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Roche’s Itovebi Approved in China for PIK3CA-Mutated Breast Cancer
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Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has received approval from China’s National Medical Products Administration (NMPA). The drug is indicated for use in combination with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Quantum Hi-Tech and ECNU Establish AI-Driven Drug Manufacturing Lab
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CRO+CDMO Quantum Hi-Tech (China) Biotechnology Co., Ltd (ChemPartner, SHE: 300149) announced plans to establish an AI drug intelligent manufacturing joint laboratory with East China Normal University (ECNU), a comprehensive research-oriented university in Shanghai. This collaboration aims to set a new paradigm for school-enterprise cooperation in the field of AI-driven pharmaceutical…
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BioCity and MSD Enter Clinical Collaboration for BC3195 and Keytruda Combination Trial
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China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK). The partnership will initiate a global Phase I/II study to evaluate the safety and efficacy of BioCity’s BC3195 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for patients with…
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Shanghai Fosun Pharmaceutical Transfers Unicorn II Holdings Stake to Warburg Pincus Subsidiary
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced plans to transfer its entire stake of 9.4 million shares in Unicorn II Holdings Limited to Calcite Gem, a subsidiary of Warburg Pincus. The transaction, valued at USD13.2 per share, totals USD124 million. Upon completion, Fosun will no…
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Salipro Biotech and Boehringer Ingelheim Collaborate on Drug Development for Membrane Proteins
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Sweden-based Salipro Biotech AB announced a research and license agreement with German pharmaceutical giant Boehringer Ingelheim. The collaboration aims to advance the development of novel drugs targeting G protein-coupled receptors (GPCRs), ion channels, transporters, and other integral membrane proteins, focusing on treatment areas such as mental health and cardio-renal-metabolic diseases.…
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CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
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Gaush Meditech’s ANTERION Ophthalmic Detector Receives NMPA Market Approval
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for the ANTERION ophthalmic detector. This multimodal imaging diagnostic platform, developed by its German partner Heidelberg Instruments, integrates three functions into one device, enhancing precision and efficiency in ophthalmic diagnostics. Technical Specifications and…
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Bio-Thera Solutions’ BAT2506 Biosimilar Accepted for Review by China’s NMPA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in the development and commercialization of this anti-TNF alpha…
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Otsuka and Lundbeck Win EU Approval for Rxulti in Adolescent Schizophrenia
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Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced receiving marketing approval from the European Commission (EC) for Rxulti (brexpiprazole). The atypical oral antipsychotic can now be used to treat schizophrenia in adolescents aged 13 years and older in the European Union (EU). Background…
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Shanghai Fosun Pharmaceutical Gains NMPA Approval for XH-S003 in PNH Treatment
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for XH-S003. The company will initiate Phase II clinical studies for this Category 1 chemical drug candidate as a treatment for paroxysmal nocturnal hemoglobinuria (PNH). Mechanism and…
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Trinomab Biotech Launches Xintituo for Tetanus Treatment in Zhuhai
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China-based Trinomab Biotech Co., Ltd announced the first delivery of its antitetanus toxin monoclonal antibody (mAb) injection Xintituo (siltartoxatug) in Zhuhai, Guangdong province. This marks a significant advancement in the treatment and prevention of tetanus, offering a more efficient and safer alternative to traditional methods. Advantages Over Traditional ProductsTraditional horse…
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Tasly Pharma’s NR-20201 Receives NMPA Approval for Acute Ischemic Stroke Trial
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China-based Tasly Pharma Co., Ltd (SHA: 600535) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its NR-20201, an in-house developed allogeneic adipose-derived mesenchymal stromal cell-based therapy. This marks a significant step forward in the development of innovative treatments for acute ischemic stroke…
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Jiangsu Aidea’s AD108 Receives NMPA Approval for Acute Ischemic Stroke
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China’s Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug AD108. This modified version of Japan-based Nichi-Iko Pharmaceutical Co., Ltd’s kallidinogenase is designed to improve neurological deficits caused by acute ischemic stroke (AIS). Drug Mechanism and…
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Insilico Medicine Closes USD110 Million Series E Round to Advance AI-Driven Drug Pipeline
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China’s generative artificial intelligence (AI)-driven biotech Insilico Medicine announced the completion of a USD110 million Series E financing round. The round was led by a private equity fund of Value Partners Group (HKG: 0806), with participation from Shanghai Pudong Venture Investment, Shanghai Pudong Development (Group), Wuxi Innovation Investment, and Yixing…
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Sanyou Medical Raises RMB214 Million for Stake in SMTP Technology
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China-based Shanghai Sanyou Medical Co., Ltd (SHA: 688085) announced the completion of a private placement of 13,032,886 shares at RMB16.42 (USD2.27) per share, raising a total of RMB214 million (USD29.5 million). The funds will be used to facilitate Sanyou’s acquisition of a 48.2% stake in compatriot firm SMTP Technology Co.,…
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Gaush Meditech Receives NMPA Approval for Femtosecond Laser Corneal Refractive Surgery System
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for its femtosecond laser corneal refractive surgery system and accompanying disposable eye fixation patient interface. Developed in collaboration with German partner SCHWIND eye-tech-solutions GmbH, the system is designed for producing corneal flaps in…
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Ipsen Appoints Olivia Brown as Global Head of Neurotoxins, Effective April 1st
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France-based pharmaceutical company Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced the appointment of Olivia Brown as Executive Vice-President (EVP), Global Head of Neurotoxins, effective April 1st, 2025. In her new role, Olivia will lead Ipsen’s global neurotoxins franchise, overseeing strategy and execution across both therapeutic and aesthetic indications. Olivia Brown’s…
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China Medical System’s CMS-D003 Receives NMPA Approval for Clinical Study in oHCM
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China Medical System Holdings (CMS; HKG: 0867) announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacological characteristics of its investigational drug CMS-D003. The study will focus on healthy adults and those with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…
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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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Haisco Pharmaceutical’s HSK44459 Receives NMPA Approval for Psoriasis and Atopic Dermatitis Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its Category 1 chemical drug HSK44459. The drug will be assessed for use in treating psoriasis and atopic dermatitis (AD), chronic, recurrent, and immune-inflammatory skin diseases with…
