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Zelgen’s ZGGS15 Accepted for NMPA Review as First Global BsAb Filing
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that a clinical trial filing for its ZGGS15, a bispecific antibody (BsAb) targeting LAG-3 and TIGIT in advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone as ZGGS15 is touted…
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Kintor’s GT20029 Shows Positive Results in US Phase I Study for AGA and Acne
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive topline data from a Phase I clinical study in the United States for its GT20029, a treatment for androgenetic alopecia (AGA) and acne. This marks a significant step in the development of a novel treatment option for these common conditions. Phase…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug conjugate (ADC), is on course to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of unresectable or metastatic breast cancer with low…
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EOC Pharma’s CDK7 Inhibitor EOC237 Accepted for CDE Review
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EOC Pharma, a biotech operating out of the US and China, has announced that a clinical trial filing for its CDK7 inhibitor EOC237 has been accepted for review by the Center for Drug Evaluation (CDE) in China. This marks a significant milestone in the development of EOC237, which is expected…
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Joincare’s Generic Seretide Accepted for NMPA Review
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China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that the market filing for its generic version of GlaxoSmithKline’s (GSK, NYSE: GSK) Seretide (salmeterol, fluticasone) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for Joincare, which holds the first-mover…
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Everest Medicines’ Nefecon Included in South Korea’s GIFT Program
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China-based Everest Medicines (HKG: 1952) has announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has included the firm’s Nefecon (targeted-release formulation-budesonide) in the Global Innovative Fast Track (GIFT) program for the treatment of primary immunoglobulin A nephropathy (IgAN). This designation is a significant step in the development…
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Hinova’s HP530S Accepted for NMPA Review as FAK Inhibitor for Solid Tumors
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China-based biopharma Hinova Pharmaceuticals (SHA: 688302) has announced that a clinical trial filing for its HP530S, a highly active and selective focal adhesion kinase (FAK) inhibitor against solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of…
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Qilu Pharmaceutical’s QLS12004 Gains Tacit Clinical Trial Approval
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The Center for Drug Evaluation (CDE) website indicates that China-based Qilu Pharmaceutical’s Category 1 chemical drug candidate QLS12004 has obtained tacit clinical trial approval. This marks a significant step forward in the development of new treatments for solid tumors, including advanced breast cancer, which is the leading malignant cancer affecting…
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ImmVira’s MVR-T3011 IT Shows Efficacy in Melanoma Treatment
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Shenzhen-based biopharma ImmVira has revealed that its first intra-tumoral injection oncolytic virus (OV) product, MVR-T3011 IT, has produced positive signs of efficacy as a treatment for melanoma in late-stage patients who have failed previous immunotherapy. In a Phase II clinical study conducted in China and the United States, monotherapy treatment…
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Grand Pharma Completes Patient Enrollment for STC3141 Sepsis Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that all patients have completed enrollment and dosing in the Phase Ib REFINE study for its drug candidate STC3141 in sepsis in Australia and Belgium. The first data readout is expected in four months’ time, marking a significant milestone in the…
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SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has announced that a market approval filing has been made in Hong Kong for its Danyelza (naxitamab) in recurrent or refractory high-risk neuroblastoma. This marks a significant step in the global expansion of this innovative…
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Harbour BioMed’s Anti-CCR8 Monoclonal Antibody HBM1022 Receives FDA IND Approval
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Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its in-house developed HBM1022, a novel anti-C-C chemokine receptor type 8 (CCR8) monoclonal antibody (mAb). This marks a significant milestone in the…
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Eli Lilly’s Tirzepatide Achieves Primary Endpoints in Chinese Obesity Study
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US major Eli Lilly (NYSE: LLY) has announced that the Phase III SURMOUNT-CN study for its glucose-dependent insulinotropic polyptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide has reached the primary endpoint and all pivotal secondary endpoints in obese or overweight Chinese adults. The study demonstrated that the overall safety profile was…
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Gracell’s CAR-T Therapy GC012F Receives FDA IND Approval
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Shanghai-based biotech Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the US FDA for its chimeric antigen receptor (CAR) T cell candidate GC012F. This dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step forward in the development…
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Sanofi Reports Strong Q4 and Full-Year 2022 Financials with 7% Growth
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France’s Sanofi (EPA: SAN) released its financial report last week, showing turnover during Q4 and full-year 2022 at EUR 10.7 billion (USD 11.6 billion) and EUR 43.0 billion (USD 46.4 billion) respectively. This represents year-on-year (YOY) growth of 2.6% and 7.0% at constant exchange rates (CER). The results highlight Sanofi’s…
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Grand Pharma’s TLX101 Accepted for NMPA Review for Glioblastoma Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its TLX101, a radionuclide drug conjugate (RDC) being developed to treat glioblastoma multiforme, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development…
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BDgene’s CRISPR-Cas9 Therapy BD111 Accepted for CDE Review
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Shanghai BDgene Technology Co., Ltd has announced that a clinical trial filing for its BD111, a CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK), has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant step forward in the development of innovative…
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JunTop Biosciences’ COVID-19 Therapy Mindewei Priced at RMB 795 per Course
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Sichuan’s provincial Healthcare Security Administration bureau has notified that Shanghai JunTop Biosciences Co., Ltd’s COVID-19 therapy Mindewei (deuremidevir) is to be initially quoted at RMB 795 (USD 117.23) per treatment course. This pricing announcement marks the entry of Mindewei into the market, offering a new treatment option for mild to…
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Mabwell’s Novel ADC 9MW2921 Accepted for NMPA Review
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its novel antibody-drug conjugate (ADC) 9MW2921 has been accepted for review by the National Medical Products Administration (NMPA). The firm is seeking to assess the ADC as a treatment for general solid tumors, marking…
