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Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
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The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
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Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its novel small-molecule FGFR4 inhibitor, irpagratinib. The designation is in recognition of the drug’s potential in treating hepatocellular carcinoma (HCC). Irpagratinib, an FGFR4 inhibitor originally discovered…
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MSD Partners with Hanmi Pharmaceutical to Develop Combination Therapy for Solid Tumors
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with South Korea’s Hanmi Pharmaceutical (KRX: 128940) to develop a combination therapy using MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) and Hanmi’s bispecific antibody (BsAb) BH3120 for the treatment of progressive or metastatic solid tumors. The financial details of the…
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Novartis Reports 11% YOY Sales Growth in Q1 2024, Led by Entresto and Cosentyx
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has reported an 11% year-on-year (YOY) increase in constant currency terms during the first quarter of 2024, reaching USD 11.8 billion in sales. The growth was driven by strong performances across all key brands and geographies. The top-selling and growth-driving drugs included hypertension therapy…
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BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
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Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
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China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
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CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
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GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
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MSD Strikes Deal with GV20 Therapeutics to Test Anti-PD-1 Combo in Solid Tumor Therapies
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a global healthcare leader, has entered into a strategic collaboration with GV20 Therapeutics, a biopharmaceutical company specializing in antibody therapeutics with operations in both China and the U.S. The partnership aims to combine GV20’s groundbreaking IGSF8-targeted biologic, GV20-0251, with MSD’s best-selling anti-PD-1 therapy,…
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Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
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Hengrui Pharmaceuticals Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company 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, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
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Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
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Impact Therapeutics Boosts War Chest with $55.2 Million Series D+ Round for Cancer Drugs
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Impact Therapeutics, a biopharmaceutical company based in China, has reportedly secured RMB 400 million (USD 55.2 million) in a Series D+ financing round. The round was co-led by GTJA Investment and KingRay Capital, a state-owned investor focused on small and micro enterprises. Additional participants in the financing round included Guojin…
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Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
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Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
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Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
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Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
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Shanghai Escugen and Anke Bio Partner to Develop ADC Products with EZWi-Fit Platform
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Shanghai Escugen, a biopharmaceutical company based in China, has entered into a licensing and cooperation agreement with Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009). Under the terms of the agreement, Escugen will grant Anke Bio the rights to its antibody-drug conjugate (ADC) technology platform, EZWi-Fit, for the development of…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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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). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
