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Cinclus Pharma’s Linaprazan for GERD Receives NMPA Marketing Approval
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Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug candidate, linaprazan, which is indicated for the treatment of gastroesophageal reflux disease (GERD). The drug is expected to be commercialized in China in 2025, marking a significant milestone for…
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CSPC Pharmaceutical’s CRB-701 Earns FDA Fast Track Designation for Cervical Cancer Treatment
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its drug candidate CRB-701 (SYS6002), which is being developed for the treatment of recurrent/refractory metastatic cervical cancer. CRB-701 (SYS6002): An Innovative ADC Targeting Nectin-4SYS6002…
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Sisram Medical’s Alma Harmony and Alma Hybrid Receive EU Medical Device Certification
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Sisram Medical Ltd (HKG: 1696), an Israel-based company and part of the Fosun Pharmaceutical Group (SHA: 600196), has announced that its subsidiary, Alma Lasers Ltd., has obtained certification under the Medical Device Regulation (MDR) in the European Union (EU) for its quality management system and dermatology products, Alma Harmony and…
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Shanghai Henlius Biotech’s HLX11 Biosimilar Accepted for Review by China’s CDE
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a market filing for its HLX11, a biosimilar version of Perjeta (pertuzumab). The company is seeking regulatory approval for…
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Wuhan Kaideweisi Biotechnology Secures Series B Funding for Gynecologic Oncology Expansion
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Wuhan Kaideweisi Biotechnology Co., Ltd, a specialist in gynecologic oncology in China, has reportedly raised close to RMB 200 million (USD 27.5 million) via a Series B financing round. The round was led by Fir Health Capital with a contribution of RMB 50 million (USD 6.9 million), and was also…
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Shanghai Henlius Biotech’s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase…
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Jiangsu Recbio Technology Secures Private Placement with Yangtze River Pharmaceutical for Vaccine Development
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China-based Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has successfully placed 142 million shares through a private placement to compatriot firm Yangtze River Pharmaceutical (Group) Co., Ltd. This transaction positions Yangtze River Pharmaceutical as the largest shareholder of Jiangsu Recbio, marking a significant strategic investment in the biotechnology sector. Proceeds…
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Hangzhou Chance Pharmaceuticals Partners with Yiling Pharmaceutical for Inhalation Powder Development
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China’s Hangzhou Chance Pharmaceuticals Co., Ltd., a specialist in lung drug delivery, has entered into a partnership with fellow Chinese firm Yiling Pharmaceutical Co., Ltd (SHE: 002603). The collaboration aims to leverage Hangzhou Chance’s experience and technology in the development of inhalation powder mist agents, thereby facilitating Yiling Pharma in…
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GRIT Biotechnology and Vitalgen BioPharma Partner on CRISPR-AaCas12bMAX Cell Therapies
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China-based cell therapy specialists GRIT Biotechnology and Shanghai Vitalgen BioPharma Co., Ltd have entered into a collaboration agreement to leverage GRIT’s CRISPR-AaCas12bMAX gene editing tool and related gene editing techniques for the development, manufacturing, and commercialization of certain cell therapies. The agreement, for which no financial details were disclosed, highlights…
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YiChang HEC ChangJiang Pharmaceutical and DP Technology Deepen Partnership with AI Focus
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China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced a comprehensive partnership with compatriot firm DP Technology, with the aim of leveraging artificial intelligence (AI) to bolster the biopharmaceutical industry. This strategic collaboration is an extension of an existing partnership between the two companies, which saw the establishment…
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Mabwell Bioscience Enters Licensing Agreement for Biosimilar Denosumab in Peru
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a licensing agreement with its partner in Peru, which will handle the marketing of Mabwell’s MAILISHU (9MW0311) and MAIWEIJIAN (9MW0321), biosimilars of denosumab in Peru. Mabwell will retain responsibility for the development, manufacturing, and commercial supply of these products. Biosimilars…
