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Dizal’s Sunvozertinib and Golidocitinib Combo Gets NMPA Approval for Phase II Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the safety, tolerability, and efficacy of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) in combination with the JAK1 inhibitor golidocitinib (DZD4205).…
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Luye Pharma’s BA1301 Receives CDE Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its antibody-drug conjugate (ADC) BA1301. The drug is indicated for use in Claudin18.2 (CLDN18.2)-positive advanced solid tumors, including advanced gastric cancer, adenocarcinoma of the gastroesophageal junction, and pancreatic cancer. This…
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China’s National Health Commission Releases Updated COVID-19 Treatment Plan
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The National Health Commission (NHC) has released the 10th edition of the national COVID-19 Diagnosis and Treatment Plan, introducing multiple changes to diagnosis and treatment guidelines, standards for admissions, discharge, and other protocols. The document aims to enhance treatment and diagnosis efficiencies, reflecting the evolving understanding and management of COVID-19.…
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HutchMed’s Sovleplenib Administered to First Patient in Phase II COVID-19 Study
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On January 4, Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) administered its novel, investigational, selective small-molecule inhibitor sovleplenib to the first patient at Huashan Hospital. The Phase II study is focused on severe/critical COVID-19 patients, marking a significant step in the development of this innovative therapy. Mechanism and DevelopmentSovleplenib…
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Zai Lab and Novocure’s TTFields Device Shows Survival Benefit in Lung Cancer Study
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Shares in Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) and its partner Novocure (NASDAQ: NVCR) surged yesterday after the companies revealed positive results from the Phase III LUNAR study. The study assessed the efficacy of the TTFields electrical field medical device in combination with immunotherapy for patients with…
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Salubris Pharmaceuticals Gains NMPA Approval for Phase I Study of SAL0133
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its 3CL protease inhibitor SAL0133 in adult patients with mild to common COVID-19. This marks a significant step forward in the development of…
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Kactus Biosystems Partners with Bioheng for Cell Therapy Raw Materials
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Shanghai-based Kactus Biosystems, a firm specializing in target proteins and raw enzymes, has announced a partnership with Nanjing Bioheng Biotech Co., Ltd to develop and domesticate raw materials for cell therapies. The collaboration focuses on the process development and raw materials domestication of universal chimeric antigen receptor (CAR)-T therapies. Bioheng,…
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Immune-Onc Therapeutics Completes $131 Million Series B Financing
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US-headquartered Immune-Onc Therapeutics, Inc. has announced the successful completion of a Series B financing round totaling USD 131 million, including a USD 25 million extension. The extension was led by existing investor Triwise Capital, with participation from new investors such as Proxima Ventures. Additionally, the company received continued strategic capital…
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Henlius Completes First Dosing in Global Phase III Study for HanSiZhuang in LS-SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC).…
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Singular Medical Secures Series B+ Funding for Cardiac Device Development
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Singular Medical, a Suzhou-based maker of cardiac rhythm and heart failure devices, has reportedly raised “hundreds of millions” of renminbi in a Series B+ financing round. The funding was led by Lotus Lake Capital and Kangyu Capital, with participation from existing investor Qiming Venture Partners. The proceeds will be used…
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Boehringer Ingelheim Enrolls First Patient in Phase II/III Study for BI 907828
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German pharmaceutical giant Boehringer Ingelheim has announced the enrollment of the first patient in the Phase II/III Brightline-1 study for its investigational MDM2-p53 antagonist BI 907828. The study is taking place at the West China Hospital and aims to assess the efficacy and safety of BI 907828 compared to doxorubicin…
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Vcanbio’s Stem Cell Therapy VUM02 Accepted for Clinical Trial Review
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) has been accepted for review by the Center for Drug Evaluation. VUM02 is a Category 1 therapeutic biologic product developed to treat patients with…
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CanSino Biologics’ mRNA Vaccine CS-2034 Shows Positive Safety and Immunogenicity Data
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China-based CanSino Biologics (HKG: 6185) has announced positive periodical data from a clinical study assessing the safety and immunogenicity of its COVID-19 mRNA vaccine CS-2034 as a sequential booster in adults aged 18 and above who have already received three doses of inactivated COVID-19 vaccines. The study, which began in…
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Mindray Partners with BOMImed for Exclusive Canadian Sales and Service
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China-based medical device giant Mindray’s North American unit has announced a partnership with Canadian biomedical firm BOMImed Inc. The deal appoints BOMImed as the exclusive sales and service provider for Mindray’s patient monitoring, anesthesia, and ultrasound solutions in Canada’s hospital market. This strategic move aims to enhance Mindray’s presence in…
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Simnova Partners with Orna Therapeutics for In Situ CAR Therapies
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Shanghai Simnova Biotech Co., Ltd. (Simnova), an affiliate of Simcere Investment Group, has announced a partnership with Cambridge, Massachusetts-based Orna Therapeutics. The deal grants Simnova access to certain of Orna’s in situ chimeric antigen receptor (isCAR) therapies in the China market, including the CD19-targeted isCAR program ORN-101. This collaboration aims…
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Aurisco Partners with Cytiva to Build Oligonucleotide Production Plant
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China-based contract development and manufacturing organization (CDMO) Aurisco Pharmaceutical Co., Ltd has revealed plans to establish its first commercial-scale production plant for oligonucleotides in partnership with US-based life sciences service provider Cytiva. The new plant, located in Yangzhou, Jiangsu Province, will utilize Cytiva’s Oligo FlexFactory platform and marks the first…
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Jiangsu Aidea’s ACC007 Approved by NMPA for HIV-1 Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that its Category 1 compound preparation ACC007 (ainuovirine, lamivudine, tenofovir disoproxil) has been approved by the National Medical Products Administration (NMPA) for the treatment of newly treated adult patients with HIV-1 infection. This approval marks a significant step forward in…
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WuXi Biologics and GSK Ink Licensing Agreement for T-Cell Engaging Antibodies
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China-based WuXi Biologics (HKG: 2269) has announced a licensing agreement with GSK plc (NYSE: GSK), granting the UK-based pharmaceutical giant exclusive licenses to up to four bi- and multi-specific T-cell engaging (TCE) antibodies. These antibodies were developed using WuXi Biologics’ proprietary technology platforms. The deal includes a pre-clinical bispecific antibody…
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Antengene Acquires Full Rights to Calithera’s CD73 Inhibitor CB-708
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China-based Antengene Corporation Ltd (HKG: 6996) has unveiled a transfer agreement with US-headquartered Calithera Biosciences Inc. (OTCMKTS: CALA), expanding on an earlier license agreement. Under the new agreement, Antengene will acquire all remaining rights to CB-708 (ATG-037), Calithera’s small-molecule CD73 inhibitor. This move underscores Antengene’s commitment to advancing innovative cancer…
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Haisco’s EGFR-PROTAC HSK40118 Accepted for Review by China’s NMPA
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing for the oral small molecule EGFR-PROTAC HSK40118 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is EGFR mutant advanced non-small cell lung cancer (NSCLC). This marks a significant…
