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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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AstraZeneca Appoints Iskra Reic as EVP, International, Amid Leon Wang’s Investigation in China
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced the appointment of Iskra Reic, Ph.D., as Executive Vice President (EVP), International. Reic will be responsible for overseeing the overall strategy and driving sustainable growth across key regions including China, Asian and Eurasian markets, the Middle East & Africa,…
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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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GSK plc Expands Pipeline with Rgenta Therapeutics Partnership for RNA-Targeted Splice Modulators
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GSK plc (NYSE: GSK), a leading global pharmaceutical company, continues to bolster its pipeline through strategic external partnerships. The US major has recently signed an agreement with US biotech Rgenta Therapeutics to discover and develop novel RNA-targeted small molecule splice modulators, adding to its earlier antibody drug conjugate (ADC) option…
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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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CSPC Pharmaceutical’s CRB-701 Earns FDA Fast Track Designation for Cervical Cancer Treatment
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its drug candidate CRB-701 (SYS6002), which is being developed for the treatment of recurrent/refractory metastatic cervical cancer. CRB-701 (SYS6002): An Innovative ADC Targeting Nectin-4SYS6002…
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Sisram Medical’s Alma Harmony and Alma Hybrid Receive EU Medical Device Certification
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Sisram Medical Ltd (HKG: 1696), an Israel-based company and part of the Fosun Pharmaceutical Group (SHA: 600196), has announced that its subsidiary, Alma Lasers Ltd., has obtained certification under the Medical Device Regulation (MDR) in the European Union (EU) for its quality management system and dermatology products, Alma Harmony and…
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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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Wuhan Kaideweisi Biotechnology Secures Series B Funding for Gynecologic Oncology Expansion
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Wuhan Kaideweisi Biotechnology Co., Ltd, a specialist in gynecologic oncology in China, has reportedly raised close to RMB 200 million (USD 27.5 million) via a Series B financing round. The round was led by Fir Health Capital with a contribution of RMB 50 million (USD 6.9 million), and was also…
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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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Jiangsu Recbio Technology Secures Private Placement with Yangtze River Pharmaceutical for Vaccine Development
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China-based Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has successfully placed 142 million shares through a private placement to compatriot firm Yangtze River Pharmaceutical (Group) Co., Ltd. This transaction positions Yangtze River Pharmaceutical as the largest shareholder of Jiangsu Recbio, marking a significant strategic investment in the biotechnology sector. Proceeds…
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Hangzhou Chance Pharmaceuticals Partners with Yiling Pharmaceutical for Inhalation Powder Development
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China’s Hangzhou Chance Pharmaceuticals Co., Ltd., a specialist in lung drug delivery, has entered into a partnership with fellow Chinese firm Yiling Pharmaceutical Co., Ltd (SHE: 002603). The collaboration aims to leverage Hangzhou Chance’s experience and technology in the development of inhalation powder mist agents, thereby facilitating Yiling Pharma in…
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GRIT Biotechnology and Vitalgen BioPharma Partner on CRISPR-AaCas12bMAX Cell Therapies
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China-based cell therapy specialists GRIT Biotechnology and Shanghai Vitalgen BioPharma Co., Ltd have entered into a collaboration agreement to leverage GRIT’s CRISPR-AaCas12bMAX gene editing tool and related gene editing techniques for the development, manufacturing, and commercialization of certain cell therapies. The agreement, for which no financial details were disclosed, highlights…
