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China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric…
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 chemical drug, KC1036, for a pediatric indication. This development signifies a significant step forward in the exploration of new treatment options for pediatric cancer…
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Elpiscience Biopharmaceuticals, a China-based biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical trial in Australia for its pipeline candidate, ES009. This investigational drug is an anti-LILRB2 (ILT4) monoclonal antibody developed to target cancers, marking a significant step in the company’s oncology research…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
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BioTroy Therapeutics, a Shanghai-based developer of cancer immunotherapies, has announced the receipt of Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its innovative anti-tumor drug, BT02. This monoclonal antibody (mAb) targets solid tumors with a novel mechanism, representing a significant step forward in cancer…
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The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
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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 investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
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China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has received a notice from US-based AbbVie Global Enterprises Ltd, announcing the termination of their license and collaboration agreement concerning CD47 antibody compounds and products. The agreement, initially signed on September 3, 2020, and amended on August 15, 2022, will officially end on November…
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Amgen (NASDAQ: AMGN) has announced the launch of a new collaboration network that connects its oncology team with eight prominent research centers across Australia, Canada, France, Germany, South Korea, Spain, and the United States. This initiative is designed to accelerate the development of new cancer treatments for conditions with unmet…
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Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG), has announced a partnership with Belgium-based Orionis Biosciences to discover molecular glue-class small-molecule treatments in oncology and neurodegeneration. This strategic collaboration aims to leverage Orionis’s proprietary platform for high-throughput discovery, rational design, and optimization of candidates that modulate intermolecular interactions,…
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Abbott (NYSE: ABT) has announced the in-licensing of several biosimilar drugs from Spain-based biotechnology firm mAbxience for select markets in Latin America, Southeast Asia, the Middle East, and Africa. mAbxience, which had its majority stake acquired by German group Fresenius (ETR: FRE) from Argentina-based Insud Pharma last year, specializes in…
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German pharmaceutical company Merck (NYSE: MRK) has announced two separate strategic collaborations with UK-based artificial intelligence-driven precision drug design companies BenevolentAI (AMS: BAI) and Exscientia (NASDAQ: EXAI). These partnerships aim to discover potential first-in-class and best-in-class small-molecule therapies in the fields of oncology, neurology, and immunology. Terms of Collaboration and…
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…