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Bio-Thera Solutions’ BAT8010 Receives NMPA Approval for Solid Tumor Clinical Trials
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that it has received approval from the National Medical Products Administration (NMPA) for its BAT8010 to enter clinical trials for the treatment of general solid tumors. The drug, independently developed by Bio-Thera, is an HER2-targeted antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2…
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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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Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged…
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Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
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Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
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Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
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Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC. FDA FeedbackThe FDA cited inadequate representation…
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Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
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Latin America is ramping up its contributions to the worldwide race for COVID-19 vaccines and treatments. Cuba’s state-owned BioCubaFarma, through its Center for Genetic Engineering and Biotechnology (CIGB), has designed a vaccine candidate and is advancing its development in collaboration with China’s Research and Development Center in Yongzhou, Hunan’s Industrial…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (HKG: 1548), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKG: 1801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (NASDAQ: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clinical Trial Approval for PD-1/CD47 Bispecific Antibody
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China-based Hanx Biopharmaceuticals Co., Ltd has announced that its self-developed anti PD-1/CD47 bispecific antibody drug, HX009, has received a clinical trial notice from the National Medical Products Administration (NMPA) on October 30, 2019 (Acceptance Number: CXSL1900098). This follows the drug’s ethical review approval in Australia in July, where Phase I…
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Shanghai Roche Pharmaceuticals Launches Erlotinib for Advanced Non-Small Cell Lung Cancer in China
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Shanghai Roche Pharmaceuticals Ltd. made headlines in March with the launch of its lung cancer treatment, Erlotinib, in the Chinese market. This targeted therapy is designed for patients with advanced non-small cell lung cancer (NSCLC) that has continued to progress despite standard chemotherapy. Erlotinib’s mechanism of action involves the specific…
