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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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Burning Rock Biotech Launches PREVENT Study for Early Cancer Detection
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Chengdu-based medical device firm Burning Rock Biotech Ltd (NASDAQ: BNR) announced the launch of a ground-breaking interventional validation study focused on the application of its early cancer test, OverC, in detecting various cancer types in asymptomatic patients. The PREVENT (Prospective multi-canceR Early-detection and interVENTional) study will enroll 12,500 individuals to…
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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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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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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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AnchorDx and West China Hospital Collaborate on Lung Cancer Early Diagnosis
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Guangzhou-based AnchorDx and West China Hospital of Sichuan University have entered into a transfer agreement for their joint patent on methylation molecular markers for detecting benign and malignant pulmonary nodules. This collaboration aims to enhance the early diagnosis of lung cancer and improve the diagnostic rate of fiberoptic bronchoscopy. Collaboration…
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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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Kelun Pharmaceutical Receives USD 30 Million from MSD for Licensing Deal
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced receiving USD 30 million from US major Merck Sharp & Dohme (MSD), triggered by a licensing agreement reached on May 16, 2022. This payment is part of a broader collaboration between the two companies to develop and commercialize an innovative…
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Antengene and BeiGene Collaborate on Selinexor and Tislelizumab Combination Trial for Lymphoma
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China-based Antengene Corporation Ltd (HKG: 6996) has announced a clinical trial collaboration with BeiGene Inc. (Nasdaq: BGNE) to evaluate the combination of Antengene’s selinexor (trade name: Xpovio) with BeiGene’s anti-PD-1 drug tislelizumab (Baizean). The open-label, multi-center Phase I/II trial aims to explore this combination as a potential treatment for patients…
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Sino Biopharmaceutical’s TQ-B3101 Accepted by NMPA for ROS1+ NSCLC Treatment
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its Category 1 product TQ-B3101 for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Drug Mechanism and EfficacyTQ-B3101 is a small molecule inhibitor targeting tyrosine kinase ROS1/ALK/c-Met. It…
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Sunshine Guojian Pharmaceutical Signs Licensing Deal for Cipterbin ADC Development
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced the signing of a licensing agreement with compatriot firm Xiling Lab’s wholly-owned unit Chengdu Kelingyuan Pharmaceutical Co., Ltd. The agreement grants Chengdu Kelingyuan global development and commercialization rights to the anti-HER2 monoclonal antibody (mAb)…
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Jumbo Drug Bank’s JDB153 Enters Phase I Trial for Advanced Solid Tumors
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Data from Fineline Cube indicates that JDB153, a potential first-in-class (FIC) small-molecule inhibitor targeting Mnk and VEGFR developed by China-based biotech Jumbo Drug Bank, entered a Phase I clinical study on June 13, 2022. The trial, initiated one week after receiving approval from the National Medical Products Administration (NMPA), is…
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Suzhou Teligene Ltd Plans IPO on Shanghai STAR Market for Cancer Drug Development
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China-based Suzhou Teligene Ltd has announced plans for an initial public offering (IPO) of 63.52 million shares on Shanghai’s Sci-Tech Innovation Board (STAR), sponsored by CICC. The proceeds will be allocated towards new drug research and development (R&D) and supplementary working capital. Company Focus and PipelineTeligene, a biopharmaceutical company specializing…
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Rakuten Medical Taiwan Administers First Dose of ASP-1929 in Phase II Trial
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Rakuten Medical Taiwan Inc. announced the administration of its photo-immunotherapy ASP-1929 to the first patient in a Phase II trial at sites in Taiwan. The trial is evaluating the drug in combination with a PD-1 therapy for head and neck squamous cell carcinoma, with the primary endpoint of objective response…
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InnoCare Pharma’s ICP-189 First Dosed in China SHP2 Inhibitor Trial
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Beijing InnoCare Pharma (HKG: 9969) has announced the first patient dosing in a clinical study of its protein tyrosine phosphatase (SHP2) allosteric inhibitor ICP-189 in China. The drug is being developed to treat liver cancer, head and neck cancer, digestive tract tumors, and other solid tumors. Mechanism and Preclinical ResultsICP-189…
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Mega Genomics Limited Makes Hong Kong IPO Debut at HKD 18 Per Share
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China-based gene testing platform company Mega Genomics Limited has successfully completed an initial public offering (IPO) of 12 million shares on the Hong Kong Stock Exchange at HKD 18 (USD 2.98) per share. The offering, sponsored by China Securities, marks a significant milestone for the company as it seeks to…
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Merck KGaA’s Erbitux Approved in China for Head and Neck Cancer Treatment
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Germany-based pharmaceutical firm Merck KGaA announced that China’s National Medical Products Administration (NMPA) has issued market approval for a new indication for the epidermal growth factor receptor (EGFR) inhibitor Erbitux (cetuximab). The approval allows Erbitux to be used in combination with radiotherapy for treating locally advanced squamous cell carcinoma of…
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CSPC’s JMT103 Accepted for Review in China, Targets RANKL-Related Deficiencies
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The Center for Drug Evaluation (CDE) website indicates that a market filing by China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) subsidiary Shanghai JMT Biotechnology Co., Ltd for its anti-RANKL monoclonal antibody (mAb) JMT103 has been accepted for review. This next-generation RANKL antibody aims to address the shortcomings of existing marketed…
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CStone Pharmaceuticals’ Ayvakit Included in Taiwan’s National Health Insurance
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China-based CStone Pharmaceuticals (HKG: 2616) announced that its Ayvakit (avapritinib), a tyrosine kinase inhibitor for treating gastrointestinal stromal tumors (GIST), has been included in Taiwan’s National Health Insurance, effective June 1, 2022. Drug Approval and BackgroundAvapritinib received approval in Taiwan under the trade name TaiShiWei in 2021 for adult patients…
