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AstraZeneca plc (LON: AZN, Nasdaq: AZN), a UK-based pharmaceutical and biopharmaceutical company, is reportedly launching an innovation program in South Korea aimed at fostering innovative collaborations and facilitating entry into the Chinese market. The company is currently accepting applications for the program until October 11, with the AZ K-Bio Expressway…
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Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
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HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product RunFlow, a heart valve balloon dilation catheter. Designed for autologous valve dilation of the aorta during artificial aortic…
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Hangzhou AimingMed Technologies Co., Ltd., a leading organoid specialist based in China, has entered into a strategic partnership with RekeyMed Technology Co., Ltd, a company focused on regenerative medicine biomaterials. The collaboration aims to leverage the complementary strengths of both entities to foster the integration and innovative application of modern…
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505), a leading biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its hemoporfin photo-dynamic therapy (PDT) in the United States. The study is focused on treating port wine stain (PWS),…
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that its marketing application for HSK21542, a Category 1 drug, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of moderate to severe itching associated with…
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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The Hainan Medical Products Administration has granted marketing approval to a heart-lung walking test data analysis software following a priority review process. This digital therapy product, classified as a Category II medical device, is designed to assist healthcare professionals in evaluating patients’ exercise cardiopulmonary function, excluding automatic diagnosis. The approval…
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Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its investigational gene therapy, FT-002. This recombinant adeno-associated virus (rAAV) gene therapy candidate marks a significant milestone as the…
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Longbio Pharma, a biopharmaceutical company specializing in biomacromolecule drug development and based in Shanghai, China, has reportedly secured nearly RMB 100 million in a Series B2 financing round. The round was led by Qiming Venture Partners, with the funds earmarked to accelerate the clinical trials of its core programs in…
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Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460), a leading pharmaceutical company in China, has released its financial report for the first half of 2024, highlighting a strategic pivot towards medical aesthetics and biopharmaceuticals. The company’s “medical aesthetics + innovative drug” dual-driven strategy has been instrumental in this transformation. For the…
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has reported Phase IIa trial results for monlunabant, an oral small-molecule cannabinoid receptor 1 (CB1) inverse agonist being developed for the treatment of obesity. The trial data, which showed statistically significant weight loss across all tested doses compared to placebo, did not…
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Yuhan, a South Korean pharmaceutical company, and its partner Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), have reportedly decided to halt the development of a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC). This strategic…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…