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Guangzhou Virotech’s Oncolytic Virus M1 Receives Tacit Clinical Approval from NMPA
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Guangzhou Virotech Pharmaceutical Co., Ltd., a China-based pharmaceutical company, has announced receiving tacit clinical approval from the National Medical Products Administration (NMPA) for its oncolytic virus therapy, M1 (VRT106). This approval paves the way for an imminent Phase I clinical study in China, which will assess the safety, tolerability, pharmacokinetics,…
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Ipsen Secures Global Licensing Agreement for Biomunex Pharmaceuticals’ BMX-502 T Cell Engager
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France-based Ipsen (OTCMKTS: IPSEY) has announced a significant global licensing agreement with compatriot firm Biomunex Pharmaceuticals concerning the latter’s T cell engager (TCE), BMX-502. Ipsen is poised to secure exclusive development, manufacturing, and commercialization rights for BMX-502 across global territories. Responsibilities and Milestones Under the AgreementUnder the terms of the…
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OncoC4, Inc. Receives FDA Clearance for AI-081, a PD-1 and VEGF Bispecific Antibody
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US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its innovative bispecific antibody, AI-081, which targets both PD-1 and VEGF pathways. Composition and Mechanism of AI-081AI-081 is composed of proprietary high-affinity clinical-stage anti-PD-1 (AI-025) and anti-VEGF (AI-011) antibodies. This…
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Luye Pharma’s Zepzelca Receives NMPA Approval for Metastatic Small Cell Lung Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are…
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Sacituzumab Tirumotecan Earns FDA Breakthrough Therapy Designation for EGFR Mutated NSCLC
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Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme (MSD, NYSE: MRK) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has been granted a breakthrough therapy designation (BTD) by the US FDA. This designation is for the treatment of non-small cell lung cancer (NSCLC)…
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Merck’s Recarbrio Approved by NMPA for Hospital-Acquired Infections and Complicated UTIs
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its combination antibacterial drug, Recarbrio (imipenem, cilastatin, and relebactam). This new treatment is indicated for patients aged 18 years and older with hospital-acquired…
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Abbisko Therapeutics Gets FDA Green Light for Phase I Study of ABSK131 Inhibitor
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
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Hefan Medicine’s Piracetam Production and Marketing Suspended Over GMP Violations
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The National Drug Alliance Procurement Office has issued a notification to suspend the manufacturing and marketing of piracetam by Zhuhai Hefan Medicine Co., Ltd. The suspension comes as a result of severe defects found in the company’s manufacturing management process, which are in direct violation of the Good Manufacturing Practice…
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InventisBio’s Oral TYK2 Inhibitor D-2570 Achieves Positive Results in Phase II Psoriasis Study
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China-based InventisBio (Shanghai) Co., Ltd (SHA: 688382) has announced the successful completion of a Phase II study for its oral TYK2 inhibitor, D-2570, in the treatment of psoriasis, with positive outcomes. Understanding Psoriasis and the Role of TYK2 InhibitionPsoriasis is an immune-mediated chronic disease characterized by recurrent, inflammatory, and systemic…
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Shanghai Henlius Biotech’s Serplulimab Approved for First-Line nsNSCLC Treatment in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as…
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Zhejiang Huahai Pharmaceutical Initiates Clinical Study for HB0056 in New Zealand
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Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521), through its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd., has announced the first subject dosing in a clinical study for its potential first-in-class drug, HB0056, in New Zealand. This marks a significant step forward in the development of this innovative therapy. HB0056: A Bispecific…
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HutchMed and Innovent Biologics’ Fruzaqla-Tyvyt Combo Gets NMPA Conditional Approval for Endometrial Cancer
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
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Acotec Scientific’s AcoArt Camellia Receives NMPA Approval for Coronary Artery Disease Treatment
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AcoArt Camellia, a paclitaxel-releasing coronary balloon dilation catheter. This medical device is now approved for the treatment of primary coronary artery disease in patients with vessel…
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REGiMMUNE and San Fu Biotech Ink Deal for RGI-2001 Development in Asia
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Taiwan-based biotechnology company REGiMMUNE Ltd has announced the signing of an out-license agreement with San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd (TPE: 4755). Under the terms of the deal, REGiMMUNE will transfer the development and commercial rights of its pipeline candidate, RGI-2001, to SFB for…
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AccurEdit Therapeutics’ ART001 Shows Over 90% TTR Reduction in ATTR Amyloidosis Trial
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Suzhou-based gene editing specialist AccurEdit Therapeutics has announced positive results from an ongoing investigator-initiated trial (ITT) for its in vivo gene editing product, ART001. This lipid nanoparticle (LNP) delivered treatment is designed for transthyretin amyloidosis (ATTR), a rare, progressive, and fatal disease. In subjects who completed at least 48 weeks…
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Sanofi Announces EUR 1 Billion Investment for New Beijing Manufacturing Plant
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced plans to invest EUR 1 billion (USD 1.05 billion) in the construction of a new manufacturing plant in the Beijing Economic-Technological Development Area. This marks the company’s largest investment in China to date. Expanding Local Manufacturing Capacities for InsulinThe new facility will…
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Huadong Medicine’s SaiYueXin Biosimilar Accepted for Review by NMPA for Pediatric Psoriasis
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication for SaiYueXin, a biosimilar to Johnson & Johnson (J&J, NYSE: JNJ)’s Stelara (ustekinumab). The Chinese pharmaceutical company is now seeking approval for the use of SaiYueXin in…
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Jiangsu Hengrui Pharmaceuticals’ Fluzoparib and Apatinib Gain NMPA Approval for Metastatic Breast Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for the use of fluzoparib alone or in combination with apatinib. This new treatment is aimed at patients with human epidermal growth factor…
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Fangzhou Inc. Expands Partnerships with Tencent Healthcare and Baidu Health at Digital Summit
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China-based Fangzhou Inc. (HKG: 6086) hosted the “Data and AI: Decoding Digital Engagement” summit in Chengdu, an event focused on the intersection of data and artificial intelligence in the digital healthcare space. During the summit, Fangzhou Inc. expanded its strategic partnerships with Tencent Healthcare and Baidu Health, two major players…
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MGI Tech Co., Ltd Partners with Universidad de San Martín de Porre for Genomic Sequencing Advancement
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China-based gene sequencing specialist MGI Tech Co., Ltd has announced a collaboration with the Universidad de San Martín de Porre in Peru. The partnership aims to strengthen human genetics research by implementing next-generation genomic sequencing (NGS) technologies in the university’s Genetic and Molecular Biology Research Center laboratory. Enhancing Genetic Heritage…
