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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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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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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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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…
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Hangzhou Highlightll Pharma Completes Pre-Series C Financing Round
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China-based Hangzhou Highlightll Pharmaceutical Co., Ltd has announced the successful completion of a Pre-Series C financing round, raising RMB 150 million (USD 20.5 million). The investment was led by Huajin Capital, Bayland Capital, Infinity Capital, and returning investor Hankang Capital. The funds will be used to enhance the clinical development…
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Aosaikang’s Generic Livtencity Accepted for Review by China’s NMPA
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed that a market filing for its generic version of Japan-based Takeda’s (TYO: 4502) Livtencity (maribavir) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the potential introduction of a more accessible…
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Sinobioway Medicine Partners with Happy Life Tech for Clinical Trial Services
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China-based Contract Manufacturing Organization (CMO) Sinobioway Medicine (SHE: 002581) has announced a clinical trial technical service agreement with compatriot firm Happy Life Tech (HLT), an affiliate of Yidu Tech (HKG: 2158). The agreement focuses on recombinant human nerve growth factor eye drops, targeting moderate to severe dry eye conditions. Phase…
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Balance Medtech’s Interventional Pulmonary Valve Receives Fast-Track Designation from NMPA
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China’s Beijing Balance Medical Technology Co., Ltd. (SHA: 688198) has announced that it has received fast-track designation from the Center for Medical Device Evaluation, NMPA, for its in-house developed all-comer interventional pulmonary valve and delivery system. This marks the third interventional valve product from Balance Medtech to receive fast-track status…
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MicuRx Pharmaceuticals’ MRX-5 Receives NMPA Approval for NTM Infections Clinical Study
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug MRX-5. The study will focus on infections caused by non-tuberculous Mycobacteria (NTM) that are sensitive to this product. MRX-5: A Promising…
