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Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
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LaNova Medicines Inks Licensing Deal with Sino Biopharmaceutical for Cancer Therapies in China
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Shanghai-based LaNova Medicines Ltd, a developer of cancer therapies, has announced another licensing deal, signing an agreement with compatriot firm Sino Biopharmaceutical Ltd (HKG: 1177) for the development and commercialization of LM-108 and other potential bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs) in mainland China. The specifics of the…
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Keymed Biosciences Enters Global Licensing Agreement with Platina Medicines for CM336
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Keymed Biosciences Inc., a China-based biopharmaceutical company (HKG: 2162), has announced a significant licensing agreement with UK-based Platina Medicines Ltd (PML). The agreement grants Platina Medicines exclusive global development, manufacturing, and commercialization rights to Keymed’s CM336, excluding mainland China, Hong Kong, Macau, and Taiwan. Financial Terms and ConsiderationsUnder the terms…
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Merck Secures Exclusive Rights to LaNova’s PD-1/VEGF Bispecific Antibody LM-299
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US pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced a significant licensing agreement with Shanghai-based LaNova Medicines Ltd, a developer of innovative cancer therapies. This deal grants Merck exclusive global rights to develop, manufacture, and commercialize LaNova’s LM-299, a novel PD-1/VEGF bispecific antibody (BsAb), marking a…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
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GSK Secures Global Rights to Chimagen Biosciences’ T Cell-Engager in $850 Million Deal
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UK pharmaceutical company GSK plc (NYSE: GSK) has entered into a licensing agreement with Chimagen Biosciences, securing all global rights to CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE). GSK will pay an upfront fee of USD 300 million and is committed to making success-based development and commercial…
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LINDIS Biotech’s Catumaxomab Receives Positive Opinion from EMA’s COMP for Malignant Ascites Treatment
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LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with…
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Alphamab Oncology and CSPC Pharma’s KN026 Phase III Trial for Breast Cancer Gets NMPA Approval
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Alphamab Oncology (HKG: 9966) and CSPC Pharma (HKG: 1093) have jointly announced that their Phase III clinical study application for the combination of HER2 bispecific antibody KN026 and nab-paclitaxel HB1801 (Study Protocol Number: KN026-004) has received approval from the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for neoadjuvant…
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Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
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Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
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Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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Janssen and Yuhan Halt Development of Next-Gen EGFR Inhibitor for NSCLC
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Yuhan, a South Korean pharmaceutical company, and its partner Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), have reportedly decided to halt the development of a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC). This strategic…
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Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…
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JiCui Cell Therapy Forms Partnership with Fosun Kite to Advance Bispecific CAR-T Cell Therapy Industrialization
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JiCui Cell Therapy Drug Research Institute, also known as Jiangsu Jicui Juechuang Biotechnology Research Institute Co., Ltd, has entered into a strategic partnership with Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) and Gilead’s subsidiary Kite Pharma. The collaboration…
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Innovent Biologics’ Mazdutide Outperforms Dulaglutide in Phase III T2D Study at EASD Meeting
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Innovent Biologics, Inc. (HKG: 1801), a biopharmaceutical company based in China, has presented significant findings from the Phase III DREAMS-2 study on its drug candidate mazdutide at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). Mazdutide, a dual agonist targeting the glucagon-like peptide-1 receptor…
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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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Innovent Biologics Presents Promising Phase I Data for IBI363 in Advanced NSCLC at WCLC
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
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Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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Zelgen Biopharma’s ZG006 Shows Promising Anti-Tumor Efficacy in Phase I/II SCLC Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced positive preliminary results from a Phase I/II clinical study assessing the tolerability, safety, efficacy, and pharmacokinetics of ZG006 in patients with advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma. The study, which included a dosage…
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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
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Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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EpimAb’s EMB-06 Secures $635 Million Licensing Agreement with Vignette for Multiple Myeloma Therapy
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EpimAb Biotherapeutics, a Shanghai-based biotech firm, has inked a licensing deal with Vignette for the development and commercialization of its T-cell engager (TCE) EMB-06 outside of Greater China. The agreement grants Vignette rights to EMB-06, a BCMA-targeting therapy, in regions excluding mainland China, Hong Kong, Macau, and Taiwan, with EpimAb…
