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TYK Medicines Secures FDA Approval for Next-Generation TKI Clinical Trial
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China-based TYK Medicines, Inc. has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed next-generation tyrosine kinase inhibitor (TKI). This marks a significant step forward in the development of the company’s pipeline, with a separate clinical trial filing for…
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Yifan Pharmaceutical Receives NMPA Approval for Hyruan ONE in Knee Osteoarthritis Treatment
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced receiving market approval from the National Medical Products Administration (NMPA) for its in-licensed Category 5.1 drug Hyruan ONE (sodium hyaluronate), which is indicated for use in knee osteoarthritis. Hyruan ONE: A Single-Dose Preparation for Knee OsteoarthritisHyruan ONE, originally developed by LG…
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Yantai Dongcheng Pharmaceutical Gets Singapore Regulatory Approval for 177Lu-LNC1004 Phase I Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving the green light from the regulatory body in Singapore to initiate a Phase I clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets fibroblast activation protein (FAP) and is under development to treat FAP-positive advanced solid tumors. This…
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Vcanbio Receives CDE Approval for VUM02 Clinical Trial in Idiopathic Pulmonary Fibrosis
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product. The therapy is set to be assessed as a treatment for idiopathic…
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Haisco Pharmaceutical Gets CDE Approval for HSK38008 Prostate Cancer Clinical Study
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug, HSK38008 oral preparation, in the treatment of prostate cancer. HSK38008: An Androgen Mutant AR-V7 Oral Degradation AgentHSK38008 is an androgen mutant…
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Yiling Pharmaceutical’s G201-Na Receives CDE Approval for Phase Ia Study in Prostate Cancer Treatment
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a single-center, randomized, double-blind, placebo-controlled, dosage escalation Phase Ia study. The study will assess the safety, tolerability, and pharmacokinetics of G201-Na in healthy adult males in China. G201-Na: A Small…
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Mabwell’s 9MW2821 ADC Shows Positive Signals in Solid Tumor Clinical Data
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced preliminary clinical data for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data demonstrated positive therapeutic signals in multiple solid tumors and exhibited a good safety profile at the recommended Phase II dosage (RP2D). Mechanism of Action and Pharmaceutical…
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AffaMed Digital Initiates Clinical Study for AMD201 at Beijing Tiantan Hospital
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AffaMed Digital, a company wholly owned by AffaMed Technologies—a joint venture between AffaMed Therapeutics and SIFI S.p.A.—has announced the first patient enrollment in a clinical study for its AMD201 at the Beijing Tiantan Hospital. This marks a significant step in the development of digital therapies for post-stroke cognitive impairment (PSCI).…
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Corxel Pharmaceuticals’ OC-01 Nasal Spray Approved as Urgently Needed Drug in Hainan
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Shanghai-based Corxel Pharmaceuticals (CORXEL), supported by RTW Investments, has announced that its OC-01 (varenicline) nasal spray has been approved by the Hainan Medical Products Administration as a clinically urgently needed import drug in Bo’ao Super Hospital. This marks a significant milestone as the product is the world’s first and only…
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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated…
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Everest Medicines’ Nefecon NDA Accepted for Review by Singapore’s HSA
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China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore has accepted for review the New Drug Application (NDA) for its Nefecon (targeted-release formulation-budesonide) for adult patients with IgA nephropathy at risk of disease progression. The drug is anticipated to receive approval within the year.…
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Hutchison China Meditech Initiates Two Phase II Studies for HMPL-453 and Orpathys
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China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor…
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CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its programmed death-ligand 1 (PD-L1) antibody, sugemalimab. The drug is proposed as a treatment for first-line unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).…
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Biosion Receives FDA Approval for Phase II Study of TSLP mAb BSI-045B
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Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended…
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OncoSec Medical’s TAVO-EP Combo Misses Primary Endpoint in Melanoma Trial
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US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512), has revealed disappointing data from a crucial pivotal Phase II trial assessing the firm’s lead DNA drug candidate TAVO-EP (tavokinogene telseplasmid) combined with the programmed death-1 (PD-1) monoclonal antibody Keytruda (pembrolizumab) as a treatment for…
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Jacobio Pharma Receives Approval for Phase I/IIa Study of LIF mAb in Advanced Solid Tumors
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase I/IIa clinical study for its leukemia inhibitory factor (LIF) monoclonal antibody (mAb) in patients with advanced solid tumors. LIF as a Target for KRAS-driven TumorsLIF is a key target in KRAS-driven tumors, including pancreatic and…
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Nanjing Zenshine Pharmaceuticals’ ZX-7101A Meets Primary Endpoint in Phase II Influenza Study
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd announced that a Phase II clinical study for its anti-influenza drug ZX-7101A in adult simple influenza has successfully reached the primary endpoint. Design and Results of the Phase II/III StudyThe multi-center, randomized, double-blind, placebo-controlled Phase II/III study is designed to…
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Lynk Pharmaceuticals Concludes Phase I Study for JAK Inhibitor LNK01003 with Positive Results
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China-based Lynk Pharmaceuticals (Hangzhou) Co., Ltd has announced the successful conclusion of a Phase I clinical study for its Category 1 innovative drug candidate, LNK01003. The trial, which assessed the molecule in healthy volunteers, demonstrated a good safety profile, tolerability, and pharmacokinetics. Design and Outcomes of the Phase I StudyThe…
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Johnson & Johnson’s Talquetamab on Track for Breakthrough Therapy Designation in Multiple Myeloma
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China’s Center for Drug Evaluation (CDE) has indicated that US pharmaceutical giant Johnson & Johnson’s (J&J, NYSE: JNJ) GPRC5D/CD3 bispecific antibody (BsAb) talquetamab is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory (R/R) multiple myeloma (MM) in patients who have undergone at least…
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CSPC Pharmaceutical Receives FDA Approval for Phase I Study of CPO301 in Lung Cancer
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study assessing the safety, pharmacokinetics, and preliminary efficacy of its antibody-drug conjugate (ADC) CPO301 in patients with advanced lung cancer characterized by…
