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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
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The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China. Blenrep: An Antibody-Drug Conjugate for Multiple MyelomaBlenrep is an innovative antibody drug conjugate (ADC) that…
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Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
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Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
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Seagen Inc. Acquires Global Rights to HBM9033 ADC in Deal with Nona Biosciences and Medilink Therapeutics
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Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), and Suzhou-based Medilink Therapeutics have jointly announced the licensing of their co-developed antibody-drug conjugate (ADC), HBM9033 (YL215), to Pfizer Inc.’s (NYSE: PFE) unit Seagen Inc. (NASDAQ: SGEN). According to the agreement, Seagen will secure global clinical development and commercialization rights…
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Pfizer’s $43 Billion Seagen Acquisition Closes Amid Lackluster 2024 Forecast
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Pfizer Inc. (NYSE: PFE) has secured all necessary regulatory approvals to finalize its $43 billion acquisition of antibody-drug conjugate (ADC) specialist Seagen Inc. (NASDAQ: SGEN), with the deal set to close today. The US pharmaceutical giant had to make concessions to address the US Federal Trade Commission’s (FTC) concerns over…
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Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
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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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Seagen and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
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Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has announced an update on an ongoing Phase III oncology study involving a combination therapy that includes the HER2 inhibitor Tukysa (tucatinib), one of Seagen’s four marketed drugs that attracted Pfizer’s interest. The trial successfully met…
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Gracell Secures Non-Exclusive License for Cell Therapies from Seagen
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China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) has secured a non-exclusive worldwide license to develop and commercialize up to five cell therapy products from US biotech company Seagen Inc (ETR: PFE). The agreement was finalized on March 8, 2023, just days before Pfizer announced its intention to acquire Seagen for USD…
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Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
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Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for the antibody drug conjugate (ADC) enfortumab vedotin, marketed under the brand name Padcev in the US. The filing…
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Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
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Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for the antibody drug conjugate (ADC) enfortumab vedotin, marketed as Padcev in the US. The filing seeks approval for…
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Zai Lab Licenses Seagen’s Tivdak for Greater China Development and Commercialization
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Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has formed a collaboration with US-based biotech Seagen Inc. (Nasdaq: SGEN) to license development and commercialization rights in Greater China (including mainland China, Hong Kong, Taiwan, and Macau) to Tivdak (tisotumab vedotin). This strategic partnership aims to bring this innovative antibody-drug…