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Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its innovative bispecific antibody-drug conjugate (ADC), DM005. This development marks a significant milestone for the company as it advances its pipeline towards…
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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
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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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Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
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Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
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Akeso Biopharma’s Ivonescimab Earns Category 1 Recommendation in China’s 2024 Lung Cancer Clinical Guideline
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Akeso Biopharma, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 9926), has achieved a significant milestone with its bispecific antibody ivonescimab (AK112). This innovative drug, which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been included in the “Clinical Practice Guideline for…
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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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Genmab CEO Signals Potential for China Partnership as BioNTech Exits acasunlimab Collaboration
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COPENHAGEN—In a strategic pivot following BioNTech (NASDAQ: BNTX)’s withdrawal from their co-development partnership on the PD-L1 x 4-1BB bispecific antibody acasunlimab, Denmark-based Genmab A/S (NASDAQ: GMAB) is reportedly seeking a commercial partner for its entry into the China market. This update was provided by CEO Jan Van de Winkel during…
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Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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Harbour BioMed Reclaims Rights to HBM7008 as Cullinan Therapeutics Cancels Licensing Deal
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Harbour BioMed (HBM), a biopharmaceutical company with operations in the Netherlands, the United States, and Suzhou, China, has announced that its U.S. partner, Cullinan Therapeutics Inc., will be returning the rights to the pipeline molecule HBM7008. This move cancels the licensing agreement that was initially focused on the development and…
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Zelgen Biopharmaceuticals’ ZG006 Earns Orphan Drug Designation from FDA for Small-Cell Lung Cancer
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, ZG006, which is under development for the treatment of small-cell lung cancer (SCLC). ZG006 is…
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Akeso Biopharma Initiates Phase III Clinical Trial for Cadonilimab in Hepatocellular Carcinoma
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced the first patient dosing in a Phase III clinical study for its drug candidate, cadonilimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE) for the treatment of unresectable, non-metastatic hepatocellular carcinoma (HCC). The study’s data for this…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
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Genor Biopharma Strikes Licensing Deal with TRC 2004 for Global Rights to GB261 Outside Greater China
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China-based Genor Biopharma Co., Ltd (HKG: 6998) has entered into a significant licensing and equity agreement with US-based TRC 2004, Inc., bestowing upon TRC 2004 the exclusive rights to develop, manufacture, and commercialize Genor’s innovative drug candidate, GB261, in all global territories excluding Greater China. This strategic partnership is set…
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Chongqing Genrix’s GR1803 Earns Breakthrough Therapy Designation in China for RRMM Treatment
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The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) is on track to receive Breakthrough Therapy Designation (BTD) for its bispecific antibody GR1803. This designation is for the treatment of recurrent refractory multiple myeloma (RRMM) in patients who have previously…
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Bristol-Myers Squibb Terminates Partnership with Agenus on TIGIT/CD96 Bispecific Antibody
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its decision to end its collaboration with Agenus Inc. (NASDAQ: AGEN) regarding the development of the TIGIT/CD96-targeted bispecific antibody BMS-986442 (AGEN1777). This move follows an initial decision to advance the antibody to Phase II trials earlier this year, which resulted…
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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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Bristol-Myers Squibb Q2 2024 Sales Boosted by Growth Portfolio, Offset by R&D Impairment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its financial results for the second quarter of 2024, with global sales increasing by 11% year-on-year to $12.2 billion, based on constant exchange rates. The growth was driven in part by the company’s ‘growth portfolio,’ which includes a dozen newer drugs that saw…
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Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
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Novartis Partners with Dren Bio to Develop Next-Generation Cancer Therapies
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Novartis (NYSE: NVS), a leading Swiss pharmaceutical company, has entered into a strategic collaboration with California-based biotech firm Dren Bio Inc. to leverage Dren’s expertise in developing bispecific antibodies for cancer treatment. Under this agreement, Novartis is particularly interested in utilizing Dren’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. As…
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Biokin Pharmaceutical Co., Ltd Eyes Secondary Listing on HKEX, Co-Sponsored by Goldman Sachs and Others
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a company listed on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR) since October 2022, is reportedly planning a secondary listing on the Hong Kong Stock Exchange (HKEX). The firm’s IPO is being co-sponsored by prominent investment banks Goldman Sachs, J.P. Morgan, and…
