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Huadong Medicine’s HDM1005 Shows Positive Results in Phase Ia/Ib Study
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced positive results from the Phase Ia/Ib study of HDM1005, a long-acting agonist targeting the GLP-1 and GIP receptors, in China. Study Details Safety ResultsThe most common adverse reactions were decreased appetite and gastrointestinal issues (nausea, vomiting, bloating), which were mild to moderate…
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PolyMed Biopharma Licenses HPB-143 to Photys Therapeutics for Global Development
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PolyMed Biopharma, a Hangzhou-based developer of Proteolysis Targeting Chimera (PROTAC) drugs, has entered into a licensing agreement with U.S.-based Photys Therapeutics, Inc. for its HPB-143, a targeted protein degrader (TPD) targeting IRAK4. Under the agreement, Photys will obtain exclusive global development, manufacturing, and commercialization rights to the drug, excluding Greater…
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Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
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South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; SB16; 120 mg vial), biosimilars of US major Amgen’s RANKL inhibitors Prolia and Xgeva, respectively. Additionally, the…
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Kexing Biopharm’s GB05 Receives FDA Approval for Pediatric RSV Infections
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its human interferon α1b inhalation solution, GB05. The drug is designed to treat pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as…
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Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
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The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar of Novo Nordisk’s (NYSE: NVO) NovoLog. Merilog, a rapid-acting insulin, is indicated for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval includes both a 3 milliliter (mL) single-patient-use…
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![Yantai Dongcheng’s Lannacheng Bio Secures RMB150m to Advance [18F] Spiritide Study](https://flcube.com/wp-content/uploads/2025/02/1709-png.avif)
Yantai Dongcheng’s Lannacheng Bio Secures RMB150m to Advance [18F] Spiritide Study
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675)’s controlling subsidiary, Yantai Lannacheng Biotechnology Co., Ltd., has secured RMB150 million (USD20.7 million) in funding from three new investors: Wenzhou Ruili Medical New Consumer Industry Investment Partnership, Shanghai Linjue Enterprise Management, and Shanghai Hanchengming Enterprise Management, as well as its parent company…
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GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
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UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets the five major serogroups of…
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3SBio and Sichuan Biokin Partner to Advance Solid Tumor Treatment in China
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China-based 3SBio Inc. (HKG: 1530) has announced a strategic partnership with fellow domestic firm Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506). The collaboration aims to advance the exploration of combining 3SBio’s 707 and Sichuan Biokin’s BL-B01D1 for the treatment of solid tumors in mainland China. Drug Profiles Collaboration DetailsThe partnership…
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LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
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Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission (EC) for its Korjuny (catumaxomab), making the trifunctional anti-CD3 x anti-EpCAM antibody (trAb) the only approved therapy for patients with malignant ascites (MA) across Europe. Drug BackgroundCatumaxomab was originally discovered by German firm Trion Pharma…
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IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
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China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
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Innovent Biologics’ IBI363 Receives FDA Fast-Track Designation for sqNSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another fast-track designation from the US Food and Drug Administration (FDA) for its IBI363. The PD-1/IL-2α bispecific antibody fusion protein, previously granted fast-track status for melanoma, has now been awarded the designation for the treatment of unresectable, locally advanced,…
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Tianyi Medical Acquires Bellco’s CRRT Filter Business for EUR11.99m
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Tianyi Medical (SHE: 301097), a Ningbo-based developer of Class III medical consumables, has announced plans to acquire the CRRT-filter business assets of Italy-based Bellco S.R.L., a leader in blood purification treatments, for EUR11.99 million (USD12.59 million). Acquisition DetailsThe acquisition is set to position Tianyi Medical as the third company globally…
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Konruns Pharmaceutical’s KC1036 Enters Phase II Trial for Ewing’s Sarcoma in Adolescents
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced the first patient dosing in a Phase II clinical study of its KC1036 for adolescents aged 12 and above with advanced Ewing’s sarcoma (ES). Drug DetailsKC1036 is a Category 1.1 chemical drug and a tyrosine kinase inhibitor (TKI) targeting AXL, VEGFR2, and…
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Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults. Drug ProfileIvarmarcitinib…
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Deep Analysis and Strategic Insights: The Impact of Vice President Yu Bing’s Departure on BCHT Biotechnology
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In a move that has sent ripples through China’s vaccine industry, Changchun BCHT Biotechnology Co., Ltd (BCHT, SHA: 688276) announced on February 15 that Vice President Yu Bing has stepped down from his roles as director and deputy general manager due to personal reasons. This departure has sparked speculation about…
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Beijing Wanjie Medical Device Completes Near-Hundred Million Yuan B-Round Financing
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Beijing Wanjie Medical Device Co., Ltd. recently announced the successful completion of a B-round financing of nearly 100 million yuan. The round was invested by the fund under CAS Investment Management Co., Ltd., with Mailin Capital serving as the exclusive financial advisor. The funds raised will be mainly used for…
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Pharmaceutical Giants Race to Integrate DeepSeek AI for Efficiency Gains
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On February 14, China’s stock market saw a significant upsurge in the AI pharmaceuticals sector, with healthcare stocks across the board performing strongly. The rally was particularly driven by AI Pharmaceuticals, medical services, and DRG/DIP segments, with companies like Shanghai Runda Medical Technology Co., Ltd. leading the charge, resulting in…
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LinkZill Completes Multi-Million-Dollar A-Round Financing Led by ProximaVentures
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Hangzhou LinkZill Technology Co., Ltd. has recently completed a multi-million-dollar A-round financing, exclusively led by Proxima Ventures. The funds will be used to accelerate product delivery and global market expansion. Company BackgroundFounded in 2019 with its headquarters in Hangzhou, China, and a research and business center in Cambridge, UK, LinkZill…
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New Guidelines for Advanced Gastric Cancer Drug Development Released in China
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The National Medical Products Administration (NMPA) of China has published the “Guidance Principles for Clinical Trial Design of New Drugs for Advanced Gastric Cancer,” offering a comprehensive framework to optimize drug development and accelerate patient access to innovative treatments. Key Components of the Guidance 1. Molecular Profiling and BiomarkersThe document…
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Bristol Myers Squibb’s Opdualag Fails to Meet Primary Endpoint in Melanoma Study
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US pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) provided an update on the RELATIVITY-098 study for its Opdualag (nivolumab and relatlimab-rmbw). The Phase III study, which evaluated the drug as an adjuvant treatment for patients with completely resected stage III-IV melanoma, failed to meet its primary endpoint of recurrence-free survival…
