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Hotgen Biotech Receives UK Approvals for Monkeypox and COVID-19 Antigen Detection Kits
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Shanghai-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced significant regulatory milestones in the United Kingdom. The company’s monkeypox virus antigen detection kit, utilizing a colloidal gold method, has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for marketing. Additionally, its novel coronavirus (2019-nCoV) antigen detection…
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Zelgen Biopharm’s Donafenib Shows Promise in Phase III Study for RAIR-DTC
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced positive results from the Phase III ZGDD3 study for its Category 1 anti-cancer drug donafenib in locally advanced/metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC). Study Details and ResultsA total of 191 patients were enrolled in the ZGDD3 study, with 128 in the…
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BGI’s Stereo-seq Tech Maps Axolotl Brain Regeneration in World-First Study
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China’s genomics giant BGI has revealed a landmark study using its proprietary Stereo-seq sequencing technology to construct the world’s first spatiotemporal cellular atlas of brain development and regeneration in axolotls, a species of salamander. The research, featured on the front cover of the latest Science issue, sheds light on vertebrate…
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Junshi Biosciences Plans USD 572M Private Placement to Fund Drug R&D and Expansion
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China’s Shanghai Junshi Biosciences Co., Ltd (SHA: 688180, HKG: 1877) announced plans to raise up to RMB 3.97 billion (USD 572 million) via private placement, with proceeds allocated to novel drug R&D and construction of its headquarters and R&D facilities. The move underscores the firm’s ambition to accelerate pipeline development…
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CanSino, Livzon Win China EUAs for COVID-19 Booster Vaccines
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China-based vaccine makers CanSino Biologics (HKG: 6185) and Livzon Pharmaceutical Group Inc. (HKG: 1513) have received emergency use authorizations (EUAs) from Chinese regulators for their respective COVID-19 vaccines as sequential booster shots. The approvals expand the country’s arsenal of heterologous boosters amid rising demand for enhanced protection. CanSino’s Inhaled VaccineCanSino’s…
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AWS Partners with Zhongshan to Launch Smart Manufacturing and Biomedical Digital Center
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Amazon Web Services (AWS) and Zhongshan’s Bureau of Commerce announced a partnership at the China Beijing International Fair for Trade in Services (CIFTIS) to establish a smart manufacturing and biomedical digital empowerment center. The initiative, leveraging AWS’s cloud, AI, and IoT technologies, aims to accelerate industrial upgrading in the Guangdong…
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BoomRay Pharmaceuticals Raises USD 43M in Series A for RDC Pipeline Expansion
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China’s BoomRay Pharmaceuticals, a specialist in radionuclide drug conjugates (RDCs), reportedly raised nearly RMB 300 million (USD 43.2 million) in a Series A financing round led by Sequoia China. The funding will accelerate clinical development, regulatory filings, and global expansion of its pipeline targeting brain, pancreatic, prostate, and other tumors.…
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Zelgen Biopharmaceuticals’ Jacktinib Wins FDA Approval for Severe Alopecia Areata
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) secured U.S. FDA approval to launch a clinical trial of its JAK inhibitor, jacktinib, for severe alopecia areata, marking the second IND clearance for the drug in the U.S. The therapy targets immune-driven inflammation via JAK/STAT pathway inhibition. Drug Profile and MechanismJacktinib, a…
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Jacobio Pharmaceuticals Doses First Patient in JAB-BX102 Phase I/IIa Trial for CD73-Targeted Cancer Therapy
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase I/IIa trial of its CD73 monoclonal antibody (mAb), JAB-BX102, for advanced solid tumors. The study, cleared by Chinese regulators in March 2022, marks the drug’s global clinical debut after U.S. approval in October 2021.…
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Northeast Pharma Licenses MedAbome’s MAb11-22.1 for ADC and CAR-T Development
