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China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
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The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
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Shouyao Holdings Receives Clinical Trial Approval for SY-7166 in Treating Multiple Myeloma
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Shouyao Holdings (Beijing) Co., Ltd, a biopharmaceutical company headquartered in Beijing and listed on the Shanghai Stock Exchange (SHA: 688197), has announced that it has obtained clinical trial approval for its drug candidate SY-7166 for the treatment of multiple myeloma (MM) as a monotherapy. SY-7166 is a highly potent and…
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Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
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Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
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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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Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
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Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
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Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
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Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
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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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Henlius Biotech Secures Exclusive Rights to Commercialize Convalife’s Generic Neratinib in China and Abroad
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. Henlius has secured the exclusive commercialization rights for Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional licensing…
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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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Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China
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SHANGHAI—Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. The deal grants Henlius the exclusive commercialization rights to Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional…
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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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Sichuan Kelun Pharmaceutical’s H1 2024 Report Highlights MSD Collaboration Milestones
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CHENGDU—Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has released its financial report for the first half of 2024, detailing significant updates on its collaboration with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK). The partnership, focused on the co-development of antibody drug conjugates (ADCs), has seen substantial progress…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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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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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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Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
