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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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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 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 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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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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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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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 (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 (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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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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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 (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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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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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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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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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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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 (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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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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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…