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HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
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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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Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
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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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BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
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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 and Bristol Myers Squibb Ink USD 8.4 Billion Licensing Deal for ADC Candidate
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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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Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
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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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Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
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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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MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
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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 Reports Kisqali Success in Reducing Recurrence Risk in Early Breast Cancer
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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 and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
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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 Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
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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 Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
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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…
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Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
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Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough therapy designation (BTD) for its Bcr-Abl inhibitor, TGRX-678, according to the China Center for Drug Evaluation (CDE) website. This designation recognizes the molecule’s promising potential for treating accelerated chronic myeloid leukemia (CML-AP) in patients who…
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Shanghai Pharmaceuticals Gains NMPA Approval for WST04 Clinical Trials in Oncology
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral probiotic preparation, WST04, aimed at treating advanced malignant solid tumors. Preclinical studies indicate that WST04 significantly enhances the anti-tumor efficacy of…
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Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), based in China, has announced that its market approval filing for the programmed death-1 (PD-1) monoclonal antibody camrelizumab, in combination with multi-kinase inhibitor famitinib for recurrent or metastatic cervical cancer, has been accepted for review by the National Medical Products Administration (NMPA). This…
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Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
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Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R…
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AbbVie Partners with BigHat Biosciences to Develop Next-Gen Antibodies for Oncology and Neuroscience
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AbbVie (NYSE: ABBV) has enlisted the expertise of BigHat Biosciences, a US-based company specializing in machine learning and wet lab platforms, to discover and develop next-generation antibodies for multiple therapeutic targets in oncology and neuroscience. BigHat will receive an upfront payment of USD 30 million, with the potential for up…
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J&J Forecasts 5-7% CAGR Through 2030, Driven by Innovative Medicine and Device Growth
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Johnson & Johnson (J&J; NYSE: JNJ) has presented an update on its business strategy, pipeline, and financial outlook amidst the loss of exclusivity for its blockbuster immunosuppressant Stelara (ustekinumab) in the US. The company anticipates operational sales growth of 5% to 6% in 2024 and 3% or more in 2025,…
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China’s Betta Pharmaceuticals Advances CFT8919 for EGFR-Mutated NSCLC After NMPA Approval
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for CFT8919, a metamorphic BiDA degradation agent licensed from U.S. firm C4 Therapeutics, Inc. (NASDAQ: CCCC). The study will focus on…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
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Yantai Dongcheng Pharmaceutical Gets NMPA Green Light for FAP-Targeting Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to proceed with a clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets advanced solid tumors. The drug is designed to treat fibroblast activation protein (FAP)-positive…
