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FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
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Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor…
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Allist Pharmaceuticals Gains NMPA Approval for Furmonertinib Clinical Study
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its furmonertinib as an adjuvant therapy for stage IB-IIIB non-small cell lung cancer (NSCLC) carrying non-classical epidermal growth factor receptor (EGFR) mutations. The study will evaluate the…
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Junshi Biosciences’ Toripalimab Gains TGA Approval for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care for its toripalimab. The anti-PD-1 monoclonal antibody can now be used in combination with cisplatin and gemcitabine for the…
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Inscinstech Secures C-Series Financing for Biopharma Expansion
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Inscinstech Co., Ltd., a leading intelligent technology company based in Suzhou, has successfully completed a C-series financing round worth hundreds of millions of RMB. The round was led by the Service Trade Innovation Development Guidance Fund, with additional investments from ORIZA Holdings and LUCION, an existing shareholder. This financing marks…
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Raytone Bio Completes Angel Round to Advance iSus® Platform
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Raytone Bio, a Shenzhen-based biopharmaceutical company, has announced the completion of a multi-million RMB Angel Round Funding. The round was led by Qianhai Triwise International Capital Management Co., Ltd., National Medical Equipment Development (NMED) Innovation Center, JenKem Technology Co., Ltd. (SHA: 688356), and Dalton Venture, with exclusive financial advisory services…
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Aosaikang’s Limertinib Approved for EGFR T790M-Mutated NSCLC
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Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharm, SHE: 002755) has recently received approval from the National Medical Products Administration (NMPA) for the registration and market launch of its drug Limertinib (Brand name: Aoyixing). The drug is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell…
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Johnson & Johnson Submits NDA for TAR-200 in High-Risk Bladder Cancer
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced the initiation of the submission of a New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for TAR-200. The drug is intended for use in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma…
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Eli Lilly’s Omvoh Approved by FDA for Crohn’s Disease Treatment
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US major Eli Lilly and Company (NYSE: LLY) has announced receiving marketing approval from the US FDA for its Omvoh (mirikizumab-mrkz), an interleukin-23p19 (IL-23p19) antagonist, to treat moderately to severely active Crohn’s disease in adults. This approval follows the FDA’s nod for its use as a first-in-class treatment for moderately…
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IVIEW Therapeutics Secures Series A++ Funding for Ophthalmology Pipeline
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IVIEW Therapeutics Inc., an ophthalmology biotech operating out of the US and China, has reportedly raised an undisclosed amount of funds via a Series A++ financing round. The round was led by Chongqing Changsheng Shenghe Investment Fund, with contributions from Hangzhou Jiurun Investment, ehroh, and existing investors Proxima Ventures Fund…
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Boehringer Ingelheim’s Iclepertin Fails to Meet Phase III Study Endpoints
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German giant Boehringer Ingelheim has disclosed negative top-line results from the Phase III CONNEX study for its iclepertin, a treatment for cognitive impairment in adults with schizophrenia. The study failed to meet either primary or key secondary endpoints, indicating no statistically significant effects on cognition or functioning in patients treated…
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Telix Pharmaceuticals’ TLX591-CDx Approved in Europe via Decentralized Procedure
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via the Decentralized Procedure (DCP) for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the regulatory body in the region. This approval marks…
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Daiichi Sankyo Acquires Gatipotuzumab IP Rights for $132.5M
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Japan-based Daiichi Sankyo Company, Ltd (TYO: 4568) has announced an investment of USD 132.5 million to acquire the intellectual property (IP) rights of gatipotuzumab, an antitumor-associated mucin-1 (TA-MUC1) antibody, from Germany-headquartered Glycotope GmbH. This strategic acquisition strengthens Daiichi Sankyo’s portfolio in cancer therapy. Acquisition Details and BackgroundDaiichi Sankyo obtained global…
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a16z Bio + Health Launches Biotech Ecosystem Venture Fund
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Andreessen Horowitz (a16z) Bio + Health has announced the establishment of the Biotech Ecosystem Venture Fund, a venture capital fund backed by Eli Lilly and Company (NYSE: LLY). The fund is designed to drive transformative progress in healthcare by investing in therapeutic platforms and cutting-edge technology companies that can bring…
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Impact Therapeutics’ Senaparib Cleared by NMPA for Ovarian Cancer Therapy
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China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA) for its senaparib to be used as maintenance therapy in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The clearance is for patients who have achieved complete or partial…
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Siemens Lays Foundation for New Medical Equipment Base in Shenzhen
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Siemens (Shenzhen) Magnetic Resonance Co., Ltd., a wholly-owned subsidiary of Siemens Ltd., China, has officially laid the foundation for its new high-end medical equipment R&D and manufacturing base project in Nanshan District, Shenzhen. This significant investment marks a major expansion of Siemens’ capabilities in the region. Project Details and TimelineThe…
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Fujian Haixi Pharmaceuticals Files for Hong Kong IPO
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China-based Fujian Haixi Pharmaceuticals Co., Ltd., a commercial-stage innovative pharmaceutical company, has made an initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKSE). The company has not disclosed the unit price or other key details at this stage, but the move marks a significant step in its…
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SciClone and Menarini Submit NDA for Vaborem in China
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China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of a New Drug Application (NDA) for Vaborem (meropenem vaborbactam) to the National Medical Products Administration (NMPA). The sought-after indication is complex urinary tract infections, including pyelonephritis. This submission marks a significant step in making this…
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Servier and Google Cloud Extend Partnership to Advance AI in Drug Development
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France-based Servier Group and US technology firm Google Cloud have announced an expansion to their five-year partnership, initially struck in August 2022, by an additional five years. The extension aims to enhance the research and development (R&D) of innovative therapeutic solutions for patients through the utilization of AI and generative…
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Cathay Biotech Plans $901M Private Placement to Boost Bio-Based Materials
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Shanghai-based Cathay Biotech Inc. (SHA: 688065) has announced plans to raise RMB 6.6 billion (USD 901 million) through a private placement of 153,595,531 shares at RMB 42.97 (USD 5.86) per share. This significant capital raise is aimed at enhancing the company’s capabilities in the research, development, manufacturing, and sales of…
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Simcere Licenses Fermion’s AI-Enabled Painkiller FZ002-037
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China-based Simcere Pharmaceutical Group Limited (HKG: 2096) has announced a licensing agreement with compatriot firm Fermion, an artificial intelligence (AI) empowered small-molecule drug developer, relating to an investigational SSTR4-targeted painkiller candidate drug, FZ002-037. This strategic partnership aims to advance the development and commercialization of FZ002-037 in Greater China, including mainland…