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Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
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Shandong Buchang Pharmaceuticals Receives NMPA Approval for BC008-1A Biologic Product Clinical Trial
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product BC008-1A. This product is intended for the treatment of glioblastoma and advanced…
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Keymed Biosciences Strikes Licensing Deal with Belenos Biosciences for Global BsAb Rights
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has entered into a licensing agreement with U.S. firm Belenos Biosciences Inc. Under the agreement, Belenos gains exclusive global rights to develop, manufacture, and commercialize Keymed’s in-house developed bispecific antibodies (BsAbs), CM512 and CM536, excluding Greater China. Belenos will…
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Doma Biopharmaceutical’s Bispecific ADC DM001 Receives FDA Clearance for Clinical Trial
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
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J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome…
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Healthcare Firms Line Up for HKEX IPOs as Biotech Market Recovery Gains Momentum
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A number of healthcare companies are seeking to capitalize on the recovering market conditions by filing for initial public offerings (IPOs) on the Hong Kong Stock Exchange (HKEX), a venue that has been gaining traction among life sciences companies for their public listings. According to the HKEX website, recent IPO…
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Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Xencor Reclaims Rights to Plamotamab After Janssen Halts Development
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Xencor Inc. (NASDAQ: XNCR), a U.S.-based biotechnology company, has announced that Johnson & Johnson (J&J, NYSE: JNJ)’s Janssen Biotech Inc. has opted not to proceed with the development of the bispecific T-cell engager plamotamab. As a result, Xencor regains exclusive global rights to the molecule, a CD20 x CD3 bispecific…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
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Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
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Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed…
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Johnson & Johnson to Acquire Biotechnology Firm Yellow Jersey for $1.25 Billion
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has entered into a definitive agreement with RTW Biotech Opportunities, a U.S. investment fund, for the acquisition of biotechnology firm Yellow Jersey. Yellow Jersey, a subsidiary of Swiss-based Numab, was previously acquired by RTW in 2021. The cash transaction, valued…
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Sino Biopharmaceutical Presents FS222 Phase I Results at ASCO Annual Meeting
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has presented updates from a Phase I clinical trial for its tetravalent bispecific antibody (BsAb), FS222, at the American Society of Clinical Oncology (ASCO) annual meeting. The study focuses on the use of FS222 in treating advanced solid tumors…
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3SBio Secures Exclusive Licensing Agreement for Seven Drug Candidates from Subsidiary
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has disclosed plans to enter into an exclusive licensing agreement with its parent company. Under this agreement, Guojian will grant 3SBio the Greater China rights to seven pipeline candidates, including 706, 709, HBT-2002, QY-F10, QY-F11, QY-F07, and…
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J&J’s Tecvayli Shows Promising Response Rates in Multiple Myeloma Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has reported updates from a Phase I/II clinical trial for its bispecific antibody (BsAb) Tecvayli (teclistamab) in patients with relapsed or refractory multiple myeloma (r/rMM) who have received three or more prior lines of treatment. With a median follow-up of 30.4 months, the trial…
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Akeso Expands Licensing Deal with Summit Therapeutics for Ivonescimab Bispecific Antibody
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced a supplementary licensing agreement with Summit Therapeutics Inc. (NASDAQ: SMMT) for ivonescimab, Akeso’s bispecific antibody (BsAb) that targets PD-1 and VEGF. The original agreement, valued at a potential USD 5 billion, was signed in December 2022 and granted…
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Akeso Biopharma’s Ivonescimab Outshines Keytruda in NSCLC Trial, Raises FDA Concerns
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FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
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Akeso Inc.’s Ivonescimab Shows Positive Interim Analysis in Phase III NSCLC Study
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with…
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Johnson & Johnson to Acquire Atopic Dermatitis Therapy NM26 in $1.25 Billion Deal
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare giant, has entered into a definitive agreement to acquire global rights to NM26, a first-in-class bispecific antibody (BsAb) for the treatment of atopic dermatitis (AD), from Switzerland-based Numab Therapeutics. The transaction, valued at $1.25 billion in cash, is anticipated to conclude…
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Alphamab Oncology’s KN046 Misses Primary Endpoint in Phase III Pancreatic Cancer Study
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in…
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Akeso Biopharma’s Ivonescimab Approved for NSCLC Treatment in China
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced that its bispecific antibody (BsAb) ivonescimab (AK112), which targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been approved for use in combination with chemotherapy to treat locally advanced or metastatic non-squamous non-small cell lung cancer…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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J&J Acquires Immune-Mediated Diseases Specialist Proteologix in a Deal Worth Up to USD 850 Million
