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Stabilizing Foreign Investment: China’s Comprehensive Action Plan for 2025
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In a significant move to bolster foreign investment and enhance the country’s economic openness, the Chinese government has unveiled an extensive set of measures aimed at creating a more attractive business environment for international investors. The initiative, outlined in a recent notice from the State Council’s General Office, focuses on…
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Nona Biosciences Licenses H2L2 Harbour Mice Platform to UAB for B Cell Research
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a licensing agreement with the University of Alabama at Birmingham (UAB) to support research in B cell development. Agreement DetailsUnder the agreement, Dr. James Kobie of UAB will receive a non-exclusive license to develop fully human…
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Innogen Pharmaceutical Launches Efsubaglutide Alfa for Type 2 Diabetes in China
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China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, announced the global launch of its efsubaglutide alfa, a next-generation ultra-long-acting glucagon-like peptide 1 (GLP-1) receptor agonist for the treatment of type 2 diabetes (T2D), in Changshu, Jiangsu province. Drug ProfileEfsubaglutide alfa, with an average half-life of…
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Bayer’s AskBio Receives RMAT Designation for AB-1005 in Parkinson’s Disease
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German pharmaceutical giant Bayer (ETR: BAYN) announced that its gene therapy subsidiary AskBio Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational gene therapy AB-1005 as a treatment for Parkinson’s disease (PD). Drug ProfileAB-1005 is an investigational gene therapy…
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Phanes Therapeutics Doses First Patient in Peluntamig Study for SCLC and NEC
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Sino-US biotech Phanes Therapeutics Inc. announced that the first patient has been dosed in a clinical study evaluating peluntamig (PT217) in combination with chemotherapy. The trial focuses on patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). Drug ProfilePeluntamig is a bispecific antibody (BsAb) targeting DLL3 and CD47.…
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Epitopea and Merck Partner to Identify Cryptigen Tumor Antigens
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UK-based RNA immunotherapy developer Epitopea announced a licensing and research cooperation agreement with US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK). The partnership aims to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. These antigens, derived from non-coding regions of the genome, are shared, non-mutated, and…
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Boehringer Ingelheim’s Zongertinib NDA Accepted by FDA for HER2-Mutated NSCLC
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Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zongertinib (BI 1810631). The drug is indicated for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have received prior systemic therapy. The…
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Hepalink Pharmaceutical’s H1710 Heparanase Inhibitor Approved for Phase I Study
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of its proprietary drug candidate H1710, a heparanase (HPA) inhibitor, for the treatment of advanced solid tumors. Drug ProfileH1710 is designed…
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Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
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Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
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Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
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Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
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Huadong Medicine’s MediBeacon TGFR System Approved by NMPA for GFR Measurement
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for the MediBeacon Transdermal GFR System (TGFR), a Category III medical device licensed from US firm MediBeacon Inc. The device is designed to assess the glomerular filtration rate (GFR)…
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Sunshine Guojian and Shenyang 3SBio License 612 and 708 Programs for Anti-Tumor Development
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd and Shenyang 3SBio Co., Ltd, both subsidiaries of 3SBio Inc. (HKG:1530), have entered into a licensing agreement for Sunshine Guojian’s 612 and 708 programs. Under the agreement, Shenyang 3SBio will obtain exclusive rights to develop, file regulatory applications, modify, use, manufacture, and market…
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Antengene to Boost T Cell Engager Platform with AI Investment and DeepSeek Deployment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced plans to increase investment in establishing a specialized artificial intelligence (AI) department. The move includes deploying DeepSeek, a Chinese advanced AI model for complex reasoning and natural language processing, to accelerate the development of its T cell engager (TCE) platform with spatial…
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Jiangxi Rimag Group and Xunfei Healthcare Form Strategic Alliance for Smart Healthcare
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China-based Jiangxi Rimag Group Co., Ltd (HKG: 2522) announced a strategic alliance with Xunfei Healthcare Technology Co., Ltd, a subsidiary of iFlytek Co., Ltd (SHE: 002230), to collaborate on smart healthcare initiatives. Collaboration FocusThe partnership will focus on:
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Rendu Biotechnology Partners with Green Apple Medical System for RNA Diagnostics Expansion
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Rendu Biotechnology Co., Ltd., (SHA: 688193) a Shanghai-based specialist in RNA molecular diagnostics, has entered into a strategic partnership with India’s Green Apple Medical System. The collaboration aims to leverage the strengths of both companies to promote the widespread application of RNA diagnostic technology in India and other markets. Partnership…
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Genuine Biotech Files for Hong Kong IPO with Azvudine and ZS-1003 in Pipeline
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China-based Genuine Biotech Limited has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, according to the bourse’s website. Key details such as the unit price and offering size have not yet been disclosed. Company ProfileGenuine Biotech is focused on the development, manufacturing, and commercialization of…
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AstraZeneca Faces Class Action Lawsuits Over China Legal Issues
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AstraZeneca plc (AZ, NASDAQ: AZN) is facing multiple class action lawsuits in the United States related to recent legal issues in China, including the arrest of its former China market president, Leon Wang. The lawsuits allege that the UK-based pharmaceutical giant made misleading statements about its operations in China, failing…
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Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
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US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc. (NASDAQ: STOK), securing exclusive commercialization rights to zorevunersen, a drug for Dravet syndrome, in all territories outside the United States, Canada, and Mexico. Drug ProfileZorevunersen is an antisense oligonucleotide (ASO) targeting the SCN1A gene, the…
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TAHO Pharma’s TAH3311 Oral Film Shows Bioequivalence to Eliquis in Study
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Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions. Study ResultsThe trial involved 60 healthy subjects, with 48 completing the…
