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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the enrollment of the first patient in a Phase III clinical study for its PD-L1 monoclonal antibody (mAb), envafolimab. The randomized, controlled, double-blinded, multi-center trial will evaluate envafolimab in combination with chemotherapy as a neoadjuvant/adjuvant therapy for patients with resectable…
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Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets…
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AbelZeta Pharma Inc., a Sino-US biotechnology company with operations in Rockville, Maryland, and Shanghai, China, has announced an updated global collaboration and licensing agreement with Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ). According to the revised agreement, Janssen will now secure commercialization rights to CAR-T therapies C-CAR039…
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AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
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The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision…
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib,…
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Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
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Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy,…
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the…
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China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety…
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China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
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Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific antibody (BsAb) BMS-986442 into a Phase II dose expansion trial. The candidate was licensed from Agenus (NASDAQ: AGEN) in 2021, and as part of the agreement, Agenus will receive a USD 25 million cash payment,…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced a landmark licensing and cooperation agreement with US pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY). The agreement focuses on Biokin’s antibody-drug conjugate (ADC) candidate, BL-B01D1, which targets EGFR and HER3. The deal was conducted specifically between…
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
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Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for C-13-60 cell preparations as a local treatment in the abdominal cavity for CEA+ advanced malignant tumors, including a range of cancers such as colorectal, esophageal, gastric,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
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Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor Kisqali (ribociclib) in early breast cancer. Data from 78.3% of patients who completed treatment showed a significant reduction in the risk of recurrence, with 30% and 24.5% decreases for stage II and stage III tumors,…
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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
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Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, according to the China Center for Drug Evaluation (CDE) website. The application targets adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously undergone BTK inhibitor…