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Bristol Myers Squibb Invests in UK Immuno-Oncology Firm NeoPhore’s Series B Extension Round
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Bristol Myers Squibb (BMS; NYSE: BMY) has participated in an oversubscribed Series B extension round for NeoPhore, a UK-based immuno-oncology company. The funds will be utilized by NeoPhore to advance its pre-clinical studies, with the goal of delivering a small-molecule candidate by 2025. The specific amount invested by BMS was…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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Eli Lilly Partners with Aktis Oncology to Advance Cancer Radiopharmaceuticals
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Eli Lilly and Company (NYSE: LLY) has announced a strategic partnership with Aktis Oncology, a US-based developer of anticancer radiopharmaceuticals, to co-develop first-in-class treatments for solid tumors and diagnostic products. Under the terms of the agreement, Aktis is set to receive an upfront payment of USD 60 million, a significant…
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MSD Partners with Dragonfly Therapeutics to Combine Keytruda with NK Cell Engager in Cancer Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK), the producer of the leading checkpoint inhibitor Keytruda (pembrolizumab), has entered into a collaborative agreement with Dragonfly Therapeutics for the combination therapy of Keytruda and Dragonfly’s tri-specific natural killer (NK) cell engager, DF9001. The partnership aims to explore treatment options for advanced solid…
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Alvotech and Dr. Reddy’s Partner to Challenge Amgen’s Denosumab with Biosimilar AVT03
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Amgen’s (NASDAQ: AMGN) dominance in the bone treatment market with its blockbuster drugs Xgeva and Prolia (denosumab) may face a new challenge as Alvotech (NASDAQ: ALVO), an Iceland-based biopharmaceutical company, has licensed its biosimilar candidate AVT03 to India’s Dr. Reddy’s Laboratories (NYSE: RDY) for the European and US markets. This…
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NK CellTech’s NK-Cell Therapy Gets Green Light from China’s NMPA for Solid Tumor Treatment
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NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
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Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
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Amoy Diagnostics Teams Up with Boehringer Ingelheim for CDx Developmen
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in China’s tumor precision medicine space, has entered into a strategic collaboration with Germany’s Boehringer Ingelheim to advance the development of companion diagnostics (CDx). The partnership is aimed at identifying non-small cell lung cancer (NSCLC) patients who are most likely…
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Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
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Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
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Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
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Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its New Drug Application (NDA) for glecirasib has been accepted by China’s National Medical Products Administration (NMPA) with priority review status. The KRAS G12C inhibitor is being reviewed for its potential as a treatment for second-line…
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Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone with its novel small-molecule chemical drug FCN-159, as indicated on the Center for Drug Evaluation’s (CDE) website. The drug has been granted priority review status for the treatment of plexiform neurofibroma (PN) in children aged…
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Jiayue Pharmaceutical’s JYP0015 Secures $365 Million Licensing Agreement with Erasca
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Guangzhou Jiayue Pharmaceutical Technology Co., Ltd, a Chinese pharmaceutical company, has entered into a licensing agreement with Erasca (NASDAQ: ERAS), a US-based biopharmaceutical company. Under the terms of this agreement, Erasca has been granted exclusive rights to research, develop, and commercialize Jiayue Pharma’s pan-RAS (ON) inhibitor, JYP0015, excluding China mainland,…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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Shanghai UniCAR-Therapy’s Innovative CAR-T Therapy Targets Breakthrough Designation with IL-6 Silencing
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Shanghai UniCAR-Therapy Bio-Medicine Technology Co., Ltd, a leading biopharmaceutical company based in China, is on track to secure breakthrough therapy designation (BTD) for its innovative autologous CD19 targeted chimeric antigen receptor (CAR) T-cell therapy. This therapy features a unique function of silencing interleukin-6 (IL-6) expression and is intended for the…
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Bayer’s 225Ac-PSMA-Trillium Therapy Begins Early-Stage Clinical Trial for mCRPC
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Bayer AG (ETR: BAYN), a multinational pharmaceutical company based in Germany, has this week commenced an early-stage trial for its targeted radionuclide therapy, 225Ac-PSMA-Trillium. The trial is focused on treating advanced metastatic castration-resistant prostate cancer (mCRPC). This innovative therapeutic candidate incorporates a PSMA-targeting small molecule designed to deliver an alpha…
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Merck KGaA Subsidiary Teams Up with Aulos Bioscience to Test PD-L1 and Anti-IL-2 Combination
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Germany’s Merck KGaA (ETR: MRK) has announced that its Switzerland-based subsidiary, Ares Trading, has entered into a partnership with US-based Aulos Bioscience. This collaboration aims to advance the clinical development of Merck’s anti-PD-L1 drug Bavencio (avelumab) in combination with Aulos’s anti-IL-2 antibody candidate, AU-007. The financial details of the agreement…
