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Genprex Inc. Receives Chinese Patent Protection for Reqorsa Immunogene Therapy
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Texas-based gene therapy company Genprex Inc., (NASDAQ: GNPX), has reported receiving a patent protection award in China for its lead pipeline candidate, Reqorsa (ONC-001/2) immunogene therapy. The China Intellectual Property Administration (CNIPA) has granted patent No: 201780076886.X, which covers the use of the therapy in combination with PD-1 antibodies, providing…
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Moderna Inc. Plans USD 1 Billion Investment in Shanghai for mRNA Vaccine Production
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US-based mRNA specialist Moderna Inc. (NASDAQ: MRNA) has revealed further details of its entry into the China market, with an agreement that vaccines manufactured locally will remain exclusively within the China market, as reported by Reuters based on an email response from a company spokesperson. This agreement is part of…
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CSPC Pharmaceutical Group Receives Marketing Approval for Desvenlafaxine in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving marketing approval in China for its Category 3 product, desvenlafaxine, signifying that it has passed the generic quality and consistency evaluation (GQCE). Desvenlafaxine: A Third-Generation Anti-DepressantDesvenlafaxine is a third-generation anti-depressant that functions by inhibiting the reuptake mechanism of 5-hydroxytryptamine norepinephrine,…
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AbbVie’s Rinvoq Receives NMPA Approval for Moderate to Severe Crohn’s Disease Treatment
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US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Rinvoq (upadacitinib), a selective JAK inhibitor, to treat moderate to severe active Crohn’s disease in adult patients who have a poor or intolerant response or a contraindication to one or…
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Luye Pharma’s Goserelin Acetate Microspheres Approved by NMPA for Prostate Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the…
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Huadong Medicine’s Liraglutide Biosimilar Gains NMPA Approval for Weight Loss Indication
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This glucagon-like peptide-1 (GLP-1) receptor agonist is now approved for use in weight loss management. Expanding…
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Abbisko Therapeutics’ EGFR Inhibitor ABSK112 Clears FDA for Global Phase I NSCLC Study
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global Phase I clinical study for its next-generation EGFR inhibitor, ABSK112, in non-small cell lung cancer (NSCLC). This development highlights the company’s progress…
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Jacobio Pharma’s KRAS Inhibitor Glecirasib Advances to Pivotal Pancreatic Cancer Trial
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a pivotal clinical study for its novel KRAS G12C inhibitor, glecirasib, in pancreatic cancer. This development marks glecirasib as the world’s first KRAS inhibitor to reach the…
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InnoCare Pharma Initiates Clinical Trial for TYK2 Inhibitor ICP-488 in Psoriasis Patients
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced a significant milestone in the clinical development of its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, with the dosing of the first psoriasis patient in China. This marks a progressive step towards addressing the treatment needs for psoriasis and other…
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ZAP-X Gyroscopic Radiosurgery Platform Receives NMPA Approval for Brain Tumor Treatment
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US-based Zap Surgical Systems Inc. has announced that it has received market approval in China for its innovative ZAP-X Gyroscopic Radiosurgery Platform. This advanced system is designed for the treatment of brain tumors, lesions, and other head and neck conditions. The ZAP-X system utilizes unique gyroscopic mobility to direct radiosurgical…
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NMPA Approves Pitolisant for Narcolepsy-Related Excessive Daytime Drowsiness and Cataplexy
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The National Medical Products Administration (NMPA) has approved pitolisant as a treatment for excessive daytime drowsiness (EDS) or cataplexy in adults with narcolepsy. This marks a significant advancement in the therapeutic options available for narcolepsy patients in China. Pitolisant’s Mechanism of Action and International DesignationsPitolisant is a selective histamine 3…
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Ascentage Pharma’s Olverembatinib Gets NMPA Greenlight for Phase III Study in Ph+ ALL
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China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a pivotal regulatory Phase III clinical study. The study will evaluate the combination of its Category 1 drug, olverembatinib, with chemotherapy in newly diagnosed Philadelphia chromosome positive (Ph+) acute…
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Amoytop Biotech’s Pegfilgrastim (Y Shape) Approved for Marketing by NMPA
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has received marketing approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) product. This Category 1 biologic is designed for use in patients with non-myeloid malignant tumors to reduce the incidence of infection with febrile neutropenia during treatment with…
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Jacobio Pharma Retakes Global Rights to SHP2 Inhibitors After Terminating AbbVie Agreement
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China-based Jacobio Pharma (HKG: 1167) has announced the cancellation of a licensing agreement with US pharmaceutical company AbbVie (NYSE: ABBV), which implies that Jacobio will regain global rights to the out-licensed SHP2 inhibitors. This decision was made as part of an asset portfolio and strategy review. Initially, the deal was…
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Binhui Biopharmaceutical and Topgene Biotechnology Partner for New Drug R&D and AI Platform Development
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Wuhan-based Binhui Biopharmaceutical and Hubei Topgene Biotechnology Co., Ltd have announced a strategic partnership to delve into new drug research and development services, technological innovation, AI platforms, and other collaborative fields. This partnership aims to promote complementary advantages, resource sharing, talent exchange, and establish a joint platform to assist in…
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Huadong Medicine’s Mirvetuximab Soravtansine Heads for Priority Review by China’s CDE
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The China’s Center for Drug Evaluation (CDE) website has indicated that Huadong Medicine Co., Ltd (SHE: 000963) is moving forward with a priority review for its mirvetuximab soravtansine, an antibody drug conjugate (ADC), for potential use in folate receptor α (FRα) positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or…
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Henlius Biotech Suspends IPO on STAR Market, Aims to Optimize Capital Strategy
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the suspension of its initial public offering (IPO) to the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR), prioritizing capital market planning. The company assures that this decision will not affect its daily operations. Henlius initially planned to dual-list on the STAR…
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Shanghai’s Huangpu District Launches RMB Fund to Boost Fintech, AI, and Biotech Firms
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The South China Morning Post reports that the local government in Shanghai’s Huangpu district has established a renminbi-denominated fund to invest in a curated list of 187 fintech, artificial intelligence (AI), and biotech firms. This fund, expected to be operational within the next 12 months, will be managed by an…
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Transcenta’s Osemitamab Combo Shows Promising PFS Data in Advanced GC/GEJ Cancer Study
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Transcenta Holding Ltd (HKG: 6628), a China-based biopharmaceutical company, has presented progression-free survival (PFS) data based on CLDN18.2 expression levels from a Phase I/II study of osemitamab (TST001) in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for advanced gastric/gastroesophageal junction (GC/GEJ) carcinoma at the ESMO World Congress…
