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Boehringer Ingelheim China and Shanghai Pharmaceuticals Holding Co. Launch Strategic Partnership for Linagliptin
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On January 7, Boehringer Ingelheim China and Shanghai Pharmaceuticals Holding Co., Ltd. (SPH, HKG: 2607, SHA: 601607) held a strategic cooperation launch ceremony, announcing a partnership on the national retail market for Outangning® (Linagliptin). Starting from January 1, 2025, the distribution and promotion of Linagliptin in non – medical institution…
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Merck KGaA Completes Acquisition of HUB Organoids, Expanding Cell Culture Portfolio
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German major Merck KGaA (ETR: MRK) announced the completion of its acquisition of Holland-based HUB Organoids Holding B.V. (HUB) last month, following regulatory approval and the fulfillment of other customary transaction conditions. The deal was initially revealed on December 17, 2024. Significance of the AcquisitionHUB is a pioneer in the…
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Amgen’s Imdylltra Gains Conditional Approval in UK for Extensive-Stage Small Cell Lung Cancer
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US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its drug Imdylltra (tarlatamab). The approval is for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after at least two prior…
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Mabwell Bioscience Files for IPO on Hong Kong Stock Exchange, Expanding Biopharma Reach
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has officially filed for an initial public offering (IPO) with the Hong Kong Stock Exchange. This move marks a significant step in the company’s growth strategy as it seeks to expand its operations and raise capital for further development. Company Overview and PipelineFounded…
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WuXi Biologics to Sell Irish Vaccine Assets to MSD for USD 500 Million
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) is poised to sell its assets related to vaccine facilities in Ireland to US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) for a consideration of USD 500 million. This strategic move reflects WuXi Biologics’ ongoing efforts…
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Junshi Biosciences’ Loqtorzi Gains Regular Approval for Melanoma Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its PD-1 inhibitor, Loqtorzi (toripalimab), has received regular approval in China for the treatment of unresectable or metastatic melanoma that has previously failed systemic therapy. This marks a significant milestone in the drug’s regulatory journey. Background and Approval…
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Simcere Zaiming’s SIM0505 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SIM0505, which targets CDH6 in advanced solid tumors. Last month, the drug also received clearance for clinical trials…
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NMPA Releases 88th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 88th batch of reference drugs for the Generic Quality Consistency Evaluation (GQCE) work. This update is part of the ongoing efforts to ensure the quality and efficacy of generic drugs in the Chinese market. Details of the ReleaseThe latest batch includes…
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Huahui Health’s HH-003 Gains Priority Review Status for Chronic Hepatitis D Treatment
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has indicated that Huahui Health’s HH-003 is on track to obtain priority review status as a “drug eligible for conditional approval.” This designation is specifically for the treatment of chronic hepatitis D virus (HDV) infection. Drug Mechanism…
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WuXi Biologics and Candid Therapeutics Ink Global Research Agreement for Trispecific T-cell Engager
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced a research service cooperation agreement with US-headquartered Candid Therapeutics, Inc. This strategic partnership aims to accelerate the development of innovative T-cell engagers for autoimmune and inflammatory diseases. Terms of the AgreementUnder the terms of the agreement,…
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Amoytop Biotech’s Pegfilgrastim Gains NMPA Approval for Preeclampsia Clinical Trials
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) to reduce the incidence of preeclampsia. This marks a significant milestone in the development of innovative therapies for pregnancy-related complications. Product Overview…
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Hengrui Pharmaceuticals Files IPO Prospectus in Hong Kong Amid Record Deal-Making
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has officially submitted an initial public offering (IPO) prospectus to the Hong Kong Stock Exchange. This move marks a significant step in the company’s expansion strategy and follows a period of substantial growth and deal-making. Out-Licensing Deals and Financial MilestonesSince 2018, Hengrui has…
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Changchun BCHT Partners with Baosight Software for Biopharmaceutical Digitization
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China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced a partnership with compatriot firm Shanghai Baosight Software Co., Ltd. The collaboration is aimed at advancing the digitization of the biopharmaceutical industry. Scope of CollaborationThe partnership will focus on in-depth collaboration across various areas, including enterprise management consulting, information technology,…
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CDE Announces 90th Batch of Reference Preparations for GQCE
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China’s Center for Drug Evaluation (CDE) has selected the 90th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes. This batch adds 43 new drugs and 9 specifications to the list, reflecting the ongoing efforts to enhance the quality and consistency of generic drugs in the market.…
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Solasia Pharma Licenses Episil to GeneScience for Greater China Region
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Japan-based Solasia Pharma K. K (TYO: 4597) has announced a licensing agreement with Changchun GeneScience Pharmaceutical Co., Ltd, granting the Chinese company exclusive commercialization rights to its oncology product episil oral liquid (sodium valproate) in mainland China, Hong Kong, Macau, and Taiwan. The agreement is effective as of the beginning…
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Alebund Pharmaceuticals Completes Series C Financing to Advance Kidney Disease Pipelines
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Shanghai-based Alebund Pharmaceuticals has announced the completion of a Series C financing round, raising RMB 550 million (USD 75.04 million). The round was led by Yangzhou Guojin Investment Group Co. Ltd and Kingray Capital, both renowned healthcare funds. The proceeds will be used to enhance the development and commercialization of…
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GSK’s Nucala Receives New Indication Approval in China for CRSwNP
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UK-based pharmaceutical company GlaxoSmithKline’s (GSK; NYSE: GSK) has announced that it has received another indication approval in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now approved as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP)…
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China’s Healthcare Bureaus Remove Drug Quantity Limits to Enhance NRDL Access
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The healthcare security administration bureaus in Shanghai, Beijing, and other regions have recently removed limits on drug use quantities in hospitals. This move is aimed at bolstering the access of drugs listed on the National Reimbursement Drug List (NRDL) to healthcare facilities. Shanghai’s Initiatives for NRDL Drug ProcurementShanghai’s healthcare security…
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Kexing Pharmaceutical Partners with Shandong Boan for Biosimilar Commercialization in Hong Kong and Macau
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into a commercialization cooperation agreement with fellow Chinese firm Shandong Boan Biotechnology Co., Ltd (HKG: 6955). The partnership aims to promote the marketing and sales of Shandong Boan’s biosimilars BA6101 and BA1102 in Hong Kong and Macau. BA6101 is a biosimilar version of…
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Shengwei Kunteng Raises RMB 200 Million in Series A Financing for POCT Development
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China-based Hunan Shengwei Kunteng Biotechnology Co., Ltd has announced that it has raised close to RMB 200 million (USD 27.3 million) in a Series A financing round led by Sansure, Sanway Spring, and Voyagers Capital. The funds will be directed towards research and development and the construction of an industrialization…
