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CDE Approves RinuaGene’s mRNA-Based RG002 for Clinical Study in Cervical Dysplasia
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China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has indicated that the Category 1 drug RG002, developed by Suzhou-based mRNA therapeutics company RinuaGene, has been approved for clinical study in cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) associated with human papillomavirus (HPV) 16 and/or…
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Eli Lilly’s Zepbound Outperforms Wegovy in SURMOUNT-5 Weight Loss Study
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has revealed a positive readout from the open-label, randomized Phase III SURMOUNT-5 study. The study assessed the weight loss effects of Zepbound (tirzepatide) compared to Wegovy (semaglutide) in adult patients with obesity or overweight, who have at least one weight-related medical…
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Phanes Therapeutics’ PT217 Earns FDA Fast Track Designation for Neuroendocrine Prostate Cancer
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Sino-US biotech company Phanes Therapeutics Inc. has announced that it has received another Fast Track designation from the US Food and Drug Administration (FDA) for its bispecific antibody (bsAb) PT217. This designation is specifically for the treatment of patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). Earlier…
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CGeneTech’s Cetagliptin Receives NMPA Approval for Type 2 Diabetes Treatment in China
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The National Medical Products Administration (NMPA) in China has indicated on its website that CGeneTech (Suzhou, China) Co., Ltd.’s Category 1 drug, cetagliptin, has been granted marketing approval. This DPP-4 inhibitor is intended to improve blood sugar control in adult patients with type 2 diabetes (T2D). Phase III Clinical Trial…
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Eisai and Biogen’s Leqembi Approved in Mexico for Early Alzheimer’s Disease Treatment
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that their co-developed drug, Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, has been approved by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. This approval marks another milestone in the treatment…
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Shanghai Escugen Receives NMPA Approval for Second Phase III Trial of ESG401 in TNBC
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Shanghai Escugen, a China-based biopharmaceutical company, has announced receiving the green light from the National Medical Products Administration (NMPA) to proceed with a second Phase III study for its antibody drug conjugate (ADC), ESG401. The study will focus on unresectable locally advanced, recurrent, or metastatic PD-L1 negative triple negative breast…
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Johnson & Johnson Submits sBLAs to FDA for Tremfya Indications in Pediatric Psoriasis and Arthritis
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Global healthcare giant Johnson & Johnson (J&J; NYSE: JNJ) has announced the submission of two supplementary Biologic License Applications (sBLAs) to the US Food and Drug Administration (FDA) for its drug Tremfya (guselkumab). The applications seek to expand the indications for children aged 6 years and older with moderate-to-severe plaque…
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Merus N.V. Receives FDA Approval for Bizengri for NRG1+ Pancreatic and Lung Cancers
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Holland-based Merus N.V. (NASDAQ: MRUS) has announced that it has received FDA approval for its bispecific antibody (BsAb), Bizengri (zenocutuzumab-zbco), targeting HER2 and HER3 for the treatment of adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are advanced, unresectable, or metastatic and harbor a neuregulin 1 (NRG1)…
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Ipsen’s Bylvay Receives NMPA Clearance for Treating Itching in PFIC Patients in China
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France-based Ipsen (EPA: IPN) has announced that it has received marketing clearance from the National Medical Products Administration (NMPA) of China for its drug odevixibatto, trading under the name Bylvay. The drug is indicated for treating itching in patients with progressive familial intrahepatic cholestasis (PFIC) who are aged six months…
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Tasly Pharma Receives NMPA Approval for Generic Lioresal (Baclofen) Oral Solution
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China-based Tasly Pharma Co., Ltd (SHA: 600535) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Swiss pharmaceutical giant Novartis’ (NYSE: NVS) Lioresal (baclofen) in the form of an oral solution. This Category 3 chemical drug is now approved…
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Humanwell Healthcare’s Recombinant Plasmid Hepatocyte Growth Factor Injection Accepted for NMPA Review
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for review of its Category 1 therapeutic biologic product, the recombinant plasmid hepatocyte growth factor injection. This development signifies a step forward in the potential approval process for…
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Haisco Pharmaceutical’s HSK46575 Receives NMPA Approval for Prostate Cancer Clinical Trial
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK46575, which is intended for the treatment of prostate cancer. HSK46575: A Promising Oral Small Molecule InhibitorHSK46575 has demonstrated significant therapeutic…
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Sichuan Kelun-Biotech’s SKB500 Receives NMPA Clinical Clearance for Solid Tumor Treatment
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, (HKG: 6990), a leading biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its novel drug candidate, SKB500. This development marks a significant step forward in the advancement of the company’s pipeline. SKB500:…
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Cinclus Pharma’s Linaprazan for GERD Receives NMPA Marketing Approval
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Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug candidate, linaprazan, which is indicated for the treatment of gastroesophageal reflux disease (GERD). The drug is expected to be commercialized in China in 2025, marking a significant milestone for…
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Shanghai Henlius Biotech’s HLX11 Biosimilar Accepted for Review by China’s CDE
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a market filing for its HLX11, a biosimilar version of Perjeta (pertuzumab). The company is seeking regulatory approval for…
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Shanghai Henlius Biotech’s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase…
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GSK plc Enters Exclusive Option Agreement with Duality Biologics for ADC Candidate DB-1324
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UK-based GSK plc (NYSE: GSK) has entered into an exclusive option agreement with Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China. The agreement is in relation to a potentially best-in-class ADC candidate, DB-1324. Terms of the Agreement and Financial DetailsUnder the…
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Guangzhou Virotech’s Oncolytic Virus M1 Receives Tacit Clinical Approval from NMPA
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Guangzhou Virotech Pharmaceutical Co., Ltd., a China-based pharmaceutical company, has announced receiving tacit clinical approval from the National Medical Products Administration (NMPA) for its oncolytic virus therapy, M1 (VRT106). This approval paves the way for an imminent Phase I clinical study in China, which will assess the safety, tolerability, pharmacokinetics,…
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Ipsen Secures Global Licensing Agreement for Biomunex Pharmaceuticals’ BMX-502 T Cell Engager
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France-based Ipsen (OTCMKTS: IPSEY) has announced a significant global licensing agreement with compatriot firm Biomunex Pharmaceuticals concerning the latter’s T cell engager (TCE), BMX-502. Ipsen is poised to secure exclusive development, manufacturing, and commercialization rights for BMX-502 across global territories. Responsibilities and Milestones Under the AgreementUnder the terms of the…
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OncoC4, Inc. Receives FDA Clearance for AI-081, a PD-1 and VEGF Bispecific Antibody
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US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its innovative bispecific antibody, AI-081, which targets both PD-1 and VEGF pathways. Composition and Mechanism of AI-081AI-081 is composed of proprietary high-affinity clinical-stage anti-PD-1 (AI-025) and anti-VEGF (AI-011) antibodies. This…
