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Bristol-Myers Squibb’s Opdivo Qvantig Receives FDA Approval for Expanded Indications
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid…
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HitGen Inc. Initiates Phase II Clinical Trial for HG146 in Adenoid Cystic Carcinoma
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China-based HitGen Inc. (SHA: 688222) has announced the commencement of the first patient enrollment in a Phase II clinical study for its Category 1.1 anti-tumor drug, HG146. This study focuses on the treatment of recurrent or metastatic adenoid cystic carcinoma, a rare and aggressive form of cancer. HG146: A Promising…
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Reforgene Medicine Secures Hundreds of Millions in Financing for Gene Therapy Expansion
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Reforgene Medicine, a prominent gene editing therapy company headquartered in Guangzhou, has reportedly secured hundreds of millions of renminbi in a new financing round. This funding round was led by Guangzhou Industry Investment, with additional contributions from Guangzhou Financial Holdings, Technology Financial Holdings, and returning investor IFSC. The capital raised…
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Xtalpi Inc. Partners with NCCS and Duke-NUS to Advance AI-Driven Drug Discovery
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Shenzhen-based QuantumPharm Inc., trading under the name Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with the National Cancer Center Singapore (NCCS) and Duke-NUS Medical School. This collaboration will harness the power of artificial intelligence (AI) to revolutionize the discovery and design of clinical drug candidates. AI-Driven Peptide Research…
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Danaher Corporation Opens Joint Office in Beijing’s Chaoyang District
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US-based Danaher Corporation (NYSE: DHR), a leading science and tech services provider, has officially launched its joint office in Northern China. The new facility is strategically located in the Chaoyang District of Beijing and spans an impressive 1,500 square meters. Subsidiaries Under One RoofThe state-of-the-art office brings together several of…
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WuXi Biologics Partners with Sino Biopharmaceutical for First-in-Class Monoclonal Antibody Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced a significant research service cooperation agreement with fellow firm Sino Biopharmaceutical Ltd (HKG: 1177). This partnership aims to empower Sino Biopharmaceutical in the development of a first-in-class monoclonal antibody (mAb), with the target currently undisclosed. Comprehensive…
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GenFleet Therapeutics Submits IPO Application to HKEX, Backed by CITIC Securities
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On December 27, 2024, GenFleet Therapeutics, a biopharmaceutical company based in Shanghai, submitted its application for listing on the Hong Kong Stock Exchange (HKEX), with CITIC Securities serving as the exclusive sponsor and overall coordinator. Company Background and FocusEstablished in 2017, GenFleet Therapeutics is a market-stage biopharmaceutical company specializing in…
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Overwhelming Shareholder Support for Hengrui Pharmaceuticals’ H-Share IPO
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On December 26, Hengrui Pharmaceuticals (SHA: 600276) held its second extraordinary general meeting of 2024, where the primary agenda was to discuss the company’s proposal to issue H shares and list them on the Hong Kong Stock Exchange (HKEX). Landmark Approval for H-Share IssuanceThe outcome of the deliberation was overwhelmingly…
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Dynamiker Biotechnology Receives Approval for IPO on Beijing Stock Exchange
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On December 27, 2024, the official website of the Beijing Stock Exchange announced that Dynamiker Biotechnology (Tianjin) Co., Ltd. has received approval for its initial public offering (IPO) from the listing committee, with Citic Securities serving as the sponsor. The company aims to raise RMB 456 million (approximately USD 64…
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MicroPort Endovascular MedTech’s Castor® Branched Stent Wins China Patent Gold Award
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The National Intellectual Property Administration has announced the winners of the 25th China Patent Awards, with Shanghai MicroPort Endovascular MedTech Co., Ltd’s (SHA: 688016) Castor® branched aortic stent graft and delivery system receiving the China Patent Gold Award. The awarded patent, titled “Branched Covered Stent, Including Its Delivery System and…
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Daiichi Sankyo and AstraZeneca Withdraw EU Application for Datopotamab Deruxtecan in Lung Cancer