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China’s Northeast Pharmaceutical Co., Ltd (SHE: 000597) has signed a licensing agreement with U.S.-based MedAbome to develop the latter’s preclinical monoclonal antibody, MAb11-22.1, for antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR)-T cell therapies. The deal follows Northeast’s 2017 in-licensing of a Herceptin biosimilar from MedAbome. Collaboration TermsUnder the agreement,…
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Alphamab Oncology Highlights KN046, KN026 Advances at ESMO 2022
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China’s Alphamab Oncology (HKG: 9966) will present updated clinical data for its bispecific antibody candidates KN046 and KN026 at the European Society for Medical Oncology (ESMO) 2022 conference. The programs target multiple cancers, including non-small cell lung cancer (NSCLC) and HER2-positive gastric cancer, with results showing promising efficacy and safety…
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AstraZeneca’s Farxiga Wins China Approval for Chronic Kidney Disease
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UK pharma giant AstraZeneca (AZ, NASDAQ: AZN) announced a new approval for Farxiga (dapagliflozin), its sodium-glucose cotransporter 2 (SGLT2) inhibitor, in China. The drug is now cleared to reduce risks of kidney function decline, end-stage kidney disease, cardiovascular death, and heart failure hospitalization in adults with chronic kidney disease (CKD),…
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Innovent Biologics Doses First Patient in Higher-Dose Mazdutide Obesity Trial
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China’s Innovent Biologics, Inc. (HKG: 1801) announced that the first participant has been dosed in the higher-dose cohort of a Phase II trial for mazdutide (IBI362), a dual agonist targeting glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR), in Chinese adults with obesity. The study follows positive results from…
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Shanghai Pharma’s CD20 Antibody Advances to Primary Nephropathy Trial After NMPA Approval
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China’s Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to launch a clinical trial for its CD20 monoclonal antibody (mAb) in primary membranous nephropathy, a chronic kidney disorder with limited treatment options. Study DetailsThe drug, developed by Shanghai Jiaolian Drug R&D Co.,…
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Walvax Biotech Wins NMPA Approval for mRNA and Recombinant COVID-19 Vaccines
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has received clinical trial approvals from the National Medical Products Administration (NMPA) for two novel coronavirus vaccines: an mRNA vaccine co-developed with Fudan University and Shanghai RNACure Biopharma, and a recombinant vaccine developed in-house by its subsidiary Shanghai Zerun Biotech. Vaccine Details Strategic…
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Medim Science Raises Funds for Macrophage-Targeting Biologics in Cancer Therapy
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Hangzhou-based Medim Science, China’s first pharma firm focused on macrophage-targeting biologics, has reportedly raised tens of millions of renminbi in a new financing round led by Ming Bioventures, with Cowin Venture Capital participating. The funds will support R&D, regulatory filings, and clinical trial applications for its pipeline targeting solid tumors.…
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China’s Pharmaceutical Industry Sees Revenue Decline Amid Export Shifts
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China’s pharmaceutical manufacturing sector reported a 1.8% year-on-year (YOY) revenue decline to RMB 1.6 trillion (USD 231 billion) in the latest National Bureau of Statistics (NBS) data, alongside a 30.7% plunge in profits to RMB 247.36 billion (USD 35.8 billion). Meanwhile, the China Chamber of Commerce for Import and Export…
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Tibet Duo Rui and Nanjing Heron Forge Pharmaceutical Collaboration in China
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China-based Tibet Duo Rui Pharmaceutical Co., Ltd and Nanjing Heron Pharmaceutical Science and Technology Co., Ltd have entered a strategic partnership to collaborate on drug research, manufacturing, and marketing. The alliance aims to accelerate the commercialization of novel therapies in mainland China by combining both firms’ core competencies. Partnership TermsUnder…
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CARsgen Therapeutics Launches GMP Manufacturing for CAR-T Cell Therapies in North Carolina
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China’s CARsgen Therapeutics Holdings Ltd (HKG: 2171), a chimeric antigen receptor (CAR)-T cell specialist, has initiated Good Manufacturing Practice (GMP)-compliant production at its new autologous CAR-T cell therapy plant in North Carolina’s Research Triangle Park (RTP). The facility marks the company’s first manufacturing site outside China and will supply clinical…
