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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.…
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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…
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Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
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China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI). The designation is for the drug’s use in combination with low-intensity chemotherapy as…
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ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
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China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy,…
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CSPC Pharma’s JMT108 Receives NMPA Clinical Approval for Advanced Malignant Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced clinical approval from the National Medical Products Administration (NMPA) for JMT108, an anti-PD-1/IL-15 bi-functional fusion protein. The targeted indication for this novel therapy is advanced malignant tumors, marking a significant step forward in the development of innovative cancer treatments in China.…
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Antengene’s Xpovio Receives Marketing Approval in Indonesia
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its Xpovio (selinexor). The approval grants the drug three indications in the Southeast Asian country. Indications ApprovedThe drug is approved for: Drug BackgroundXpovio, the world’s first and only FDA-approved oral XPO1 inhibitor, was discovered by US-based…
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RongCan Biotech’s mRNA HPV Vaccine Receives FDA Clinical Approval
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China-based mRNA specialist RongCan (Shanghai) Biotech Co., Ltd announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its mRNA-based human papillomavirus (HPV) therapeutic vaccine. Clinical Approval and SignificanceThis approval marks a significant step forward in the development of therapeutic options for HPV-related conditions.…
