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SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized,…
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ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Jincheng Pharmaceutical Group Co., Ltd. (SHE: 300233), has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for VGX-3100. This drug, hailed as the world’s first therapeutic vaccine for human papillomavirus (HPV), is…
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received the green light from the U.S. Food and Drug Administration (FDA) to commence a Phase I/IIa clinical study for its investigational new drug, JAB-23E73. This in-house developed pan-KRAS inhibitor has shown promise in simultaneously inhibiting both active and…
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Hybribio Limited (SHE: 300639), a Guangdong-based pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its chloroquine phosphate gel, a patented pharmaceutical preparation in China. The gel, designed for topical administration, is intended to reduce systemic exposure and is formulated…
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Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration (NMPA) in China has accepted its New Drug Application (NDA) for OT-502 (DEXYCU, dexamethasone implant). This ophthalmic new drug is designed to treat postoperative inflammation and is indicated for suppressing inflammation and related complications in…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received clinical trial approval from the National Medical Products Administration (NMPA) for its 18F-LNC1007 injection, a novel radioactive diagnostic drug. This drug is designed to target fibroblast activating protein (FAP) and integrin alpha-v beta-3, which are biomarkers…
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in China, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang, in combination with carboplatin and…
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At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN) presented updated data from the HIMALAYA Phase III trial, demonstrating sustained and clinically meaningful overall survival (OS) benefits for patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy and for whom…
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Aligos Therapeutics, a clinical-stage biopharmaceutical company focused on liver and viral diseases, has announced positive topline results from its Phase 2a HERALD study for ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH). The study, which is the first to demonstrate the benefits of…
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Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza…
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Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor…
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Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV). The vaccine’s approval follows a…
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China-based artificial intelligence (AI) drug developer Insilico Medicine has reported initial positive data from its Phase IIa study for ISM001-055, an in-house generative AI-generated drug candidate for idiopathic pulmonary fibrosis (IPF). The molecule, which targets TNIK (Traf2- and NCK- interacting kinase), has shown a positive safety profile and dose-dependent lung…
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its generic version of Allergan’s (NYSE: AGN) Lumigan (bimatoprost), a treatment for glaucoma. The product, marketed under the Chinese trade…
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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 accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
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Ocumension Therapeutics (HKG: 1477), a leading ophthalmology specialist in China, has announced that its histamine H1 receptor-targeted drug Zerviate (OT-1001) has been granted marketing approval in China with priority review status. The drug is indicated for the treatment of itching symptoms associated with allergic conjunctivitis. Zerviate, originally developed by the…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment…
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its interleukin-5 (IL-5)-targeted antibody, Fasenra (benralizumab), for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal disease. The approval comes on the…
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Global pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN, LON: AZN) has reported updated results from the Phase III LAURA study on its EGFR-tyrosine kinase inhibitor (EGFR-TKI), Tagrisso (osimertinib), at the 2024 European Society of Medical Oncology (ESMO) Congress. The study included data from the Chinese cohort, highlighting the drug’s efficacy in…
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China-based biotech company Keymed Biosciences Inc. (HKG: 2162) has reached a significant milestone with its drug candidate stapokibart, as it receives its first prescription in the country. This marks a pivotal step for the IL-4Rα monoclonal antibody (mAb), which is the first drug developed by a Chinese biotech to target…