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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. The study demonstrated the drug’s potential in treating psoriasis and other autoimmune diseases by inhibiting…
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China’s Ascletis Pharma Inc. (HKG: 1672) is navigating legal proceedings involving its oral thyroid hormone receptor-beta (THRβ) agonist ASC41 and a compound preparation ASC43F, both under development for the treatment of non-alcoholic steatohepatitis (NASH). US-based Viking Therapeutics (NASDAQ: VKTX) filed a lawsuit in the United States against Ascletis in December…
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. ICP-488 is a potent and selective TYK2 allosteric inhibitor that is being developed to treat…
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase (FASN) inhibitor co-developed with US partner Sagimet Biosciences Inc. (NASDAQ: SGMT), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The designation is for the treatment of patients with…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
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US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
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German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or…
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U.S. pharmaceutical giant Pfizer (NYSE: PFE) has decided to discontinue the development of sisunatovir, an antiviral drug for respiratory syncytial virus (RSV), following challenges including drug-drug interactions with antacids. The drug had reached the Phase II/III trial stage, and the decision will see two trials discontinued, according to Endpoints News.…
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Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the National Medical Products Administration (NMPA) for its drug Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) who have a superoxide dismutase 1 (SOD1) gene mutation. ALS is a rare disease,…
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received another market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres, now indicated for the treatment of endometriosis. Triptorelin microspheres are an in-house developed long-acting formulation administered via monthly intramuscular injection as…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
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Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
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China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
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The National Health Commission (NHC) of China, through its Center for Drug Evaluation (CDE), has announced that Pfizer (NSE: PFIZER, NYSE: PFE, ETR: PFE)’s Marstaximab (PF-06741086) has been included in the “Care Plan” for patient-centered rare disease drug development. The publicity period for this decision ends on October 12, 2024.…
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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Shanghai-based Unixell Biotechnology Co., Ltd. has announced that its Investigational New Drug (IND) application for “UX-DA001 Injection (Human Midbrain Dopaminergic Neuronal Precursor Cell Injection)” has been accepted by the Center for Drug Evaluation (CDE). The therapy, which aligns with the company’s inaugural pipeline, is speculated to target Parkinson’s disease. Founded…