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare giant, has announced a deal to acquire Proteologix, a US-based specialist in immune-mediated diseases, for a base purchase price of USD 850 million with additional potential milestone payments. The transaction is anticipated to be finalized by mid-2024. Proteologix is known for…
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Novo Nordisk’s Mim8 for Haemophilia A Exceeds Endpoints in Late-Stage Trial
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Denmark-based healthcare company Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its bispecific antibody (BsAb) Mim8, used for the treatment of haemophilia A. The trial successfully met its primary endpoints, which focused on the reduction of treated bleeding episodes. The study demonstrated that once-weekly and…
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BioNTech Secures Global Rights to Biotheus Inc.’s Pre-Clinical Bispecific Antibody
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Biotheus Inc., a biopharmaceutical company based in China, has announced that its German partner BioNTech (NASDAQ: BNTX) has exercised a global exclusive option right, securing the rights to globally develop, manufacture, and commercialize Biotheus’s in-house developed pre-clinical bispecific antibody (BsAb) candidate drug. Upon the option exercise, Biotheus will receive option…
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Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
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Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted…
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German Study Highlights Potential of Amgen’s Blinatumomab in Treating Rheumatoid Arthritis
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Researchers from Germany’s University of Erlangen-Nuremberg have unveiled promising clinical data on the use of bispecific T cell engagers (BiTes) in combating B-cell mediated autoimmune diseases, such as rheumatoid arthritis (RA). The study, titled “Bispecific T cell engager therapy for refractory rheumatoid arthritis,” published in Nature Medicine in December 2023,…
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MSD Partners with Hanmi Pharmaceutical to Develop Combination Therapy for Solid Tumors
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with South Korea’s Hanmi Pharmaceutical (KRX: 128940) to develop a combination therapy using MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) and Hanmi’s bispecific antibody (BsAb) BH3120 for the treatment of progressive or metastatic solid tumors. The financial details of the…
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Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the completion of the first patient dosing in a Phase I clinical study for HLX6018, a GARP/TGF-β1 compound monoclonal antibody (mAb). The drug is under development for the treatment of fibrosis-related diseases and has been tested…
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Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
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China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
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Roche’s Columvi Meets Overall Survival Endpoint in Diffuse Large B-Cell Lymphoma Trial
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Roche (SWX: RO), a leading Swiss pharmaceutical company, has announced that a late-stage clinical trial for its bispecific antibody Columvi (glofitamab) has successfully met its primary endpoint of overall survival (OS) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The trial involved patients who had received…
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Simcere Pharmaceutical’s SIM0500 Earns FDA Fast-Track Designation for Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), a leading China-based pharmaceutical company, has announced that its trispecific antibody SIM0500 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). The drug targets GPRC5D, BCMA, and CD3, and is intended for patients who have…
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Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its investigational drug M701. M701 is a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, currently under assessment as…
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VIVA Biotech Secures Licensing Deal with Lonza for Advanced Bispecific Antibody Technology
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VIVA Biotech Holdings (HKG: 1873), a China-based Contract Research Organization (CRO), has entered into a licensing agreement with Swiss Contract Manufacturing Organization (CMO) Lonza, securing access to Lonza’s innovative bYlok bispecific pairing technology. Financial terms of the agreement were not disclosed. Lonza’s bYlok technology addresses the prevalent industry challenge of…
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Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
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The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio (elranatamab), a bispecific antibody targeting BCMA and CD3, is on track for priority review as a potential treatment for triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). This development signifies a significant step…
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Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
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Gilead and Merus Form Strategic Oncology Alliance to Develop Trispecific T-Cell Engagers
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Gilead Sciences Inc., (NASDAQ: GILD), has entered into a strategic partnership with Netherlands-based Merus N.V. (NASDAQ: MRUS) to discover two to three trispecific T-cell engagers in the field of oncology. Merus is set to receive an upfront payment of $56 million, an equity investment worth $25 million, and is eligible…
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J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
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The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
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FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen of Johnson & Johnson’s (J&J; NYSE: JNJ) bispecific T-cell engager (BiTE) Tecvayli (teclistamab). Tecvayli received accelerated approval in 2022 for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have undergone at…
