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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…
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MegaRobo and Danaher Life Sciences Partner on Lab Automation in China
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Beijing-based MegaRobo Technologies, a robotics and AI firm in life sciences, has partnered with Danaher Life Sciences China to develop smart automation solutions. The collaboration targets lab automation and applications in drug screening, biopharmaceuticals, and cell gene therapy, combining both companies’ technical strengths. Partnership DetailsThe alliance will integrate MegaRobo’s AI-powered…
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Hengrui Medicine’s HRG2101 Inhaler Wins NMPA Approval for IPF Clinical Trial
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China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial of its HRG2101 inhaler for idiopathic pulmonary fibrosis (IPF). The drug, with no similar marketed products in China, targets fibroblast activity and inflammatory pathways to address the…
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U Protech Secures Angel Financing for PROTAC and Molecular Glue Drug Pipeline
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U Protech, a Hangzhou-based biotech focused on next-generation protein degradation therapies, has raised tens of millions of renminbi in Angel and Angel+ financing rounds. The funding, led by Shanghai Biomedical Industry Equity Investment Fund’s transformation fund and Zheshang Venture Capital, will accelerate development of its PROTAC and molecular glue drug…
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J&J China, Tencent Launch Digital Rhinitis Platform “Love Nose e-Station”
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Johnson & Johnson’s (J&J, NYSE: JNJ) J&J China Self Care and China’s Tencent have launched the “Love Nose e-Station” app, a digital rhinitis management platform, following their March 2022 partnership. The app offers end-to-end health management solutions for rhinitis patients, from prevention to treatment, aiming to boost disease awareness and…
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Neukio Biotherapeutics Completes USD 50M Series A-1 Financing for iPSC-CAR-NK Therapy
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Shanghai-based Neukio Biotherapeutics, a developer of iPSC-derived chimeric antigen receptor natural killer (CAR-NK) cell therapies, announced the completion of a USD 50 million Series A-1 financing round. The funding, led by CD Capital, will support pre-clinical validation, clinical trials, and talent recruitment for its universal off-the-shelf CAR-NK pipeline. Financing DetailsThe…
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Acorda Therapeutics Licenses Preclinical Drug Nepicastat to China’s Asieris
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US-based Acorda Therapeutics Inc. (Nasdaq: ACOR) announced a licensing agreement with China’s Asieris Pharmaceuticals for its preclinical drug candidate nepicastat, a small-molecule inhibitor of dopamine beta-hydroxylase (DBH). Asieris will develop the drug for non-psychiatric indications, with a focus on cardiovascular diseases linked to sympathetic nervous system overactivation. Deal TermsUnder the…
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SAMR Issues New Rules for Online Drug Sales in China
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China’s State Administration for Market Regulation (SAMR) has released the “Measures for the Supervision and Administration of Online Drug Sales,” effective December 1, 2022. The 42-article regulation aims to ensure drug quality, safety, and accessibility, targeting online retailers, platforms, and prescription drug sales. Drug Operator ResponsibilitiesThe rules clarify qualifications for…
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NMPA Designates Shijiazhuang Airport as Drug Import Port for Narcotics, Psychotropics
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China’s National Medical Products Administration (NMPA) has designated Shijiazhuang Airport in Hebei Province as an official drug import port, following approval from the State Council. The move allows the import of select Chinese medicines, chemicals, narcotics, and psychotropic drugs through the airport. Port ResponsibilitiesThe Shijiazhuang market administration bureau has been…
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Henlius Biotech Plans US Bridging Study for Serplulimab in ES-SCLC
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Shanghai Henlius Biotech (HKG: 2696) is advancing its checkpoint inhibitor serplulimab toward the U.S. market, with plans to launch a bridging study in H2 2022 for extensive-stage small-cell lung cancer (ES-SCLC). The decision follows a meeting with the U.S. FDA, as the firm seeks to replicate its Phase III success…
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RedCloud Bio Doses First Patient in H002 EGFR TKI Phase I/IIa Trial for NSCLC
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Shanghai-based RedCloud Bio announced that the first patient has been dosed in a Phase I/IIa multi-center trial of H002, its fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for non-small cell lung cancer (NSCLC) patients with resistance to prior TKIs, including C797S mutations. Drug ProfileH002, discovered in-house by…
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Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
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China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan drug designation (ODD) to its antibody-drug conjugate (ADC) MRG002 for gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ). The drug is in a Phase I/II trial in the U.S. targeting HER2-positive, advanced or metastatic GC/GEJ. Drug…
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CDE Releases 62nd Batch of Chemical Generic References, Updates 39 Specifications
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The Center for Drug Evaluation (CDE) has released the 62nd batch of chemical generic reference preparations, marking a significant update to its regulatory framework. This latest batch includes 27 new specifications and updates information on 39 previously published specifications, reflecting ongoing efforts to enhance the transparency and efficiency of China’s…
