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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…
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Hybio Pharmaceutical’s Liraglutide Biosimilar Withdrawn from NMPA Filing
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has approved its application to withdraw the market filing for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This decision comes as part of a strategic adjustment in response to policy and…
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Sinotau Pharmaceutical Secures Over RMB 1.1 Billion in Latest Financing Round
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Sinotau Pharmaceutical Group, a prominent nuclear medicine (radiopharmaceutical) company headquartered in Beijing, has reportedly raised over RMB 1.1 billion (USD 150 million) in a new financing round. This capital influx is set to bolster the company’s research and development efforts, as well as the clinical application of diagnostic and therapeutic…
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Innovent Biologics and IASO Biotherapeutics’ Fucaso Approved for Multiple Myeloma Treatment in China
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Innovent Biologics, Inc. (HKG: 1801) and IASO Biotherapeutics have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their jointly developed and commercialized product, Fucaso (equecabtagene autoleucel). This approval positions Fucaso as the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy approved…
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SciClone Pharmaceuticals’ Danyelza Officially Launched in China for Neuroblastoma Treatment
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) has reached a significant milestone with the first prescription of Danyelza (naxitamab) in China, signifying its official commercial launch. Danyelza, a GD2-targeted monoclonal antibody, was originally developed by Y-mAbs Therapeutics Inc. and was fast-tracked for marketing approval in China in November 2020. Licensing Agreement and…
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Zai Lab’s Vyvgart Receives NMPA Approval as First-in-Class FcRn Antagonist for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has approved its Biologics License Application (BLA) for Vyvgart (efgartigimod alfa injection). Vyvgart, a first-in-class neonatal Fc receptor (FcRn) antagonist, is now approved for use as an add-on to standard…
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InnoCare Pharma and Keymed Biosciences Initiate Clinical Trial for ICP-B02 with First Subcutaneous Injection
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InnoCare Pharma (HKG: 9969; SHA: 688428) and Keymed Biosciences Inc., (HKG: 2162) have announced a significant milestone in their joint development of ICP-B02 (CM355), a bispecific antibody (BsAb) targeting CD20 and CD3. The first subcutaneous injection administration has been successfully administered to a Chinese patient, marking a new route of…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-4357 Clinical Study in Prostate Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 radiotherapeutic drug, HRS-4357. This novel molecule is under development for the treatment of prostate specific…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for BL-B01D1 Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its drug candidate, BL-B01D1. This in-house developed antibody-drug conjugate (ADC) targets EGFR and HER3, key drivers…
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RareStone Group’s Pitolisant Earns Priority Review Status for Narcolepsy Treatment in China
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The Center for Drug Evaluation (CDE) website in China has indicated that RareStone Group, a China-based rare disease specialist formerly known as Citrine Medicine, has secured priority review status for its in-licensed drug candidate, pitolisant. This status is awarded for the drug’s potential as a treatment for excessive daytime drowsiness…
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Joincare Pharmaceutical Initiates Phase III Study for Anti-IL-17A mAb in Plaque Psoriasis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced the initiation of a Phase III clinical study for its anti-IL-17A monoclonal antibody (mAb) in the treatment of moderate to severe plaque psoriasis. The study, which was approved in China in February 2020, marks a significant step forward in…
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Bio-heart’s Iberis-HTN Study Shows Promising Results in Treating Primary Hypertension
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China-based Bio-heart Biological Technology Co., Ltd. (HKG: 2185) and its holding subsidiary Angiocare have announced the clinical results for the Iberis-HTN trial at the China Interventional Therapeutics 2023 conference. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial designed to evaluate the safety and efficacy of the Iberis Multi-Electrode Renal…
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Sisram Medical’s Alma Lasers Acquires PhotonMed International Ltd, Expanding Global Presence
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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 wholly-owned subsidiary, Alma Lasers Ltd (HKG: 1696), has closed a deal to fully acquire PhotonMed International Ltd, a leading distributor of energy source equipment in China. This acquisition is…
