver Disease Treatment
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China-based EOC Pharma Group has announced that its drug, lusutrombopag, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of chronic liver disease (CLD) patients with thrombocytopenia. The drug is specifically indicated for patients being prepared for surgery, including diagnostic procedures. Lusutrombopag: An Oral TPO-RA…
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Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablets for AIS Accepted by NMPA for Review
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for edaravone, borneol sublingual tablets, a treatment for acute ischemic stroke (AIS). Edaravone, Borneol Sublingual Tablets: A Rapid-Acting Oral Preparation for AISThe edaravone, borneol sublingual…
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Shanghai Junshi Biosciences Gets FDA Approval for Phase III Study of Tifcemalimab in Small-Cell Lung Cancer
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a randomized, double-blind, placebo-controlled, global multi-center Phase III study for its drug tifcemalimab (TAB004/JS004) in combination with Tuoyi (toripalimab). This consolidation therapy is intended for patients with limited-stage small-cell…
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AIM Vaccine Receives NMPA Approval for mRNA Vaccine Clinical Study Targeting COVID-19 Variants
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I/II clinical study for its mRNA vaccine targeting COVID-19 variants Delta and Omicron BA.5. This development marks a significant step in the company’s efforts to combat the evolving…
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Shandong Buchang Pharmaceuticals’ BC001 Gets Clinical Trial Approval for Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced receiving clinical trial approval for its investigational injectable product BC001. The drug is intended for use in combination with pucotenlimab for the treatment of advanced solid tumors, including first-line HER-2 negative advanced or metastatic gastric cancer/adenocarcinoma at…
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Beijing Tiantan Biological Completes Phase I Study for Recombinant Coagulation Factor VIIa
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China-based Beijing Tiantan Biological Products Co., Ltd (SHA: 600161) has announced the conclusion of a Phase I clinical study for its recombinant human coagulation factor VIIa for injection. The company is now preparing for a Phase III study, which is expected to commence soon. This advanced treatment is aimed at…
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Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020. Phase I Study Design…
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Teva Pharmaceutical’s Copaxone Approved by NMPA for Multiple Sclerosis Treatment in China
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The National Medical Products Administration (NMPA) website has indicated that Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) innovative chemical drug Copaxone (glatiramer acetate) has been approved for use as a treatment for multiple sclerosis (MS) in China. This marks the second MS therapy available in China following Bristol-Myers Squibb (BMS, NYSE:…
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Daewoong Pharmaceutical Files NDA in China for Potassium-Competitive Acid Blocker Fexuclu
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South Korea-based Daewoong Pharmaceutical (KRX: 069620) has revealed that a new drug application (NDA) has been filed in China for Fexuclu/Abcito (fexuprazan) in a 40mg dosage form. Fexuclu, an in-house developed potassium-competitive acid blocker (P-CAB), represents a new generation of therapies for gastroesophageal reflux disease (GERD). Advantages of P-CABs Over…
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Insilico Medicine’s AI-Discovered Drug INS018_055 Reaches Phase II Clinical Trial Milestone
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China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has announced that its lead pipeline candidate, INS018_055, has completed first dosing in patients in a Phase II clinical trial. This small-molecule, oral anti-fibrotic drug, entirely generated by Insilico’s AI platforms, is hailed as the world’s first AI-discovered molecule to reach the…
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AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its fixed dose combination of dapagliflozin and metformin, a treatment for type 2 diabetes. This once-daily compound is now the only sustained-release formulation in China…
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LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
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The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm LianBio (Nasdaq: LIAN) has been awarded priority review status for its drug mavacamten. This status is for the treatment of adult patients with symptomatic New York Heart Association (NYHA) heart function II-III obstructive hypertrophic cardiomyopathy…
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CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its in-house developed Category 1 antibody, JMT203. This marks a significant step forward in the development of this novel treatment for cancer cachexia.…
