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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…
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VFLO Medical Partners with Inari Medical to Expand Access in Greater China
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China-based VFLO Medical, a peripheral vascular device firm incubated by 6 Dimensions Capital, has announced a strategic partnership with US firm Inari Medical, Inc. (NASDAQ: NARI). The deal will enable Inari to leverage VFLO’s established infrastructure, local relationships, and deep commercial expertise for the commercialization of its devices in Greater…
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Uni-Bio Science Group Achieves Milestones in Medical Aesthetics with New Product Approvals
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China-based Uni-Bio Science Group Limited (HKG: 0690) has announced two significant achievements in the medical aesthetics and skincare fields. The company’s recombinant collagen dressing, co-developed with Chongqing Minji Medical Device Co., Ltd., has been granted a Category II device approval by the National Medical Products Administration (NMPA). Concurrently, its in-house…
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Ocumen Therapeutics’ OT-301 Phase III Denali Study Surpasses 140 Patient Enrollment in China
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Chinese ophthalmology specialist Ocumen Therapeutics (HKG: 1477) has announced the enrollment of more than 140 patients in the second Phase III Denali study for its OT-301 (NCX470) in China. This follows the commencement of the first Phase III MontBlanc study for the drug in the United States in June 2020,…
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China Medical System Holdings Secures Exclusive Rights to Atom Therapeutics’ Gout Drug ABP-671
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China Medical System Holdings (CMS; HKG: 0867) has entered into a licensing agreement with compatriot firm Atom Therapeutics, securing exclusive commercialization rights to ABP-671, a Category 1 chemical drug for gout and hyperuricemia, in mainland China, Hong Kong, and Macau. The financial specifics of the agreement were not disclosed. ABP-671:…
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Novartis Secures Global Rights to PTC Therapeutics’ Huntington’s Disease Treatment PTC518
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has entered into a global license and collaboration agreement with US firm PTC Therapeutics (NASDAQ: PTCT), obtaining development, manufacturing, and commercialization rights to PTC518, an HTT mRNA splice modulator targeting Huntington’s disease. Financial Terms and Milestones of the AgreementUnder the terms of the agreement,…
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UCB Partners with BioRay Biopharmaceutical for Bimzelx Commercial Promotion in China
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Belgium based UCB (EBR: UCB) is fulfilling its commitment to enhance attention to innovative products and local partnerships in the Chinese market by signing an agreement with Zhejiang based BioRay Pharmaceutical Co., Ltd. for the commercial promotion of its Bimzelx (bimekizumab) in China. The financial details of the deal have…
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Minghui Pharmaceutical’s MH004 Ointment Meets Primary Endpoints in Atopic Dermatitis Phase III Study
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Shanghai-based Minghui Pharmaceutical, a late-stage biopharmaceutical company specializing in immunology and oncology, has announced positive topline results from its Phase III study for MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents and adults with mild to moderate atopic dermatitis (AD). Study Design and Participant EnrollmentA total of…
