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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…
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Youwe Bio’s Series B Financing to Advance Microneedle Technology Commercialization
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China-based Youwe (Zhuhai) Biotechnology Co., Ltd, a developer of soluble microneedle transdermal drug delivery technology, has reportedly raised close to RMB 100 million (USD 14.9 million) in a Series B financing round. Cenova Ventures was the sole investor. The proceeds will be used for the commercialization of soluble microneedle technology…
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NHSA Updates NRDL with Focus on Expert Review and Simplified Renewals
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The National Healthcare Security Administration (NHSA) has released the “2022 National Reimbursement Drug List (NRDL) Adjustment Work Plan” along with relevant documents. This official update to the draft proposal issued on June 13th outlines the full details and processes for this year’s NRDL update. List Adjustment ScopeThe scope of the…
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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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Gritgen Therapeutics Secures Hundreds of Millions in A-Round Financing for Gene Therapy Pipeline
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Gritgen Therapeutics, a leading gene therapy drug developer based in Suzhou, has announced the successful completion of a A-round financing round worth several hundred million yuan. The financing was led by Sequoia China, with participation from Sunlight Insurance, Qingsong Capital, and Beijing Life Science Park Venture Fund. Existing shareholders including…
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Shenzhen-Based Pregbio Raises Funds for Non-Invasive Prenatal Gene Detection
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Pregbio, a Shenzhen-based non-invasive prenatal gene detection company, has reportedly raised an undisclosed amount of money in an angel financing round. The sole contributor to the round was ASB Ventures. The proceeds will be used to promote early screening and diagnosis of preterm labor and pre-eclampsia, non-invasive prenatal screening, and…
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Novartis Cuts Back on US Development of BeiGene’s PD-1 Inhibitor Tislelizumab
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Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended…
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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…