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced the voluntary withdrawal of the marketing authorization application (MAA) in the European Union for their co-developed drug, datopotamab deruxtecan (Dato-DXd). This decision pertains to the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell…
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AstraZeneca China Announces Structural Adjustments to Oncology Business Divisions
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UK major AstraZeneca’s (AZ, NASDAQ: AZN) China unit has announced a new round of structural adjustments, effective January 1, 2025. The oncology business will be reorganized into four distinct divisions: the lung cancer business division, the urogynecology and digestive cancer business division, the breast cancer business division, and the blood…
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Beijing Releases List of Novel Drugs and Technologies Exempt from CHS-DRG Payment Scheme
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The Beijing Municipal Medical Insurance Bureau has released the list of the first batch of novel drugs and technologies that will enjoy payment outside of the China Health-care Security Diagnosis Related Groups (CHS-DRG) payment scheme. A total of 24 payment items are included, featuring small molecule inhibitors such as olaparib,…
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Johnson & Johnson Secures Licensing Deal with Kaken Pharmaceutical for STAT6 Program
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US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced an exclusive licensing agreement with Japan-based Kaken Pharmaceutical Co., Ltd. This agreement grants Johnson & Johnson global development, manufacturing, and commercialization rights for a STAT6 program aimed at treating autoimmune and allergic diseases, including atopic dermatitis (AD). Under the terms…
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Ascentage Pharma Announces Secondary Offering on Nasdaq, Expanding Global Reach
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China-based Ascentage Pharma (HKG: 6855) has unveiled plans for a secondary offering of up to 33,739,347 shares on the Nasdaq, as reported by the China Securities Regulatory Commission. This strategic move is aimed at bolstering the company’s financial capacity to further its research and development efforts in innovative oncology treatments.…
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Auzone Submits NDA for Oral Edaravone TTYP01 to Treat ALS
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Auzone Biological Technology has announced the submission of a New Drug Application (NDA) for its product candidate TTYP01 (edaravone) (Product Name: AUKONTALS）to the US Food and Drug Administration (FDA). The Chinese company is seeking approval for the drug to treat amyotrophic lateral sclerosis (ALS). Notably, the FDA previously awarded an…
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Pediatrix Therapeutics’ Neffy NDA Accepted by NMPA for Allergy Treatment
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China-based Pediatrix Therapeutics has announced that the New Drug Application (NDA) for its neffy (epinephrine nasal spray) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication for neffy is the emergency treatment of type I allergic reactions, including severe allergic reactions, in adults and…
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Immunochina Pharmaceuticals and Cell Store Partner to Advance Cell Therapy Commercialization in China
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Beijing-based firms Immunochina Pharmaceuticals and Cell Store have announced a strategic partnership aimed at bolstering the industrialization and commercialization of cell therapies in China. The financial details of the collaboration have not been disclosed. Innovative Cryopreservation Technology from Cell StoreCell Store is an innovative biotech company that specializes in “controlled…
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Hinova Pharmaceuticals Enrolls First Patient in Phase II Study for HP518 in mCRPC
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China-based biopharma Hinova Pharmaceuticals has announced the enrollment of the first patient in an open, multi-center Phase II study assessing the safety, pharmacokinetics, and anti-tumor activity of its Category 1 chemical drug, HP518, in patients with metastatic castration resistant prostate cancer (mCRPC). Innovative Mechanism of Action for HP518HP518 is an…
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Xbiome Partners with ZoHealth to Advance Microbiome Drug Development and Precision Nutrition
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China-based Xbiome, an AI-driven microbiome drug development company, has announced a strategic alliance with Australia-headquartered ZoHealth. This collaboration focuses on the development of human gut microbiota, precision nutrition, and health product innovation. Core Program Focused on Probiotic ProductsThe core program of the partnership will center around Xbiome’s proprietary bacterial strains,…
