-
Sichuan Kelun-Biotech Presents Positive Results for Sacituzumab Tirumotecan at AACR 2024
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
-
Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
-
Genmab Acquires Profound Bio for $1.8 Billion, Targeting Expanding ADC Pipeline
•
Denmark-based biotech Genmab A/S (NASDAQ: GMAB) has announced a significant all-cash acquisition of Sino-US biotech Profound Bio, targeting its antibody drug conjugate (ADC) pipeline in a deal valued at $1.8 billion, set to close in the first half of 2024. The agreement has received approval from the boards of both…
-
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
•
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
-
Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) BL-M07D1 in patients with advanced solid tumors. The trial will evaluate BL-M07D1 in combination…
-
Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
-
Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
•
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
-
Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
-
FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
•
This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
-
Biocytogen and ABL Bio Forge Partnership to Advance Bispecific ADC Development
•
China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315) has entered into a partnership with South Korea’s ABL Bio Inc. (KOSDAQ: 298380) to advance the development of bispecific antibody drug conjugates (ADCs). ABL Bio is a research-driven biotechnology firm recognized for its pioneering work in bispecific antibodies aimed at treating immuno-oncology…
-
Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
•
Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
-
Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
•
Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
-
CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody drug conjugate (ADC) SYS6023 in patients with advanced solid tumors. SYS6023 is designed to target specific receptors on tumor surfaces, allowing…
-
WuXi XDC Breaks Ground on State-of-the-Art Manufacturing Base in Singapore to Boost ADC Production
•
WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced plans to construct a new manufacturing base at the Tuas Biomedical Park in Singapore. This strategic expansion is designed to enhance the joint venture’s…
-
Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
•
The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug conjugate (ADC), TRS005, which targets CD20, is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory CD20-positive diffuse large B-cell lymphoma (DLBCL). The drug is being developed specifically for…
-
Hansoh Pharmaceutical Secures Global Rights to Biotheus’ BsAb HS-20117/PM1080
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading pharmaceutical company based in China, has announced a licensing agreement with domestic firm Biotheus. Under the terms of the agreement, Hansoh will secure exclusive global rights to develop, manufacture, and commercialize Biotheus’s bispecific antibody (BsAb) HS-20117/PM1080, along with sub-license rights. The…
-
Mabwell’s Nectin-4 Targeting ADC 9MW2821 Shows Promise in Cervical Cancer Clinical Study
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced positive results from a clinical study of its pipeline candidate, the antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data, highlighting the potential of 9MW2821 in treating cervical cancer, is set to be presented…
-
Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
•
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China. HLX42 is an innovative ADC…
-
Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its antibody drug conjugate (ADC) BL-M05D1, targeting locally advanced solid tumors. BL-M05D1 utilizes the same “linker+toxin” platform as BL-B01D1, an EGFR/HER3-targeted ADC that was the…
-
Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
•
Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
