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Bristol-Myers Squibb’s Opdivo Shows Survival Benefit in CheckMate-816 Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced the final analysis of overall survival (OS) data from the Phase III CheckMate-816 study for its Opdivo (nivolumab) in patients with resectable non-small cell lung cancer (NSCLC). Study HighlightsThe CheckMate-816 study evaluated Opdivo in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult…
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Corxel Pharmaceuticals to Test JX10 in Acute Ischemic Stroke Patients with NMPA Approval
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China-based Corxel Pharmaceuticals (CORXEL) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the functional recovery of acute ischemic stroke (AIS) patients treated with JX10 within a time window of 4.5 to 24 hours from the “last known well.” Drug ProfileJX10 is an…
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Harbour BioMed and Insilico Medicine Partner on AI-Powered Antibody Development
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China-based Harbour BioMed (HKG: 2142) announced a strategic partnership with Insilico Medicine, a generative artificial intelligence (AI)-driven biotech firm. The collaboration aims to leverage their respective strengths in antibody discovery and AI to accelerate the development of innovative therapeutic antibodies. Partnership DetailsThe partnership combines Harbour BioMed’s industry-leading technology platform, proprietary…
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Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response…
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FibroGen to Sell China Subsidiary to AstraZeneca for ~$160M, Roxadustat Rights Included
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US-based biopharma FibroGen Inc. (NASDAQ: FGEN) has entered into an agreement to sell its China subsidiary to UK-based AstraZeneca (NASDAQ: AZN) for approximately USD160 million. The deal includes the transfer of all rights to roxadustat, a treatment for anemia caused by chronic kidney disease (CKD), in China. Transaction DetailsUnder the…
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Waterdrop Integrates DeepSeek AI to Boost Insurance Ecosystem
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China-based Waterdrop Inc. (NYSE: WDH), a crowdfunding-based health insurance platform, announced a strategic integration with DeepSeek, a Chinese artificial intelligence (AI) company specializing in large language models (LLMs). This collaboration marks a significant advancement in Waterdrop’s AI-driven insurance ecosystem. Company BackgroundSince its founding in 2016, Waterdrop has focused on promoting…
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Boehringer Ingelheim Launches LENTICLAIR Study for CF Gene Therapy BI 3720931
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German pharmaceutical company Boehringer Ingelheim announced the initiation of the Phase I/II LENTICLAIR study for its gene therapy candidate BI 3720931 in cystic fibrosis (CF). The study is being conducted in collaboration with IP Group, the UK Respiratory Gene Therapy Consortium (GTC), and OXB. Study DetailsBI 3720931 is an inhaled…
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Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Denmark-based Novo Nordisk A/S’s (NYSE: NVO) Tresiba (insulin degludec) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is adult type 2 diabetes. Drug ProfileInsulin degludec, a…
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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)…
