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BioNTech Seals Acquisition of China’s Biotheus for Up to $950M
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China’s Biotheus Inc. has entered into a definitive acquisition agreement with Germany-based BioNTech SE (NASDAQ: BNTX), marking a significant expansion of BioNTech’s operations in China. The deal underscores BioNTech’s commitment to enhancing its research and development capabilities and production capacity in the region. Deal Terms and FinancialsUnder the agreement, BioNTech…
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Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
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Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043…
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Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
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Duality Biotherapeutics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half…
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US FDA Approves Updated COVID-19 mRNA Vaccines from Pfizer/BioNTech and Moderna Ahead of Winter
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The U.S. Food and Drug Administration (FDA) has granted approval to two updated mRNA COVID-19 vaccines in anticipation of the winter season. Pfizer/BioNTech and Moderna have both received authorization for their vaccines, which are designed to address the KP.2 variant of the virus, a subset of the omicron strain. The…
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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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BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
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FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
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BioNTech Ends Collaboration with Genmab on Acasunlimab Development
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, has announced that its German partner BioNTech SE (NASDAQ: BNTX) has opted to discontinue their collaboration on the development of the bispecific antibody (BsAb) acasunlimab. Acasunlimab, which targets the programmed death-ligand 1 (PD-L1) and 4-1BB pathways, was under joint development with both…
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BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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China’s Triastek and Germany’s BioNTech Join Forces for 3D Printed Oral Therapeutics
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Triastek Inc., a China-based pharmaceutical company specializing in 3D printing technology, has entered into a strategic partnership with Germany’s BioNTech SE (NASDAQ: BNTX), a leading figure in the biopharmaceutical industry. This collaboration aims to leverage Triastek’s cutting-edge 3D drug printing capabilities to develop a breakthrough oral preparation designed to address…
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BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
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BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause…
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Medilink Therapeutics Partners with BioNTech to Develop ADC Products Using TMALIN Technology
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Medilink Therapeutics, based in Suzhou, has entered into another partnership agreement with German biotechnology company BioNTech SE (NASDAQ: BNTC). This collaboration allows BioNTech to utilize Medilink’s TMALIN ADC technology platform for the development of specific antibody drug conjugate (ADC) products. According to the terms of the deal, BioNTech will make…
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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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BioNTech Acquires Pre-Clinical Asset and ADC Technology from Portuguese Biotech CellmAbs
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Germany’s BioNTech (NASDAQ: BNTX) has licensed a pre-clinical antibody candidate and additional antibody-drug conjugate (ADC) technology from Portugal-based biotechnology company CellmAbs. The agreement marks Portugal’s first billion-dollar transaction in the life sciences sector. Under the terms, CellmAbs will receive undisclosed upfront and near-term payments, potential milestone payments reaching several hundred…
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WuXi Biologics Partners with BioNTech to Develop Next-Gen Antibodies in $20 Million Deal
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WuXi Biologics (HKG: 2269), a China-based Contract Research, Development, and Manufacturing Organization (CRDMO), has entered into a research service agreement with Germany’s BioNTech (NASDAQ: BNTX). As part of the collaboration, WuXi Bio will leverage its patented technology platform to develop antibodies targeting two undisclosed targets for BioNTech, aimed at advancing…
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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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Medilink Therapeutics Enters Global Licensing Agreement with BioNTech for HER3-Targeted Antibody Drug Conjugates
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Suzhou-based Medilink Therapeutics has announced a strategic cooperation and global licensing agreement with Germany-headquartered BioNTech SE (NASDAQ: BNTX). Under this partnership, the two companies will collaborate to develop next-generation antibody drug conjugates (ADCs) targeting the human epidermal growth factor receptor 3 (HER3). Leveraging TMALIN Technology for Enhanced Efficacy The ADC…
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Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children…
