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AIM Vaccine Co. Ltd Receives NMPA Approval for Human Diploid Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its human diploid rabies vaccine. This marks a significant step forward in the development of more effective rabies prevention measures. Vaccine Features and AdvantagesThe updated human…
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NewCo Model: China’s Innovative Drug Companies’ New Transaction Mode in Capital Winter
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NewCo is a new transaction model developed by Chinese innovative drug companies in response to capital winter and internationalization needs. It involves licensing overseas rights of early-stage R&D pipelines to newly established independent companies, bringing in overseas capital and management teams to accelerate development and share risks. This model combines…
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Hangzhou Chance Pharmaceuticals Secures New Funding for Inhalation Powder Aerosol Development
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Hangzhou Chance Pharmaceuticals recently announced the completion of a new funding round, led by Zhejiang’s “4+1” Biomedical and High-end Medical Device Industry Fund and Qihang Investment Management Co., Ltd., with Lighthouse Capital serving as the exclusive financial advisor. The funds will propel the Phase III clinical trial of CXG87, a…
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Sino Biopharmaceutical Licenses Nanjing Delova’s QP001 for Mainland China Rights
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced acquiring exclusive rights to Nanjing Delova Biotech Co.,Ltd’s Category 2 drug QP001 in mainland China via a licensing deal. QP001, a nonsteroidal anti-inflammatory drug (NSAID), is a me-better version of Boehringer Ingelheim’s Mobic (meloxicam) and is awaiting regulatory decisions in China and the…
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Fosun Pharmaceutical’s Foritinib Accepted for Review by China’s NMPA for NSCLC Treatment
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration(NMPA) has accepted for review a market filing for its subsidiary Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.’s Category 1 chemical drug foritinib. This novel small molecule chemical drug is designed to treat…
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Everest Medicines Begins Clinical Trial for Personalized mRNA Cancer Vaccine EVM16
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China-based Everest Medicines (HKG: 1952) has announced the first patient dosing of an investigator-initiated clinical trial (IIT) for its personalized mRNA cancer vaccine, EVM16. The trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 alone or combined with a PD-1 inhibitor in advanced or recurrent…
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Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SCTT11 therapy in thyroid eye disease (TED). This marks a significant step forward in addressing a complex autoimmune condition closely linked to thyroid disorders. Understanding Thyroid…
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Johnson & Johnson Terminate Phase III VENTURA Program for Aticaprant in adjunctive treatment of MDD
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced the termination of the Phase III VENTURA development program assessing aticaprant as an adjunctive treatment for major depressive disorder (aMDD). The decision was influenced by the insufficient efficacy of aticaprant in the target population. Safety and Future ExplorationWhile the data confirmed…
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Gan & Lee Pharmaceuticals Joins Brazil’s PDP for Localized Insulin Production
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced receiving a financial pledge of BRL130 million (USD23 million) from the Brazilian government as part of the Parcerias para o Desenvolvimento Produtivo (PDP). This initiative, co-promoted by domestic companies in Brazil and Brazilian Ministry of Health affiliated enterprises, aims to secure the…
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Insilico Medicine’s AI-Discovered Drug Rentosertib Approved for Clinical Trials
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China’s generative artificial intelligence (AI)-driven biotech Insilico Medicine announced approval by the United States Adopted Names (USAN) Council to name its ISM001-055 as rentosertib. This groundbreaking drug candidate for idiopathic pulmonary fibrosis (IPF) represents a milestone in AI-driven drug discovery. Rentosertib’s Development and Clinical ResultsRentosertib is the world’s first drug…
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4C Medical Lands $175M Series D to Advance AltaValve TMVR System
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US-based 4C Medical Technologies, Inc., a medical device company controlled by China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), announced the completion of a $175 million Series D financing round. The funding, led by Boston Scientific Corporation, will accelerate clinical development and commercialization of 4C Medical’s AltaValve System, a next-generation…
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Merck KGaA Reports 2024 Revenue Growth Despite Challenges in Life Sciences
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German major Merck KGaA (ETR: MRK) this week released its 2024 annual report, highlighting a mixed performance across its business segments. The company reported global revenues up 2.0% year-on-year (YoY) in organic terms to EUR 21.16 billion (USD 2.3 billion). The Healthcare unit drove growth, while the Life Sciences segment…
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Astellas Pharma and YASKAWA Establish JV for Cell Therapy Product Manufacturing Platform
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Japan-based Astellas Pharma Inc. (TYO: 4503) is set to establish a joint venture (JV) with compatriot firm YASKAWA Electric Corporation (TYO: 6506). The collaboration aims to develop a cell therapy product manufacturing platform utilizing Maholo, a cutting-edge dual-arm robot developed by YASKAWA’s subsidiary, the Robotic Biology Institute. This innovative platform…
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Johnson & Johnson Officially Launches Spravato in China for Depression Treatment
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US giant Johnson & Johnson (J&J; NYSE: JNJ) officially launched Spravato (esketamine) nasal spray in China to alleviate depressive symptoms in adult depression patients. The announcement comes after a swift approval by China’s National Medical Products Administration (NMPA) in April 2023. Spravato’s novel mechanism and rapid resultsSpravato is the first…
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Abbisko Therapeutics’ ABSK131 Receives Clinical Trial Approval from China’s NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for its small molecule inhibitor ABSK131. This follows a similar approval from US regulators in December of last year. ABSK131: Promising Anti-Tumor ActivityABSK131…
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Cryofocus Medtech’s Malignant Stenosis Cryoablation System Approved by NMPA for Chinese Market
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Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd (HKG: 6922) has announced receiving endorsement from the National Medical Products Administration (NMPA) to market its malignant stenosis cryoablation system in China. This innovative technology represents a significant advancement in the treatment of malignant airway tumors. Innovative Cryoablation TechnologyThe malignant stenosis…
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Suzhou GenAssist’s GEN6050X Receives FDA Clearance for Duchenne Muscular Dystrophy Treatment
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China-based Suzhou GenAssist Therapeutic Co., Ltd has announced receiving clearance from the US Food and Drug Administration (FDA) to initiate clinical trials for its base editing drug, GEN6050X, as a treatment for Duchenne muscular dystrophy (DMD). This groundbreaking therapy represents a significant advancement in gene editing technologies for rare diseases.…
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BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
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Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. The drug, an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, is being developed to treat ROR1-positive hematological malignancies and solid tumors, marking a significant…
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CStone Pharmaceuticals’ CS5001 Enters Phase Ib Trial for Diffuse Large B-Cell Lymphoma
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for its ROR1-targeted antibody-drug conjugate (ADC), CS5001, in combination with first-line standard-of-care (SoC) for diffuse large B-cell lymphoma (DLBCL). The move underscores the company’s commitment to expanding the therapeutic potential of CS5001 across hematologic and solid…
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Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. The filing…
