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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes…
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has presented updated data from the SCORES study for its drug candidate suvemcitug at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Suvemcitug, also known as sevacizumab; APX-003; BD-0801, is being studied in platinum-resistant ovarian cancer. The…
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in Suzhou, has announced a wall poster presentation showcasing the latest data for its FAK/ALK/ROS1 inhibitor APG-2449 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study determined the recommended Phase II dosage (RP2D) of APG-2449 to be 1200…
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, presented updated data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting for its KRAS G12C inhibitor glecirasib (JAB-21822) in combination with an SHP2 inhibitor (JAB-3312) as a frontline treatment for non-small cell lung cancer (NSCLC) patients with…
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 Phase I Study:The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC),…
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Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for…
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). IMM01 is an SIRPαFc fusion protein that is being studied for use in combination with…
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical company in the U.S., has announced the launch of a new formula for Taltz (ixekizumab) in China, following its approval in the country in November of the previous year. The new formula of the IL-17A monoclonal antibody (mAb) is free from…
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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 drug candidates: HRS-5346 tablets and SHR-9539 injection. HRS-5346, a small molecule drug developed in-house, is…
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JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has presented new clinical data for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), at the European Alliance of Associations for Rheumatology (EULAR) 2024 annual meeting. The data was for adult patients in China with active…
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with…
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a pivotal Phase III clinical study. The multi-center, randomized, double-blinded, placebo-controlled trial is designed to evaluate the efficacy of QX005N, a monoclonal antibody (mAb) targeting IL-4Rα for the…
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Wanbangde New Building Materials Co., Ltd (SHE: 002082), a company operating in China, has announced that its drug candidate, huperzine A, has been granted an orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE). This designation is a significant…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II/III study for its Category 1 product candidate, jacktinib tablets. The study will focus on adolescent and adult patients suffering from non-segmental vitiligo.…