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Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
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Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
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The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for Two Cancer Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study of its Category 1 drug candidate, HS-20105, for the treatment of advanced solid tumors. This development marks a…
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MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
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AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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Biocytogen Pharmaceuticals Enters Agreement with Myricx Bio for ADC Development
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced an antibody evaluation, option, and license agreement with Myricx Bio, a UK biotech company specializing in the discovery and development of a novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs). These payloads are based on inhibitors of…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
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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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AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
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The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
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Takeda Secures Exclusive Rights to ImmunoGen’s Elahere in Japan Through New Agreement
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Japanese pharmaceutical company Takeda (TYO: 4502) has entered into an exclusive collaboration and license agreement with ImmunoGen (NASDAQ: IMGN) to develop and commercialize ImmunoGen’s antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) in Japan. Elahere has received accelerated approval in the United States for the treatment of FRα-positive platinum-resistant epithelial ovarian, fallopian…
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Harbour BioMed’s HBM9033 ADC Receives US FDA IND Clearance for Clinical Trials
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China-based Harbour BioMed (HKG: 2142) has announced receiving Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HBM9033. This ADC specifically targets human mesothelin (MSLN), a tumor-associated antigen that is upregulated in various solid tumors, including mesothelioma, ovarian, lung, breast,…
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Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its third-generation antibody drug conjugate (ADC), STRO-002, in advanced malignant solid tumors. STRO-002: A Third-Generation ADC Targeting FRαSTRO-002, originated by US firm Sutro Biopharma Inc.,…
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Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
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Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing an accidental disclosure of the second interim analysis from an ongoing Phase III study. The study involves the anti-TIGIT biologic tiragolumab, used with and without the PD-L1 inhibitor Tecentriq (atezolizumab), for patients with PD-L1-high locally…
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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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Amoy Diagnostics and AstraZeneca Expand Collaboration on Companion Diagnostic Development
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced a new cooperation agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN), focusing on the development of a companion diagnostic (CDx). This collaboration builds upon a global strategic master collaboration agreement that was first signed at the end of 2021.…
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Bio-Thera Solutions’ BAT8006 Shows Positive Phase I Results in Solid Tumor Treatment
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced positive Phase I clinical data for BAT8006 (Folate-Receptor-α-ADC) at the Bethune Obstetrics and Gynecology Forum in China. The study evaluated the safety and efficacy of the antibody-drug conjugate (ADC) in a dose escalation trial. BAT8006: A Promising ADC for Solid TumorsBAT8006 is…