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Analytical BioSciences Sells Global Rights to Pre-Clinical Anti-Tumor Drugs to Gilead
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Sino-US firm Analytical BioSciences Limited has entered into an asset purchase agreement with Gilead (NASDAQ: GILD), granting the US firm global rights to Analytical’s multiple pre-clinical anti-tumor candidate drug assets. The financial details of the upfront and milestone payments remain undisclosed, and Gilead will also grant Analytical priority purchase rights…
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CanSino Biologics Partners with Etana for Inhaled Tuberculosis Vaccine Development
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has entered into a strategic partnership with Indonesia-based PT Etana Biotechnologies (Etana) to focus on the research and development of inhaled tuberculosis vaccines. The collaboration aims to leverage both companies’ expertise to advance novel vaccination methods against tuberculosis, although no financial details of…
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Zhida Pharma Secures Licensing Deal for Vivesto AB’s Apealea in China
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Zhejiang-based Zhida Pharma has announced a licensing deal with Sweden-headquartered Vivesto AB (STO: VIVE), securing all rights to Vivesto’s EU-registered Apealea (paclitaxel micellar) in China. This agreement expands Zhida Pharma’s portfolio and introduces a novel treatment option for patients in China. Apealea: A Cremophor-Free Paclitaxel Formulation for Ovarian CancerApealea is…
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Guangzhou Innogen Pharmaceutical Files for IPO on Hong Kong Stock Exchange
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Guangzhou Innogen Pharmaceutical Group Co., Ltd., a China-based pharmaceutical company, has made an initial public offering (IPO) filing with the Hong Kong Stock Exchange. While the unit price and other key details of the offering have not been disclosed, the move marks a significant step in the company’s journey to…
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Coherus BioSciences Sells Udenyca Franchise to Intas Pharmaceuticals in Asset Purchase Deal
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US-based Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) has announced an asset purchase agreement with Indian-headquartered Intas Pharmaceuticals Ltd. (Intas) regarding the divestment of Udenyca (pegfilgrastim-cbqv), a filgrastim biosimilar used to reduce the risk of febrile neutropenia in cancer patients post-chemotherapy. Terms of the Agreement and Product TransferUnder the agreement, Coherus…
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GSK plc Enters Exclusive Option Agreement with Duality Biologics for ADC Candidate DB-1324
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UK-based GSK plc (NYSE: GSK) has entered into an exclusive option agreement with Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China. The agreement is in relation to a potentially best-in-class ADC candidate, DB-1324. Terms of the Agreement and Financial DetailsUnder the…
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Keros Therapeutics and Takeda Enter Licensing Agreement for Elritercept Development
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US-based Keros Therapeutics, Inc. (NASDAQ: KROS) has announced a significant licensing agreement with Japan-headquartered Takeda (TYO: 4502) to strengthen the research and development of its late-stage investigational activin inhibitor, elritercept. Elritercept’s Clinical Studies and IndicationsElritercept is currently the subject of two clinical studies, one focusing on myelodysplastic syndromes (MDS) and…
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Gilead Sciences Secures Exclusive Option for Tubulis’ Tubutecan and Alco5 Platforms to Develop ADC
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US-based Gilead Sciences Inc., (NASDAQ: GILD) has announced an exclusive option and license agreement with Tubulis GmbH, a German firm. This agreement grants Gilead access to Tubulis’ proprietary Tubutecan and Alco5 platforms for the joint development of an antibody-drug conjugate (ADC) targeting solid tumors. Financial Terms and Milestones of the…
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Ophthalmology Biotech Cloudbreak Pharma Inc. Pursues Hong Kong IPO
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Cloudbreak Pharma Inc., a Cayman Island-registered ophthalmology biotech company, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, with major details undisclosed at this stage. This marks the company’s third attempt to go public, following previous efforts in November 2023 and May 2024. Innovative Pipeline…
