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Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer…
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BeiGene’s Tislelizumab Shows Survival Benefit in Esophageal Cancer Study
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BeiGene (NASDAQ: BGNE) has released the latest results of the global Phase III RATIONALE 306 study, which evaluated the efficacy of its programmed death – 1 (PD – 1) inhibitor tislelizumab in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not previously…
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Huadong Medicine’s Biosimilar Ozempic (Semaglutide) Wins NMPA Clinical Trial Approval
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that a clinical trial filing for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide), submitted by subsidiaries Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd and Chongqing Peg-Bio Biopharma Co., Ltd, has been approved by the National Medical Products Administration (NMPA). Drug ProfileOriginally developed…
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Jixing Pharmaceuticals Enrolls First Patient in Etripamil Phase III Study for PSVT
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China-based Ji Xing Pharmaceuticals Ltd (Jixing) announced the first patient enrollment in a Phase III clinical study in China for etripamil, a drug candidate being assessed as a treatment for paroxysmal supraventricular tachycardia (PSVT). The multi-center, randomized, double-blind, placebo-controlled Phase III study will evaluate the efficacy and safety of self-administered…
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Takeda’s Obizur Prioritized for Review in Acquired Hemophilia A Treatment
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The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd’s Obizur (susoctocog alfa) has been prioritized for review for the on-demand treatment and control of bleeding events in adults with acquired hemophilia A. Drug Profile and MechanismAcquired hemophilia A is an acquired bleeding disorder characterized by reduced…
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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for First-Line NSCLC Treatment
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for furmonertinib. The third-generation epidermal growth factor receptor (EGFR) inhibitor is now approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR…
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Ascentage Pharma’s APG-5918 Receives FDA Approval for First-in-Human Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a first-in-human clinical study of its embryonic ectoderm development (EED) inhibitor APG-5918. The study will assess the safety, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced…
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Ascletis Pharma Doses First Patient in China’s Phase II Trial for HIV-1 Treatment with ASC22
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the dosing of the first patient in its Phase II clinical trial for ASC22 (envafolimab) in combination with anti-retroviral therapy (ART) for the immune restoration and functional cure of human immunodeficiency virus 1 (HIV-1) infection. This trial marks a significant step forward in…
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Jixing Pharmaceuticals’ Aficamten Receives CDE Approval for Phase III HCM Study
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China-based Ji Xing Pharmaceuticals announced receiving approval from the Center for Drug Evaluation (CDE) to initiate a Phase III clinical study for its aficamten (CK-3773274) in symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This study is part of the global multi-center SEQUOIA-HCM trial. Drug Profile and MechanismAficamten is a next-generation cardiac myosin…
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BDgene Advances CRISPR-Based BD111 for Herpes Keratitis with IND Filing
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Shanghai BDgene Technology Co., Ltd has completed efficacy and preliminary safety studies for BD111, its CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK). The company plans to file for Investigational New Drug (IND) approval and was awarded orphan drug designation (ODD) status in the US last week.…
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Bayer’s Kerendia Approved by China’s NMPA for Diabetic Kidney Disease
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The National Medical Products Administration (NMPA) has approved Bayer’s (ETR: BAYN) Category 1 drug Kerendia (finerenone) for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. This approval marks a significant advancement in the treatment of diabetic kidney disease, offering a new option to slow disease progression…
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Hengrui Medicine’s SHR3680 Approved for High Burden Metastatic Prostate Cancer
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China’s Hengrui Medicine Co., Ltd. (SHA: 600276) announced that its Category 1 drug SHR3680 has received conditional approval from the National Medical Products Administration (NMPA) via priority review procedures. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. Mechanism and AdvantagesSHR3680…
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Akeso Biopharma’s Cadonilimab Approved for Cervical Cancer Treatment
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China-based biotech company Akeso Biopharma (HKG: 9926) announced that its self-discovered bispecific antibody (BsAb) cadonilimab (AK104) has received conditional market approval from the National Medical Products Administration (NMPA). The drug is indicated for the treatment of recurrent or metastatic cervical cancer that has failed previous platinum-based chemotherapy. Drug Profile and…
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Humanwell Healthcare Wins NMPA Approval for RFUS-144 in Pain Management
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 drug RFUS-144, designed to relieve pain and itching. This marks a significant step forward in the company’s efforts to develop innovative therapies for…
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Eli Lilly’s Donanemab Receives Tacit Approval for Alzheimer’s Clinical Trial in China
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The Center for Drug Evaluation (CDE) website indicates that US major Eli Lilly’s (NYSE: LLY) donanemab has obtained tacit clinical trial approval for assessment in treating early symptomatic Alzheimer’s disease (AD), including mild cognitive impairment due to AD, and mild AD. This approval marks a significant step forward in the…
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Recbio’s R520A mRNA COVID-19 Vaccine Receives Clinical Approval in the Philippines
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China-based Jiangsu Recbio Technology Co., Ltd has announced receiving clinical trial approval from the Food and Drug Administration of the Philippines for its mRNA COVID-19 vaccine R520A. This approval marks a significant milestone in the global rollout of Recbio’s innovative vaccine targeting the Omicron variant. Vaccine InnovationR520A, developed by Wuhan…
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Pfizer’s Besponsa First Prescribed in China for Leukemia Treatment
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US major Pfizer (NYSE: PFE) has announced the first prescriptions for its leukemia therapy Besponsa (inotuzumab ozogamicin) in multiple cities in China. This marks the official application of the world’s first antibody drug conjugate (ADC) in relapsed or refractory precursor B-cell ALL (R/R B-ALL). Mechanism of ActionBesponsa targets CD22, which…
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Clover Biopharmaceuticals’ SCB-2019 COVID-19 Vaccine Shows Strong Immune Response in Third Shot Study
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has published clinical data for its COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) as a third shot. The double-blind, randomized, controlled study demonstrated significant increases in neutralizing antibodies against Omicron variants BA.2 and BA.1. Clinical Study ResultsThe study enrolled 3,755 subjects in Brazil, the Philippines,…
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Harbour BioMed Receives FDA Approval for HBM7008 Clinical Trials
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China-based Harbour BioMed (HKG: 2142) has announced receiving clinical trial approval from the US FDA for its bispecific antibody HBM7008. The drug, which targets the tumor antigen B7H4 and T cell co-stimulatory molecule 4-1BB, was first dosed in Phase I clinical trials in Australia in May and obtained clinical approval…
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Sinovac Biotech’s CoronaVac Receives Conditional Registration from South African Regulator
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China-based Sinovac Biotech Ltd (NASDAQ: SVA) has announced that the South African Health Products Regulatory Authority (SAHPRA) has awarded conditional registration to the company’s COVID-19 vaccine CoronaVac. The approval permits the vaccine’s use in adults aged 18 and over, administered in two doses with a 14-28-day interval. Approval BackgroundThis conditional…
