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Hebei Changshan Biochemical’s Albenatide File for Type 2 Diabetes Accepted by China’s NMPA
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for albenatide (CJC‑1134‑PC) for review. The company is seeking initial approval for the drug as an adjunct to diet and exercise to improve blood glucose control…
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Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
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MicroPort MedBot Reports 384.2% YOY Revenue Increase in 2023, Driven by Robotic Surgical Devices
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced its financial results for 2023, reporting a substantial year-on-year (YOY) increase of 384.2%, with revenues reaching RMB 104.6 million (USD 14.43 million). The significant growth is attributed to the sales of its core products: the Toumai endoscopic surgery robot, SkyWalker…
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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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Hubei Province Issues Anti-Commercial Bribery Guidelines for Medical Industry
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The Hubei provincial market supervision administration has released a set of guidelines titled “Anti-Commercial Bribery Compliance Management” for medical industry enterprises within the province. The document is designed to guide pharmaceutical companies in developing a culture of compliance and fair competition, establishing robust anti-bribery management systems, and mitigating legal risks…
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Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or…
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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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Jenscare Scientific’s LuX-Valve Fails to Gain Approval from China’s CDME
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its transcatheter tricuspid valve replacement system, LuX-Valve, did not pass the approval review by China’s Center for Medical Device Evaluation (CDME). The LuX-Valve, which was granted innovative medical device status in China in 2019 and…
