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Huadong Medicine Seeks Regular Approval for Elahere in Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to regular approval for Elahere (mirvetuximab soravtansine) has been accepted by the National Medical Products Administration (NMPA). This antibody drug conjugate (ADC) targets folate receptor α (FRα) and represents a significant step forward in the treatment…
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Lundbeck’s Amlenetug Receives Orphan Drug Designation in Japan for Multiple System Atrophy
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Denmark-based pharmaceutical company Lundbeck A/S (OTCMKTS: HLUBF) announced receiving Orphan Drug Designation (ODD) from Japan’s Ministry of Health, Labor, and Welfare (MHLW) for its investigational drug amlenetug. This designation positions amlenetug as a promising new treatment option for patients with multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder.…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-4029 in Acute Ischemic Stroke
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for HRS-4029. The novel neuroprotective agent will now be assessed in a clinical study as a treatment for acute ischemic stroke (AIS). Preclinical FindingsPreclinical studies have demonstrated that HRS-4029 can…
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InnoCare Pharma Presents Positive Phase II Results of ICP-488 in Psoriasis at AAD Meeting
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the oral presentation of results from the Phase II study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor ICP-488 in psoriasis vulgaris at the American Academy of Dermatology Annual Meeting (AAD). The results demonstrate significant improvements in patients treated with ICP-488…
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LiteDD’s LIT0922 Approved for Phase I Trial in Marker-Expressing Advanced Solid Tumors
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The Center for Drug Evaluation (CDE) of China has approved LiteDD’s Category 1 product LIT0922 to enter a Phase I clinical study in advanced solid tumors expressing specific markers. This approval marks a significant milestone for LiteDD in developing innovative therapies for oncology patients. Mechanism of ActionLIT0922 is positioned as…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
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US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive…
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AbbVie’s Skyrizi Approved by China’s NMPA for Moderate to Severe Crohn’s Disease
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US giant AbbVie (NYSE: ABBV) announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its Skyrizi (risankizumab). The drug is approved to treat adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response, or intolerance to traditional or biologic treatments. The…
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Pfizer’s Elrexfio Receives Conditional NMPA Approval for Relapsed Multiple Myeloma
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US giant Pfizer (NYSE: PFE) announced receiving conditional approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Elrexfio (elranatamab). The drug is now approved to treat triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). Mechanism of ActionElrexfio works by binding to CD3 on T…
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TYK Medicines Inc.’s TY-9591 Shows Superiority Over Osimertinib in EGFR Mutated Lung Cancer with Brain Metastasis
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Zhejiang-based TYK Medicines Inc. (HKG: 2410) announced positive results from a pivotal Phase II study positioning TY-9591 against osimertinib as a first-line treatment for epidermal growth factor receptor (EGFR) mutated lung cancer with brain metastasis. The data demonstrated statistical significance and significant clinical benefits, marking a potential breakthrough in the…
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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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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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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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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.…
