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CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
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Ningbo Menovo Pharmaceutical Partners with Nanjing Huawe Medicine for High-End Product Development
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Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has entered into a strategic partnership with Nanjing Huawe Medicine Technology Group Co., Ltd, a move aimed at leveraging synergies in research and development (R&D) and manufacturing resources. The collaboration seeks to reduce drug development costs and enhance product competitiveness in the high-end…
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CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
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Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
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Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
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Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
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Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
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China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
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MicroPort Endovascular MedTech’s Fiber Wool Plug Spring Coil Gains NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National Medical Products Administration (NMPA) for its fiber wool plug spring coil, a device used for the filling treatment of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas. The spring coil is constructed from a platinum…
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Kailera Therapeutics Emerges with USD 400 Million in Series A Funding for Anti-Obesity Pipeline
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Kailera Therapeutics, a newly launched US-based biotechnology company, secured USD 400 million in Series A financing last week. Previously operating as Hercules CM Newco Inc., the company was established by a consortium of investors including Bain Capital Life Sciences, RTW Investments, Atlas Venture, and Lyra Capital. The pipeline of Kailera…
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AstraZeneca Strikes Exclusive Licensing Deal with CSPC Pharma for Oral Lp(a) Disruptor
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced the signing of an exclusive license agreement with China-based CSPC Pharmaceutical Group Ltd (HKEX: 01093). The deal grants AstraZeneca the rights to develop YS2302018, a preclinical stage oral Lp(a) disruptor intended for lipid-lowering therapy to treat various cardiovascular disease (CVD)…
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Innovent Biologics and ASK Pharma Forge Strategic Partnership for Limertinib in Lung Cancer Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) and Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, SHE: 002755) have announced a strategic collaboration and licensing agreement focused on ASK’s limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment. Under the terms of the deal,…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Cassava Sciences to Pay Over USD 40 Million to Settle SEC Charges Over Alzheimer’s Drug Claims
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The US Securities and Exchange Commission (SEC) has announced that US-based biotech firm Cassava Sciences Inc., along with its founder and former CEO Remi Barbier, and a former vice-president of neuroscience, have consented to pay in excess of USD 40 million to settle allegations of misleading statements concerning the efficacy…
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Wuhan YZY Biopharma Grants Rights to CD3/EpCAM Antibody M701 to Chi Ta TianQing Pharma in China
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced that it has granted Chi Ta TianQing Pharma the rights to its CD3/EpCAM bispecific antibody, M701, in Mainland China. Chi Ta Tian Qing Pharma will pay YZY Biopharma an upfront payment of up to RMB 315 million, plus additional development milestone…
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Regor Therapeutics Strikes Deal with Genentech for CDK Inhibitors, Fetching USD 850 Million Upfront
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Regor Therapeutics Group, a US-based biotech with significant ties to China, has entered into a licensing agreement with Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG; OTCMKTS: RHHBY) . Under the agreement, Genentech will acquire the rights to develop, manufacture, and commercialize Regor’s next-generation CDK inhibitors, including the…
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China’s CDE Announces “Care Plan” to Include Pfizer’s Marstaximab for Rare Disease Drug Development
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The National Health Commission (NHC) of China, through its Center for Drug Evaluation (CDE), has announced that Pfizer (NSE: PFIZER, NYSE: PFE, ETR: PFE)’s Marstaximab (PF-06741086) has been included in the “Care Plan” for patient-centered rare disease drug development. The publicity period for this decision ends on October 12, 2024.…
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Genor Biopharma to Acquire EOC Pharma Group in a Merger Deal, Eyeing Commercialization Synergies
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Genor Biopharma Holdings Limited (HKG: 6998) has announced a definitive merger agreement with EOC Pharma Group (China) Co., Ltd. As part of the agreement, Genor Biopharma will acquire EOC Pharma through a share exchange, resulting in a reverse takeover. The company will change its name to “Edding Genor Group Holdings…
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WuXi AppTec and WuXi Biologics Weigh Asset Sales in US and Europe Over Biosecure Act Concerns
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Reports emerged last week in the Financial Times suggesting that WuXi AppTec (HKG: 2359) and WuXi Biologics (HKG: 2269) are contemplating the sale of certain US and European assets due to the anticipated negative implications of the Biosecure Act, which is currently under review in the US legislative process. Both…
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Tigermed Announces Acquisition of Majority Stake in Shanghai Guanhe Pharmaceutical for CNY 140 Million
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Tigermed (SHE: 300347, HKG: 3347) has announced its intention to acquire a 40.5650% stake in Shanghai Guanhe Pharmaceutical Co., Ltd (hereinafter referred to as “Guanhe Pharmaceutical”) from DiAn Diagnostics (SHE: 300244) and Suzhou Yingkai Xinyun Enterprise Management Consulting Co., Ltd (hereinafter referred to as “Suzhou Yingkai”, a subsidiary of DiAn…
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Insilico Medicine and Seto Biopartner to Leverage AI in Synthetic Biology and Drug Discovery
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Insilico Medicine has announced a strategic partnership with Seto Bio (SHE: 300583) to harness cutting-edge AI technology to explore and optimize key steps in the engineering transformation of biological systems, advancing synthetic biology research and innovative drug development. Established in 2014, Insilico Medicine has built over 30 proprietary drug pipeline…
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Legend Biotech Corporation to Establish Advanced R&D Center in Philadelphia for Next-Generation Cell Therapies
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Legend Biotech Corporation (NASDAQ: LEGN), a leading chimeric antigen receptor (CAR) T cell therapy specialist based in China, has announced plans to establish a state-of-the-art research and development center in Philadelphia, Pennsylvania. The new 31,000 sq. ft. facility, expected to open in the third quarter of 2025, will focus on…
