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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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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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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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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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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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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 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 (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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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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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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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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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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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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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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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…
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Bristol-Myers Squibb (BMS, NYSE: BMY) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its ozanimod, a novel selective sphingosine-1-phosphate (S1P) receptor modulator. The drug is now approved to treat recurrent multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple…
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of December 31, 2022. This figure, yet to be independently audited,…
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Chinese ophthalmology specialist OcuMension Therapeutics (HKG: 1477) has announced the conclusion of a Phase I clinical study for its OT-202, a tyrosine kinase inhibitor (TKI) being developed to treat dry eye. This marks a significant step in the development of innovative treatments for this common condition. Study Design and ResultsThe…
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China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2. ATG-022: Mechanism and Preclinical…