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NMPA Releases Plans to Support HK and Macau Drug, Device Production in Mainland Cities
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The National Medical Products Administration (NMPA) has released two implementation plans aimed at supporting Hong Kong and Macau drug marketing authorization holders and medical device registrants to produce drugs and devices in nine mainland cities within the Greater Bay Area. These initiatives allow drug Marketing Authorization Holders (MAHs) and device…
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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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Harbour BioMed’s Partner NK Celltech Raises RMB 100M in Series A Financing
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China-based Harbour BioMed (HKG: 2142) announced that its strategic partner NK Celltech, a company focusing on NK cell-based cell therapies, has successfully raised over RMB 100 million (USD 14.9 million) in a Series A financing round. The round was led by HUAGAI Capital, with participation from CAS Venture Capital, Qiandao…
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NMPA Releases 55th Batch of Reference Drugs for Generic Evaluation
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The National Medical Products Administration (NMPA) has released the 55th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 16 injectables among a total of 78 new specifications. Additionally, 21 specifications saw modifications, including four injectables. Batch DetailsThe latest batch aims to provide updated reference…
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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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NMPA Releases Work Plans for Temporary Import of Urgently Needed Drugs
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The National Medical Products Administration (NMPA) has officially released the “Work Plan for the Temporary Import of Clinically Urgently Needed Drugs” and the “Work Plan for the Temporary Import of Clobazam.” The final policies are essentially unchanged from the draft proposals published three months ago. Clobazam, a benzodiazepine class medication…
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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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Corestar Biotech Secures Series A Funding for POCT R&D Expansion
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Shenzhen-based point-of-care testing (POCT) specialist Corestar Biotechnology Co., Ltd has raised “tens of millions” of renminbi in a Series A financing round led by IDG Capital. The proceeds will be used for research and development (R&D) laboratory construction, new product pipeline expansion, and team expansion. Company BackgroundFounded in 2017, Corestar…
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Great Robotics Raises RMB 100M for Surgical Robot Development
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Great Robotics, a Beijing-based medical robotics company, has reportedly raised close to RMB 100 million (USD 14.9 million) in a pre-Series A financing round. The round was led by INCE Capital, with participation from Orient Jiafu Asset Management. The proceeds will be used for testing and clinical studies of an…
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Visum Pharma Series B+ Financing to Advance R&D and GMP Workshop Construction
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Visum Pharmaceutical Co., Ltd reportedly raised close to RMB 100 million (USD 14.9 million) in a Series B+ financing round led by Zhejiang Hisoar Pharmaceutical Co., Ltd (SHE: 002099). The proceeds will be used to support the research and development (R&D) of high-end preparations and the construction of a GMP…
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Yunnan Jianzhijia Plans Acquisition of Hebei Tangren Pharmacy in USD 309 Million Deal
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China-based Yunnan Jianzhijia Health-Chain Co, Ltd (SHA: 605266) plans to acquire 100% of compatriot firm Hebei Tangren Pharmacy Co., Ltd in a deal valued at RMB 2.07 billion (USD 309 million) in cash. The acquisition will be completed in two installments. Jianzhijia, which provides efficient, differentiated promotion and marketing services…
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Sun Pharma Loses VBP Bid for Bicalutamide in China Due to Quality Failures
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The Shanghai Medical Products Administration (SMPA) has revoked the winning bid of India-based Sun Pharmaceutical Industries Ltd. for its prostate cancer drug bicalutamide in the fifth round of China’s national volume-based procurement (VBP) program. This decision follows random inspections that revealed Sun Pharma’s product failed to meet import drug regulations…
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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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Dakang Medical Secures RMB 400M in Series E Round for Hemodialysis Center Expansion
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Dakang Medical (DiaCare Medical), a Beijing-based provider of blood purification chain medical services, has reportedly raised RMB 400 million (USD 59.7 million) in a Series E financing round, the largest deal in the segment. The round was led by Jiangxi Ganjiang New District Development and Investment Group Co., Ltd, with…
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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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Luzhu Bio Files for Hong Kong IPO After RMB 4.42 Billion Valuation
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Beijing Luzhu Biotechnology Co., Ltd, a leading developer of human vaccines and therapeutic biologics, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, with CICC as the sponsor. The Chinese firm previously secured a Series C financing round that valued the company at RMB 4.42…