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Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886, a…
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Amgen’s Q4 2023 Results Showcase 9% YOY Growth, 18 Drugs Hit Record Sales
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Biopharmaceutical giant Amgen (NASDAQ: AMGN) has reported its financial results for Q4 2023, announcing annual sales of USD 26.9 billion, reflecting a substantial 9% year-on-year (YOY) increase, primarily driven by volume growth. In an earnings call, CEO Robert Bradway highlighted that a remarkable 18 of the company’s medicines achieved record…
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Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
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Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
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Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…
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Roche Posts Modest 2023 Growth Amid Shifts in Demand for COVID-Related Products
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Swiss pharmaceutical giant Roche (SWX: ROG) has published its 2023 financial results, showing a modest 1% year-on-year (YOY) increase in global sales at constant exchange rates (CER) to CHF 58.7 billion (USD 68.5 billion). This growth was primarily due to a 6% YOY expansion in the pharmaceutical business to CHF…
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Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
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The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
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Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
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Harbour BioMed Gets FDA Green Light for Phase I Study of BsAb Targeting PD-L1 and CD40
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and anti-tumor…
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Chipscreen NewWay Biosciences Initiates Phase I Trial for PD-1/CD40 Bispecific Antibody Candidate NWY001
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China-based Chengdu Chipscreen NewWay Biosciences Co., Ltd has announced that the first patient has been dosed in a Phase I clinical trial for its investigational PD-1/CD40 bispecific antibody (BsAb) candidate, NWY001. The multi-center, non-random, open-label trial is conducted under the leadership of Sun Yat-Sen University Cancer Center, with objectives to…
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Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
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Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission of a new indication supplementary approval filing for its bispecific antibody (BsAb) drug candidate, cadonilimab (AK104). The company is seeking to expand the use of cadonilimab in combination with chemotherapy as a first-line treatment for…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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Elpiscience Partners with Astellas for Bi-Specific Macrophage Engager Research
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China-based Elpiscience Biopharmaceuticals has announced a research collaboration and licensing agreement with Japan’s Astellas Pharma Inc. (TYO: 4503), focusing on Elpiscience’s innovative bi-specific macrophage engager, ES019, along with another program. The partnership will involve joint early-stage research on these two initiatives, with Elpiscience granting Astellas the option to include up…
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Biocytogen and Lepu Biotechnology Develop WT1-Targeted Trispecific Antibody for Cancer Treatment
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd, (HKG: 2315) and Lepu Biotechnology Co., Ltd (HKG: 2157) have announced significant progress in the co-development of their trispecific T cell connector, having identified a WT1/HLA-A02 targeted T-cell connector, WT1×CD3×4-1BB trispecific antibody, as part of their collaboration initiated last year. Pre-clinical data for this product…
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J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
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The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Biocytogen Pharmaceuticals Inks Antibody Deal with Neurocrine Biosciences
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd, (HKG: 2315) has announced an antibody assessment and option agreement with US firm Neurocrine Biosciences Inc. The agreement grants Neurocrine access to Biocytogen’s fully human antibodies targeting multiple specified therapeutic areas, with an option to license selected antibodies for global development, manufacturing, and commercialization.…
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AbbVie and Genmab’s Epcoritamab Shows Promising Results in Follicular Lymphoma Study
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AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
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Amgen’s Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer Treatment
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The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision…
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BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
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Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific antibody (BsAb) BMS-986442 into a Phase II dose expansion trial. The candidate was licensed from Agenus (NASDAQ: AGEN) in 2021, and as part of the agreement, Agenus will receive a USD 25 million cash payment,…
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Roche’s Mosunetuzumab and AnHeart’s Taletrectinib Poised for Priority Review in China
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The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio (mosunetuzumab) and AnHeart Therapeutics’ taletrectinib are on track to receive priority review status. Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, has already been approved for the treatment of adult recurrent refractory follicular lymphoma (FL)…
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AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving…
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Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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BioNTech Secures Exclusive Rights to Biotheus Inc.’s BsAb PM8002 in Landmark Deal
