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ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
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China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy,…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Amulirafusp Alfa in NMOSD
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced the commencement of a Phase Ib study for its innovative dual-target macromolecular drug, amulirafusp alfa (IMM0306), in patients with neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step as the first patient has been dosed in the…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for Lupus Nephritis Phase II Study
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for its dual-target macromolecular drug, amulirafusp alfa (IMM0306), in lupus nephritis (LN). Dual-Targeting Therapy with IMM0306IMM0306 is a bispecific antibody (BsAb) that targets…
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BioNTech Acquires Biotheus for $800 Million, Enhancing Oncology Pipeline
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BioNTech (NASDAQ: BNTX), the biotech giant recognized for its role in developing the COVID-19 vaccine, has acquired Biotheus for an upfront payment of $800 million, with additional milestone payments potentially reaching up to $150 million. Founded in 2018 and headquartered in Zhuhai, China, Biotheus has developed eight clinical-stage products and…
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ImmuneOnco Initiates Phase II Study for IMM27M in ER+ Advanced Breast Cancer
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a leading biopharmaceutical company specializing in immuno-oncology, has announced the commencement of a Phase II clinical study for its investigational drug, IMM27M, targeting estrogen receptor positive (ER+) advanced breast cancer following endocrine therapy failure or recurrence. This announcement coincides with the enrollment of…
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ImmuneOnco Biopharmaceuticals Partners with Yangtze River Pharmaceutical to Boost Pipeline Development
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a biopharmaceutical company based in China, has entered into a strategic partnership with fellow Chinese firm Yangtze River Pharmaceutical (Group) Co., Ltd. This collaboration aims to strengthen and enhance the development of ImmuneOnco’s investigational pipeline programs. The partnership encompasses a wide range of…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
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ImmuneOnco Receives Second Payment from Instil Bio, Highlighting Ongoing Licensing Deal
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the receipt of a further payment of USD 5 million from its U.S. partner Instil Bio Inc (NASDAQ: TIL), following an initial USD 10 million payment made last month. These payments are part of a licensing agreement executed in August 2024,…
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ImmuneOnco Receives USD 10 Million Upfront Payment from Instil Bio Subsidiary for Licensing Deal
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has received a USD 10 million upfront payment from SynBioTx, the wholly owned subsidiary of US-based Instil Bio Inc (Nasdaq: TIL). This payment is in accordance with a licensing agreement finalized earlier this month. The agreement outlines the potential for an additional USD…
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ImmuneOnco Biopharmaceuticals Strikes Licensing Deal with Instil Bio for Global Rights to Dual-Targeted Antibodies
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has entered into a definitive licensing agreement with US-based Instil Bio Inc. (Nasdaq: TIL), granting InstilBio development and commercial rights outside China for ImmuneOnco’s proprietary PD-L1- and VEGF-targeted bispecific antibody, IMM2510, and its next-generation anti-CTLA-4 antibody, IMM27M. As per the agreement, a subsidiary…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for CD47 and CD20 Dual-Targeted BsAb in SLE
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for IMC-002, a bispecific antibody (BsAb) targeting CD47 and CD20 for the treatment of systemic lupus erythematosus (SLE). IMC-002 is designed to enhance antibody dependent cell phagocytosis…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of Timdarpacept in CMML
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). IMM01 is an SIRPαFc fusion protein that is being studied for use in combination with…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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ImmuneOnco Biopharmaceuticals’ Timdarpacept (IMM01) Earns Orphan Drug Designation for CMML
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug timdarpacept (IMM01). This marks a significant milestone for the company’s first SIRPαFc fusion protein targeting CD47, which was designed in China.…
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ImmuneOnco Initiates Phase I Trial for CD24-Targeted Monoclonal Antibody IMM47
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the first patient dosing in a Phase I clinical study in Australia for its investigational drug, IMM47, a first-in-class CD24-targeted monoclonal antibody (mAb). This marks a significant step in the development of a novel immunotherapy approach for cancer treatment. IMM47’s Mechanism…
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ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each. IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid TumorsIMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on…
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ImmuneOnco Biopharmaceuticals Begins Trading on HKEX with Successful IPO
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) marked its debut on the Hong Kong Stock Exchange this morning, with a positive start as its share price surpassed the issuance price of RMB 18.6 per share in early trading. The initial public offering (IPO) is anticipated to raise over HKD 300…
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ImmuneOnco Biopharmaceuticals Launches IPO to Raise HKD 319 Million on Hong Kong Stock Exchange
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) is poised to raise HKD 319 million (USD 40.7 million) through an initial public offering (IPO) on the Hong Kong Stock Exchange. The biotech company will offer 17,147,200 shares at a price point of HKD 18.6 per share, with ImmuneOnco set to list…
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Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment
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Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy. HX009’s Clinical…
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ImmuneOnco Gains NMPA Approval for Phase Ib/II Study of IMM27M in Advanced Tumors
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its IMM27M. This ADCC-enhanced CTLA-4 monoclonal antibody (mAb) will be combined with the programmed death-1 (PD-1) inhibitor tislelizumab for the treatment…