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Germany’s BioNTech (NASDAQ: BNTX) has entered into an exclusive license and collaboration agreement with China-based Biotheus Inc., focusing on the development and commercialization of the bispecific antibody (BsAb) PM8002. The deal grants BioNTech development, manufacturing, and commercial rights to PM8002 in all markets outside of Greater China, marking a significant…
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BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
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The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
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Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
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US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
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Amgen Reports Q3 2023 Financials: 5% Growth Driven by Volume Expansion
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Amgen (NASDAQ: AMGN) has released its Q3 2023 financial results, showcasing a 5% year-on-year (YOY) increase in global sales, reaching USD 6.5 billion. This growth comes despite a 3% decrease in net selling price, primarily fueled by an impressive 11% increase in volume. Notably, this marks the company’s fourth consecutive…
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Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
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Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
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TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular…
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Roche Agrees to Acquire Telavant for $7.1 Billion to Boost IBD Treatment Portfolio
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) announced this week an agreement to purchase Telavant Holdings, a biotechnology firm co-owned by UK’s Roivant Sciences (NASDAQ: ROIV) and US-based Pfizer (NYSE: PFE). The acquisition will grant Roche rights to RVT-3101, a potential best-in-class and first-in-class anti-TL1A subcutaneous antibody, in the US and…
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Alphamab Oncology Presents Promising Data for KN046 and KN026 at ESMO 2023
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China-based Alphamab Oncology (HKG: 9966) has released data snapshots from clinical studies for two of its pipeline candidates, KN046 and KN026, at the European Society for Medical Oncology (ESMO) Congress 2023. These bispecific antibodies (BsAbs) are being evaluated for their efficacy and safety in treating various types of cancers, with…
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Qilu Pharmaceutical Presents Promising Data for QL1706 and QL1209 at ESMO 2023
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China-based Qilu Pharmaceutical has announced the presentation of clinical data for two of its pipeline candidates, QL1706 and QL1209, at the European Society for Medical Oncology (ESMO) Congress 2023. The data highlights the therapeutic potential of these drugs in treating various forms of cancer, showcasing Qilu’s commitment to innovation in…
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EpimAb Biotherapeutics Licenses Bispecific Antibody Platform to Almirall
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Shanghai-based EpimAb Biotherapeutics has entered into a strategic license agreement with Spanish pharmaceutical company Almirall for the development of bispecific antibodies (BsAbs) against up to three undisclosed target pairs. This partnership marks a significant step in leveraging EpimAb’s innovative Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate BsAbs, with Almirall securing exclusive…
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MSD Partners with Phanes Therapeutics for Innovative Cancer Combo Therapy
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Global pharmaceutical leader Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic partnership with US-based biotechnology firm Phanes Therapeutics to develop a novel combination therapy. The collaboration will see MSD’s anti-PD-1 blockbuster Keytruda (pembrolizumab) paired with Phanes’s first-in-class CD47×claudin 18.2 drug PT886, targeting claudin 18.2-positive gastric or gastroesophageal…
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Simcere’s SIM0237 Receives NMPA Approval for Bladder Cancer Trial
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China-based pharmaceutical innovator Simcere Pharmaceutical Group (HKG: 2096) has announced the receipt of an additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational bispecific antibody (BsAb), SIM0237. This molecule, targeting both PD-L1 and IL-15, is set to be evaluated as a novel treatment for non-muscular…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
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RemeGen and Akeso Biopharma Initiate Phase II Study for Gastric Cancer Combo Therapy
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China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric…
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EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
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Chime Biologics Partners with Panolos Bioscience to Speed Up Multi-Specific Protein Development
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China-based Contract Development and Manufacturing Organization (CDMO) Chime Biologics Ltd has announced a strategic cooperation with South Korean biotech firm Panolos Bioscience. The partnership aims to accelerate the development of multi-specific proteins, although no financial details have been disclosed. Focus on Multi-Specific TherapeuticsPanolos Bioscience is a biopharmaceutical company specializing in…
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Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
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Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received approval from China’s Center for Drug Evaluation to proceed with a clinical study in patients with advanced malignant solid tumors. This marks the sixth in-house developed BsAb from the Chinese firm to enter clinical development.…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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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…
